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Trump: No health insurance, no U.S. entry
Health insurance or the ability to pay for care soon will be a requirement for immigrants seeking U.S. visas, under a proclamation from President Trump.
Effective Nov. 3, 2019, visa applicants must demonstrate to immigration authorities that they can obtain coverage by an approved health insurer within 30 days of entering the United States or show evidence they possess the financial resources to pay for foreseeable medical costs. Approved coverage includes, but is not limited to, an employer-sponsored plan, an unsubsidized health plan offered in the individual market, a family member’s plan, or a visitor health insurance plan that provides coverage for at least 364 days, according to the proclamation.
President Trump said that the restriction protects Americans from bearing the burden of uncompensated health care costs generated by immigrants.
“While our health care system grapples with the challenges caused by uncompensated care, the United States government is making the problem worse by admitting thousands of aliens who have not demonstrated any ability to pay for their health care costs,” President Trump said in the proclamation. “Notably, data show that lawful immigrants are about three times more likely than United States citizens to lack health insurance. Immigrants who enter this country should not further saddle our health care system, and subsequently American taxpayers, with higher costs.”
The rule does not apply to refugees or asylum seekers, immigrants holding valid visas prior to Nov. 3, noncitizen children of U.S. citizens, unaccompanied minors, or permanent residents returning to the country after less than a year overseas.
The rule is the latest in a series of immigration restrictions by President Trump. Most recently in August 2019, the Trump administration amended the federal public charge rule, a longstanding policy that allows authorities to refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs.
The proclamation is consistent with the President’s recent public charge rule, and it is sound immigration policy, said Dale Wilcox, executive director and general counsel for the Immigration Reform Law Institute.
“If U.S. citizens are responsible for the health care costs of the world, then the world will show up at our doorstep for free health care,” Mr. Wilcox said in an interview. “That is unfair to American citizens and would financially devastate health care providers. The impact of this proclamation would be a more manageable immigration policy that welcomes immigrants who will contribute to our country as well as benefit from it.”
J. Wesley Boyd, MD, of the Center for Bioethics at Harvard University, Boston, said he was saddened to learn about the proclamation, adding that the Trump administration is relying on inaccurate information and falsified facts to justify the new restriction. Dr. Boyd, cofounder of the Human Rights and Asylum Clinic at Cambridge Health Alliance in Cambridge, Mass., coauthored a 2018 study finding that immigrants pay more into the U.S. health care system than they use.
That analysis, which examined 188 peer-reviewed studies related to immigrants and U.S. health care expenditures, found that per capita expenditures from private and public insurance sources were about 40% lower for immigrants, compared with native-born Americans. Expenditures for undocumented immigrants were even lower. Immigrants also made a greater contribution to Medicare’s trust fund than they withdrew, the study found (Int J Health Serv. 2018 Aug. 8 doi: 10.1177/0020731418791963).
Immigrants use less health care resources because they are generally younger and healthier than native-born Americans, and they are less likely to access health care services – regardless of health status, Dr. Boyd said in an interview. In addition, many immigrants who contribute to Medicare through payroll and/or taxes are no longer in the U.S. when they reach Medicare age.
“The Trump administration, in this case, is making yet another set of excuses for why they are trying to keep immigrants out of the country,” Dr. Boyd said. “The potential impact of this restriction is devastating. Obviously, the Trump administration is doing anything that it possibly can to try to limit immigrants from coming into our country and seeking a better life for themselves.”
The proclamation also could have a chilling effect on immigrants currently in the United States who are in need of medical treatment, Dr. Boyd noted.
“The real effect is you’re going to have immigrants who are already here, not [accessing] health care when they need it, for fear they somehow become known to the government,” he said.
Health insurance or the ability to pay for care soon will be a requirement for immigrants seeking U.S. visas, under a proclamation from President Trump.
Effective Nov. 3, 2019, visa applicants must demonstrate to immigration authorities that they can obtain coverage by an approved health insurer within 30 days of entering the United States or show evidence they possess the financial resources to pay for foreseeable medical costs. Approved coverage includes, but is not limited to, an employer-sponsored plan, an unsubsidized health plan offered in the individual market, a family member’s plan, or a visitor health insurance plan that provides coverage for at least 364 days, according to the proclamation.
President Trump said that the restriction protects Americans from bearing the burden of uncompensated health care costs generated by immigrants.
“While our health care system grapples with the challenges caused by uncompensated care, the United States government is making the problem worse by admitting thousands of aliens who have not demonstrated any ability to pay for their health care costs,” President Trump said in the proclamation. “Notably, data show that lawful immigrants are about three times more likely than United States citizens to lack health insurance. Immigrants who enter this country should not further saddle our health care system, and subsequently American taxpayers, with higher costs.”
The rule does not apply to refugees or asylum seekers, immigrants holding valid visas prior to Nov. 3, noncitizen children of U.S. citizens, unaccompanied minors, or permanent residents returning to the country after less than a year overseas.
The rule is the latest in a series of immigration restrictions by President Trump. Most recently in August 2019, the Trump administration amended the federal public charge rule, a longstanding policy that allows authorities to refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs.
The proclamation is consistent with the President’s recent public charge rule, and it is sound immigration policy, said Dale Wilcox, executive director and general counsel for the Immigration Reform Law Institute.
“If U.S. citizens are responsible for the health care costs of the world, then the world will show up at our doorstep for free health care,” Mr. Wilcox said in an interview. “That is unfair to American citizens and would financially devastate health care providers. The impact of this proclamation would be a more manageable immigration policy that welcomes immigrants who will contribute to our country as well as benefit from it.”
J. Wesley Boyd, MD, of the Center for Bioethics at Harvard University, Boston, said he was saddened to learn about the proclamation, adding that the Trump administration is relying on inaccurate information and falsified facts to justify the new restriction. Dr. Boyd, cofounder of the Human Rights and Asylum Clinic at Cambridge Health Alliance in Cambridge, Mass., coauthored a 2018 study finding that immigrants pay more into the U.S. health care system than they use.
That analysis, which examined 188 peer-reviewed studies related to immigrants and U.S. health care expenditures, found that per capita expenditures from private and public insurance sources were about 40% lower for immigrants, compared with native-born Americans. Expenditures for undocumented immigrants were even lower. Immigrants also made a greater contribution to Medicare’s trust fund than they withdrew, the study found (Int J Health Serv. 2018 Aug. 8 doi: 10.1177/0020731418791963).
Immigrants use less health care resources because they are generally younger and healthier than native-born Americans, and they are less likely to access health care services – regardless of health status, Dr. Boyd said in an interview. In addition, many immigrants who contribute to Medicare through payroll and/or taxes are no longer in the U.S. when they reach Medicare age.
“The Trump administration, in this case, is making yet another set of excuses for why they are trying to keep immigrants out of the country,” Dr. Boyd said. “The potential impact of this restriction is devastating. Obviously, the Trump administration is doing anything that it possibly can to try to limit immigrants from coming into our country and seeking a better life for themselves.”
The proclamation also could have a chilling effect on immigrants currently in the United States who are in need of medical treatment, Dr. Boyd noted.
“The real effect is you’re going to have immigrants who are already here, not [accessing] health care when they need it, for fear they somehow become known to the government,” he said.
Health insurance or the ability to pay for care soon will be a requirement for immigrants seeking U.S. visas, under a proclamation from President Trump.
Effective Nov. 3, 2019, visa applicants must demonstrate to immigration authorities that they can obtain coverage by an approved health insurer within 30 days of entering the United States or show evidence they possess the financial resources to pay for foreseeable medical costs. Approved coverage includes, but is not limited to, an employer-sponsored plan, an unsubsidized health plan offered in the individual market, a family member’s plan, or a visitor health insurance plan that provides coverage for at least 364 days, according to the proclamation.
President Trump said that the restriction protects Americans from bearing the burden of uncompensated health care costs generated by immigrants.
“While our health care system grapples with the challenges caused by uncompensated care, the United States government is making the problem worse by admitting thousands of aliens who have not demonstrated any ability to pay for their health care costs,” President Trump said in the proclamation. “Notably, data show that lawful immigrants are about three times more likely than United States citizens to lack health insurance. Immigrants who enter this country should not further saddle our health care system, and subsequently American taxpayers, with higher costs.”
The rule does not apply to refugees or asylum seekers, immigrants holding valid visas prior to Nov. 3, noncitizen children of U.S. citizens, unaccompanied minors, or permanent residents returning to the country after less than a year overseas.
The rule is the latest in a series of immigration restrictions by President Trump. Most recently in August 2019, the Trump administration amended the federal public charge rule, a longstanding policy that allows authorities to refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs.
The proclamation is consistent with the President’s recent public charge rule, and it is sound immigration policy, said Dale Wilcox, executive director and general counsel for the Immigration Reform Law Institute.
“If U.S. citizens are responsible for the health care costs of the world, then the world will show up at our doorstep for free health care,” Mr. Wilcox said in an interview. “That is unfair to American citizens and would financially devastate health care providers. The impact of this proclamation would be a more manageable immigration policy that welcomes immigrants who will contribute to our country as well as benefit from it.”
J. Wesley Boyd, MD, of the Center for Bioethics at Harvard University, Boston, said he was saddened to learn about the proclamation, adding that the Trump administration is relying on inaccurate information and falsified facts to justify the new restriction. Dr. Boyd, cofounder of the Human Rights and Asylum Clinic at Cambridge Health Alliance in Cambridge, Mass., coauthored a 2018 study finding that immigrants pay more into the U.S. health care system than they use.
That analysis, which examined 188 peer-reviewed studies related to immigrants and U.S. health care expenditures, found that per capita expenditures from private and public insurance sources were about 40% lower for immigrants, compared with native-born Americans. Expenditures for undocumented immigrants were even lower. Immigrants also made a greater contribution to Medicare’s trust fund than they withdrew, the study found (Int J Health Serv. 2018 Aug. 8 doi: 10.1177/0020731418791963).
Immigrants use less health care resources because they are generally younger and healthier than native-born Americans, and they are less likely to access health care services – regardless of health status, Dr. Boyd said in an interview. In addition, many immigrants who contribute to Medicare through payroll and/or taxes are no longer in the U.S. when they reach Medicare age.
“The Trump administration, in this case, is making yet another set of excuses for why they are trying to keep immigrants out of the country,” Dr. Boyd said. “The potential impact of this restriction is devastating. Obviously, the Trump administration is doing anything that it possibly can to try to limit immigrants from coming into our country and seeking a better life for themselves.”
The proclamation also could have a chilling effect on immigrants currently in the United States who are in need of medical treatment, Dr. Boyd noted.
“The real effect is you’re going to have immigrants who are already here, not [accessing] health care when they need it, for fear they somehow become known to the government,” he said.
Appeals court to hear prescription drug privacy rights case
An appeals court may soon decide whether federal authorities can access a patient’s medical records through a statewide prescription drug monitoring database without a warrant or if such searches infringe upon privacy rights.
On Oct. 10, the 1st U.S. Circuit Court of Appeals will hear arguments in U.S. Department of Justice v. Jonas, which centers on an investigatory subpoena issued by the U.S. Drug Enforcement Agency in 2018 that sought records about a certain patient from New Hampshire’s Prescription Drug Monitoring Program (PDMP). The subpoena’s recipient, PDMP program manager Michelle Ricco-Jonas, refused to comply, citing state law that prohibits law enforcement from accessing the database without a court order based on probable cause. Releasing PDMP records to authorities without cause violate patients’ privacy protections under the Fourth Amendment, Ms. Jonas and the New Hampshire Attorney General’s Office argued.
The U.S. Department of Justice sued to enforce the subpoena, contending that the DEA’s authority to investigate suspected criminal drug activity preempts New Hampshire’s law under the Supremacy Clause. In November 2018, U.S. Magistrate Judge Andrea K. Johnstone agreed with the DOJ and recommended the district judge grant the government’s motion to enforce the subpoena, a decision affirmed by the U.S. District Court for the District of New Hampshire in January 2019. The court ruled the government met its burden to satisfy the modest requirements for enforcement of the subpoena. Attorneys for New Hampshire appealed to the 1st Circuit.
The case is being closely watched by states, physician groups, pharmacies, and patient advocacy groups. In a joint court brief by the New Hampshire Medical Society and the American Civil Liberties Union, the organizations urged the appeals court to protect patient privacy by finding in favor of New Hampshire.
“The DEA has sought to enforce a subpoena that both injures Jonas and threatens to invade the Fourth Amendment privacy rights of individuals whose private medical information resides in the database, and whose privacy and confidentiality Jonas is statutorily charged with protecting. ... but who have no ability to challenge that impending harm,” the groups wrote in the brief. “The prescription records at issue in this case reveal intimate, private, and potentially stigmatizing details about patients’ health, including details of those patients’ underlying medical conditions. For that reason, as with other medical records, people have a reasonable expectation of privacy in them.”
Oregon’s PDMP faced a similar legal challenge in 2012. In that case, the DEA attempted to access the records of one patient and two prescribing physicians from Oregon’s prescription database. The state sued to prevent release of the records, and the ACLU intervened as a plaintiff on behalf of several unnamed patients and a doctor. A district court ruled in favor of the plaintiffs, finding that the DEA’s actions constituted a Fourth Amendment violation. However, the 9th U.S. Circuit Court in 2017 overturned the decision, ruling that federal law regarding administrative subpoenas trumps Oregon law. In addition, the appeals court ruled that the ACLU lacked standing to intervene and seek relief different from that sought by Oregon. By invalidating ACLU from the suit, the Fourth Amendment argument was never resolved by the 9th Circuit.
New Hampshire is one of 49 states that have Prescription Drug Monitoring Programs in addition to the District of Columbia. The programs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by physicians and pharmacies with the aim of reducing prescription drug abuse and diversion.
An appeals court may soon decide whether federal authorities can access a patient’s medical records through a statewide prescription drug monitoring database without a warrant or if such searches infringe upon privacy rights.
On Oct. 10, the 1st U.S. Circuit Court of Appeals will hear arguments in U.S. Department of Justice v. Jonas, which centers on an investigatory subpoena issued by the U.S. Drug Enforcement Agency in 2018 that sought records about a certain patient from New Hampshire’s Prescription Drug Monitoring Program (PDMP). The subpoena’s recipient, PDMP program manager Michelle Ricco-Jonas, refused to comply, citing state law that prohibits law enforcement from accessing the database without a court order based on probable cause. Releasing PDMP records to authorities without cause violate patients’ privacy protections under the Fourth Amendment, Ms. Jonas and the New Hampshire Attorney General’s Office argued.
The U.S. Department of Justice sued to enforce the subpoena, contending that the DEA’s authority to investigate suspected criminal drug activity preempts New Hampshire’s law under the Supremacy Clause. In November 2018, U.S. Magistrate Judge Andrea K. Johnstone agreed with the DOJ and recommended the district judge grant the government’s motion to enforce the subpoena, a decision affirmed by the U.S. District Court for the District of New Hampshire in January 2019. The court ruled the government met its burden to satisfy the modest requirements for enforcement of the subpoena. Attorneys for New Hampshire appealed to the 1st Circuit.
The case is being closely watched by states, physician groups, pharmacies, and patient advocacy groups. In a joint court brief by the New Hampshire Medical Society and the American Civil Liberties Union, the organizations urged the appeals court to protect patient privacy by finding in favor of New Hampshire.
“The DEA has sought to enforce a subpoena that both injures Jonas and threatens to invade the Fourth Amendment privacy rights of individuals whose private medical information resides in the database, and whose privacy and confidentiality Jonas is statutorily charged with protecting. ... but who have no ability to challenge that impending harm,” the groups wrote in the brief. “The prescription records at issue in this case reveal intimate, private, and potentially stigmatizing details about patients’ health, including details of those patients’ underlying medical conditions. For that reason, as with other medical records, people have a reasonable expectation of privacy in them.”
Oregon’s PDMP faced a similar legal challenge in 2012. In that case, the DEA attempted to access the records of one patient and two prescribing physicians from Oregon’s prescription database. The state sued to prevent release of the records, and the ACLU intervened as a plaintiff on behalf of several unnamed patients and a doctor. A district court ruled in favor of the plaintiffs, finding that the DEA’s actions constituted a Fourth Amendment violation. However, the 9th U.S. Circuit Court in 2017 overturned the decision, ruling that federal law regarding administrative subpoenas trumps Oregon law. In addition, the appeals court ruled that the ACLU lacked standing to intervene and seek relief different from that sought by Oregon. By invalidating ACLU from the suit, the Fourth Amendment argument was never resolved by the 9th Circuit.
New Hampshire is one of 49 states that have Prescription Drug Monitoring Programs in addition to the District of Columbia. The programs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by physicians and pharmacies with the aim of reducing prescription drug abuse and diversion.
An appeals court may soon decide whether federal authorities can access a patient’s medical records through a statewide prescription drug monitoring database without a warrant or if such searches infringe upon privacy rights.
On Oct. 10, the 1st U.S. Circuit Court of Appeals will hear arguments in U.S. Department of Justice v. Jonas, which centers on an investigatory subpoena issued by the U.S. Drug Enforcement Agency in 2018 that sought records about a certain patient from New Hampshire’s Prescription Drug Monitoring Program (PDMP). The subpoena’s recipient, PDMP program manager Michelle Ricco-Jonas, refused to comply, citing state law that prohibits law enforcement from accessing the database without a court order based on probable cause. Releasing PDMP records to authorities without cause violate patients’ privacy protections under the Fourth Amendment, Ms. Jonas and the New Hampshire Attorney General’s Office argued.
The U.S. Department of Justice sued to enforce the subpoena, contending that the DEA’s authority to investigate suspected criminal drug activity preempts New Hampshire’s law under the Supremacy Clause. In November 2018, U.S. Magistrate Judge Andrea K. Johnstone agreed with the DOJ and recommended the district judge grant the government’s motion to enforce the subpoena, a decision affirmed by the U.S. District Court for the District of New Hampshire in January 2019. The court ruled the government met its burden to satisfy the modest requirements for enforcement of the subpoena. Attorneys for New Hampshire appealed to the 1st Circuit.
The case is being closely watched by states, physician groups, pharmacies, and patient advocacy groups. In a joint court brief by the New Hampshire Medical Society and the American Civil Liberties Union, the organizations urged the appeals court to protect patient privacy by finding in favor of New Hampshire.
“The DEA has sought to enforce a subpoena that both injures Jonas and threatens to invade the Fourth Amendment privacy rights of individuals whose private medical information resides in the database, and whose privacy and confidentiality Jonas is statutorily charged with protecting. ... but who have no ability to challenge that impending harm,” the groups wrote in the brief. “The prescription records at issue in this case reveal intimate, private, and potentially stigmatizing details about patients’ health, including details of those patients’ underlying medical conditions. For that reason, as with other medical records, people have a reasonable expectation of privacy in them.”
Oregon’s PDMP faced a similar legal challenge in 2012. In that case, the DEA attempted to access the records of one patient and two prescribing physicians from Oregon’s prescription database. The state sued to prevent release of the records, and the ACLU intervened as a plaintiff on behalf of several unnamed patients and a doctor. A district court ruled in favor of the plaintiffs, finding that the DEA’s actions constituted a Fourth Amendment violation. However, the 9th U.S. Circuit Court in 2017 overturned the decision, ruling that federal law regarding administrative subpoenas trumps Oregon law. In addition, the appeals court ruled that the ACLU lacked standing to intervene and seek relief different from that sought by Oregon. By invalidating ACLU from the suit, the Fourth Amendment argument was never resolved by the 9th Circuit.
New Hampshire is one of 49 states that have Prescription Drug Monitoring Programs in addition to the District of Columbia. The programs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by physicians and pharmacies with the aim of reducing prescription drug abuse and diversion.
Judge rules for insurer in doctor’s allocation lawsuit
A judge has sided with a medical malpractice insurer in a legal challenge that accused the company of misallocating blame among physicians after a liability settlement.
In a Sept. 27 decision, Judge Debra Squires-Lee of the Commonwealth of Massachusetts Superior Court ruled that Medical Professional Mutual Insurance Company (ProMutual) acted reasonably when it settled a medical liability claim for $500,000 against several health providers and allocated responsibility for 30% of the settlement ($150,000) to internist Nataly Minkina, MD. ProMutual was well within its rights and obligations when it settled the underlying claim and did not act in bad faith when assigning responsibility in the case, Judge Squires-Lee wrote in her 49-page ruling.
“At its heart, this case is about a multiple defendant malpractice lawsuit with finger pointing by Dr. Minkina against her codefendants and others, and a disagreement about ProMutual’s ultimate determination about how to allocate a global settlement with the plaintiffs amongst ProMutual’s insureds,” Judge Squires-Lee wrote in the decision. “Dr. Minkina strongly believes that she did not fail [the patient], that she acted reasonably, and that her treatment of [the patient] satisfied the standard of care. She also questions why ProMutual failed to allocate liability in the [patient’s] suit to other physicians. However ... the question for this court is whether ProMutual committed unfair or deceptive acts or practices in its settlement and allocation of its settlement. I conclude that ProMutual did not.”
The case stems from a patient’s lawsuit against Dr. Minkina and several others at Blue Hills Medical Associates in Braintree, Mass. The patient alleged that the health care professionals were responsible for a missed breast cancer diagnosis. Dr. Minkina saw the patient just once in 2002 while covering for another doctor. During the visit, she confirmed some nodularity in the 55-year-old women’s breast and referred her for a mammogram and an ultrasound. A radiologist twice reported no abnormalities, which Dr. Minkina said she relayed to the patient. Dr. Minkina left the practice shortly after.
The patient visited the practice several more times and was referred for another mammogram in 2006, the results of which revealed some signs of malignancy, according to court documents. However, a nurse at the practice misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent magnetic resonance imaging of the brain and the breast, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.
ProMutual settled the case against the defendants for $500,000 in 2008, allocating 30% of the liability to Dr. Minkina, 10% of the nurse practitioner, 60% to the medical practice, and no liability to the other doctors named. ProMutual contended Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of causation factors and standard of care violations, namely that Dr. Minkina should have pursued a biopsy for the patient.
Dr. Minkina sued the insurer in 2012, claiming chiefly that the insurer allocated an unjustifiably high percentage of liability to her because she was no longer insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.
A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.
But Judge Squires-Lee ruled that trial evidence showed that ProMutual did not act for its own benefit or favor other insureds over Dr. Minkina. The judge wrote that the insurer satisfied its contractual and legal obligations when defending the underlying legal claim.
Dr. Minkina said she was disappointed with the ruling, but that she is considering her legal avenues.
“[The] judge’s decision in my case against ProMutual is obviously disappointing, but it is not the first time [the] trial court decided against me in this case,” Dr. Minkina said in an interview. “It is a battle between David and Goliath, [a] single physician against [a] $3.6 billion insurance company with unlimited resources. The decision has just been announced and it is voluminous. I am still reading it and evaluating my options with my attorneys, but it is not the end of the road yet.”
ProMutual declined to comment about the decision.
A judge has sided with a medical malpractice insurer in a legal challenge that accused the company of misallocating blame among physicians after a liability settlement.
In a Sept. 27 decision, Judge Debra Squires-Lee of the Commonwealth of Massachusetts Superior Court ruled that Medical Professional Mutual Insurance Company (ProMutual) acted reasonably when it settled a medical liability claim for $500,000 against several health providers and allocated responsibility for 30% of the settlement ($150,000) to internist Nataly Minkina, MD. ProMutual was well within its rights and obligations when it settled the underlying claim and did not act in bad faith when assigning responsibility in the case, Judge Squires-Lee wrote in her 49-page ruling.
“At its heart, this case is about a multiple defendant malpractice lawsuit with finger pointing by Dr. Minkina against her codefendants and others, and a disagreement about ProMutual’s ultimate determination about how to allocate a global settlement with the plaintiffs amongst ProMutual’s insureds,” Judge Squires-Lee wrote in the decision. “Dr. Minkina strongly believes that she did not fail [the patient], that she acted reasonably, and that her treatment of [the patient] satisfied the standard of care. She also questions why ProMutual failed to allocate liability in the [patient’s] suit to other physicians. However ... the question for this court is whether ProMutual committed unfair or deceptive acts or practices in its settlement and allocation of its settlement. I conclude that ProMutual did not.”
The case stems from a patient’s lawsuit against Dr. Minkina and several others at Blue Hills Medical Associates in Braintree, Mass. The patient alleged that the health care professionals were responsible for a missed breast cancer diagnosis. Dr. Minkina saw the patient just once in 2002 while covering for another doctor. During the visit, she confirmed some nodularity in the 55-year-old women’s breast and referred her for a mammogram and an ultrasound. A radiologist twice reported no abnormalities, which Dr. Minkina said she relayed to the patient. Dr. Minkina left the practice shortly after.
The patient visited the practice several more times and was referred for another mammogram in 2006, the results of which revealed some signs of malignancy, according to court documents. However, a nurse at the practice misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent magnetic resonance imaging of the brain and the breast, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.
ProMutual settled the case against the defendants for $500,000 in 2008, allocating 30% of the liability to Dr. Minkina, 10% of the nurse practitioner, 60% to the medical practice, and no liability to the other doctors named. ProMutual contended Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of causation factors and standard of care violations, namely that Dr. Minkina should have pursued a biopsy for the patient.
Dr. Minkina sued the insurer in 2012, claiming chiefly that the insurer allocated an unjustifiably high percentage of liability to her because she was no longer insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.
A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.
But Judge Squires-Lee ruled that trial evidence showed that ProMutual did not act for its own benefit or favor other insureds over Dr. Minkina. The judge wrote that the insurer satisfied its contractual and legal obligations when defending the underlying legal claim.
Dr. Minkina said she was disappointed with the ruling, but that she is considering her legal avenues.
“[The] judge’s decision in my case against ProMutual is obviously disappointing, but it is not the first time [the] trial court decided against me in this case,” Dr. Minkina said in an interview. “It is a battle between David and Goliath, [a] single physician against [a] $3.6 billion insurance company with unlimited resources. The decision has just been announced and it is voluminous. I am still reading it and evaluating my options with my attorneys, but it is not the end of the road yet.”
ProMutual declined to comment about the decision.
A judge has sided with a medical malpractice insurer in a legal challenge that accused the company of misallocating blame among physicians after a liability settlement.
In a Sept. 27 decision, Judge Debra Squires-Lee of the Commonwealth of Massachusetts Superior Court ruled that Medical Professional Mutual Insurance Company (ProMutual) acted reasonably when it settled a medical liability claim for $500,000 against several health providers and allocated responsibility for 30% of the settlement ($150,000) to internist Nataly Minkina, MD. ProMutual was well within its rights and obligations when it settled the underlying claim and did not act in bad faith when assigning responsibility in the case, Judge Squires-Lee wrote in her 49-page ruling.
“At its heart, this case is about a multiple defendant malpractice lawsuit with finger pointing by Dr. Minkina against her codefendants and others, and a disagreement about ProMutual’s ultimate determination about how to allocate a global settlement with the plaintiffs amongst ProMutual’s insureds,” Judge Squires-Lee wrote in the decision. “Dr. Minkina strongly believes that she did not fail [the patient], that she acted reasonably, and that her treatment of [the patient] satisfied the standard of care. She also questions why ProMutual failed to allocate liability in the [patient’s] suit to other physicians. However ... the question for this court is whether ProMutual committed unfair or deceptive acts or practices in its settlement and allocation of its settlement. I conclude that ProMutual did not.”
The case stems from a patient’s lawsuit against Dr. Minkina and several others at Blue Hills Medical Associates in Braintree, Mass. The patient alleged that the health care professionals were responsible for a missed breast cancer diagnosis. Dr. Minkina saw the patient just once in 2002 while covering for another doctor. During the visit, she confirmed some nodularity in the 55-year-old women’s breast and referred her for a mammogram and an ultrasound. A radiologist twice reported no abnormalities, which Dr. Minkina said she relayed to the patient. Dr. Minkina left the practice shortly after.
The patient visited the practice several more times and was referred for another mammogram in 2006, the results of which revealed some signs of malignancy, according to court documents. However, a nurse at the practice misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent magnetic resonance imaging of the brain and the breast, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.
ProMutual settled the case against the defendants for $500,000 in 2008, allocating 30% of the liability to Dr. Minkina, 10% of the nurse practitioner, 60% to the medical practice, and no liability to the other doctors named. ProMutual contended Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of causation factors and standard of care violations, namely that Dr. Minkina should have pursued a biopsy for the patient.
Dr. Minkina sued the insurer in 2012, claiming chiefly that the insurer allocated an unjustifiably high percentage of liability to her because she was no longer insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.
A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.
But Judge Squires-Lee ruled that trial evidence showed that ProMutual did not act for its own benefit or favor other insureds over Dr. Minkina. The judge wrote that the insurer satisfied its contractual and legal obligations when defending the underlying legal claim.
Dr. Minkina said she was disappointed with the ruling, but that she is considering her legal avenues.
“[The] judge’s decision in my case against ProMutual is obviously disappointing, but it is not the first time [the] trial court decided against me in this case,” Dr. Minkina said in an interview. “It is a battle between David and Goliath, [a] single physician against [a] $3.6 billion insurance company with unlimited resources. The decision has just been announced and it is voluminous. I am still reading it and evaluating my options with my attorneys, but it is not the end of the road yet.”
ProMutual declined to comment about the decision.
Clinician burnout can impact quality of care
Burnout among health care professionals has been associated with lower quality of care, but the effect may be smaller than it seems, based on data from a meta-analysis of more than 200,000 clinicians.
Previous studies have reported associations between burnout and lower quality of care, but a standardized approach to analyze bias in the studies is lacking, wrote Daniel S. Tawfik, MD, of Stanford (Calif.) University and colleagues.
In a study published in the Annals of Internal Medicine, the researchers identified 123 publications from 1994 to 2019 with 142 study populations that included 241,553 health care providers.
Emotional exhaustion was the primary predictor for lower quality of care in 75 study populations, and overall burnout and depersonalization were the primary predictors for 56 and 11 study populations, respectively.
In an analysis of 114 unique burnout-quality combinations, 58 showed effects of burnout related to poor-quality care, 6 showed burnout related to high-quality care, and 50 showed no significant effect. Approximately one-third (33%) of the burnout-quality combinations were reported at least three times. In a review of the 46 burnout-quality combinations with primary effect sizes, 24 showed a significant effect of burnout on poor quality of care, 1 showed a significant effect of burnout on high quality of care, and 21 showed no significant effect.
The researchers also tested study bias using the Ioannidis test and found “an excess of observed versus predicted statistically significant studies (73% observed vs. 62%).”
The findings were limited by several factors, including the use of many cross-sectional, observational studies that could not show causality, the researchers noted. However, the results suggest several implications for future research including the need to consider exaggerated effects and reduce bias.
“Although the effect sizes in the published literature are modestly strong, our finding of excess significance implies that the true magnitude may be smaller than reported, and the studies that attempted to lower the risk of bias demonstrate fewer significant associations than the full evidence base,” the researchers noted.
“Whether curtailing burnout improves quality of care, or whether improving quality of care reduces burnout, is not yet known, and adequately powered and designed randomized trials will be indispensable in answering these questions,” they concluded.
The study was supported by the Stanford Maternal and Child Health Research Institute. Dr. Tawfik disclosed grants from Stanford Maternal and Child Health Research Institute during the study period.
SOURCE: Tawfik DS et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1152.
The current meta-analysis is consistent with previous research, but offers nothing new on the relationship between clinician burnout and quality of care, wrote Carolyn S. Dewa, MPH, PhD, Karen Nieuwenhuijsen, PhD, and Jeffrey S. Hoch, PhD, in an accompanying editorial.
Some of the concerns they expressed included variability in the methods used to measure provider burnout, as well as variability in measuring and defining medical error. They suggested that the researchers could have conducted a subgroup analysis based on error definition. “Such analyses might shed light on the types of errors associated with burnout and suggest directions for the design of robust psychometric studies about the error metrics,” they wrote.
The editorialists also expressed concerns about the heterogeneity of the studies included in the review and the potential for confounding. Finally, they noted that the use of observational studies in a meta-analysis can be challenging because “the assessment of observational studies is not straightforward.” They added that knowing the limitations of the studies is important in allowing readers to be confident in the estimates from any meta-analyses.
“Considering the limitations of the available literature, prior reviews, and Tawfik and colleagues’ current meta-analysis, we conclude that higher burnout is associated with lower quality, but we are left without clear answers about the magnitude or clinical significance of the relationship,” they wrote (Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2760).
Dr. Dewa and Dr. Hoch are affiliated with the University of California, Davis. Dr. Nieuwenhuijsen is affiliated with the University of Amsterdam. The editorialists had no financial conflicts to disclose.
The current meta-analysis is consistent with previous research, but offers nothing new on the relationship between clinician burnout and quality of care, wrote Carolyn S. Dewa, MPH, PhD, Karen Nieuwenhuijsen, PhD, and Jeffrey S. Hoch, PhD, in an accompanying editorial.
Some of the concerns they expressed included variability in the methods used to measure provider burnout, as well as variability in measuring and defining medical error. They suggested that the researchers could have conducted a subgroup analysis based on error definition. “Such analyses might shed light on the types of errors associated with burnout and suggest directions for the design of robust psychometric studies about the error metrics,” they wrote.
The editorialists also expressed concerns about the heterogeneity of the studies included in the review and the potential for confounding. Finally, they noted that the use of observational studies in a meta-analysis can be challenging because “the assessment of observational studies is not straightforward.” They added that knowing the limitations of the studies is important in allowing readers to be confident in the estimates from any meta-analyses.
“Considering the limitations of the available literature, prior reviews, and Tawfik and colleagues’ current meta-analysis, we conclude that higher burnout is associated with lower quality, but we are left without clear answers about the magnitude or clinical significance of the relationship,” they wrote (Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2760).
Dr. Dewa and Dr. Hoch are affiliated with the University of California, Davis. Dr. Nieuwenhuijsen is affiliated with the University of Amsterdam. The editorialists had no financial conflicts to disclose.
The current meta-analysis is consistent with previous research, but offers nothing new on the relationship between clinician burnout and quality of care, wrote Carolyn S. Dewa, MPH, PhD, Karen Nieuwenhuijsen, PhD, and Jeffrey S. Hoch, PhD, in an accompanying editorial.
Some of the concerns they expressed included variability in the methods used to measure provider burnout, as well as variability in measuring and defining medical error. They suggested that the researchers could have conducted a subgroup analysis based on error definition. “Such analyses might shed light on the types of errors associated with burnout and suggest directions for the design of robust psychometric studies about the error metrics,” they wrote.
The editorialists also expressed concerns about the heterogeneity of the studies included in the review and the potential for confounding. Finally, they noted that the use of observational studies in a meta-analysis can be challenging because “the assessment of observational studies is not straightforward.” They added that knowing the limitations of the studies is important in allowing readers to be confident in the estimates from any meta-analyses.
“Considering the limitations of the available literature, prior reviews, and Tawfik and colleagues’ current meta-analysis, we conclude that higher burnout is associated with lower quality, but we are left without clear answers about the magnitude or clinical significance of the relationship,” they wrote (Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2760).
Dr. Dewa and Dr. Hoch are affiliated with the University of California, Davis. Dr. Nieuwenhuijsen is affiliated with the University of Amsterdam. The editorialists had no financial conflicts to disclose.
Burnout among health care professionals has been associated with lower quality of care, but the effect may be smaller than it seems, based on data from a meta-analysis of more than 200,000 clinicians.
Previous studies have reported associations between burnout and lower quality of care, but a standardized approach to analyze bias in the studies is lacking, wrote Daniel S. Tawfik, MD, of Stanford (Calif.) University and colleagues.
In a study published in the Annals of Internal Medicine, the researchers identified 123 publications from 1994 to 2019 with 142 study populations that included 241,553 health care providers.
Emotional exhaustion was the primary predictor for lower quality of care in 75 study populations, and overall burnout and depersonalization were the primary predictors for 56 and 11 study populations, respectively.
In an analysis of 114 unique burnout-quality combinations, 58 showed effects of burnout related to poor-quality care, 6 showed burnout related to high-quality care, and 50 showed no significant effect. Approximately one-third (33%) of the burnout-quality combinations were reported at least three times. In a review of the 46 burnout-quality combinations with primary effect sizes, 24 showed a significant effect of burnout on poor quality of care, 1 showed a significant effect of burnout on high quality of care, and 21 showed no significant effect.
The researchers also tested study bias using the Ioannidis test and found “an excess of observed versus predicted statistically significant studies (73% observed vs. 62%).”
The findings were limited by several factors, including the use of many cross-sectional, observational studies that could not show causality, the researchers noted. However, the results suggest several implications for future research including the need to consider exaggerated effects and reduce bias.
“Although the effect sizes in the published literature are modestly strong, our finding of excess significance implies that the true magnitude may be smaller than reported, and the studies that attempted to lower the risk of bias demonstrate fewer significant associations than the full evidence base,” the researchers noted.
“Whether curtailing burnout improves quality of care, or whether improving quality of care reduces burnout, is not yet known, and adequately powered and designed randomized trials will be indispensable in answering these questions,” they concluded.
The study was supported by the Stanford Maternal and Child Health Research Institute. Dr. Tawfik disclosed grants from Stanford Maternal and Child Health Research Institute during the study period.
SOURCE: Tawfik DS et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1152.
Burnout among health care professionals has been associated with lower quality of care, but the effect may be smaller than it seems, based on data from a meta-analysis of more than 200,000 clinicians.
Previous studies have reported associations between burnout and lower quality of care, but a standardized approach to analyze bias in the studies is lacking, wrote Daniel S. Tawfik, MD, of Stanford (Calif.) University and colleagues.
In a study published in the Annals of Internal Medicine, the researchers identified 123 publications from 1994 to 2019 with 142 study populations that included 241,553 health care providers.
Emotional exhaustion was the primary predictor for lower quality of care in 75 study populations, and overall burnout and depersonalization were the primary predictors for 56 and 11 study populations, respectively.
In an analysis of 114 unique burnout-quality combinations, 58 showed effects of burnout related to poor-quality care, 6 showed burnout related to high-quality care, and 50 showed no significant effect. Approximately one-third (33%) of the burnout-quality combinations were reported at least three times. In a review of the 46 burnout-quality combinations with primary effect sizes, 24 showed a significant effect of burnout on poor quality of care, 1 showed a significant effect of burnout on high quality of care, and 21 showed no significant effect.
The researchers also tested study bias using the Ioannidis test and found “an excess of observed versus predicted statistically significant studies (73% observed vs. 62%).”
The findings were limited by several factors, including the use of many cross-sectional, observational studies that could not show causality, the researchers noted. However, the results suggest several implications for future research including the need to consider exaggerated effects and reduce bias.
“Although the effect sizes in the published literature are modestly strong, our finding of excess significance implies that the true magnitude may be smaller than reported, and the studies that attempted to lower the risk of bias demonstrate fewer significant associations than the full evidence base,” the researchers noted.
“Whether curtailing burnout improves quality of care, or whether improving quality of care reduces burnout, is not yet known, and adequately powered and designed randomized trials will be indispensable in answering these questions,” they concluded.
The study was supported by the Stanford Maternal and Child Health Research Institute. Dr. Tawfik disclosed grants from Stanford Maternal and Child Health Research Institute during the study period.
SOURCE: Tawfik DS et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1152.
FROM THE ANNALS OF INTERNAL MEDICINE
Hypoxia-related discoveries net Nobel Prize
Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”
William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.
Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.
Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.
Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.
Dr. Semenza also discovered a protein complex, hypoxia-inducible factor (HIF), that binds to the identified DNA segments in an oxygen-dependent manner. Additional investigation revealed that HIF consists of two transcription factors, HIF-1a and ARNT.
Several research groups found that HIF-1a is protected from degradation in hypoxia. In low-oxygen conditions, the amount of HIF-1a increases so it can bind to and regulate EPO and other genes with HIF-binding DNA segments. However, at normal oxygen levels, ubiquitin is added to HIF-1a, tagging it for degradation in the proteasome. It wasn’t clear how ubiquitin binds to HIF-1a in an oxygen-dependent manner, but Dr. Kaelin’s work provided some insight.
Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.
Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.
Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.
Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.
This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.
“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”
Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”
William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.
Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.
Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.
Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.
Dr. Semenza also discovered a protein complex, hypoxia-inducible factor (HIF), that binds to the identified DNA segments in an oxygen-dependent manner. Additional investigation revealed that HIF consists of two transcription factors, HIF-1a and ARNT.
Several research groups found that HIF-1a is protected from degradation in hypoxia. In low-oxygen conditions, the amount of HIF-1a increases so it can bind to and regulate EPO and other genes with HIF-binding DNA segments. However, at normal oxygen levels, ubiquitin is added to HIF-1a, tagging it for degradation in the proteasome. It wasn’t clear how ubiquitin binds to HIF-1a in an oxygen-dependent manner, but Dr. Kaelin’s work provided some insight.
Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.
Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.
Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.
Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.
This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.
“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”
Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”
William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.
Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.
Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.
Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.
Dr. Semenza also discovered a protein complex, hypoxia-inducible factor (HIF), that binds to the identified DNA segments in an oxygen-dependent manner. Additional investigation revealed that HIF consists of two transcription factors, HIF-1a and ARNT.
Several research groups found that HIF-1a is protected from degradation in hypoxia. In low-oxygen conditions, the amount of HIF-1a increases so it can bind to and regulate EPO and other genes with HIF-binding DNA segments. However, at normal oxygen levels, ubiquitin is added to HIF-1a, tagging it for degradation in the proteasome. It wasn’t clear how ubiquitin binds to HIF-1a in an oxygen-dependent manner, but Dr. Kaelin’s work provided some insight.
Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.
Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.
Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.
Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.
This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.
“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”
Small-practice neurologists still have a role to play
Another solo-practice neurologist and I were talking last week. He’s understandably worried about the local hospital starting construction on a new “neuroscience center” down the street from us. They have ambitious plans for it, which apparently don’t include those of us who’ve served the community for 20-30 years.
Whatever. I’ve been in a large practice before, and don’t want to be a part of one again.
His concern, which I have, too, is that the hospital center will drive us little guys out of business. This seems to be a common medical practice model these days.
I hope not. I’ve been doing this for a long time, and am happy with my little world. I also believe, perhaps naively, that there’s still a place for a small practice.
My staff and I know my patients. We’re generally tuned in to who needs what, or how much time. We return all calls within a few hours (or less) and try be on top of getting medication refills and records requests done the same day they come in.
While a large practice has some advantages, based on my time with one I’d have to say we didn’t do those things as well there. Messages often weren’t relayed, or were sent to the wrong doctor. Here there’s only me.
I may not make as much, but my appointment times and intervals aren’t dictated by an accountant. This allows me to generally spend as much time as needed with each person and not feel rushed as the day goes on. I hope patients still desire that in a physician, as opposed to a place advertising “20 neurologists, no waiting!” on a sign that would fit in on the Vegas strip.
Obviously, I can’t control what the hospital will do. I can only manage my own little world. I’ll continue doing that as best I can, as long as I’m able.
Time spent worrying about things I can’t change isn’t productive and is bad for one’s blood pressure. So I’ll focus on what I can do, and try not to worry about the rest.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Another solo-practice neurologist and I were talking last week. He’s understandably worried about the local hospital starting construction on a new “neuroscience center” down the street from us. They have ambitious plans for it, which apparently don’t include those of us who’ve served the community for 20-30 years.
Whatever. I’ve been in a large practice before, and don’t want to be a part of one again.
His concern, which I have, too, is that the hospital center will drive us little guys out of business. This seems to be a common medical practice model these days.
I hope not. I’ve been doing this for a long time, and am happy with my little world. I also believe, perhaps naively, that there’s still a place for a small practice.
My staff and I know my patients. We’re generally tuned in to who needs what, or how much time. We return all calls within a few hours (or less) and try be on top of getting medication refills and records requests done the same day they come in.
While a large practice has some advantages, based on my time with one I’d have to say we didn’t do those things as well there. Messages often weren’t relayed, or were sent to the wrong doctor. Here there’s only me.
I may not make as much, but my appointment times and intervals aren’t dictated by an accountant. This allows me to generally spend as much time as needed with each person and not feel rushed as the day goes on. I hope patients still desire that in a physician, as opposed to a place advertising “20 neurologists, no waiting!” on a sign that would fit in on the Vegas strip.
Obviously, I can’t control what the hospital will do. I can only manage my own little world. I’ll continue doing that as best I can, as long as I’m able.
Time spent worrying about things I can’t change isn’t productive and is bad for one’s blood pressure. So I’ll focus on what I can do, and try not to worry about the rest.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Another solo-practice neurologist and I were talking last week. He’s understandably worried about the local hospital starting construction on a new “neuroscience center” down the street from us. They have ambitious plans for it, which apparently don’t include those of us who’ve served the community for 20-30 years.
Whatever. I’ve been in a large practice before, and don’t want to be a part of one again.
His concern, which I have, too, is that the hospital center will drive us little guys out of business. This seems to be a common medical practice model these days.
I hope not. I’ve been doing this for a long time, and am happy with my little world. I also believe, perhaps naively, that there’s still a place for a small practice.
My staff and I know my patients. We’re generally tuned in to who needs what, or how much time. We return all calls within a few hours (or less) and try be on top of getting medication refills and records requests done the same day they come in.
While a large practice has some advantages, based on my time with one I’d have to say we didn’t do those things as well there. Messages often weren’t relayed, or were sent to the wrong doctor. Here there’s only me.
I may not make as much, but my appointment times and intervals aren’t dictated by an accountant. This allows me to generally spend as much time as needed with each person and not feel rushed as the day goes on. I hope patients still desire that in a physician, as opposed to a place advertising “20 neurologists, no waiting!” on a sign that would fit in on the Vegas strip.
Obviously, I can’t control what the hospital will do. I can only manage my own little world. I’ll continue doing that as best I can, as long as I’m able.
Time spent worrying about things I can’t change isn’t productive and is bad for one’s blood pressure. So I’ll focus on what I can do, and try not to worry about the rest.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Cleveland Clinic taps Abraham as chair
Jame Abraham, MD, has been appointed chair of the hematology/medical oncology department at Cleveland Clinic in Ohio. In this new role, Dr. Abraham will “recruit and develop staff and guide the department’s focus on patient access and a multidisciplinary approach to care,” according to a statement.
Dr. Abraham is also director of the breast oncology program at Taussig Cancer Institute, codirector of the Cleveland Clinic comprehensive breast cancer program, and a professor of medicine at Cleveland Clinic Lerner College of Medicine. He takes the helm from hematologist Matt Kalaycio, MD. Dr. Kalaycio also serves as editor-in-chief of Hematology News.
In other news, Zhe Ying, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, has received a 5-year Pathway to Independence Award from the National Institute of Dental and Craniofacial Research.
With this award funding, Dr. Ying will investigate oncogene-induced differentiation in PI3K-mutant head and neck squamous cell carcinoma. Specifically, he aims to determine if genetic mutations and niche factors can overcome oncogene-induced differentiation to promote tumorigenesis.
Another grant winner is Gina Mantia-Smaldone, MD, of Fox Chase Cancer Center in Philadelphia. She will receive 3 years of funding from the Gynecologic Oncology Group Foundation and NRG Oncology to study gynecologic malignancies.
This award will also provide Dr. Mantia-Smaldone with research mentorship and opportunities to collaborate with other researchers. Her research is focused on developing targeted therapies for ovarian and endometrial cancers that will, ideally, improve patients’ quality of life.
Lastly, Edna (Eti) Cukierman, PhD, of Fox Chase Cancer Center, received a grant to conduct research with Ashani Weeraratna, PhD, of Johns Hopkins University in Baltimore, and Vivek Shenoy, PhD, and Arjun Raj, PhD, both of the University of Pennsylvania in Philadelphia.
The grant, from the National Cancer Institute, will be used to investigate the link between cell aging and melanoma. Dr. Cukierman, Dr. Weeraratna, Dr. Shenoy, and Dr. Raj will focus their research "on better understanding the deterioration of collagen integrity via cellular aging and its role in melanoma metastasis,” according to a statement.
Jame Abraham, MD, has been appointed chair of the hematology/medical oncology department at Cleveland Clinic in Ohio. In this new role, Dr. Abraham will “recruit and develop staff and guide the department’s focus on patient access and a multidisciplinary approach to care,” according to a statement.
Dr. Abraham is also director of the breast oncology program at Taussig Cancer Institute, codirector of the Cleveland Clinic comprehensive breast cancer program, and a professor of medicine at Cleveland Clinic Lerner College of Medicine. He takes the helm from hematologist Matt Kalaycio, MD. Dr. Kalaycio also serves as editor-in-chief of Hematology News.
In other news, Zhe Ying, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, has received a 5-year Pathway to Independence Award from the National Institute of Dental and Craniofacial Research.
With this award funding, Dr. Ying will investigate oncogene-induced differentiation in PI3K-mutant head and neck squamous cell carcinoma. Specifically, he aims to determine if genetic mutations and niche factors can overcome oncogene-induced differentiation to promote tumorigenesis.
Another grant winner is Gina Mantia-Smaldone, MD, of Fox Chase Cancer Center in Philadelphia. She will receive 3 years of funding from the Gynecologic Oncology Group Foundation and NRG Oncology to study gynecologic malignancies.
This award will also provide Dr. Mantia-Smaldone with research mentorship and opportunities to collaborate with other researchers. Her research is focused on developing targeted therapies for ovarian and endometrial cancers that will, ideally, improve patients’ quality of life.
Lastly, Edna (Eti) Cukierman, PhD, of Fox Chase Cancer Center, received a grant to conduct research with Ashani Weeraratna, PhD, of Johns Hopkins University in Baltimore, and Vivek Shenoy, PhD, and Arjun Raj, PhD, both of the University of Pennsylvania in Philadelphia.
The grant, from the National Cancer Institute, will be used to investigate the link between cell aging and melanoma. Dr. Cukierman, Dr. Weeraratna, Dr. Shenoy, and Dr. Raj will focus their research "on better understanding the deterioration of collagen integrity via cellular aging and its role in melanoma metastasis,” according to a statement.
Jame Abraham, MD, has been appointed chair of the hematology/medical oncology department at Cleveland Clinic in Ohio. In this new role, Dr. Abraham will “recruit and develop staff and guide the department’s focus on patient access and a multidisciplinary approach to care,” according to a statement.
Dr. Abraham is also director of the breast oncology program at Taussig Cancer Institute, codirector of the Cleveland Clinic comprehensive breast cancer program, and a professor of medicine at Cleveland Clinic Lerner College of Medicine. He takes the helm from hematologist Matt Kalaycio, MD. Dr. Kalaycio also serves as editor-in-chief of Hematology News.
In other news, Zhe Ying, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, has received a 5-year Pathway to Independence Award from the National Institute of Dental and Craniofacial Research.
With this award funding, Dr. Ying will investigate oncogene-induced differentiation in PI3K-mutant head and neck squamous cell carcinoma. Specifically, he aims to determine if genetic mutations and niche factors can overcome oncogene-induced differentiation to promote tumorigenesis.
Another grant winner is Gina Mantia-Smaldone, MD, of Fox Chase Cancer Center in Philadelphia. She will receive 3 years of funding from the Gynecologic Oncology Group Foundation and NRG Oncology to study gynecologic malignancies.
This award will also provide Dr. Mantia-Smaldone with research mentorship and opportunities to collaborate with other researchers. Her research is focused on developing targeted therapies for ovarian and endometrial cancers that will, ideally, improve patients’ quality of life.
Lastly, Edna (Eti) Cukierman, PhD, of Fox Chase Cancer Center, received a grant to conduct research with Ashani Weeraratna, PhD, of Johns Hopkins University in Baltimore, and Vivek Shenoy, PhD, and Arjun Raj, PhD, both of the University of Pennsylvania in Philadelphia.
The grant, from the National Cancer Institute, will be used to investigate the link between cell aging and melanoma. Dr. Cukierman, Dr. Weeraratna, Dr. Shenoy, and Dr. Raj will focus their research "on better understanding the deterioration of collagen integrity via cellular aging and its role in melanoma metastasis,” according to a statement.
Disclosure After Adverse Medical Outcomes: A Multidimensional Challenge
From The Communication in Healthcare Group, Seattle, WA.
Abstract
- Objective: To review established approaches to disclosure and resolution following adverse medical outcomes and highlight barriers that may hinder universal implementation of effective disclosure/resolution practices.
- Methods: An overview of established approaches to disclosure and resolution of adverse medical outcomes is presented.
- Results: Clinicians must be equipped to manage situations where adverse medical outcomes occur even though the care provided was reasonable, within the standard, as well as in situations where preventable problems in the care provided were likely the cause of patient harm. Established approaches that have proven useful for investigating, disclosing, and resolving situations, captured in the acronyms AIDR, ALEE, and TEAM, can assist clinicians in the disclosure and ultimate resolution of these 2 types of situations.
- Conclusion: Health care organizations with a solid commitment and a reliable structure for ensuring adherence to full disclosure and fair resolution of adverse outcomes have demonstrated sustainable progress in ethically and effectively resolving situations where patients are harmed by medical care.
Keywords: safety; medical error; adverse outcomes; resolution; communication.
Much has been learned over the 20 years since the Institute of Medicine’s (IOM) report To Err Is Human1 was published. At the time it was published, the IOM report made it clear that only a minority of preventable patient harms were being acknowledged, investigated, and reported. In the face of adverse outcomes “dissemble, deny, and defend” was a common strategy of many clinicians, institutions, and liability carriers.2 The health care system appeared to place a priority on protecting itself from reputational and financial harm over the rights of injured patients to be given an accurate understanding of what had happened in their care and to pursue restitution, if appropriate.3-5
The emerging quality improvement movement was accompanied by calls for increased patient advocacy. This included the goal of greater transparency and more timely and equitable resolutions with patients who have been harmed by problems in care. Health care systems pressed for confidentiality protections in exchange for increased focus on quality improvement.6 Applying medical ethics of autonomy, no-maleficence, beneficence, and justice initially took a backseat, as risk management was given priority.7 Insurance carriers have no ethical obligation, and a clear disincentive, to assure that harmed patients are fully informed and offered restitution. Some self-insured health systems, however, began experimenting with more proactive and transparent approaches to disclosure and resolution. In contrast to the often-reported fear of a liability explosion, they reported reduced claims and suits, shorter time to resolution, and reduced overall financial cost,8-10 providing some evidence that perhaps greater openness could work after all.
But for providers and staff to allow transparency and candor to become the norm, institutions needed to create a more “just culture” for managing errors. Individual impairment or willful disregard of safe practice would need to be handled differently from the slips and lapses that more often contributed to preventable harm.11 For example, the nurse who was inadequately oriented to the equipment on an unfamiliar unit where she was asked to work a double shift due to a staffing shortage should not be held as accountable as an employee who knowingly violated agreed upon safe practices, even though patient harm resulted in each situation. It became clear that patient harm was usually the result of multiple factors involving individuals, communication, procedures, systems, and equipment. Blaming and disciplining individuals at the sharp end would not reliably reduce adverse outcomes.
Since the 1999 IOM report, we have developed general agreement on best practices for investigating, disclosing, and resolving situations where patients are harmed by medical care.12,13 This article reviews the perspectives and practices that appear necessary for effective disclosure and resolution after an adverse outcome and highlights barriers to reliably enacting them in practice.
Elements of Effective Disclosure
Effective disclosure to patients and families hinges on determining and providing an accurate understanding of what happened in the patient’s care. It should be the care providers’ and their institution’s responsibility to determine causation and disclose it. This should not require only the most upset patients and families initiating a legal process taking 3 years or more to complete. The most consequential question must be answered, “Was the care provided reasonable?” That is, was everything done within the standard, as would have been expected by similarly trained clinicians with the information and resources available at that time? It follows that if care was reasonable, then the adverse outcome could not normally have been prevented, no correction in care processes is called for, and no financial compensation is required. If the care review reveals deficiencies in care that were linked to patient harm, then achieving a satisfying resolution would be more complex and difficult.13 First, individuals would have to accept that they have contributed to patient harm, itself an often-contentious process and psychologically devastating realization. Then they must have this difficult conversation with patient and family, creating liability risk for themselves in the process. They must commit to correcting the problems that contributed to the harm. They must facilitate, rather than obstruct, a path to a restitution that addresses the medical, practical, and financial harms that have resulted. Given the challenges inherent to disclosure and resolution, it is no wonder that dissembling, denying, and defending was the common practice for the preceding decades.14
Disclosure and Resolution Pathways
I was the co-developer of an approach to disclosure and resolution which is now widely accepted and that has been taught across the United States and Canada to more than 50,000 health care providers and administrators over 18 years.15,16 We learned that resolving adverse medical outcomes is a 4-part process (anticipate, investigate, disclose, resolve [AIDR]). Most adverse or simply disappointing outcomes occur despite reasonable care (eg, due to biological variability, the imprecision of the science and limitations and risks of the procedures). The minority of harms are associated with deficiencies in the care (ie, unreasonable care). We need to equip ourselves to manage both situations effectively. The approach we developed can be captured in 3 acronyms: AIDR, ALEE, and TEAM,
AIDR
This acronym encapsulates the overview guidance for clinicians after an adverse event or outcome, regardless of the cause.
Anticipate the thoughts and feelings of the harmed/disappointed patient and family and reach out immediately with an expression of sympathy.
Investigate sufficiently to address questions about most likely causation and do not conjecture prior to investigation. Ask for patience—“You deserve more than a guess”—and keep in regular contact to reinforce the promise that there will be a full reporting when the review is complete.
Disclose (in a planned and coordinated manner) what has been learned in the investigation.
Resolve the situation with the patient and family consistent with our ethical principles.
If our failure caused the harm (care unreasonable/breached the standard), then working toward a fair restitution and taking corrective actions are appropriate. If the care was found to have been reasonable, then compensation would not be offered and corrective action is unwarranted. The organization would defend reasonable care if a claim was still pursued.
This process involves ethical clarity, emotional intelligence, and discipline. Clinicians must first acknowledge that a disappointing outcome or event has occurred. Clinicians involved in the care, usually led by the attending provider, then immediately reach out to the patient and family with sympathy, a plan of care to address the medical issues, and the promise to investigate and follow-up with the patient and family when the harm and its causes are more clearly determined. To disclose simply means to provide an accurate understanding (ie, the understanding determined by the investigation we conducted) of what happened, its causes, and consequences. Depending on the extent of the harm and the complexity and time needed for the investigation, a “coach” or “disclosure coordinator” who has advanced training in managing these situations is brought in to guide the process. The disclosure coach/coordinator provides a consistent and steady hand throughout the process of investigation, disclosure, and ultimately resolution with patient and family. Patients and families often move across settings during the time of the AIDR process, and it is easy to lose track of them unless someone is following the entire process until resolved.
ALEE
When the investigation of an adverse/disappointing outcome determines the care was reasonable and therefore the adverse outcome could not have been prevented, we use the ALEE pathway to guide the disclosure conversation (Step 3 in AIDR) with the patient and family:
Anticipate. What are the questions, thoughts, and feelings we would expect the patient and family will have? On this track, there is nothing to apologize for since the care was reasonable, yet expressing compassion and sympathy for the patient’s experience is essential. “I/we really sympathize with how differently this has turned out than we had hoped.”
Listen. Invite and listen for their questions and concerns, how they are seeing the situation, and where and what they are finding most upsetting and in need of explanation.
Empathize. There are 2 kinds of empathy required here. Cognitive empathy means showing that we understand their thinking from their perspective, separate from whether we fully agree. Emotional empathy involves demonstrating that their emotions are understandable given the situation, even if those emotions are painful for clinicians to experience. Listening in step 2 is how we learned their perspective and emotions. Now we can show accurate empathy: I/we can understand how upsetting it is to be facing another set of procedures to treat the unfortunate complications from your last surgery.
Explain. Even when care is reasonable, questions and perhaps suspicions are to be expected. Listening and empathizing sets us up to focus our explanations on the patient’s and family’s key questions with a level of thoughtfulness and transparency that conveys credibility. We should not assume, however, that they have accepted our explanation. Instead, solicit their reactions and unresolved questions as part of the disclosure discussion. It is normal for additional concerns to emerge in the days after the disclosure discussion, and we should be ready to address these concerns until resolved. In some instances, the patient and family will not be satisfied and it may be helpful to offer an independent review of the care. If the unresolved patient and family engages an attorney, that will be the first step taken anyway. Proactively offering an independent review signals confidence in your objectivity and sensitivity to the importance of fairness for the patient and family: Your questions and concerns are completely normal in light of the disappointing experience you have had. Let me see if I/we can address those now to your satisfaction.
TEAM
If the investigation determines that aspects of the care were unreasonable (breached the standard) and the adverse outcome/harm was related to the deficiencies in the care, then we use the TEAM pathway to disclose and resolve the situation with the patient and family
Truthful and Transparent and Teamwork. We should be offering our most accurate understanding of how the adverse outcome occurred, with sufficient depth and clarity that the patient and family can see how we reached that conclusion. In straightforward situations involving minor harm (eg, an allergic reaction to a medication that the clinician overlooked and that resulted in an urgent care center visit), a very limited investigation may clarify the situation sufficiently that the prescribing provider, accompanied by an office or staff nurse as support and witness, may be able to complete an effective disclosure in a single discussion, and simply writing off a bill or arranging to reimburse the urgent care center visit cost may satisfy the affected patient.
In more complex situations involving greater harm, a number of people must be involved to accomplish TEAM tasks: to offer an explanation, to answer questions, to make apologies, to explain changes intended to reduce the chance of harm to others in the future, and to work through any restitution that may be appropriate. Appointing a disclosure coach/coordinator/facilitator who has had extended training in the disclosure process can help guide these more complex situations. Risk management, insurance carriers, and legal counsel should be aware and advising throughout the process and participating directly in meetings with the patient and family, as appropriate. Since on the TEAM track we are admitting liability, offering a path to financial restitution may be warranted and the disclosure process may trigger reporting requirements with regulatory as well as human resource implications.
The patient and family may want to include other people on their “team” as well. Since complex disclosure meetings need to be carefully planned in advance, we should clarify who will be attending from the health care side and who the family intends to involve. We should anticipate potential requests and questions such as: Would it be OK to record this meeting? Can we ask our attorney to attend? Who are all these people and why are they in this meeting? (We should introduce all team members and clarify how their involvement is necessary to help reach the most satisfying resolution for all involved.)
Empathize. Admitting that deficient aspects in the care contributed to the harm will trigger thoughts, emotions, and expectations for the patient and family. Empathizing involves seeing the whole situation from their perspective and acknowledging their emotions as understandable. Empathizing is not the same as fully agreeing with the patient’s and family’s perspective, but we will not be able to effectively address concerns and expectations that we have not understood. Organizations should have supports in place for staff who are involved in these difficult situations. Nonetheless, we must prioritize the patient’s and family‘s feelings in a disclosure meeting.
Apologize and be Accountable. This calls for both expressions of sympathy as well as a genuine apology for having caused harm by failure in some aspect of care: We are very sorry you are going through this difficult situation. We are especially sorry to tell you that we now recognize that problems in the care we provided are the most likely cause of this harm. Would this be a good time to explain what we learned?
Having the responsible clinicians present increases the chances of achieving the most complete resolution in a single planned and well facilitated meeting. The tasks for that meeting include: offering an explanation that reveals the problems in care that contributed to the adverse outcome, making sincere apologies, and explaining changes to reduce chance of harm to others. The disclosure coach can work with individuals to help them understand how and why their involvement can be important and to help staff members become ready to participate constructively in the disclosure meeting. When individuals appear unable or unwilling to contribute constructively, a plan is needed for how their part can be replaced (eg, a charge nurse or department chair might need to step in to explain and apologize for the care of a subordinate). Managers/administrators can explain contributory factors for what may at first appear to have been simply individual negligence. Administrators can describe the actions that the organization is taking to correct problems that contributed to the patient harm: As nursing executive, it is my responsibility to see that all our staff have been adequately trained on the equipment we are asking them to use. We now recognize that the nurse’s lack of familiarity with that equipment contributed to the harm you experienced and I am very sorry for that. It is my responsibility to get that problem corrected, and we are already taking steps to assure that. Patients and families often have ideas for improving care processes and appreciate being invited to share these ideas as a service to future patients.
Manage until resolved. On the “care unreasonable” track, we must signal openness to helping with the patient’s and family’s immediate and longer-term needs, as well as their expectations about financial and other forms of restitution. Someone should be in the meeting who can describe the next steps in working towards a fair restitution and how that process will take place following the conclusion of the disclosure meeting. The close involvement of risk and claims professionals throughout the process of investigation through to the disclosure discussion itself will assure a more satisfactory handoff to questions about around financial compensation
Psychological Barriers to Implementation of Disclosure Pathways
Many organizations and researchers agree that disclosure and resolution pathways as just described are the most ethical and effective ways for all parties to resolve these painful situations. So why isn’t this approach universally practiced? In concluding this article, it may be helpful to point out some of the human dynamics that make resolution more difficult and how they might be addressed.
A key issue is the “urge to self-preservation.” Health care organizations have often been accused of disclosing only what they cannot hide. We have repeatedly observed how individuals and organizations are often initially motivated to do whatever is needed to protect themselves, even when those behaviors are frankly deceptive. This is almost to be expected. By age 4 children have learned to use deception as a defensive strategy when confronted with misbehavior. Research shows that children and adults continue the strategy to escape censure or punishment and simply get better at hiding their tracks.18 Because people want to preserve their image as ethical individuals, they have also learned to rationalize/justify this deception as necessary for self-preservation (“My dad would have killed me,” “I will lose my license,” “It is not fair that I take the blame when others have done the same thing and gotten away with it.”). Imagining the most extreme, and therefore “unfair” consequences, helps justify the individual’s use of dissembling and frank deception in order to avoid them. Clinicians and organizations may convince themselves that they are the victims entitled to protection rather than the injured patient. Patients and families often accept explanations that are less than candid, as doctors and nurses remain among the most trusted of professionals. Sufficiently understanding the complexities of the care is beyond the capability of most lay people. Successfully challenging the clinician’s or institution’s exculpatory explanation for an adverse outcome is very difficult, even though many clinicians believe that the tort system is stacked against them.
As a result, even the most sensible of best practices, toolkits, and trainings will not make full disclosure and fair resolution of adverse outcomes more likely without a counterweight of solid ethical commitment and a reliable structure for ensuring adherence. Sustainable progress has been demonstrated in those institutions8,10,17 where: (1) institutional values and ethics around disclosure were elevated above self-protection, (2) efficient processes for recognizing and objectively reviewing care involving an adverse outcome were developed and followed, (3) salaried and institutionally insured staff and providers were required to participate in and accept a fair path to resolution in the context of a just culture, and (4) the institution was able to deliver on any commitments (eg, financial, corrective actions) it has made. Conversely, disclosure and resolution programs have struggled in the following situations: where values and ethics are not clarified and made primary; where the processes for reviewing adverse outcomes are slow, inconsistent, and open to political interference; where independent providers have latitude to insist on self-protective behaviors; and where liability carriers who place highest priority on avoiding financial exposure are involved.
Conclusion
The challenge of effectively disclosing and resolving adverse medical outcomes will continue to be most formidable for health care systems with independent medical staffs with separate liability carriers. Can these systems get a firm consensus on the ethics that are paramount in disclosure situations? Can they create care review systems that are efficient and objective and reach conclusions that are binding on those involved? Are they willing to provide explanations to patients and families regardless of the consequences to themselves? Can they coordinate an efficient path to financial and other forms of restitution in those situations where problems in the care contributed to the patient being harmed? And can they enforce these practices despite the self-concerns of all the involved parties? The good news is we now know how to disclose and resolve adverse medical outcomes with patients and families in a way that is fair to providers, staff, and institutions and will not break the bank. For health care organizations, implementing effective disclosure and resolution practices starts with a commitment to both build consensus for this process and consistently enforce it.
Corresponding author: Daniel O’Connell, PhD, 2212 Queen Anne Ave. N. #810, Seattle, WA 98109; danoconn@me.com.
Financial disclosures: None.
1. Kohn L, Corrigan J, Donaldson M, eds. To Err Is Human: Building a Safer Health System. Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academies Press; 1999.
2. Gibson R, Singh JP. Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington, DC: Lifeline Press; 2003.
3. Rathert C, Phillips W. Medical error disclosure training: evidence for values-based ethical environments. J Bus Ethics. 2010;97:491-503.
4. Wu AW, Cavanaugh TA, McPhee SJ, et al. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997;12:770-775.
5. Gallagher TH, Waterman AD, Ebers AG, et al. Patients’ and doctors’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001-1007.
6. The Patient Safety and Quality Improvement Act of 2005 (PSQIA); Public Law 109-41, 119 Stat. 424-434, which amended the Public Health Service Act.
7. Banja J. Moral courage in medicine—disclosing medical error. Bioethics Forum. 2001;17:7-115
8. Boothman R, Imhoff SJ, Campbell DA. Nurturing a culture of patient safety and achieving lower malpractice risk through disclosure: Lessons learned and future directions. Front Health Serv Manage. 2012;28:13-27.
9. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010;153:213-221.
10. Mello MM, Boothman RC, McDonald T, et al. Communication and resolution programs: the challenges and lessons learned from six early adopters. Health Affairs. 2014;33:20-29.
11. Marx D. Patient Safety and the Just Culture: A Primer for Health Care Executives. New York, NY: Trustees of Columbia University; 2001.
12. AHRQ Communication and Optimal Resolution (CANDOR) Toolkit. Rockville, MD: Agency for Healthcare Research and Quality; May 2016.
13. O’Connell D, White MK, Platt F. Disclosing unanticipated outcomes and medical errors. J Clin Outcomes Manag. 2003;10:25-29.
14. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. Baltimore, MD: Johns Hopkins University Press; 2005.
15. O’Connell D, Reifsteck SW Disclosing unexpected outcomes and medical error. J Med Prac Manag. 2004;19:317-323.
16. Robson R, and Pelletier E. Giving back the pen: Disclosure, apology and early compensation discussions after harm in the healthcare setting. Healthc Q. 2008;11(3 Spec No.)85-90.
17. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999;131:963-967.
18. Ding XP, Wellman HM, WangY, et al. Theory-of-mind training causes honest young children to lie. Psychol Sci. 2015;26:1812-1821.
From The Communication in Healthcare Group, Seattle, WA.
Abstract
- Objective: To review established approaches to disclosure and resolution following adverse medical outcomes and highlight barriers that may hinder universal implementation of effective disclosure/resolution practices.
- Methods: An overview of established approaches to disclosure and resolution of adverse medical outcomes is presented.
- Results: Clinicians must be equipped to manage situations where adverse medical outcomes occur even though the care provided was reasonable, within the standard, as well as in situations where preventable problems in the care provided were likely the cause of patient harm. Established approaches that have proven useful for investigating, disclosing, and resolving situations, captured in the acronyms AIDR, ALEE, and TEAM, can assist clinicians in the disclosure and ultimate resolution of these 2 types of situations.
- Conclusion: Health care organizations with a solid commitment and a reliable structure for ensuring adherence to full disclosure and fair resolution of adverse outcomes have demonstrated sustainable progress in ethically and effectively resolving situations where patients are harmed by medical care.
Keywords: safety; medical error; adverse outcomes; resolution; communication.
Much has been learned over the 20 years since the Institute of Medicine’s (IOM) report To Err Is Human1 was published. At the time it was published, the IOM report made it clear that only a minority of preventable patient harms were being acknowledged, investigated, and reported. In the face of adverse outcomes “dissemble, deny, and defend” was a common strategy of many clinicians, institutions, and liability carriers.2 The health care system appeared to place a priority on protecting itself from reputational and financial harm over the rights of injured patients to be given an accurate understanding of what had happened in their care and to pursue restitution, if appropriate.3-5
The emerging quality improvement movement was accompanied by calls for increased patient advocacy. This included the goal of greater transparency and more timely and equitable resolutions with patients who have been harmed by problems in care. Health care systems pressed for confidentiality protections in exchange for increased focus on quality improvement.6 Applying medical ethics of autonomy, no-maleficence, beneficence, and justice initially took a backseat, as risk management was given priority.7 Insurance carriers have no ethical obligation, and a clear disincentive, to assure that harmed patients are fully informed and offered restitution. Some self-insured health systems, however, began experimenting with more proactive and transparent approaches to disclosure and resolution. In contrast to the often-reported fear of a liability explosion, they reported reduced claims and suits, shorter time to resolution, and reduced overall financial cost,8-10 providing some evidence that perhaps greater openness could work after all.
But for providers and staff to allow transparency and candor to become the norm, institutions needed to create a more “just culture” for managing errors. Individual impairment or willful disregard of safe practice would need to be handled differently from the slips and lapses that more often contributed to preventable harm.11 For example, the nurse who was inadequately oriented to the equipment on an unfamiliar unit where she was asked to work a double shift due to a staffing shortage should not be held as accountable as an employee who knowingly violated agreed upon safe practices, even though patient harm resulted in each situation. It became clear that patient harm was usually the result of multiple factors involving individuals, communication, procedures, systems, and equipment. Blaming and disciplining individuals at the sharp end would not reliably reduce adverse outcomes.
Since the 1999 IOM report, we have developed general agreement on best practices for investigating, disclosing, and resolving situations where patients are harmed by medical care.12,13 This article reviews the perspectives and practices that appear necessary for effective disclosure and resolution after an adverse outcome and highlights barriers to reliably enacting them in practice.
Elements of Effective Disclosure
Effective disclosure to patients and families hinges on determining and providing an accurate understanding of what happened in the patient’s care. It should be the care providers’ and their institution’s responsibility to determine causation and disclose it. This should not require only the most upset patients and families initiating a legal process taking 3 years or more to complete. The most consequential question must be answered, “Was the care provided reasonable?” That is, was everything done within the standard, as would have been expected by similarly trained clinicians with the information and resources available at that time? It follows that if care was reasonable, then the adverse outcome could not normally have been prevented, no correction in care processes is called for, and no financial compensation is required. If the care review reveals deficiencies in care that were linked to patient harm, then achieving a satisfying resolution would be more complex and difficult.13 First, individuals would have to accept that they have contributed to patient harm, itself an often-contentious process and psychologically devastating realization. Then they must have this difficult conversation with patient and family, creating liability risk for themselves in the process. They must commit to correcting the problems that contributed to the harm. They must facilitate, rather than obstruct, a path to a restitution that addresses the medical, practical, and financial harms that have resulted. Given the challenges inherent to disclosure and resolution, it is no wonder that dissembling, denying, and defending was the common practice for the preceding decades.14
Disclosure and Resolution Pathways
I was the co-developer of an approach to disclosure and resolution which is now widely accepted and that has been taught across the United States and Canada to more than 50,000 health care providers and administrators over 18 years.15,16 We learned that resolving adverse medical outcomes is a 4-part process (anticipate, investigate, disclose, resolve [AIDR]). Most adverse or simply disappointing outcomes occur despite reasonable care (eg, due to biological variability, the imprecision of the science and limitations and risks of the procedures). The minority of harms are associated with deficiencies in the care (ie, unreasonable care). We need to equip ourselves to manage both situations effectively. The approach we developed can be captured in 3 acronyms: AIDR, ALEE, and TEAM,
AIDR
This acronym encapsulates the overview guidance for clinicians after an adverse event or outcome, regardless of the cause.
Anticipate the thoughts and feelings of the harmed/disappointed patient and family and reach out immediately with an expression of sympathy.
Investigate sufficiently to address questions about most likely causation and do not conjecture prior to investigation. Ask for patience—“You deserve more than a guess”—and keep in regular contact to reinforce the promise that there will be a full reporting when the review is complete.
Disclose (in a planned and coordinated manner) what has been learned in the investigation.
Resolve the situation with the patient and family consistent with our ethical principles.
If our failure caused the harm (care unreasonable/breached the standard), then working toward a fair restitution and taking corrective actions are appropriate. If the care was found to have been reasonable, then compensation would not be offered and corrective action is unwarranted. The organization would defend reasonable care if a claim was still pursued.
This process involves ethical clarity, emotional intelligence, and discipline. Clinicians must first acknowledge that a disappointing outcome or event has occurred. Clinicians involved in the care, usually led by the attending provider, then immediately reach out to the patient and family with sympathy, a plan of care to address the medical issues, and the promise to investigate and follow-up with the patient and family when the harm and its causes are more clearly determined. To disclose simply means to provide an accurate understanding (ie, the understanding determined by the investigation we conducted) of what happened, its causes, and consequences. Depending on the extent of the harm and the complexity and time needed for the investigation, a “coach” or “disclosure coordinator” who has advanced training in managing these situations is brought in to guide the process. The disclosure coach/coordinator provides a consistent and steady hand throughout the process of investigation, disclosure, and ultimately resolution with patient and family. Patients and families often move across settings during the time of the AIDR process, and it is easy to lose track of them unless someone is following the entire process until resolved.
ALEE
When the investigation of an adverse/disappointing outcome determines the care was reasonable and therefore the adverse outcome could not have been prevented, we use the ALEE pathway to guide the disclosure conversation (Step 3 in AIDR) with the patient and family:
Anticipate. What are the questions, thoughts, and feelings we would expect the patient and family will have? On this track, there is nothing to apologize for since the care was reasonable, yet expressing compassion and sympathy for the patient’s experience is essential. “I/we really sympathize with how differently this has turned out than we had hoped.”
Listen. Invite and listen for their questions and concerns, how they are seeing the situation, and where and what they are finding most upsetting and in need of explanation.
Empathize. There are 2 kinds of empathy required here. Cognitive empathy means showing that we understand their thinking from their perspective, separate from whether we fully agree. Emotional empathy involves demonstrating that their emotions are understandable given the situation, even if those emotions are painful for clinicians to experience. Listening in step 2 is how we learned their perspective and emotions. Now we can show accurate empathy: I/we can understand how upsetting it is to be facing another set of procedures to treat the unfortunate complications from your last surgery.
Explain. Even when care is reasonable, questions and perhaps suspicions are to be expected. Listening and empathizing sets us up to focus our explanations on the patient’s and family’s key questions with a level of thoughtfulness and transparency that conveys credibility. We should not assume, however, that they have accepted our explanation. Instead, solicit their reactions and unresolved questions as part of the disclosure discussion. It is normal for additional concerns to emerge in the days after the disclosure discussion, and we should be ready to address these concerns until resolved. In some instances, the patient and family will not be satisfied and it may be helpful to offer an independent review of the care. If the unresolved patient and family engages an attorney, that will be the first step taken anyway. Proactively offering an independent review signals confidence in your objectivity and sensitivity to the importance of fairness for the patient and family: Your questions and concerns are completely normal in light of the disappointing experience you have had. Let me see if I/we can address those now to your satisfaction.
TEAM
If the investigation determines that aspects of the care were unreasonable (breached the standard) and the adverse outcome/harm was related to the deficiencies in the care, then we use the TEAM pathway to disclose and resolve the situation with the patient and family
Truthful and Transparent and Teamwork. We should be offering our most accurate understanding of how the adverse outcome occurred, with sufficient depth and clarity that the patient and family can see how we reached that conclusion. In straightforward situations involving minor harm (eg, an allergic reaction to a medication that the clinician overlooked and that resulted in an urgent care center visit), a very limited investigation may clarify the situation sufficiently that the prescribing provider, accompanied by an office or staff nurse as support and witness, may be able to complete an effective disclosure in a single discussion, and simply writing off a bill or arranging to reimburse the urgent care center visit cost may satisfy the affected patient.
In more complex situations involving greater harm, a number of people must be involved to accomplish TEAM tasks: to offer an explanation, to answer questions, to make apologies, to explain changes intended to reduce the chance of harm to others in the future, and to work through any restitution that may be appropriate. Appointing a disclosure coach/coordinator/facilitator who has had extended training in the disclosure process can help guide these more complex situations. Risk management, insurance carriers, and legal counsel should be aware and advising throughout the process and participating directly in meetings with the patient and family, as appropriate. Since on the TEAM track we are admitting liability, offering a path to financial restitution may be warranted and the disclosure process may trigger reporting requirements with regulatory as well as human resource implications.
The patient and family may want to include other people on their “team” as well. Since complex disclosure meetings need to be carefully planned in advance, we should clarify who will be attending from the health care side and who the family intends to involve. We should anticipate potential requests and questions such as: Would it be OK to record this meeting? Can we ask our attorney to attend? Who are all these people and why are they in this meeting? (We should introduce all team members and clarify how their involvement is necessary to help reach the most satisfying resolution for all involved.)
Empathize. Admitting that deficient aspects in the care contributed to the harm will trigger thoughts, emotions, and expectations for the patient and family. Empathizing involves seeing the whole situation from their perspective and acknowledging their emotions as understandable. Empathizing is not the same as fully agreeing with the patient’s and family’s perspective, but we will not be able to effectively address concerns and expectations that we have not understood. Organizations should have supports in place for staff who are involved in these difficult situations. Nonetheless, we must prioritize the patient’s and family‘s feelings in a disclosure meeting.
Apologize and be Accountable. This calls for both expressions of sympathy as well as a genuine apology for having caused harm by failure in some aspect of care: We are very sorry you are going through this difficult situation. We are especially sorry to tell you that we now recognize that problems in the care we provided are the most likely cause of this harm. Would this be a good time to explain what we learned?
Having the responsible clinicians present increases the chances of achieving the most complete resolution in a single planned and well facilitated meeting. The tasks for that meeting include: offering an explanation that reveals the problems in care that contributed to the adverse outcome, making sincere apologies, and explaining changes to reduce chance of harm to others. The disclosure coach can work with individuals to help them understand how and why their involvement can be important and to help staff members become ready to participate constructively in the disclosure meeting. When individuals appear unable or unwilling to contribute constructively, a plan is needed for how their part can be replaced (eg, a charge nurse or department chair might need to step in to explain and apologize for the care of a subordinate). Managers/administrators can explain contributory factors for what may at first appear to have been simply individual negligence. Administrators can describe the actions that the organization is taking to correct problems that contributed to the patient harm: As nursing executive, it is my responsibility to see that all our staff have been adequately trained on the equipment we are asking them to use. We now recognize that the nurse’s lack of familiarity with that equipment contributed to the harm you experienced and I am very sorry for that. It is my responsibility to get that problem corrected, and we are already taking steps to assure that. Patients and families often have ideas for improving care processes and appreciate being invited to share these ideas as a service to future patients.
Manage until resolved. On the “care unreasonable” track, we must signal openness to helping with the patient’s and family’s immediate and longer-term needs, as well as their expectations about financial and other forms of restitution. Someone should be in the meeting who can describe the next steps in working towards a fair restitution and how that process will take place following the conclusion of the disclosure meeting. The close involvement of risk and claims professionals throughout the process of investigation through to the disclosure discussion itself will assure a more satisfactory handoff to questions about around financial compensation
Psychological Barriers to Implementation of Disclosure Pathways
Many organizations and researchers agree that disclosure and resolution pathways as just described are the most ethical and effective ways for all parties to resolve these painful situations. So why isn’t this approach universally practiced? In concluding this article, it may be helpful to point out some of the human dynamics that make resolution more difficult and how they might be addressed.
A key issue is the “urge to self-preservation.” Health care organizations have often been accused of disclosing only what they cannot hide. We have repeatedly observed how individuals and organizations are often initially motivated to do whatever is needed to protect themselves, even when those behaviors are frankly deceptive. This is almost to be expected. By age 4 children have learned to use deception as a defensive strategy when confronted with misbehavior. Research shows that children and adults continue the strategy to escape censure or punishment and simply get better at hiding their tracks.18 Because people want to preserve their image as ethical individuals, they have also learned to rationalize/justify this deception as necessary for self-preservation (“My dad would have killed me,” “I will lose my license,” “It is not fair that I take the blame when others have done the same thing and gotten away with it.”). Imagining the most extreme, and therefore “unfair” consequences, helps justify the individual’s use of dissembling and frank deception in order to avoid them. Clinicians and organizations may convince themselves that they are the victims entitled to protection rather than the injured patient. Patients and families often accept explanations that are less than candid, as doctors and nurses remain among the most trusted of professionals. Sufficiently understanding the complexities of the care is beyond the capability of most lay people. Successfully challenging the clinician’s or institution’s exculpatory explanation for an adverse outcome is very difficult, even though many clinicians believe that the tort system is stacked against them.
As a result, even the most sensible of best practices, toolkits, and trainings will not make full disclosure and fair resolution of adverse outcomes more likely without a counterweight of solid ethical commitment and a reliable structure for ensuring adherence. Sustainable progress has been demonstrated in those institutions8,10,17 where: (1) institutional values and ethics around disclosure were elevated above self-protection, (2) efficient processes for recognizing and objectively reviewing care involving an adverse outcome were developed and followed, (3) salaried and institutionally insured staff and providers were required to participate in and accept a fair path to resolution in the context of a just culture, and (4) the institution was able to deliver on any commitments (eg, financial, corrective actions) it has made. Conversely, disclosure and resolution programs have struggled in the following situations: where values and ethics are not clarified and made primary; where the processes for reviewing adverse outcomes are slow, inconsistent, and open to political interference; where independent providers have latitude to insist on self-protective behaviors; and where liability carriers who place highest priority on avoiding financial exposure are involved.
Conclusion
The challenge of effectively disclosing and resolving adverse medical outcomes will continue to be most formidable for health care systems with independent medical staffs with separate liability carriers. Can these systems get a firm consensus on the ethics that are paramount in disclosure situations? Can they create care review systems that are efficient and objective and reach conclusions that are binding on those involved? Are they willing to provide explanations to patients and families regardless of the consequences to themselves? Can they coordinate an efficient path to financial and other forms of restitution in those situations where problems in the care contributed to the patient being harmed? And can they enforce these practices despite the self-concerns of all the involved parties? The good news is we now know how to disclose and resolve adverse medical outcomes with patients and families in a way that is fair to providers, staff, and institutions and will not break the bank. For health care organizations, implementing effective disclosure and resolution practices starts with a commitment to both build consensus for this process and consistently enforce it.
Corresponding author: Daniel O’Connell, PhD, 2212 Queen Anne Ave. N. #810, Seattle, WA 98109; danoconn@me.com.
Financial disclosures: None.
From The Communication in Healthcare Group, Seattle, WA.
Abstract
- Objective: To review established approaches to disclosure and resolution following adverse medical outcomes and highlight barriers that may hinder universal implementation of effective disclosure/resolution practices.
- Methods: An overview of established approaches to disclosure and resolution of adverse medical outcomes is presented.
- Results: Clinicians must be equipped to manage situations where adverse medical outcomes occur even though the care provided was reasonable, within the standard, as well as in situations where preventable problems in the care provided were likely the cause of patient harm. Established approaches that have proven useful for investigating, disclosing, and resolving situations, captured in the acronyms AIDR, ALEE, and TEAM, can assist clinicians in the disclosure and ultimate resolution of these 2 types of situations.
- Conclusion: Health care organizations with a solid commitment and a reliable structure for ensuring adherence to full disclosure and fair resolution of adverse outcomes have demonstrated sustainable progress in ethically and effectively resolving situations where patients are harmed by medical care.
Keywords: safety; medical error; adverse outcomes; resolution; communication.
Much has been learned over the 20 years since the Institute of Medicine’s (IOM) report To Err Is Human1 was published. At the time it was published, the IOM report made it clear that only a minority of preventable patient harms were being acknowledged, investigated, and reported. In the face of adverse outcomes “dissemble, deny, and defend” was a common strategy of many clinicians, institutions, and liability carriers.2 The health care system appeared to place a priority on protecting itself from reputational and financial harm over the rights of injured patients to be given an accurate understanding of what had happened in their care and to pursue restitution, if appropriate.3-5
The emerging quality improvement movement was accompanied by calls for increased patient advocacy. This included the goal of greater transparency and more timely and equitable resolutions with patients who have been harmed by problems in care. Health care systems pressed for confidentiality protections in exchange for increased focus on quality improvement.6 Applying medical ethics of autonomy, no-maleficence, beneficence, and justice initially took a backseat, as risk management was given priority.7 Insurance carriers have no ethical obligation, and a clear disincentive, to assure that harmed patients are fully informed and offered restitution. Some self-insured health systems, however, began experimenting with more proactive and transparent approaches to disclosure and resolution. In contrast to the often-reported fear of a liability explosion, they reported reduced claims and suits, shorter time to resolution, and reduced overall financial cost,8-10 providing some evidence that perhaps greater openness could work after all.
But for providers and staff to allow transparency and candor to become the norm, institutions needed to create a more “just culture” for managing errors. Individual impairment or willful disregard of safe practice would need to be handled differently from the slips and lapses that more often contributed to preventable harm.11 For example, the nurse who was inadequately oriented to the equipment on an unfamiliar unit where she was asked to work a double shift due to a staffing shortage should not be held as accountable as an employee who knowingly violated agreed upon safe practices, even though patient harm resulted in each situation. It became clear that patient harm was usually the result of multiple factors involving individuals, communication, procedures, systems, and equipment. Blaming and disciplining individuals at the sharp end would not reliably reduce adverse outcomes.
Since the 1999 IOM report, we have developed general agreement on best practices for investigating, disclosing, and resolving situations where patients are harmed by medical care.12,13 This article reviews the perspectives and practices that appear necessary for effective disclosure and resolution after an adverse outcome and highlights barriers to reliably enacting them in practice.
Elements of Effective Disclosure
Effective disclosure to patients and families hinges on determining and providing an accurate understanding of what happened in the patient’s care. It should be the care providers’ and their institution’s responsibility to determine causation and disclose it. This should not require only the most upset patients and families initiating a legal process taking 3 years or more to complete. The most consequential question must be answered, “Was the care provided reasonable?” That is, was everything done within the standard, as would have been expected by similarly trained clinicians with the information and resources available at that time? It follows that if care was reasonable, then the adverse outcome could not normally have been prevented, no correction in care processes is called for, and no financial compensation is required. If the care review reveals deficiencies in care that were linked to patient harm, then achieving a satisfying resolution would be more complex and difficult.13 First, individuals would have to accept that they have contributed to patient harm, itself an often-contentious process and psychologically devastating realization. Then they must have this difficult conversation with patient and family, creating liability risk for themselves in the process. They must commit to correcting the problems that contributed to the harm. They must facilitate, rather than obstruct, a path to a restitution that addresses the medical, practical, and financial harms that have resulted. Given the challenges inherent to disclosure and resolution, it is no wonder that dissembling, denying, and defending was the common practice for the preceding decades.14
Disclosure and Resolution Pathways
I was the co-developer of an approach to disclosure and resolution which is now widely accepted and that has been taught across the United States and Canada to more than 50,000 health care providers and administrators over 18 years.15,16 We learned that resolving adverse medical outcomes is a 4-part process (anticipate, investigate, disclose, resolve [AIDR]). Most adverse or simply disappointing outcomes occur despite reasonable care (eg, due to biological variability, the imprecision of the science and limitations and risks of the procedures). The minority of harms are associated with deficiencies in the care (ie, unreasonable care). We need to equip ourselves to manage both situations effectively. The approach we developed can be captured in 3 acronyms: AIDR, ALEE, and TEAM,
AIDR
This acronym encapsulates the overview guidance for clinicians after an adverse event or outcome, regardless of the cause.
Anticipate the thoughts and feelings of the harmed/disappointed patient and family and reach out immediately with an expression of sympathy.
Investigate sufficiently to address questions about most likely causation and do not conjecture prior to investigation. Ask for patience—“You deserve more than a guess”—and keep in regular contact to reinforce the promise that there will be a full reporting when the review is complete.
Disclose (in a planned and coordinated manner) what has been learned in the investigation.
Resolve the situation with the patient and family consistent with our ethical principles.
If our failure caused the harm (care unreasonable/breached the standard), then working toward a fair restitution and taking corrective actions are appropriate. If the care was found to have been reasonable, then compensation would not be offered and corrective action is unwarranted. The organization would defend reasonable care if a claim was still pursued.
This process involves ethical clarity, emotional intelligence, and discipline. Clinicians must first acknowledge that a disappointing outcome or event has occurred. Clinicians involved in the care, usually led by the attending provider, then immediately reach out to the patient and family with sympathy, a plan of care to address the medical issues, and the promise to investigate and follow-up with the patient and family when the harm and its causes are more clearly determined. To disclose simply means to provide an accurate understanding (ie, the understanding determined by the investigation we conducted) of what happened, its causes, and consequences. Depending on the extent of the harm and the complexity and time needed for the investigation, a “coach” or “disclosure coordinator” who has advanced training in managing these situations is brought in to guide the process. The disclosure coach/coordinator provides a consistent and steady hand throughout the process of investigation, disclosure, and ultimately resolution with patient and family. Patients and families often move across settings during the time of the AIDR process, and it is easy to lose track of them unless someone is following the entire process until resolved.
ALEE
When the investigation of an adverse/disappointing outcome determines the care was reasonable and therefore the adverse outcome could not have been prevented, we use the ALEE pathway to guide the disclosure conversation (Step 3 in AIDR) with the patient and family:
Anticipate. What are the questions, thoughts, and feelings we would expect the patient and family will have? On this track, there is nothing to apologize for since the care was reasonable, yet expressing compassion and sympathy for the patient’s experience is essential. “I/we really sympathize with how differently this has turned out than we had hoped.”
Listen. Invite and listen for their questions and concerns, how they are seeing the situation, and where and what they are finding most upsetting and in need of explanation.
Empathize. There are 2 kinds of empathy required here. Cognitive empathy means showing that we understand their thinking from their perspective, separate from whether we fully agree. Emotional empathy involves demonstrating that their emotions are understandable given the situation, even if those emotions are painful for clinicians to experience. Listening in step 2 is how we learned their perspective and emotions. Now we can show accurate empathy: I/we can understand how upsetting it is to be facing another set of procedures to treat the unfortunate complications from your last surgery.
Explain. Even when care is reasonable, questions and perhaps suspicions are to be expected. Listening and empathizing sets us up to focus our explanations on the patient’s and family’s key questions with a level of thoughtfulness and transparency that conveys credibility. We should not assume, however, that they have accepted our explanation. Instead, solicit their reactions and unresolved questions as part of the disclosure discussion. It is normal for additional concerns to emerge in the days after the disclosure discussion, and we should be ready to address these concerns until resolved. In some instances, the patient and family will not be satisfied and it may be helpful to offer an independent review of the care. If the unresolved patient and family engages an attorney, that will be the first step taken anyway. Proactively offering an independent review signals confidence in your objectivity and sensitivity to the importance of fairness for the patient and family: Your questions and concerns are completely normal in light of the disappointing experience you have had. Let me see if I/we can address those now to your satisfaction.
TEAM
If the investigation determines that aspects of the care were unreasonable (breached the standard) and the adverse outcome/harm was related to the deficiencies in the care, then we use the TEAM pathway to disclose and resolve the situation with the patient and family
Truthful and Transparent and Teamwork. We should be offering our most accurate understanding of how the adverse outcome occurred, with sufficient depth and clarity that the patient and family can see how we reached that conclusion. In straightforward situations involving minor harm (eg, an allergic reaction to a medication that the clinician overlooked and that resulted in an urgent care center visit), a very limited investigation may clarify the situation sufficiently that the prescribing provider, accompanied by an office or staff nurse as support and witness, may be able to complete an effective disclosure in a single discussion, and simply writing off a bill or arranging to reimburse the urgent care center visit cost may satisfy the affected patient.
In more complex situations involving greater harm, a number of people must be involved to accomplish TEAM tasks: to offer an explanation, to answer questions, to make apologies, to explain changes intended to reduce the chance of harm to others in the future, and to work through any restitution that may be appropriate. Appointing a disclosure coach/coordinator/facilitator who has had extended training in the disclosure process can help guide these more complex situations. Risk management, insurance carriers, and legal counsel should be aware and advising throughout the process and participating directly in meetings with the patient and family, as appropriate. Since on the TEAM track we are admitting liability, offering a path to financial restitution may be warranted and the disclosure process may trigger reporting requirements with regulatory as well as human resource implications.
The patient and family may want to include other people on their “team” as well. Since complex disclosure meetings need to be carefully planned in advance, we should clarify who will be attending from the health care side and who the family intends to involve. We should anticipate potential requests and questions such as: Would it be OK to record this meeting? Can we ask our attorney to attend? Who are all these people and why are they in this meeting? (We should introduce all team members and clarify how their involvement is necessary to help reach the most satisfying resolution for all involved.)
Empathize. Admitting that deficient aspects in the care contributed to the harm will trigger thoughts, emotions, and expectations for the patient and family. Empathizing involves seeing the whole situation from their perspective and acknowledging their emotions as understandable. Empathizing is not the same as fully agreeing with the patient’s and family’s perspective, but we will not be able to effectively address concerns and expectations that we have not understood. Organizations should have supports in place for staff who are involved in these difficult situations. Nonetheless, we must prioritize the patient’s and family‘s feelings in a disclosure meeting.
Apologize and be Accountable. This calls for both expressions of sympathy as well as a genuine apology for having caused harm by failure in some aspect of care: We are very sorry you are going through this difficult situation. We are especially sorry to tell you that we now recognize that problems in the care we provided are the most likely cause of this harm. Would this be a good time to explain what we learned?
Having the responsible clinicians present increases the chances of achieving the most complete resolution in a single planned and well facilitated meeting. The tasks for that meeting include: offering an explanation that reveals the problems in care that contributed to the adverse outcome, making sincere apologies, and explaining changes to reduce chance of harm to others. The disclosure coach can work with individuals to help them understand how and why their involvement can be important and to help staff members become ready to participate constructively in the disclosure meeting. When individuals appear unable or unwilling to contribute constructively, a plan is needed for how their part can be replaced (eg, a charge nurse or department chair might need to step in to explain and apologize for the care of a subordinate). Managers/administrators can explain contributory factors for what may at first appear to have been simply individual negligence. Administrators can describe the actions that the organization is taking to correct problems that contributed to the patient harm: As nursing executive, it is my responsibility to see that all our staff have been adequately trained on the equipment we are asking them to use. We now recognize that the nurse’s lack of familiarity with that equipment contributed to the harm you experienced and I am very sorry for that. It is my responsibility to get that problem corrected, and we are already taking steps to assure that. Patients and families often have ideas for improving care processes and appreciate being invited to share these ideas as a service to future patients.
Manage until resolved. On the “care unreasonable” track, we must signal openness to helping with the patient’s and family’s immediate and longer-term needs, as well as their expectations about financial and other forms of restitution. Someone should be in the meeting who can describe the next steps in working towards a fair restitution and how that process will take place following the conclusion of the disclosure meeting. The close involvement of risk and claims professionals throughout the process of investigation through to the disclosure discussion itself will assure a more satisfactory handoff to questions about around financial compensation
Psychological Barriers to Implementation of Disclosure Pathways
Many organizations and researchers agree that disclosure and resolution pathways as just described are the most ethical and effective ways for all parties to resolve these painful situations. So why isn’t this approach universally practiced? In concluding this article, it may be helpful to point out some of the human dynamics that make resolution more difficult and how they might be addressed.
A key issue is the “urge to self-preservation.” Health care organizations have often been accused of disclosing only what they cannot hide. We have repeatedly observed how individuals and organizations are often initially motivated to do whatever is needed to protect themselves, even when those behaviors are frankly deceptive. This is almost to be expected. By age 4 children have learned to use deception as a defensive strategy when confronted with misbehavior. Research shows that children and adults continue the strategy to escape censure or punishment and simply get better at hiding their tracks.18 Because people want to preserve their image as ethical individuals, they have also learned to rationalize/justify this deception as necessary for self-preservation (“My dad would have killed me,” “I will lose my license,” “It is not fair that I take the blame when others have done the same thing and gotten away with it.”). Imagining the most extreme, and therefore “unfair” consequences, helps justify the individual’s use of dissembling and frank deception in order to avoid them. Clinicians and organizations may convince themselves that they are the victims entitled to protection rather than the injured patient. Patients and families often accept explanations that are less than candid, as doctors and nurses remain among the most trusted of professionals. Sufficiently understanding the complexities of the care is beyond the capability of most lay people. Successfully challenging the clinician’s or institution’s exculpatory explanation for an adverse outcome is very difficult, even though many clinicians believe that the tort system is stacked against them.
As a result, even the most sensible of best practices, toolkits, and trainings will not make full disclosure and fair resolution of adverse outcomes more likely without a counterweight of solid ethical commitment and a reliable structure for ensuring adherence. Sustainable progress has been demonstrated in those institutions8,10,17 where: (1) institutional values and ethics around disclosure were elevated above self-protection, (2) efficient processes for recognizing and objectively reviewing care involving an adverse outcome were developed and followed, (3) salaried and institutionally insured staff and providers were required to participate in and accept a fair path to resolution in the context of a just culture, and (4) the institution was able to deliver on any commitments (eg, financial, corrective actions) it has made. Conversely, disclosure and resolution programs have struggled in the following situations: where values and ethics are not clarified and made primary; where the processes for reviewing adverse outcomes are slow, inconsistent, and open to political interference; where independent providers have latitude to insist on self-protective behaviors; and where liability carriers who place highest priority on avoiding financial exposure are involved.
Conclusion
The challenge of effectively disclosing and resolving adverse medical outcomes will continue to be most formidable for health care systems with independent medical staffs with separate liability carriers. Can these systems get a firm consensus on the ethics that are paramount in disclosure situations? Can they create care review systems that are efficient and objective and reach conclusions that are binding on those involved? Are they willing to provide explanations to patients and families regardless of the consequences to themselves? Can they coordinate an efficient path to financial and other forms of restitution in those situations where problems in the care contributed to the patient being harmed? And can they enforce these practices despite the self-concerns of all the involved parties? The good news is we now know how to disclose and resolve adverse medical outcomes with patients and families in a way that is fair to providers, staff, and institutions and will not break the bank. For health care organizations, implementing effective disclosure and resolution practices starts with a commitment to both build consensus for this process and consistently enforce it.
Corresponding author: Daniel O’Connell, PhD, 2212 Queen Anne Ave. N. #810, Seattle, WA 98109; danoconn@me.com.
Financial disclosures: None.
1. Kohn L, Corrigan J, Donaldson M, eds. To Err Is Human: Building a Safer Health System. Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academies Press; 1999.
2. Gibson R, Singh JP. Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington, DC: Lifeline Press; 2003.
3. Rathert C, Phillips W. Medical error disclosure training: evidence for values-based ethical environments. J Bus Ethics. 2010;97:491-503.
4. Wu AW, Cavanaugh TA, McPhee SJ, et al. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997;12:770-775.
5. Gallagher TH, Waterman AD, Ebers AG, et al. Patients’ and doctors’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001-1007.
6. The Patient Safety and Quality Improvement Act of 2005 (PSQIA); Public Law 109-41, 119 Stat. 424-434, which amended the Public Health Service Act.
7. Banja J. Moral courage in medicine—disclosing medical error. Bioethics Forum. 2001;17:7-115
8. Boothman R, Imhoff SJ, Campbell DA. Nurturing a culture of patient safety and achieving lower malpractice risk through disclosure: Lessons learned and future directions. Front Health Serv Manage. 2012;28:13-27.
9. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010;153:213-221.
10. Mello MM, Boothman RC, McDonald T, et al. Communication and resolution programs: the challenges and lessons learned from six early adopters. Health Affairs. 2014;33:20-29.
11. Marx D. Patient Safety and the Just Culture: A Primer for Health Care Executives. New York, NY: Trustees of Columbia University; 2001.
12. AHRQ Communication and Optimal Resolution (CANDOR) Toolkit. Rockville, MD: Agency for Healthcare Research and Quality; May 2016.
13. O’Connell D, White MK, Platt F. Disclosing unanticipated outcomes and medical errors. J Clin Outcomes Manag. 2003;10:25-29.
14. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. Baltimore, MD: Johns Hopkins University Press; 2005.
15. O’Connell D, Reifsteck SW Disclosing unexpected outcomes and medical error. J Med Prac Manag. 2004;19:317-323.
16. Robson R, and Pelletier E. Giving back the pen: Disclosure, apology and early compensation discussions after harm in the healthcare setting. Healthc Q. 2008;11(3 Spec No.)85-90.
17. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999;131:963-967.
18. Ding XP, Wellman HM, WangY, et al. Theory-of-mind training causes honest young children to lie. Psychol Sci. 2015;26:1812-1821.
1. Kohn L, Corrigan J, Donaldson M, eds. To Err Is Human: Building a Safer Health System. Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academies Press; 1999.
2. Gibson R, Singh JP. Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington, DC: Lifeline Press; 2003.
3. Rathert C, Phillips W. Medical error disclosure training: evidence for values-based ethical environments. J Bus Ethics. 2010;97:491-503.
4. Wu AW, Cavanaugh TA, McPhee SJ, et al. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997;12:770-775.
5. Gallagher TH, Waterman AD, Ebers AG, et al. Patients’ and doctors’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001-1007.
6. The Patient Safety and Quality Improvement Act of 2005 (PSQIA); Public Law 109-41, 119 Stat. 424-434, which amended the Public Health Service Act.
7. Banja J. Moral courage in medicine—disclosing medical error. Bioethics Forum. 2001;17:7-115
8. Boothman R, Imhoff SJ, Campbell DA. Nurturing a culture of patient safety and achieving lower malpractice risk through disclosure: Lessons learned and future directions. Front Health Serv Manage. 2012;28:13-27.
9. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. 2010;153:213-221.
10. Mello MM, Boothman RC, McDonald T, et al. Communication and resolution programs: the challenges and lessons learned from six early adopters. Health Affairs. 2014;33:20-29.
11. Marx D. Patient Safety and the Just Culture: A Primer for Health Care Executives. New York, NY: Trustees of Columbia University; 2001.
12. AHRQ Communication and Optimal Resolution (CANDOR) Toolkit. Rockville, MD: Agency for Healthcare Research and Quality; May 2016.
13. O’Connell D, White MK, Platt F. Disclosing unanticipated outcomes and medical errors. J Clin Outcomes Manag. 2003;10:25-29.
14. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. Baltimore, MD: Johns Hopkins University Press; 2005.
15. O’Connell D, Reifsteck SW Disclosing unexpected outcomes and medical error. J Med Prac Manag. 2004;19:317-323.
16. Robson R, and Pelletier E. Giving back the pen: Disclosure, apology and early compensation discussions after harm in the healthcare setting. Healthc Q. 2008;11(3 Spec No.)85-90.
17. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999;131:963-967.
18. Ding XP, Wellman HM, WangY, et al. Theory-of-mind training causes honest young children to lie. Psychol Sci. 2015;26:1812-1821.
Optimizing a Total Joint Replacement Care Pathway to Reduce Skilled Nursing Facility Utilization
From Grant Medical Center (Dr. Wasielewski, Dr. Polonia, Ms. Barca, Ms. Cebriak, Ms. Lucki), and OhioHealth Group (Mr. Rogers, Ms. St. John, Dr. Gascon), Columbus, OH.
Abstract
- Background: Organizations participating in the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative enter into payment arrangements that include financial and performance accountability for episodes of care. There is growing evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care (eg, skilled nursing facilities [SNF], long-term care facilities, and inpatient rehabilitation facilities).
- Objective: To describe a pilot program designed to reduce the utilization of institutional post-acute care for total joint replacement surgical patients.
- Methods: A multidisciplinary intervention team optimized scheduling, preadmission testing, patient communication, and patient education along a total joint replacement care pathway.
- Results: Among Medicare patients, total discharges to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period. The risk of SNF utilization among patients in the intervention period was nearly half (0.45; 95% confidence interval, 0.314-0.639) that of patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001). The readmission rate was substantially lower than national norms.
- Conclusion: Optimizing patient care throughout the care pathway using the concerted efforts of a multidisciplinary team is possible given a common vision, shared goals, and clearly communicated expectations.
Keywords: arthroplasty; readmissions; Medicare; post-acute care; Bundled Payment for Care Improvement.
Quality improvement in health care is partially dependent upon processes that standardize episodes of care. This is especially true in the post–acute care setting, where efforts to increase patient engagement and care coordination can improve a patient’s recovery process. One framework for optimizing patient care across an episode of care is the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, which links payments for the multiple services patients receive during an episode of care. Organizations participating in the BPCI initiative enter into payment arrangements that include financial and performance accountability for episodes of care. The BPCI initiative provides a framework for episodes of care across multiple types of facilities and clinicians over periods of time (30-day, 60-day, and 90-day episodes).1-5 Evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality is accumulating. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care, such as skilled nursing facilities (SNF), long-term care facilities, and inpatient rehabilitation facilities.1
Our hospital, the Grant Medical Center, which is part of the OhioHealth system, had agreed to participate in the CMS BPCI–Advanced Model for major joint replacement of the lower extremity, with a start date of October 1, 2018. Prior to adopting this bundled payment and service delivery model for major joint replacement through the BPCI program, we implemented strategic interventions to improve the efficiency of care delivery and reduce post-acute utilization. Although the BPCI program applied only to Medicare patients, the interventions that were developed, implemented, and evaluated in this quality improvement project, which we describe in this article, were provided to all patients who underwent lower-extremity joint replacement, regardless of payer.
Gap Analysis
Prior to developing and implementing the intervention, a gap analysis was performed to determine differences between Grant Medical Center’s care pathway/processes and evidence-based best practice. A steering committee comprised of physician champions, rehabilitation services, senior leadership from the Bone and Joint Center, and care management was gathered. The gap analysis examined the care paths in the preoperative phase, index admission phase, and the post-acute phase of care. Findings of the gap analysis included an underutilized joint education class, overutilization of SNF placement, and lack of key resources to assess the needs of patients prior to surgery.
The Grant Bone and Joint Center offered a comprehensive joint education class in person, but also gave patients the option of utilizing an online learning source. While both were successful, staff believed the in-person class had a greater impact than the online version. Patients who attended the class completed a preoperative assessment by hand, which included a social assessment for identifying potential challenges prior to admission. However, because class attendance was low (< 10%), this assessment tool was not utilized until the patient’s admission in most cases. The gap analysis also identified that the educational content of the class lacked key points to encourage a home-going plan.
The baseline SNF utilization rate (using data from July 1, 2015–June 30, 2016) within the Medicare population was 39.5% (70/177), with an overall (all payers) rate of 22.9% (192/838). This SNF utilization rate was higher than the national benchmark, underscoring the need to focus on a preoperative “plan for home” message. In addition, review of Medicare fee-for-service data from 2014 to 2016 revealed that Grant Medical Center utilized 83 different SNFs over the course of approximately 2 years. In this context, staff saw an opportunity to develop stronger relationships with fewer SNF partners, as well as OhioHealth Home Care, in order to improve care by standardizing functional recovery in post-acute care management.
In sum, the gap analysis found that a lack of standardization, follow through, and engagement in daily multidisciplinary rounds often led to a plan for SNF discharge instead of home. As such, it was determined that the pilot program would target the preoperative and post-acute phases of care and that its primary endpoint would be the reduction of the SNF discharge rate among Medicare fee-for-service patients.
Literature Review
Targeting the SNF discharge rate as the endpoint was also supported by a recent study that showed that most of the reduction in spending for total joint replacement within BPCI hospitals was linked to reduced use of institutional post-acute care.1 Other studies in the joint replacement literature have delineated the specific aspects of care redesign that allow hospitals to provide more efficient and effective care delivery during an episode of care.6-8 A review of these and similar studies of joint replacement quality improvement interventions yielded a number of actionable findings:
- Engaging and educating patients and families is critical. Families and other caregivers must be identified preoperatively, actively engaged, and committed to helping the patient recover.
- Providers must build the expectation in patients that they will return home as soon as it is safe to do so. This includes working to restore physiologic function, managing pain with oral medication, and restoring the physical capability of adapting to a home environment.
- Relationships must be established with post-acute care providers who are able to demonstrate best practices and be willing partners on performance outcomes.
- Providers need to invest in personnel to coordinate care transitions initiated preoperatively that continue through the post-acute phase of care.
- Providers must promote processes that allow patients to more fully own their recovery through coaching and improved communication.
A total joint replacement initiative undertaken at another hospital within the OhioHealth system, Riverside Methodist Hospital, that incorporated these aspects of care redesign demonstrated a significant reduction in SNF utilization. That success informed the development of the initiative at Grant Medical Center.
Methods
Setting
This pilot project was conducted from July 2017 through July 2018 at the Grant Bone and Joint Center in the Grant Medical Center, an urban hospital in Columbus, Ohio. The Bone and Joint Center performs more than 7400 surgeries each year, of which 12% are total joint replacements. Grant Medical Center is a Level I Trauma Center that has received a fourth designation in Magnet Nursing status and has attained The Joint Commission Disease-Specific Care Certification for its total knee and hip arthroplasty, total shoulder, and hip fracture programs.
Intervention
The findings from the gap analysis were incorporated into a standardized preoperative care pathway at the Center. Standardization of the care pathway required developing relationships between office staff, schedulers, inpatient work teams, and preadmission testing, as well as physician group realignment with the larger organization.
During this time, the steering committee identified the need for a designated full-time pre-habilitation case manager to support patients undergoing hip and knee replacements at the Center. With the addition of a new role, prehab case manager, attention was directed to patient social assessment and communication. After the surgery was scheduled but prior to the preoperative education class, each patient received a screening phone call from the prehab case manager that included an initial social assessment. The electronic health record (EHR) was utilized to communicate the results of the assessment, including barriers to a home-going plan. The phone call allowed the case manager to reinforce the importance of class attendance for the patient and primary caregiver, and also allowed any specific concerns identified to be addressed and resolved prior to surgery.
A work group consisting of the prehab case manager, office staff, and the bone and joint leadership team focused on improving the core preoperative education content, same-day preadmission clearance, and class attendance. To support these efforts, the work group (1) created a scheduling document to align preadmission testing and the preoperative education class so they occurred on the same day, (2) improved prior authorization of the surgery to support the post-surgical care team, (3) clarified expectations and roles among office staff and care management staff to optimize the discharge process, and (4) engaged the physician team to encourage a culture change towards setting patient expectations to be discharged to home or a preferred SNF location. Regarding prior authorization communications, prior to the intervention, communication was insufficient, paper driven, and lacking in continuity. Utilizing the EHR, an EPIC platform, a designated documentation location was created, which increased communication among the office schedulers, preadmission testing, and surgery schedulers. The consistent location for recording prior authorization avoided canceled surgeries and claim denials due to missing pieces of information. In addition to these process changes, the surgical offices were geographically realigned to a new single location, a change that brought the staff together and in turn allowed for role clarification and team building and also allowed the staff to identify opportunities for improvement.
The core content of the education class was redesigned to support patients’ understanding of the procedure and what to expect during the hospital stay and discharge for home. Staff worked first to align all preadmission patient requirements with the content of the class. In pilot studies, patients were asked to provide feedback, and this feedback was incorporated into subsequent revisions. Staff developed multilingual handouts, including a surgery instruction sheet with a preoperative social assessment, in addition to creating opportunities for 1:1 education when it was medically or socially appropriate.
The work group brought the physicians in the care pathway together for a focused conversation and education regarding the need for including class attendance as part of their practice. They worked with the physicians’ support team to coordinate standardized follow-up care in the post-acute setting and encouraged the physicians to create a “home-going” culture and reset expectations for length of stay. Prior to the start of this project, the rehabilitation department began using the 6-Clicks Inpatient Basic Mobility Short Form, a standardized instrument comprised of short forms created from the Activity Measure for Post-Acute Care (AM-PAC) instrument. The AMPAC score is used to help establish the patient’s functional level; patients scoring 18 or higher have a higher probability of a successful return home (rather than an institutional discharge). Physical therapists at the Center adminster the 6-Clicks tool for each therapy patient daily, and document the AM-PAC score in the appropriate flowsheet in the EHR in a manner consistent with best practices.9-11 The group utilized the AMPAC score to determine functional status upon discharge, offering guidance for the correct post-acute discharge plan.
The workgroup also established a relationship with the lead home health care service to develop a standard notification process to set volume and service expectations. Finally, they worked with the lead SNFs to explain the surgical procedure and set expectations for patient recovery at the facilities. These changes are summarized in the Figure.
Analysis
Descriptive statistics were used to describe patients and metrics in the baseline and performance periods. The difference in the proportion of patients discharged to a SNF in the baseline and performance periods was examined by a Z-test of proportion and change in relative risk. A Z-test of proportion was also used examine differences in the 90-day all-cause readmission rate and in the average length of stay between the 2 periods.
Results
Differences between Medicare fee-for-service patients in the baseline and performance periods are reported in Table 1. While age, sex, diagnoses, and surgical types were similar, AM-PAC scores and the proportion of patients married or living with someone were higher in the performance period. The AM-PAC score in Table 1 represents the last documented score prior to discharge.
The proportion of Medicare patients discharged to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period (Table 2). The 21.9% difference was significant at the 0.05 level (Z = 4.6586, P = 0.0001). Medicare patients in the intervention period had nearly half (0.45) the risk (95% confidence interval, 0.314-0.639) of SNF utilization compared with patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001).
Concomitantly, the 90-day all-cause readmission rate among Medicare patients rose from 2.8% (5/177) to 4.7% (9/192), but the difference in proportions was not statistically significant (Z = –0.9356, P = 0.3495). Similarly, the average length of stay for Medicare patients was 2.9 days in both the baseline and performance periods.
Discussion
The intervention was associated with a statistically significant decrease in the SNF discharge rate following total joint replacement. The readmission rate and average length of stay were statistically unchanged. The lack of a statistically significant change in readmissions is important, as previous research has found that total joint replacement patients discharged to a SNF have higher odds of hospital readmission within 90 days than those discharged home.12 Moreover, the readmission rate in the performance period (4.7%) was still substantially lower than the national estimate of 90-day readmission rates associated with total hip arthroplasty (7.7%) and total knee arthroplasty (9.7%).13 For patients, these quality improvements are associated with improved outcomes and lower costs of care.
These outcomes were achieved after a substantial effort at the facility level to onboard new staff; orient them and their colleagues in each step along the care pathway, from scheduling through post-acute care; and build trust among all team members. The critical difference was changing expectations for post-acute recovery and rehabilitation throughout both the new clinical coordination workflow and processes and the existing processes. Orientation of the clinical coordination role was necessary to establish relationships with inpatient team members who were not as intimately involved with the position and expectations. To accomplish this, competing priorities had to be addressed and resolved through standardization efforts developed and implemented by the multidisciplinary team. The team first reviewed reports of such efforts in the initial review of the BPCI literature.1-5 Subsequent analyses of the most germane study3 and related research14 confirmed that a team-based approach to standardization could be successful. The former study used physician and affiliated care teams to build a care pathway that minimized variation in practices across the episode of care, and the latter used a multidisciplinary team approach to develop rapid recovery protocols. Subsequent research has validated the findings that hospital-based multidisciplinary teams have long been associated with improved patient safety, shorter length of stay, and fewer complications.15
Limitations
This quality improvement project was limited to a single facility. As such, adapting the improvements made to Grant Medical Center’s care pathway for implementation throughout the OhioHealth system will take time due to variation of care provided at each campus; scale-up efforts are ongoing. In the Grant facility, the project uncovered instances of unstandardized provider communication pathways, clinical staff workflows, and expectations for patients. Standardization in all 3 instances improved the patient experience. Additionally, data collection requirements for rigorous research and evaluation efforts that had to be done by hand during the project are now being integrated into the EHR.
The improvements described here, which were implemented in anticipation of adopting the CMS BPCI bundled payment model for joint replacement of the lower extremity, were provided to every patient regardless of payer. Patient outcomes varied across payer, as did preoperative education rates and other variables (Table 1). These differences are being tracked and analyzed following the Center’s entry into the CMS BPCI model on October 1, 2018.
Corresponding author: Gregg M. Gascon, PhD, CHDA, OhioHealth Group, 155 E. Broad Street, Suite 1700, Columbus, Ohio 43215; ggascon@ohiohealthgroup.com.
Financial disclosures: None.
1. Dummit LA, Kahvecioglu D, Marrufo G, et al. Association between hospital participation in a Medicare bundled payment initiative and payments and quality outcomes for lower extremity joint replacement episodes. JAMA. 2016;316:1267-1278.
2. Urdapilleta O, Weinberg D, Pedersen S, et al. Evaluation of the Medicare Acute Care Episodes (ACE) demonstration: final evaluation report. Centers for Medicare & Medicaid Services. May 31, 2013. http://downloads.cms.gov/files/cmmi/ACE-EvaluationReport-Final-5-2-14.pdf.
3. Froemke C, Wang L, DeHart ML, et al. Standardizing care and improving quality under a bundled payment initiative for total joint arthroplasty. J Arthroplasty. 2015;30:1676-1682.
4. US Department of Health and Human Services. (2015 Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. New Release. January 26, 2015.
5. Tsai TC, Joynt KE, Wild RC, et al. Medicare’s Bundled Payment Initiatives: most hospitals are focused on a few high-volume conditions. Health Aff (Millwood). 2015;34;371-380.
6. Mechanic RE. Opportunities and challenges for episode-based payment. N Engl J Med. 2011,365:777-779.
7. Mallinson TR, Bateman J, Tseng HY, et al. A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery. Arch Phys Med Rehabil. 2011:92:712-720.
8. Froimson M, Deadwiller M, Schill M, Cousineau K. Early results of a total joint bundled payment program: the BPCI initiative. Poster No. 2026. Poster presented at Orthopaedic Research Society Annual Meeting; March 15-18, 2014; New Orleans, LA.
9. Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42(1 Suppl):S49-S61.
10. Jette DU, Stilphen M, Ranganathan VK, et al. Validity of the AM-PAC “6-Clicks” inpatient daily activity and basic mobility short forms. Phys Ther. 2014;94;379-391.
11. Jette DU, Stilphen M, Ranganathan VK, et al. AM-PAC “6-Clicks” functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014;94:1252-1261.
12. Bini SA, Fithian DC, Paxton LW, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25:114-117.
13. Ramkumar PN, Chu CT, Harris JD, et al. Causes and rates of unplanned readmissions after elective primary total joint arthroplasty: a systematic review and meta-analysis. Am J Orthop. 2015;44:397-405.
14. Klingenstein GG, Schoifet SD, Jain RK, et al. Rapid discharge to home after total knee arthroplasty is safe in eligible Medicare patients. J Arthroplasty. 2017;32:3308-3313.
15. Epstein NE. Multidisciplinary in-hospital teams improve patient outcomes: A review. Surg Neurol Int. 2014;5(Suppl 7):S295-S303.
From Grant Medical Center (Dr. Wasielewski, Dr. Polonia, Ms. Barca, Ms. Cebriak, Ms. Lucki), and OhioHealth Group (Mr. Rogers, Ms. St. John, Dr. Gascon), Columbus, OH.
Abstract
- Background: Organizations participating in the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative enter into payment arrangements that include financial and performance accountability for episodes of care. There is growing evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care (eg, skilled nursing facilities [SNF], long-term care facilities, and inpatient rehabilitation facilities).
- Objective: To describe a pilot program designed to reduce the utilization of institutional post-acute care for total joint replacement surgical patients.
- Methods: A multidisciplinary intervention team optimized scheduling, preadmission testing, patient communication, and patient education along a total joint replacement care pathway.
- Results: Among Medicare patients, total discharges to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period. The risk of SNF utilization among patients in the intervention period was nearly half (0.45; 95% confidence interval, 0.314-0.639) that of patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001). The readmission rate was substantially lower than national norms.
- Conclusion: Optimizing patient care throughout the care pathway using the concerted efforts of a multidisciplinary team is possible given a common vision, shared goals, and clearly communicated expectations.
Keywords: arthroplasty; readmissions; Medicare; post-acute care; Bundled Payment for Care Improvement.
Quality improvement in health care is partially dependent upon processes that standardize episodes of care. This is especially true in the post–acute care setting, where efforts to increase patient engagement and care coordination can improve a patient’s recovery process. One framework for optimizing patient care across an episode of care is the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, which links payments for the multiple services patients receive during an episode of care. Organizations participating in the BPCI initiative enter into payment arrangements that include financial and performance accountability for episodes of care. The BPCI initiative provides a framework for episodes of care across multiple types of facilities and clinicians over periods of time (30-day, 60-day, and 90-day episodes).1-5 Evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality is accumulating. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care, such as skilled nursing facilities (SNF), long-term care facilities, and inpatient rehabilitation facilities.1
Our hospital, the Grant Medical Center, which is part of the OhioHealth system, had agreed to participate in the CMS BPCI–Advanced Model for major joint replacement of the lower extremity, with a start date of October 1, 2018. Prior to adopting this bundled payment and service delivery model for major joint replacement through the BPCI program, we implemented strategic interventions to improve the efficiency of care delivery and reduce post-acute utilization. Although the BPCI program applied only to Medicare patients, the interventions that were developed, implemented, and evaluated in this quality improvement project, which we describe in this article, were provided to all patients who underwent lower-extremity joint replacement, regardless of payer.
Gap Analysis
Prior to developing and implementing the intervention, a gap analysis was performed to determine differences between Grant Medical Center’s care pathway/processes and evidence-based best practice. A steering committee comprised of physician champions, rehabilitation services, senior leadership from the Bone and Joint Center, and care management was gathered. The gap analysis examined the care paths in the preoperative phase, index admission phase, and the post-acute phase of care. Findings of the gap analysis included an underutilized joint education class, overutilization of SNF placement, and lack of key resources to assess the needs of patients prior to surgery.
The Grant Bone and Joint Center offered a comprehensive joint education class in person, but also gave patients the option of utilizing an online learning source. While both were successful, staff believed the in-person class had a greater impact than the online version. Patients who attended the class completed a preoperative assessment by hand, which included a social assessment for identifying potential challenges prior to admission. However, because class attendance was low (< 10%), this assessment tool was not utilized until the patient’s admission in most cases. The gap analysis also identified that the educational content of the class lacked key points to encourage a home-going plan.
The baseline SNF utilization rate (using data from July 1, 2015–June 30, 2016) within the Medicare population was 39.5% (70/177), with an overall (all payers) rate of 22.9% (192/838). This SNF utilization rate was higher than the national benchmark, underscoring the need to focus on a preoperative “plan for home” message. In addition, review of Medicare fee-for-service data from 2014 to 2016 revealed that Grant Medical Center utilized 83 different SNFs over the course of approximately 2 years. In this context, staff saw an opportunity to develop stronger relationships with fewer SNF partners, as well as OhioHealth Home Care, in order to improve care by standardizing functional recovery in post-acute care management.
In sum, the gap analysis found that a lack of standardization, follow through, and engagement in daily multidisciplinary rounds often led to a plan for SNF discharge instead of home. As such, it was determined that the pilot program would target the preoperative and post-acute phases of care and that its primary endpoint would be the reduction of the SNF discharge rate among Medicare fee-for-service patients.
Literature Review
Targeting the SNF discharge rate as the endpoint was also supported by a recent study that showed that most of the reduction in spending for total joint replacement within BPCI hospitals was linked to reduced use of institutional post-acute care.1 Other studies in the joint replacement literature have delineated the specific aspects of care redesign that allow hospitals to provide more efficient and effective care delivery during an episode of care.6-8 A review of these and similar studies of joint replacement quality improvement interventions yielded a number of actionable findings:
- Engaging and educating patients and families is critical. Families and other caregivers must be identified preoperatively, actively engaged, and committed to helping the patient recover.
- Providers must build the expectation in patients that they will return home as soon as it is safe to do so. This includes working to restore physiologic function, managing pain with oral medication, and restoring the physical capability of adapting to a home environment.
- Relationships must be established with post-acute care providers who are able to demonstrate best practices and be willing partners on performance outcomes.
- Providers need to invest in personnel to coordinate care transitions initiated preoperatively that continue through the post-acute phase of care.
- Providers must promote processes that allow patients to more fully own their recovery through coaching and improved communication.
A total joint replacement initiative undertaken at another hospital within the OhioHealth system, Riverside Methodist Hospital, that incorporated these aspects of care redesign demonstrated a significant reduction in SNF utilization. That success informed the development of the initiative at Grant Medical Center.
Methods
Setting
This pilot project was conducted from July 2017 through July 2018 at the Grant Bone and Joint Center in the Grant Medical Center, an urban hospital in Columbus, Ohio. The Bone and Joint Center performs more than 7400 surgeries each year, of which 12% are total joint replacements. Grant Medical Center is a Level I Trauma Center that has received a fourth designation in Magnet Nursing status and has attained The Joint Commission Disease-Specific Care Certification for its total knee and hip arthroplasty, total shoulder, and hip fracture programs.
Intervention
The findings from the gap analysis were incorporated into a standardized preoperative care pathway at the Center. Standardization of the care pathway required developing relationships between office staff, schedulers, inpatient work teams, and preadmission testing, as well as physician group realignment with the larger organization.
During this time, the steering committee identified the need for a designated full-time pre-habilitation case manager to support patients undergoing hip and knee replacements at the Center. With the addition of a new role, prehab case manager, attention was directed to patient social assessment and communication. After the surgery was scheduled but prior to the preoperative education class, each patient received a screening phone call from the prehab case manager that included an initial social assessment. The electronic health record (EHR) was utilized to communicate the results of the assessment, including barriers to a home-going plan. The phone call allowed the case manager to reinforce the importance of class attendance for the patient and primary caregiver, and also allowed any specific concerns identified to be addressed and resolved prior to surgery.
A work group consisting of the prehab case manager, office staff, and the bone and joint leadership team focused on improving the core preoperative education content, same-day preadmission clearance, and class attendance. To support these efforts, the work group (1) created a scheduling document to align preadmission testing and the preoperative education class so they occurred on the same day, (2) improved prior authorization of the surgery to support the post-surgical care team, (3) clarified expectations and roles among office staff and care management staff to optimize the discharge process, and (4) engaged the physician team to encourage a culture change towards setting patient expectations to be discharged to home or a preferred SNF location. Regarding prior authorization communications, prior to the intervention, communication was insufficient, paper driven, and lacking in continuity. Utilizing the EHR, an EPIC platform, a designated documentation location was created, which increased communication among the office schedulers, preadmission testing, and surgery schedulers. The consistent location for recording prior authorization avoided canceled surgeries and claim denials due to missing pieces of information. In addition to these process changes, the surgical offices were geographically realigned to a new single location, a change that brought the staff together and in turn allowed for role clarification and team building and also allowed the staff to identify opportunities for improvement.
The core content of the education class was redesigned to support patients’ understanding of the procedure and what to expect during the hospital stay and discharge for home. Staff worked first to align all preadmission patient requirements with the content of the class. In pilot studies, patients were asked to provide feedback, and this feedback was incorporated into subsequent revisions. Staff developed multilingual handouts, including a surgery instruction sheet with a preoperative social assessment, in addition to creating opportunities for 1:1 education when it was medically or socially appropriate.
The work group brought the physicians in the care pathway together for a focused conversation and education regarding the need for including class attendance as part of their practice. They worked with the physicians’ support team to coordinate standardized follow-up care in the post-acute setting and encouraged the physicians to create a “home-going” culture and reset expectations for length of stay. Prior to the start of this project, the rehabilitation department began using the 6-Clicks Inpatient Basic Mobility Short Form, a standardized instrument comprised of short forms created from the Activity Measure for Post-Acute Care (AM-PAC) instrument. The AMPAC score is used to help establish the patient’s functional level; patients scoring 18 or higher have a higher probability of a successful return home (rather than an institutional discharge). Physical therapists at the Center adminster the 6-Clicks tool for each therapy patient daily, and document the AM-PAC score in the appropriate flowsheet in the EHR in a manner consistent with best practices.9-11 The group utilized the AMPAC score to determine functional status upon discharge, offering guidance for the correct post-acute discharge plan.
The workgroup also established a relationship with the lead home health care service to develop a standard notification process to set volume and service expectations. Finally, they worked with the lead SNFs to explain the surgical procedure and set expectations for patient recovery at the facilities. These changes are summarized in the Figure.
Analysis
Descriptive statistics were used to describe patients and metrics in the baseline and performance periods. The difference in the proportion of patients discharged to a SNF in the baseline and performance periods was examined by a Z-test of proportion and change in relative risk. A Z-test of proportion was also used examine differences in the 90-day all-cause readmission rate and in the average length of stay between the 2 periods.
Results
Differences between Medicare fee-for-service patients in the baseline and performance periods are reported in Table 1. While age, sex, diagnoses, and surgical types were similar, AM-PAC scores and the proportion of patients married or living with someone were higher in the performance period. The AM-PAC score in Table 1 represents the last documented score prior to discharge.
The proportion of Medicare patients discharged to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period (Table 2). The 21.9% difference was significant at the 0.05 level (Z = 4.6586, P = 0.0001). Medicare patients in the intervention period had nearly half (0.45) the risk (95% confidence interval, 0.314-0.639) of SNF utilization compared with patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001).
Concomitantly, the 90-day all-cause readmission rate among Medicare patients rose from 2.8% (5/177) to 4.7% (9/192), but the difference in proportions was not statistically significant (Z = –0.9356, P = 0.3495). Similarly, the average length of stay for Medicare patients was 2.9 days in both the baseline and performance periods.
Discussion
The intervention was associated with a statistically significant decrease in the SNF discharge rate following total joint replacement. The readmission rate and average length of stay were statistically unchanged. The lack of a statistically significant change in readmissions is important, as previous research has found that total joint replacement patients discharged to a SNF have higher odds of hospital readmission within 90 days than those discharged home.12 Moreover, the readmission rate in the performance period (4.7%) was still substantially lower than the national estimate of 90-day readmission rates associated with total hip arthroplasty (7.7%) and total knee arthroplasty (9.7%).13 For patients, these quality improvements are associated with improved outcomes and lower costs of care.
These outcomes were achieved after a substantial effort at the facility level to onboard new staff; orient them and their colleagues in each step along the care pathway, from scheduling through post-acute care; and build trust among all team members. The critical difference was changing expectations for post-acute recovery and rehabilitation throughout both the new clinical coordination workflow and processes and the existing processes. Orientation of the clinical coordination role was necessary to establish relationships with inpatient team members who were not as intimately involved with the position and expectations. To accomplish this, competing priorities had to be addressed and resolved through standardization efforts developed and implemented by the multidisciplinary team. The team first reviewed reports of such efforts in the initial review of the BPCI literature.1-5 Subsequent analyses of the most germane study3 and related research14 confirmed that a team-based approach to standardization could be successful. The former study used physician and affiliated care teams to build a care pathway that minimized variation in practices across the episode of care, and the latter used a multidisciplinary team approach to develop rapid recovery protocols. Subsequent research has validated the findings that hospital-based multidisciplinary teams have long been associated with improved patient safety, shorter length of stay, and fewer complications.15
Limitations
This quality improvement project was limited to a single facility. As such, adapting the improvements made to Grant Medical Center’s care pathway for implementation throughout the OhioHealth system will take time due to variation of care provided at each campus; scale-up efforts are ongoing. In the Grant facility, the project uncovered instances of unstandardized provider communication pathways, clinical staff workflows, and expectations for patients. Standardization in all 3 instances improved the patient experience. Additionally, data collection requirements for rigorous research and evaluation efforts that had to be done by hand during the project are now being integrated into the EHR.
The improvements described here, which were implemented in anticipation of adopting the CMS BPCI bundled payment model for joint replacement of the lower extremity, were provided to every patient regardless of payer. Patient outcomes varied across payer, as did preoperative education rates and other variables (Table 1). These differences are being tracked and analyzed following the Center’s entry into the CMS BPCI model on October 1, 2018.
Corresponding author: Gregg M. Gascon, PhD, CHDA, OhioHealth Group, 155 E. Broad Street, Suite 1700, Columbus, Ohio 43215; ggascon@ohiohealthgroup.com.
Financial disclosures: None.
From Grant Medical Center (Dr. Wasielewski, Dr. Polonia, Ms. Barca, Ms. Cebriak, Ms. Lucki), and OhioHealth Group (Mr. Rogers, Ms. St. John, Dr. Gascon), Columbus, OH.
Abstract
- Background: Organizations participating in the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative enter into payment arrangements that include financial and performance accountability for episodes of care. There is growing evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care (eg, skilled nursing facilities [SNF], long-term care facilities, and inpatient rehabilitation facilities).
- Objective: To describe a pilot program designed to reduce the utilization of institutional post-acute care for total joint replacement surgical patients.
- Methods: A multidisciplinary intervention team optimized scheduling, preadmission testing, patient communication, and patient education along a total joint replacement care pathway.
- Results: Among Medicare patients, total discharges to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period. The risk of SNF utilization among patients in the intervention period was nearly half (0.45; 95% confidence interval, 0.314-0.639) that of patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001). The readmission rate was substantially lower than national norms.
- Conclusion: Optimizing patient care throughout the care pathway using the concerted efforts of a multidisciplinary team is possible given a common vision, shared goals, and clearly communicated expectations.
Keywords: arthroplasty; readmissions; Medicare; post-acute care; Bundled Payment for Care Improvement.
Quality improvement in health care is partially dependent upon processes that standardize episodes of care. This is especially true in the post–acute care setting, where efforts to increase patient engagement and care coordination can improve a patient’s recovery process. One framework for optimizing patient care across an episode of care is the Centers for Medicare and Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, which links payments for the multiple services patients receive during an episode of care. Organizations participating in the BPCI initiative enter into payment arrangements that include financial and performance accountability for episodes of care. The BPCI initiative provides a framework for episodes of care across multiple types of facilities and clinicians over periods of time (30-day, 60-day, and 90-day episodes).1-5 Evidence that the use of these payment incentives reduces spending for episodes of care while maintaining or improving quality is accumulating. A recent study of BPCI and quality outcomes in joint replacement episodes found that nearly all the reduction in spending within BPCI hospitals was generated from the reduced use of institutional post-acute care, such as skilled nursing facilities (SNF), long-term care facilities, and inpatient rehabilitation facilities.1
Our hospital, the Grant Medical Center, which is part of the OhioHealth system, had agreed to participate in the CMS BPCI–Advanced Model for major joint replacement of the lower extremity, with a start date of October 1, 2018. Prior to adopting this bundled payment and service delivery model for major joint replacement through the BPCI program, we implemented strategic interventions to improve the efficiency of care delivery and reduce post-acute utilization. Although the BPCI program applied only to Medicare patients, the interventions that were developed, implemented, and evaluated in this quality improvement project, which we describe in this article, were provided to all patients who underwent lower-extremity joint replacement, regardless of payer.
Gap Analysis
Prior to developing and implementing the intervention, a gap analysis was performed to determine differences between Grant Medical Center’s care pathway/processes and evidence-based best practice. A steering committee comprised of physician champions, rehabilitation services, senior leadership from the Bone and Joint Center, and care management was gathered. The gap analysis examined the care paths in the preoperative phase, index admission phase, and the post-acute phase of care. Findings of the gap analysis included an underutilized joint education class, overutilization of SNF placement, and lack of key resources to assess the needs of patients prior to surgery.
The Grant Bone and Joint Center offered a comprehensive joint education class in person, but also gave patients the option of utilizing an online learning source. While both were successful, staff believed the in-person class had a greater impact than the online version. Patients who attended the class completed a preoperative assessment by hand, which included a social assessment for identifying potential challenges prior to admission. However, because class attendance was low (< 10%), this assessment tool was not utilized until the patient’s admission in most cases. The gap analysis also identified that the educational content of the class lacked key points to encourage a home-going plan.
The baseline SNF utilization rate (using data from July 1, 2015–June 30, 2016) within the Medicare population was 39.5% (70/177), with an overall (all payers) rate of 22.9% (192/838). This SNF utilization rate was higher than the national benchmark, underscoring the need to focus on a preoperative “plan for home” message. In addition, review of Medicare fee-for-service data from 2014 to 2016 revealed that Grant Medical Center utilized 83 different SNFs over the course of approximately 2 years. In this context, staff saw an opportunity to develop stronger relationships with fewer SNF partners, as well as OhioHealth Home Care, in order to improve care by standardizing functional recovery in post-acute care management.
In sum, the gap analysis found that a lack of standardization, follow through, and engagement in daily multidisciplinary rounds often led to a plan for SNF discharge instead of home. As such, it was determined that the pilot program would target the preoperative and post-acute phases of care and that its primary endpoint would be the reduction of the SNF discharge rate among Medicare fee-for-service patients.
Literature Review
Targeting the SNF discharge rate as the endpoint was also supported by a recent study that showed that most of the reduction in spending for total joint replacement within BPCI hospitals was linked to reduced use of institutional post-acute care.1 Other studies in the joint replacement literature have delineated the specific aspects of care redesign that allow hospitals to provide more efficient and effective care delivery during an episode of care.6-8 A review of these and similar studies of joint replacement quality improvement interventions yielded a number of actionable findings:
- Engaging and educating patients and families is critical. Families and other caregivers must be identified preoperatively, actively engaged, and committed to helping the patient recover.
- Providers must build the expectation in patients that they will return home as soon as it is safe to do so. This includes working to restore physiologic function, managing pain with oral medication, and restoring the physical capability of adapting to a home environment.
- Relationships must be established with post-acute care providers who are able to demonstrate best practices and be willing partners on performance outcomes.
- Providers need to invest in personnel to coordinate care transitions initiated preoperatively that continue through the post-acute phase of care.
- Providers must promote processes that allow patients to more fully own their recovery through coaching and improved communication.
A total joint replacement initiative undertaken at another hospital within the OhioHealth system, Riverside Methodist Hospital, that incorporated these aspects of care redesign demonstrated a significant reduction in SNF utilization. That success informed the development of the initiative at Grant Medical Center.
Methods
Setting
This pilot project was conducted from July 2017 through July 2018 at the Grant Bone and Joint Center in the Grant Medical Center, an urban hospital in Columbus, Ohio. The Bone and Joint Center performs more than 7400 surgeries each year, of which 12% are total joint replacements. Grant Medical Center is a Level I Trauma Center that has received a fourth designation in Magnet Nursing status and has attained The Joint Commission Disease-Specific Care Certification for its total knee and hip arthroplasty, total shoulder, and hip fracture programs.
Intervention
The findings from the gap analysis were incorporated into a standardized preoperative care pathway at the Center. Standardization of the care pathway required developing relationships between office staff, schedulers, inpatient work teams, and preadmission testing, as well as physician group realignment with the larger organization.
During this time, the steering committee identified the need for a designated full-time pre-habilitation case manager to support patients undergoing hip and knee replacements at the Center. With the addition of a new role, prehab case manager, attention was directed to patient social assessment and communication. After the surgery was scheduled but prior to the preoperative education class, each patient received a screening phone call from the prehab case manager that included an initial social assessment. The electronic health record (EHR) was utilized to communicate the results of the assessment, including barriers to a home-going plan. The phone call allowed the case manager to reinforce the importance of class attendance for the patient and primary caregiver, and also allowed any specific concerns identified to be addressed and resolved prior to surgery.
A work group consisting of the prehab case manager, office staff, and the bone and joint leadership team focused on improving the core preoperative education content, same-day preadmission clearance, and class attendance. To support these efforts, the work group (1) created a scheduling document to align preadmission testing and the preoperative education class so they occurred on the same day, (2) improved prior authorization of the surgery to support the post-surgical care team, (3) clarified expectations and roles among office staff and care management staff to optimize the discharge process, and (4) engaged the physician team to encourage a culture change towards setting patient expectations to be discharged to home or a preferred SNF location. Regarding prior authorization communications, prior to the intervention, communication was insufficient, paper driven, and lacking in continuity. Utilizing the EHR, an EPIC platform, a designated documentation location was created, which increased communication among the office schedulers, preadmission testing, and surgery schedulers. The consistent location for recording prior authorization avoided canceled surgeries and claim denials due to missing pieces of information. In addition to these process changes, the surgical offices were geographically realigned to a new single location, a change that brought the staff together and in turn allowed for role clarification and team building and also allowed the staff to identify opportunities for improvement.
The core content of the education class was redesigned to support patients’ understanding of the procedure and what to expect during the hospital stay and discharge for home. Staff worked first to align all preadmission patient requirements with the content of the class. In pilot studies, patients were asked to provide feedback, and this feedback was incorporated into subsequent revisions. Staff developed multilingual handouts, including a surgery instruction sheet with a preoperative social assessment, in addition to creating opportunities for 1:1 education when it was medically or socially appropriate.
The work group brought the physicians in the care pathway together for a focused conversation and education regarding the need for including class attendance as part of their practice. They worked with the physicians’ support team to coordinate standardized follow-up care in the post-acute setting and encouraged the physicians to create a “home-going” culture and reset expectations for length of stay. Prior to the start of this project, the rehabilitation department began using the 6-Clicks Inpatient Basic Mobility Short Form, a standardized instrument comprised of short forms created from the Activity Measure for Post-Acute Care (AM-PAC) instrument. The AMPAC score is used to help establish the patient’s functional level; patients scoring 18 or higher have a higher probability of a successful return home (rather than an institutional discharge). Physical therapists at the Center adminster the 6-Clicks tool for each therapy patient daily, and document the AM-PAC score in the appropriate flowsheet in the EHR in a manner consistent with best practices.9-11 The group utilized the AMPAC score to determine functional status upon discharge, offering guidance for the correct post-acute discharge plan.
The workgroup also established a relationship with the lead home health care service to develop a standard notification process to set volume and service expectations. Finally, they worked with the lead SNFs to explain the surgical procedure and set expectations for patient recovery at the facilities. These changes are summarized in the Figure.
Analysis
Descriptive statistics were used to describe patients and metrics in the baseline and performance periods. The difference in the proportion of patients discharged to a SNF in the baseline and performance periods was examined by a Z-test of proportion and change in relative risk. A Z-test of proportion was also used examine differences in the 90-day all-cause readmission rate and in the average length of stay between the 2 periods.
Results
Differences between Medicare fee-for-service patients in the baseline and performance periods are reported in Table 1. While age, sex, diagnoses, and surgical types were similar, AM-PAC scores and the proportion of patients married or living with someone were higher in the performance period. The AM-PAC score in Table 1 represents the last documented score prior to discharge.
The proportion of Medicare patients discharged to a SNF fell from 39.5% (70/177) in the baseline period to 17.7% (34/192) in the performance period (Table 2). The 21.9% difference was significant at the 0.05 level (Z = 4.6586, P = 0.0001). Medicare patients in the intervention period had nearly half (0.45) the risk (95% confidence interval, 0.314-0.639) of SNF utilization compared with patients in the baseline period. Using Fisher’s exact test and a 2-tailed test, this reduction was found to be significant (P < 0.0001).
Concomitantly, the 90-day all-cause readmission rate among Medicare patients rose from 2.8% (5/177) to 4.7% (9/192), but the difference in proportions was not statistically significant (Z = –0.9356, P = 0.3495). Similarly, the average length of stay for Medicare patients was 2.9 days in both the baseline and performance periods.
Discussion
The intervention was associated with a statistically significant decrease in the SNF discharge rate following total joint replacement. The readmission rate and average length of stay were statistically unchanged. The lack of a statistically significant change in readmissions is important, as previous research has found that total joint replacement patients discharged to a SNF have higher odds of hospital readmission within 90 days than those discharged home.12 Moreover, the readmission rate in the performance period (4.7%) was still substantially lower than the national estimate of 90-day readmission rates associated with total hip arthroplasty (7.7%) and total knee arthroplasty (9.7%).13 For patients, these quality improvements are associated with improved outcomes and lower costs of care.
These outcomes were achieved after a substantial effort at the facility level to onboard new staff; orient them and their colleagues in each step along the care pathway, from scheduling through post-acute care; and build trust among all team members. The critical difference was changing expectations for post-acute recovery and rehabilitation throughout both the new clinical coordination workflow and processes and the existing processes. Orientation of the clinical coordination role was necessary to establish relationships with inpatient team members who were not as intimately involved with the position and expectations. To accomplish this, competing priorities had to be addressed and resolved through standardization efforts developed and implemented by the multidisciplinary team. The team first reviewed reports of such efforts in the initial review of the BPCI literature.1-5 Subsequent analyses of the most germane study3 and related research14 confirmed that a team-based approach to standardization could be successful. The former study used physician and affiliated care teams to build a care pathway that minimized variation in practices across the episode of care, and the latter used a multidisciplinary team approach to develop rapid recovery protocols. Subsequent research has validated the findings that hospital-based multidisciplinary teams have long been associated with improved patient safety, shorter length of stay, and fewer complications.15
Limitations
This quality improvement project was limited to a single facility. As such, adapting the improvements made to Grant Medical Center’s care pathway for implementation throughout the OhioHealth system will take time due to variation of care provided at each campus; scale-up efforts are ongoing. In the Grant facility, the project uncovered instances of unstandardized provider communication pathways, clinical staff workflows, and expectations for patients. Standardization in all 3 instances improved the patient experience. Additionally, data collection requirements for rigorous research and evaluation efforts that had to be done by hand during the project are now being integrated into the EHR.
The improvements described here, which were implemented in anticipation of adopting the CMS BPCI bundled payment model for joint replacement of the lower extremity, were provided to every patient regardless of payer. Patient outcomes varied across payer, as did preoperative education rates and other variables (Table 1). These differences are being tracked and analyzed following the Center’s entry into the CMS BPCI model on October 1, 2018.
Corresponding author: Gregg M. Gascon, PhD, CHDA, OhioHealth Group, 155 E. Broad Street, Suite 1700, Columbus, Ohio 43215; ggascon@ohiohealthgroup.com.
Financial disclosures: None.
1. Dummit LA, Kahvecioglu D, Marrufo G, et al. Association between hospital participation in a Medicare bundled payment initiative and payments and quality outcomes for lower extremity joint replacement episodes. JAMA. 2016;316:1267-1278.
2. Urdapilleta O, Weinberg D, Pedersen S, et al. Evaluation of the Medicare Acute Care Episodes (ACE) demonstration: final evaluation report. Centers for Medicare & Medicaid Services. May 31, 2013. http://downloads.cms.gov/files/cmmi/ACE-EvaluationReport-Final-5-2-14.pdf.
3. Froemke C, Wang L, DeHart ML, et al. Standardizing care and improving quality under a bundled payment initiative for total joint arthroplasty. J Arthroplasty. 2015;30:1676-1682.
4. US Department of Health and Human Services. (2015 Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. New Release. January 26, 2015.
5. Tsai TC, Joynt KE, Wild RC, et al. Medicare’s Bundled Payment Initiatives: most hospitals are focused on a few high-volume conditions. Health Aff (Millwood). 2015;34;371-380.
6. Mechanic RE. Opportunities and challenges for episode-based payment. N Engl J Med. 2011,365:777-779.
7. Mallinson TR, Bateman J, Tseng HY, et al. A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery. Arch Phys Med Rehabil. 2011:92:712-720.
8. Froimson M, Deadwiller M, Schill M, Cousineau K. Early results of a total joint bundled payment program: the BPCI initiative. Poster No. 2026. Poster presented at Orthopaedic Research Society Annual Meeting; March 15-18, 2014; New Orleans, LA.
9. Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42(1 Suppl):S49-S61.
10. Jette DU, Stilphen M, Ranganathan VK, et al. Validity of the AM-PAC “6-Clicks” inpatient daily activity and basic mobility short forms. Phys Ther. 2014;94;379-391.
11. Jette DU, Stilphen M, Ranganathan VK, et al. AM-PAC “6-Clicks” functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014;94:1252-1261.
12. Bini SA, Fithian DC, Paxton LW, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25:114-117.
13. Ramkumar PN, Chu CT, Harris JD, et al. Causes and rates of unplanned readmissions after elective primary total joint arthroplasty: a systematic review and meta-analysis. Am J Orthop. 2015;44:397-405.
14. Klingenstein GG, Schoifet SD, Jain RK, et al. Rapid discharge to home after total knee arthroplasty is safe in eligible Medicare patients. J Arthroplasty. 2017;32:3308-3313.
15. Epstein NE. Multidisciplinary in-hospital teams improve patient outcomes: A review. Surg Neurol Int. 2014;5(Suppl 7):S295-S303.
1. Dummit LA, Kahvecioglu D, Marrufo G, et al. Association between hospital participation in a Medicare bundled payment initiative and payments and quality outcomes for lower extremity joint replacement episodes. JAMA. 2016;316:1267-1278.
2. Urdapilleta O, Weinberg D, Pedersen S, et al. Evaluation of the Medicare Acute Care Episodes (ACE) demonstration: final evaluation report. Centers for Medicare & Medicaid Services. May 31, 2013. http://downloads.cms.gov/files/cmmi/ACE-EvaluationReport-Final-5-2-14.pdf.
3. Froemke C, Wang L, DeHart ML, et al. Standardizing care and improving quality under a bundled payment initiative for total joint arthroplasty. J Arthroplasty. 2015;30:1676-1682.
4. US Department of Health and Human Services. (2015 Better, smarter, healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value. New Release. January 26, 2015.
5. Tsai TC, Joynt KE, Wild RC, et al. Medicare’s Bundled Payment Initiatives: most hospitals are focused on a few high-volume conditions. Health Aff (Millwood). 2015;34;371-380.
6. Mechanic RE. Opportunities and challenges for episode-based payment. N Engl J Med. 2011,365:777-779.
7. Mallinson TR, Bateman J, Tseng HY, et al. A comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after lower-extremity joint replacement surgery. Arch Phys Med Rehabil. 2011:92:712-720.
8. Froimson M, Deadwiller M, Schill M, Cousineau K. Early results of a total joint bundled payment program: the BPCI initiative. Poster No. 2026. Poster presented at Orthopaedic Research Society Annual Meeting; March 15-18, 2014; New Orleans, LA.
9. Haley SM, Coster WJ, Andres PL, et al. Activity outcome measurement for postacute care. Med Care. 2004;42(1 Suppl):S49-S61.
10. Jette DU, Stilphen M, Ranganathan VK, et al. Validity of the AM-PAC “6-Clicks” inpatient daily activity and basic mobility short forms. Phys Ther. 2014;94;379-391.
11. Jette DU, Stilphen M, Ranganathan VK, et al. AM-PAC “6-Clicks” functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014;94:1252-1261.
12. Bini SA, Fithian DC, Paxton LW, et al. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25:114-117.
13. Ramkumar PN, Chu CT, Harris JD, et al. Causes and rates of unplanned readmissions after elective primary total joint arthroplasty: a systematic review and meta-analysis. Am J Orthop. 2015;44:397-405.
14. Klingenstein GG, Schoifet SD, Jain RK, et al. Rapid discharge to home after total knee arthroplasty is safe in eligible Medicare patients. J Arthroplasty. 2017;32:3308-3313.
15. Epstein NE. Multidisciplinary in-hospital teams improve patient outcomes: A review. Surg Neurol Int. 2014;5(Suppl 7):S295-S303.
Malpractice risk: Focus on care, documentation
SAN DIEGO – Mental health professionals can lower the risk of legal exposure from patients filing malpractice suits through proper assessment and proper documentation, a psychiatrist said at the annual Psych Congress.
“You don’t have to have a perfect performance, but you do have to gather relevant data. And you’ll be judged on whether you took reasonable precautions once you identified the risk,” said Phillip J. Resnick, MD, professor of psychiatry at Case Western Reserve University, Cleveland.
Research suggests that 35% of malpractice claims involve incorrect treatment and 19% involve medication problems. More than half of all U.S. physicians reportedly have been sued, and psychiatrists are named in lawsuits less often than other medical specialists.
What’s “reasonable” in terms of assessment and precautions? In the past, courts may have held to a community standard: Did you provide the usual care that others in your region would provide? This approach allowed physicians to avoid responsibility if “you could prove that the majority of [local] doctors do what you did,” Dr. Resnick said, even if they’re “sloppy and bad.”
A newer, “reasonably prudent practitioner” standard expects medical professionals to do the right thing no matter where they live. who has consulted on numerous well-known cases, including that of Jeffrey Dahmer, Susan Smith, Timothy McVey, and Theodore Kaczynski.
Psychiatrists can be vulnerable legally if they refuse to respond to concerns from family members, Dr. Resnick said. The best approach is to listen. “You don’t need permission to listen – only to release information. You can always listen.”
Dr. Resnick is a former president of the American Academy of Psychiatry and the Law. He has no disclosures.
SAN DIEGO – Mental health professionals can lower the risk of legal exposure from patients filing malpractice suits through proper assessment and proper documentation, a psychiatrist said at the annual Psych Congress.
“You don’t have to have a perfect performance, but you do have to gather relevant data. And you’ll be judged on whether you took reasonable precautions once you identified the risk,” said Phillip J. Resnick, MD, professor of psychiatry at Case Western Reserve University, Cleveland.
Research suggests that 35% of malpractice claims involve incorrect treatment and 19% involve medication problems. More than half of all U.S. physicians reportedly have been sued, and psychiatrists are named in lawsuits less often than other medical specialists.
What’s “reasonable” in terms of assessment and precautions? In the past, courts may have held to a community standard: Did you provide the usual care that others in your region would provide? This approach allowed physicians to avoid responsibility if “you could prove that the majority of [local] doctors do what you did,” Dr. Resnick said, even if they’re “sloppy and bad.”
A newer, “reasonably prudent practitioner” standard expects medical professionals to do the right thing no matter where they live. who has consulted on numerous well-known cases, including that of Jeffrey Dahmer, Susan Smith, Timothy McVey, and Theodore Kaczynski.
Psychiatrists can be vulnerable legally if they refuse to respond to concerns from family members, Dr. Resnick said. The best approach is to listen. “You don’t need permission to listen – only to release information. You can always listen.”
Dr. Resnick is a former president of the American Academy of Psychiatry and the Law. He has no disclosures.
SAN DIEGO – Mental health professionals can lower the risk of legal exposure from patients filing malpractice suits through proper assessment and proper documentation, a psychiatrist said at the annual Psych Congress.
“You don’t have to have a perfect performance, but you do have to gather relevant data. And you’ll be judged on whether you took reasonable precautions once you identified the risk,” said Phillip J. Resnick, MD, professor of psychiatry at Case Western Reserve University, Cleveland.
Research suggests that 35% of malpractice claims involve incorrect treatment and 19% involve medication problems. More than half of all U.S. physicians reportedly have been sued, and psychiatrists are named in lawsuits less often than other medical specialists.
What’s “reasonable” in terms of assessment and precautions? In the past, courts may have held to a community standard: Did you provide the usual care that others in your region would provide? This approach allowed physicians to avoid responsibility if “you could prove that the majority of [local] doctors do what you did,” Dr. Resnick said, even if they’re “sloppy and bad.”
A newer, “reasonably prudent practitioner” standard expects medical professionals to do the right thing no matter where they live. who has consulted on numerous well-known cases, including that of Jeffrey Dahmer, Susan Smith, Timothy McVey, and Theodore Kaczynski.
Psychiatrists can be vulnerable legally if they refuse to respond to concerns from family members, Dr. Resnick said. The best approach is to listen. “You don’t need permission to listen – only to release information. You can always listen.”
Dr. Resnick is a former president of the American Academy of Psychiatry and the Law. He has no disclosures.
REPORTING FROM PSYCH CONGRESS 2019