Paper ED Discharge Instructions: Ready, Set, Delete?

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CHICAGO – Roughly a fourth of ED patients are ready to hit the delete button on standard written discharge instructions.

When asked 30 days post discharge how they preferred to receive their antibiotic discharge instructions, 26% of patients said they prefer text messages or voice mail to written instructions alone.

Dr. Travis Olives

"It’s an interesting finding, and it’s not really been discussed in the literature that I could find," lead author Dr. Travis Olives said at the annual meeting of the Society for Academic Emergency Medicine.

He pointed out that ED discharge information is commonly written at 8th- to 13th-grade reading levels and that as many as 45% of ED patients are unable to comprehend this level of written complexity yet are unaware of their low level of comprehension.

"I can’t understand them myself when I read them, frankly," he quipped.

It was in this context that the investigators sought to determine whether patient preference for discharge instruction modality varies by health literacy levels.

The secondary analysis included 660 patients enrolled in a prospective randomized trial who were discharged with outpatient antibiotics from an urban county ED with an annual census of 100,000. Patients were randomly assigned to typed and verbal medication and case-specific instructions (standard of care) or standard of care plus text messages sent to the patient’s cell phone or standard of care plus voice-mailed instructions sent to the patient’s cell phone.

Health literacy assessment using the Newest Vital Sign test classified 23% as likely having limited literacy (NVS score 0-1), 31% as possibly having limited literacy (score 2-3), and 46% as having adequate literacy (score 4-6). Their median age was 30 years, and 55% were female.

Among the 51% of participants reached by telephone at 30 days, more than 50% across all health literacy levels preferred either a modality other than written or a combination of modalities, said Dr. Olives, a resident with the Hennepin County Medical Center in Minneapolis.

Text messages were preferred by 18.75% of participants with limited health literacy, 10.4% with possibly limited literacy, and 12.5% with adequate literacy. Voice-mailed instructions were preferred by 7.5%, 3.25%, and 6%, respectively.

To protect the privacy of participants, all text messages and voice mails were sent without identifiers or a diagnosis. For example, the script for a text simply said: "Take doxycycline 100 mg two times a day for 7 days."

Standard typewritten instructions were preferred by 40% of patients with limited literacy, 32% with possibly limited literacy, and 44% with adequate literacy, he said during the poster presentation.

© Hocus Focus Studio/iStockphoto.com
26% of emergency patients said they would prefer their discharge instructions to be delivered via text messages or a voice mail.

The proportion of patients who preferred discharge instructions in written form plus another modality varied significantly across health literacy levels (13.75% NVS score 0-1, 42% NVS score 2-3, and 20% NVS score 4-6; P = .017). With the exception of "written plus another modality," patient preference was similar across all NVS score groups.

Dr. Olives said the study is ongoing and that the goal is to access hard outcomes such as antibiotic compliance among 3,000 ED patients. So far 1,800 patients have been enrolled. The data show, not surprisingly, that 72-hour prescription pickup varies by health literacy level, with compliance increasing with increasing health literacy, he said.

An audience member asked whether the investigators had a hard time tracking patients down by telephone, remarking that when ED physicians ask a patient for a contact number, the number they’re given is usually different from the number the patient gave at registration.

Dr. Olives said they verified the phone number directly with the patient and then cross-referenced it with what was in the electronic medical record. If any discrepancy was found, health coordinators corrected the phone numbers in the record.

He said fewer than a dozen patients gave a bad cell phone number and pointed out that a recent unpublished study reported patient cell phone penetration of more than 99%.

"I know that’s not the case for all populations, but it’s a lot higher than I anticipated going in to this study," Dr. Olives added. "We did not have a lot of trouble with patients without a cell phone."

Dr. Olives reported no relevant conflicts of interest.

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CHICAGO – Roughly a fourth of ED patients are ready to hit the delete button on standard written discharge instructions.

When asked 30 days post discharge how they preferred to receive their antibiotic discharge instructions, 26% of patients said they prefer text messages or voice mail to written instructions alone.

Dr. Travis Olives

"It’s an interesting finding, and it’s not really been discussed in the literature that I could find," lead author Dr. Travis Olives said at the annual meeting of the Society for Academic Emergency Medicine.

He pointed out that ED discharge information is commonly written at 8th- to 13th-grade reading levels and that as many as 45% of ED patients are unable to comprehend this level of written complexity yet are unaware of their low level of comprehension.

"I can’t understand them myself when I read them, frankly," he quipped.

It was in this context that the investigators sought to determine whether patient preference for discharge instruction modality varies by health literacy levels.

The secondary analysis included 660 patients enrolled in a prospective randomized trial who were discharged with outpatient antibiotics from an urban county ED with an annual census of 100,000. Patients were randomly assigned to typed and verbal medication and case-specific instructions (standard of care) or standard of care plus text messages sent to the patient’s cell phone or standard of care plus voice-mailed instructions sent to the patient’s cell phone.

Health literacy assessment using the Newest Vital Sign test classified 23% as likely having limited literacy (NVS score 0-1), 31% as possibly having limited literacy (score 2-3), and 46% as having adequate literacy (score 4-6). Their median age was 30 years, and 55% were female.

Among the 51% of participants reached by telephone at 30 days, more than 50% across all health literacy levels preferred either a modality other than written or a combination of modalities, said Dr. Olives, a resident with the Hennepin County Medical Center in Minneapolis.

Text messages were preferred by 18.75% of participants with limited health literacy, 10.4% with possibly limited literacy, and 12.5% with adequate literacy. Voice-mailed instructions were preferred by 7.5%, 3.25%, and 6%, respectively.

To protect the privacy of participants, all text messages and voice mails were sent without identifiers or a diagnosis. For example, the script for a text simply said: "Take doxycycline 100 mg two times a day for 7 days."

Standard typewritten instructions were preferred by 40% of patients with limited literacy, 32% with possibly limited literacy, and 44% with adequate literacy, he said during the poster presentation.

© Hocus Focus Studio/iStockphoto.com
26% of emergency patients said they would prefer their discharge instructions to be delivered via text messages or a voice mail.

The proportion of patients who preferred discharge instructions in written form plus another modality varied significantly across health literacy levels (13.75% NVS score 0-1, 42% NVS score 2-3, and 20% NVS score 4-6; P = .017). With the exception of "written plus another modality," patient preference was similar across all NVS score groups.

Dr. Olives said the study is ongoing and that the goal is to access hard outcomes such as antibiotic compliance among 3,000 ED patients. So far 1,800 patients have been enrolled. The data show, not surprisingly, that 72-hour prescription pickup varies by health literacy level, with compliance increasing with increasing health literacy, he said.

An audience member asked whether the investigators had a hard time tracking patients down by telephone, remarking that when ED physicians ask a patient for a contact number, the number they’re given is usually different from the number the patient gave at registration.

Dr. Olives said they verified the phone number directly with the patient and then cross-referenced it with what was in the electronic medical record. If any discrepancy was found, health coordinators corrected the phone numbers in the record.

He said fewer than a dozen patients gave a bad cell phone number and pointed out that a recent unpublished study reported patient cell phone penetration of more than 99%.

"I know that’s not the case for all populations, but it’s a lot higher than I anticipated going in to this study," Dr. Olives added. "We did not have a lot of trouble with patients without a cell phone."

Dr. Olives reported no relevant conflicts of interest.

CHICAGO – Roughly a fourth of ED patients are ready to hit the delete button on standard written discharge instructions.

When asked 30 days post discharge how they preferred to receive their antibiotic discharge instructions, 26% of patients said they prefer text messages or voice mail to written instructions alone.

Dr. Travis Olives

"It’s an interesting finding, and it’s not really been discussed in the literature that I could find," lead author Dr. Travis Olives said at the annual meeting of the Society for Academic Emergency Medicine.

He pointed out that ED discharge information is commonly written at 8th- to 13th-grade reading levels and that as many as 45% of ED patients are unable to comprehend this level of written complexity yet are unaware of their low level of comprehension.

"I can’t understand them myself when I read them, frankly," he quipped.

It was in this context that the investigators sought to determine whether patient preference for discharge instruction modality varies by health literacy levels.

The secondary analysis included 660 patients enrolled in a prospective randomized trial who were discharged with outpatient antibiotics from an urban county ED with an annual census of 100,000. Patients were randomly assigned to typed and verbal medication and case-specific instructions (standard of care) or standard of care plus text messages sent to the patient’s cell phone or standard of care plus voice-mailed instructions sent to the patient’s cell phone.

Health literacy assessment using the Newest Vital Sign test classified 23% as likely having limited literacy (NVS score 0-1), 31% as possibly having limited literacy (score 2-3), and 46% as having adequate literacy (score 4-6). Their median age was 30 years, and 55% were female.

Among the 51% of participants reached by telephone at 30 days, more than 50% across all health literacy levels preferred either a modality other than written or a combination of modalities, said Dr. Olives, a resident with the Hennepin County Medical Center in Minneapolis.

Text messages were preferred by 18.75% of participants with limited health literacy, 10.4% with possibly limited literacy, and 12.5% with adequate literacy. Voice-mailed instructions were preferred by 7.5%, 3.25%, and 6%, respectively.

To protect the privacy of participants, all text messages and voice mails were sent without identifiers or a diagnosis. For example, the script for a text simply said: "Take doxycycline 100 mg two times a day for 7 days."

Standard typewritten instructions were preferred by 40% of patients with limited literacy, 32% with possibly limited literacy, and 44% with adequate literacy, he said during the poster presentation.

© Hocus Focus Studio/iStockphoto.com
26% of emergency patients said they would prefer their discharge instructions to be delivered via text messages or a voice mail.

The proportion of patients who preferred discharge instructions in written form plus another modality varied significantly across health literacy levels (13.75% NVS score 0-1, 42% NVS score 2-3, and 20% NVS score 4-6; P = .017). With the exception of "written plus another modality," patient preference was similar across all NVS score groups.

Dr. Olives said the study is ongoing and that the goal is to access hard outcomes such as antibiotic compliance among 3,000 ED patients. So far 1,800 patients have been enrolled. The data show, not surprisingly, that 72-hour prescription pickup varies by health literacy level, with compliance increasing with increasing health literacy, he said.

An audience member asked whether the investigators had a hard time tracking patients down by telephone, remarking that when ED physicians ask a patient for a contact number, the number they’re given is usually different from the number the patient gave at registration.

Dr. Olives said they verified the phone number directly with the patient and then cross-referenced it with what was in the electronic medical record. If any discrepancy was found, health coordinators corrected the phone numbers in the record.

He said fewer than a dozen patients gave a bad cell phone number and pointed out that a recent unpublished study reported patient cell phone penetration of more than 99%.

"I know that’s not the case for all populations, but it’s a lot higher than I anticipated going in to this study," Dr. Olives added. "We did not have a lot of trouble with patients without a cell phone."

Dr. Olives reported no relevant conflicts of interest.

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Major Finding: Among the 51% of participants reached by telephone at 30 days, more than 50% across all health literacy levels preferred either a modality other than written or a combination of modalities.

Data Source: Data are from a secondary analysis of 660 urban ED patients enrolled in a prospective, randomized trial and discharged with outpatient antibiotic instructions.

Disclosures: Dr. Olives reported no relevant disclosures.

Massachusetts Health Reform Impact on ED Visits Tepid

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CHICAGO – The 2006 Massachusetts health care reform law that expanded insurance coverage to unprecedented levels resulted in modest increases in emergency department and hospital utilization among adults, according to preliminary results from a large observational study.

For adults under age 65, ED visits increased from 1,970,976 in 2005 to 2,279,492 in 2009, while hospitalizations increased from 457,298 to 490,458.

Dr. Peter Smulowitz

Adults older than 65 years had 450,933 ED visits before reform and 470,109 ED visits after reform, while hospitalizations in this group totaled 223,229 before and 300,596 after reform.

The rate of uninsured patients decreased over the same period, from 6.2% to 3.7% among ED patients and from 1.3% to 0.6% among hospitalized patients, Dr. Peter Smulowitz, an instructor in medicine at Harvard Medical School in Boston, said at the annual meeting of the Society for Academic Emergency Medicine.

In regression modeling that controlled for secular trends and other confounders, the increased insurance rates had a positive but nonsignificant effect on ED visits among those under age 65 (P = .09) and a significant, positive impact on those over 65 (P = .01).

Increasing insurance predicted increasing hospitalizations for the under-65 population (P = .03), while there was a negative effect for increasing insurance on hospitalizations for the over-65 population (P = .003).

The modest, nonsignificant uptick in ED use among younger adults may represent barriers in access to primary care, Dr. Smulowitz suggested. "The results are mostly consistent with our hypothesis that limitations and access to care will make it so that patients who are newly insured will not necessarily have another place to gain care, and so emergency department visits will remain constant, if not slightly increase, and hospitalizations might increase as well," he said.

The 2006 Massachusetts law has been used as a model for the Affordable Care Act and is being closely watched. Many physicians thought insurance would increase ED use because of continued barriers in access to care, while many policy makers thought reform efforts would result in a dramatic decrease in ED visits, Dr. Smulowitz observed.

Earlier research showed a null effect of the 2006 law on ED use in Massachusetts compared with neighboring Vermont and New Hampshire (N. Engl. J. Med. 2011;365:e25).

The current analysis compared geographic differences, at the zip code level, in the percentage of uninsured during a 1-year period before health care reform and an identical period after reform using administrative data from 2005 to 2009 in the Massachusetts Division of Health Care Finance and Policy Acute Hospital Case Mix database. Overall, there were 2,421,909 ED visits and 680,527 hospitalizations before reform and 2,580,088 ED visits and 791,054 hospitalizations after reform.

Session moderator Dr. Katherine Heilpern, chair of emergency medicine at Emory University in Atlanta, said the findings of a modest increase in ED and hospital utilization fly in the face of dire headlines about the Massachusetts experience, and asked whether the issue is just a matter of granularity.

Dr. Smulowitz responded that the ability to delve into the data over several years and to control for secular trends provides a very different take than just looking at raw numbers. He said additional models are warranted to further clarify the findings, particularly in terms of comparing differences in ED and hospitalization rates between the under- and over-65 populations.

He also stressed that the data are preliminary, and acknowledged that the study was limited by assumptions that the population within a zip code remains stable over time and that the changing insurance rate mirrors the overall population.

Dr. Smulowitz reported funding from the Charles A. King Trust Postdoctoral Research Fellow program and the Eleanor and Miles Shore Fellowship Program for Scholars in Medicine.

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CHICAGO – The 2006 Massachusetts health care reform law that expanded insurance coverage to unprecedented levels resulted in modest increases in emergency department and hospital utilization among adults, according to preliminary results from a large observational study.

For adults under age 65, ED visits increased from 1,970,976 in 2005 to 2,279,492 in 2009, while hospitalizations increased from 457,298 to 490,458.

Dr. Peter Smulowitz

Adults older than 65 years had 450,933 ED visits before reform and 470,109 ED visits after reform, while hospitalizations in this group totaled 223,229 before and 300,596 after reform.

The rate of uninsured patients decreased over the same period, from 6.2% to 3.7% among ED patients and from 1.3% to 0.6% among hospitalized patients, Dr. Peter Smulowitz, an instructor in medicine at Harvard Medical School in Boston, said at the annual meeting of the Society for Academic Emergency Medicine.

In regression modeling that controlled for secular trends and other confounders, the increased insurance rates had a positive but nonsignificant effect on ED visits among those under age 65 (P = .09) and a significant, positive impact on those over 65 (P = .01).

Increasing insurance predicted increasing hospitalizations for the under-65 population (P = .03), while there was a negative effect for increasing insurance on hospitalizations for the over-65 population (P = .003).

The modest, nonsignificant uptick in ED use among younger adults may represent barriers in access to primary care, Dr. Smulowitz suggested. "The results are mostly consistent with our hypothesis that limitations and access to care will make it so that patients who are newly insured will not necessarily have another place to gain care, and so emergency department visits will remain constant, if not slightly increase, and hospitalizations might increase as well," he said.

The 2006 Massachusetts law has been used as a model for the Affordable Care Act and is being closely watched. Many physicians thought insurance would increase ED use because of continued barriers in access to care, while many policy makers thought reform efforts would result in a dramatic decrease in ED visits, Dr. Smulowitz observed.

Earlier research showed a null effect of the 2006 law on ED use in Massachusetts compared with neighboring Vermont and New Hampshire (N. Engl. J. Med. 2011;365:e25).

The current analysis compared geographic differences, at the zip code level, in the percentage of uninsured during a 1-year period before health care reform and an identical period after reform using administrative data from 2005 to 2009 in the Massachusetts Division of Health Care Finance and Policy Acute Hospital Case Mix database. Overall, there were 2,421,909 ED visits and 680,527 hospitalizations before reform and 2,580,088 ED visits and 791,054 hospitalizations after reform.

Session moderator Dr. Katherine Heilpern, chair of emergency medicine at Emory University in Atlanta, said the findings of a modest increase in ED and hospital utilization fly in the face of dire headlines about the Massachusetts experience, and asked whether the issue is just a matter of granularity.

Dr. Smulowitz responded that the ability to delve into the data over several years and to control for secular trends provides a very different take than just looking at raw numbers. He said additional models are warranted to further clarify the findings, particularly in terms of comparing differences in ED and hospitalization rates between the under- and over-65 populations.

He also stressed that the data are preliminary, and acknowledged that the study was limited by assumptions that the population within a zip code remains stable over time and that the changing insurance rate mirrors the overall population.

Dr. Smulowitz reported funding from the Charles A. King Trust Postdoctoral Research Fellow program and the Eleanor and Miles Shore Fellowship Program for Scholars in Medicine.

CHICAGO – The 2006 Massachusetts health care reform law that expanded insurance coverage to unprecedented levels resulted in modest increases in emergency department and hospital utilization among adults, according to preliminary results from a large observational study.

For adults under age 65, ED visits increased from 1,970,976 in 2005 to 2,279,492 in 2009, while hospitalizations increased from 457,298 to 490,458.

Dr. Peter Smulowitz

Adults older than 65 years had 450,933 ED visits before reform and 470,109 ED visits after reform, while hospitalizations in this group totaled 223,229 before and 300,596 after reform.

The rate of uninsured patients decreased over the same period, from 6.2% to 3.7% among ED patients and from 1.3% to 0.6% among hospitalized patients, Dr. Peter Smulowitz, an instructor in medicine at Harvard Medical School in Boston, said at the annual meeting of the Society for Academic Emergency Medicine.

In regression modeling that controlled for secular trends and other confounders, the increased insurance rates had a positive but nonsignificant effect on ED visits among those under age 65 (P = .09) and a significant, positive impact on those over 65 (P = .01).

Increasing insurance predicted increasing hospitalizations for the under-65 population (P = .03), while there was a negative effect for increasing insurance on hospitalizations for the over-65 population (P = .003).

The modest, nonsignificant uptick in ED use among younger adults may represent barriers in access to primary care, Dr. Smulowitz suggested. "The results are mostly consistent with our hypothesis that limitations and access to care will make it so that patients who are newly insured will not necessarily have another place to gain care, and so emergency department visits will remain constant, if not slightly increase, and hospitalizations might increase as well," he said.

The 2006 Massachusetts law has been used as a model for the Affordable Care Act and is being closely watched. Many physicians thought insurance would increase ED use because of continued barriers in access to care, while many policy makers thought reform efforts would result in a dramatic decrease in ED visits, Dr. Smulowitz observed.

Earlier research showed a null effect of the 2006 law on ED use in Massachusetts compared with neighboring Vermont and New Hampshire (N. Engl. J. Med. 2011;365:e25).

The current analysis compared geographic differences, at the zip code level, in the percentage of uninsured during a 1-year period before health care reform and an identical period after reform using administrative data from 2005 to 2009 in the Massachusetts Division of Health Care Finance and Policy Acute Hospital Case Mix database. Overall, there were 2,421,909 ED visits and 680,527 hospitalizations before reform and 2,580,088 ED visits and 791,054 hospitalizations after reform.

Session moderator Dr. Katherine Heilpern, chair of emergency medicine at Emory University in Atlanta, said the findings of a modest increase in ED and hospital utilization fly in the face of dire headlines about the Massachusetts experience, and asked whether the issue is just a matter of granularity.

Dr. Smulowitz responded that the ability to delve into the data over several years and to control for secular trends provides a very different take than just looking at raw numbers. He said additional models are warranted to further clarify the findings, particularly in terms of comparing differences in ED and hospitalization rates between the under- and over-65 populations.

He also stressed that the data are preliminary, and acknowledged that the study was limited by assumptions that the population within a zip code remains stable over time and that the changing insurance rate mirrors the overall population.

Dr. Smulowitz reported funding from the Charles A. King Trust Postdoctoral Research Fellow program and the Eleanor and Miles Shore Fellowship Program for Scholars in Medicine.

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Analysis Supports FAST Exam in Pediatric Blunt Trauma

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CHICAGO – The bedside focused assessment with sonography for trauma exam is used infrequently in children with blunt abdominal trauma.

When the FAST exam was used in children with a low to moderate risk of intra-abdominal injury (IAI), however, there was a substantial reduction in subsequent abdominal CT use, a planned subanalysis of a large prospective, observational trial showed.

Patrice Wendling/IMNG Medical Media
Dr. James Holmes

Although the FAST exam was shown to safely decrease abdominal CT use in two randomized trials in adults, its use in children who have blunt abdominal trauma is controversial, Dr. James Holmes observed at the annual meeting of the Society for Academic Emergency Medicine.

"One of the concerns is that ultrasound is not 100% sensitive," he said. "Depending on what study you look at, it’s about 60%-70% for all intra-abdominal injuries and 80%-90% for fluid. So there’s the risk that – if you have a negative ultrasound – that child could still have an intra-abdominal injury." However, he added, "we had no patients that had a negative ultrasound that subsequently had a missed injury."

The 20-center prospective study enrolled children younger than 18 years (median, 10.7 years) with blunt abdominal trauma and a Glasgow Coma Scale score greater than 8. Children were excluded from the analysis if they went directly from the emergency department to the operating suite prior to CT, had age-adjusted hypotension, or came from one of eight centers performing FAST exams on fewer than 5% of patients.

In all, 6,558 patients were eligible, 3,076 (47%) underwent abdominal CT, 381 (5.8%) were diagnosed with IAI, and 887 (13.5%) underwent the FAST exam.

Although FAST was not used that often, the variability among sites was quite impressive, with some centers just barely above the cutoff at 5.5% and others using the exam in 58% of eligible patients, said Dr. Holmes, professor of emergency medicine at University of California Davis Health System in Sacramento.

Notably, use of the FAST exam increased as clinician suspicion for IAI increased: 11% in patients with a less-than-1% (very low) risk of IAI, 13.5% with a low (1%-5%) risk, 20.5% with a moderate (6%-10%) risk, 23.2% with a high (11%-50%) risk, and 30.7% with a very high (greater than 50%) risk.

Overall CT rates were 22.2%, 67%, 89.7%, 95%, and 97.2%, respectively.

Relative risk calculations for CT use stratified by clinician suspicion of IAI showed that patients with low or moderate risk of IAI were less likely to undergo CT scans following a FAST exam than were those who did not have the exam, Dr. Holmes said. The CT rate with a FAST exam was 55.2% vs. 68% without the exam among low-risk patients (relative risk, 0.81) and 80% vs. 92.4% among moderate-risk patients (RR, 0.85).

"That’s a substantial reduction in CT use in those populations," he noted.

No difference was seen when the FAST exam was performed in children at high risk (RR, 0.99) or very high risk (RR, 0.97) of IAI because they essentially all went on to CT. Similarly, those at very low risk of IAI derived little benefit from the exam (RR, 0.97), probably because the vast majority of these patients don’t undergo CT scans, he said.

During a discussion of the results, Dr. Holmes said the observation that FAST use decreases CT scans in low- to moderate-risk patients makes sense because the FAST exam has a reported negative likelihood ratio of 0.2 in children.

"If you have someone who has a 5% risk, once you apply that ultrasound to that patient and a likelihood ratio of 0.2, it decreases their risk substantially such that they’re at really low risk of having an intra-abdominal injury," he said. "We think the sweet spot is that group around 5%, based upon that prior literature that showed a negative likelihood ratio of 0.2."

According to the researchers, led by Dr. Jay Menaker of the University of Maryland Medical Center in Baltimore, a randomized, controlled trial is required to determine the benefits and drawbacks of the FAST exam in the evaluation of pediatric blunt trauma.

Dr. Holmes said they are already in the process of a single-site trial using 1:1 block randomization to the FAST exam after initial history and physical examination or to no FAST exam, with patients followed through their hospital course, if admitted, or contacted by telephone 1 week later, if discharged from the ED. Outcomes will include CT rates, length of stay in the ED, missed intra-abdominal injury, or delayed diagnosis of IAI.

This work was supported by the Centers for Disease Control and Prevention and the Emergency Medical Services for Children Program.

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CHICAGO – The bedside focused assessment with sonography for trauma exam is used infrequently in children with blunt abdominal trauma.

When the FAST exam was used in children with a low to moderate risk of intra-abdominal injury (IAI), however, there was a substantial reduction in subsequent abdominal CT use, a planned subanalysis of a large prospective, observational trial showed.

Patrice Wendling/IMNG Medical Media
Dr. James Holmes

Although the FAST exam was shown to safely decrease abdominal CT use in two randomized trials in adults, its use in children who have blunt abdominal trauma is controversial, Dr. James Holmes observed at the annual meeting of the Society for Academic Emergency Medicine.

"One of the concerns is that ultrasound is not 100% sensitive," he said. "Depending on what study you look at, it’s about 60%-70% for all intra-abdominal injuries and 80%-90% for fluid. So there’s the risk that – if you have a negative ultrasound – that child could still have an intra-abdominal injury." However, he added, "we had no patients that had a negative ultrasound that subsequently had a missed injury."

The 20-center prospective study enrolled children younger than 18 years (median, 10.7 years) with blunt abdominal trauma and a Glasgow Coma Scale score greater than 8. Children were excluded from the analysis if they went directly from the emergency department to the operating suite prior to CT, had age-adjusted hypotension, or came from one of eight centers performing FAST exams on fewer than 5% of patients.

In all, 6,558 patients were eligible, 3,076 (47%) underwent abdominal CT, 381 (5.8%) were diagnosed with IAI, and 887 (13.5%) underwent the FAST exam.

Although FAST was not used that often, the variability among sites was quite impressive, with some centers just barely above the cutoff at 5.5% and others using the exam in 58% of eligible patients, said Dr. Holmes, professor of emergency medicine at University of California Davis Health System in Sacramento.

Notably, use of the FAST exam increased as clinician suspicion for IAI increased: 11% in patients with a less-than-1% (very low) risk of IAI, 13.5% with a low (1%-5%) risk, 20.5% with a moderate (6%-10%) risk, 23.2% with a high (11%-50%) risk, and 30.7% with a very high (greater than 50%) risk.

Overall CT rates were 22.2%, 67%, 89.7%, 95%, and 97.2%, respectively.

Relative risk calculations for CT use stratified by clinician suspicion of IAI showed that patients with low or moderate risk of IAI were less likely to undergo CT scans following a FAST exam than were those who did not have the exam, Dr. Holmes said. The CT rate with a FAST exam was 55.2% vs. 68% without the exam among low-risk patients (relative risk, 0.81) and 80% vs. 92.4% among moderate-risk patients (RR, 0.85).

"That’s a substantial reduction in CT use in those populations," he noted.

No difference was seen when the FAST exam was performed in children at high risk (RR, 0.99) or very high risk (RR, 0.97) of IAI because they essentially all went on to CT. Similarly, those at very low risk of IAI derived little benefit from the exam (RR, 0.97), probably because the vast majority of these patients don’t undergo CT scans, he said.

During a discussion of the results, Dr. Holmes said the observation that FAST use decreases CT scans in low- to moderate-risk patients makes sense because the FAST exam has a reported negative likelihood ratio of 0.2 in children.

"If you have someone who has a 5% risk, once you apply that ultrasound to that patient and a likelihood ratio of 0.2, it decreases their risk substantially such that they’re at really low risk of having an intra-abdominal injury," he said. "We think the sweet spot is that group around 5%, based upon that prior literature that showed a negative likelihood ratio of 0.2."

According to the researchers, led by Dr. Jay Menaker of the University of Maryland Medical Center in Baltimore, a randomized, controlled trial is required to determine the benefits and drawbacks of the FAST exam in the evaluation of pediatric blunt trauma.

Dr. Holmes said they are already in the process of a single-site trial using 1:1 block randomization to the FAST exam after initial history and physical examination or to no FAST exam, with patients followed through their hospital course, if admitted, or contacted by telephone 1 week later, if discharged from the ED. Outcomes will include CT rates, length of stay in the ED, missed intra-abdominal injury, or delayed diagnosis of IAI.

This work was supported by the Centers for Disease Control and Prevention and the Emergency Medical Services for Children Program.

CHICAGO – The bedside focused assessment with sonography for trauma exam is used infrequently in children with blunt abdominal trauma.

When the FAST exam was used in children with a low to moderate risk of intra-abdominal injury (IAI), however, there was a substantial reduction in subsequent abdominal CT use, a planned subanalysis of a large prospective, observational trial showed.

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Dr. James Holmes

Although the FAST exam was shown to safely decrease abdominal CT use in two randomized trials in adults, its use in children who have blunt abdominal trauma is controversial, Dr. James Holmes observed at the annual meeting of the Society for Academic Emergency Medicine.

"One of the concerns is that ultrasound is not 100% sensitive," he said. "Depending on what study you look at, it’s about 60%-70% for all intra-abdominal injuries and 80%-90% for fluid. So there’s the risk that – if you have a negative ultrasound – that child could still have an intra-abdominal injury." However, he added, "we had no patients that had a negative ultrasound that subsequently had a missed injury."

The 20-center prospective study enrolled children younger than 18 years (median, 10.7 years) with blunt abdominal trauma and a Glasgow Coma Scale score greater than 8. Children were excluded from the analysis if they went directly from the emergency department to the operating suite prior to CT, had age-adjusted hypotension, or came from one of eight centers performing FAST exams on fewer than 5% of patients.

In all, 6,558 patients were eligible, 3,076 (47%) underwent abdominal CT, 381 (5.8%) were diagnosed with IAI, and 887 (13.5%) underwent the FAST exam.

Although FAST was not used that often, the variability among sites was quite impressive, with some centers just barely above the cutoff at 5.5% and others using the exam in 58% of eligible patients, said Dr. Holmes, professor of emergency medicine at University of California Davis Health System in Sacramento.

Notably, use of the FAST exam increased as clinician suspicion for IAI increased: 11% in patients with a less-than-1% (very low) risk of IAI, 13.5% with a low (1%-5%) risk, 20.5% with a moderate (6%-10%) risk, 23.2% with a high (11%-50%) risk, and 30.7% with a very high (greater than 50%) risk.

Overall CT rates were 22.2%, 67%, 89.7%, 95%, and 97.2%, respectively.

Relative risk calculations for CT use stratified by clinician suspicion of IAI showed that patients with low or moderate risk of IAI were less likely to undergo CT scans following a FAST exam than were those who did not have the exam, Dr. Holmes said. The CT rate with a FAST exam was 55.2% vs. 68% without the exam among low-risk patients (relative risk, 0.81) and 80% vs. 92.4% among moderate-risk patients (RR, 0.85).

"That’s a substantial reduction in CT use in those populations," he noted.

No difference was seen when the FAST exam was performed in children at high risk (RR, 0.99) or very high risk (RR, 0.97) of IAI because they essentially all went on to CT. Similarly, those at very low risk of IAI derived little benefit from the exam (RR, 0.97), probably because the vast majority of these patients don’t undergo CT scans, he said.

During a discussion of the results, Dr. Holmes said the observation that FAST use decreases CT scans in low- to moderate-risk patients makes sense because the FAST exam has a reported negative likelihood ratio of 0.2 in children.

"If you have someone who has a 5% risk, once you apply that ultrasound to that patient and a likelihood ratio of 0.2, it decreases their risk substantially such that they’re at really low risk of having an intra-abdominal injury," he said. "We think the sweet spot is that group around 5%, based upon that prior literature that showed a negative likelihood ratio of 0.2."

According to the researchers, led by Dr. Jay Menaker of the University of Maryland Medical Center in Baltimore, a randomized, controlled trial is required to determine the benefits and drawbacks of the FAST exam in the evaluation of pediatric blunt trauma.

Dr. Holmes said they are already in the process of a single-site trial using 1:1 block randomization to the FAST exam after initial history and physical examination or to no FAST exam, with patients followed through their hospital course, if admitted, or contacted by telephone 1 week later, if discharged from the ED. Outcomes will include CT rates, length of stay in the ED, missed intra-abdominal injury, or delayed diagnosis of IAI.

This work was supported by the Centers for Disease Control and Prevention and the Emergency Medical Services for Children Program.

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Vitals

Major Finding: The CT rate with a FAST exam was 55% vs. 68% without a FAST exam among low-risk patients (RR 0.81) and 80% vs. 92.4% among moderate-risk patients (RR 0.85).

Data Source: Data are from a planned subanalysis of a 20-center prospective observational study of children with blunt abdominal trauma.

Disclosures: This work was supported by the Centers for Disease Control and Prevention and the Emergency Medical Services for Children Program.

Childhood Obesity Weighs Heavily on EDs

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CHICAGO – Overweight children are 20% more likely to visit the emergency department than are normal-weight children, and they do so for reasons other than injuries and accidents, according to a nationally representative survey.

"I suspect that a big reason we’re seeing this increase in the overweight is that they have chronic conditions that are getting them to the ED," lead author James Dziura, Ph.D., an epidemiologist in the department of emergency medicine and deputy director of the Yale Center for Analytical Sciences in New Haven, Conn., said in an interview.

Dr. James Dziura

That supposition is supported by an alarming new report showing that the prevalence of prediabetes and diabetes among adolescents aged 12-19 years jumped from 9% in 1999 to 23% in 2008 (Pediatrics 2012 May 21 [doi: 10.1542/peds.2011-1082]).

The current analysis used parent-reported weight and height data for 46,707 children, aged 10-17 years, from the cross-sectional, telephone-administered National Survey of Children’s Health. Body mass index was calculated using sex-specific BMI for age growth charts from the Centers for Disease Control and Prevention. Children were categorized as underweight (BMI percentile of 5 or less), normal weight (more than 5 to less than 85), at risk for overweight (85 to less than 95), and overweight (95 or more).

Overall, 15.5% of children were reported to have used the ED in the past year, with the prevalence of at least one ED visit increasing significantly with BMI percentile, from 13% of underweight children to 15% of normal-weight or at-risk children to 19% of overweight children (P less than .001 for overweight vs. all groups or vs. normal weight). Additionally, overweight children were more likely to have more than one visit, Dr. Dziura reported at the annual meeting of the Society for Academic Emergency Medicine.

After adjustment for age, sex, race, ethnicity, insurance type, parent’s education, and parent’s primary language, the odds ratio for ED use was 1.24 in overweight children, compared with those at normal weight. The impact of BMI category was not significantly modified by sex, race, or Hispanic ethnicity.

In all, 49% of overweight children reported an injury, poisoning, or accident as the reason for their ED visit, compared with 61% of at-risk, 62% of normal-weight, and 63% of underweight children (P less than .05; odds ratio, 0.68 for overweight vs. normal weight). The survey asked only if the children came to the ED for one of those three reasons, so specific data on chronic conditions such as diabetes and asthma are not readily available, Dr. Dziura said.

Still, it’s likely that as rates of childhood obesity continue to skyrocket in the United States, there will be greater demands on the ED and an increased emphasis on the care of chronic conditions.

"Given the numbers that were reported in Pediatrics, ... the types of problems that these children are going into the ED with are totally different than what many people in the ED might have been trained for," he said. "So dealing with chronic conditions is going to be a big part of an ED doctor’s skill set."

The investigators hope to conduct a survey looking at the interaction between BMI and chronic conditions and the types of services given and problems encountered in the ED. Eventually, they hope to design a brief screening and intervention for obesity in the ambulatory setting.

"A lot of these children and parents of these children have never been told by a primary care physician they have a weight problem," he said.

A recent study suggests that despite some progress over the last decade, fewer than a quarter of parents of children with a BMI in the 85th percentile or higher report having been told by a physician or health care provider that their child was overweight (Arch. Pediatr. Adolesc. Med. 2012;166:317-22).

The authors reported having no disclosures.

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CHICAGO – Overweight children are 20% more likely to visit the emergency department than are normal-weight children, and they do so for reasons other than injuries and accidents, according to a nationally representative survey.

"I suspect that a big reason we’re seeing this increase in the overweight is that they have chronic conditions that are getting them to the ED," lead author James Dziura, Ph.D., an epidemiologist in the department of emergency medicine and deputy director of the Yale Center for Analytical Sciences in New Haven, Conn., said in an interview.

Dr. James Dziura

That supposition is supported by an alarming new report showing that the prevalence of prediabetes and diabetes among adolescents aged 12-19 years jumped from 9% in 1999 to 23% in 2008 (Pediatrics 2012 May 21 [doi: 10.1542/peds.2011-1082]).

The current analysis used parent-reported weight and height data for 46,707 children, aged 10-17 years, from the cross-sectional, telephone-administered National Survey of Children’s Health. Body mass index was calculated using sex-specific BMI for age growth charts from the Centers for Disease Control and Prevention. Children were categorized as underweight (BMI percentile of 5 or less), normal weight (more than 5 to less than 85), at risk for overweight (85 to less than 95), and overweight (95 or more).

Overall, 15.5% of children were reported to have used the ED in the past year, with the prevalence of at least one ED visit increasing significantly with BMI percentile, from 13% of underweight children to 15% of normal-weight or at-risk children to 19% of overweight children (P less than .001 for overweight vs. all groups or vs. normal weight). Additionally, overweight children were more likely to have more than one visit, Dr. Dziura reported at the annual meeting of the Society for Academic Emergency Medicine.

After adjustment for age, sex, race, ethnicity, insurance type, parent’s education, and parent’s primary language, the odds ratio for ED use was 1.24 in overweight children, compared with those at normal weight. The impact of BMI category was not significantly modified by sex, race, or Hispanic ethnicity.

In all, 49% of overweight children reported an injury, poisoning, or accident as the reason for their ED visit, compared with 61% of at-risk, 62% of normal-weight, and 63% of underweight children (P less than .05; odds ratio, 0.68 for overweight vs. normal weight). The survey asked only if the children came to the ED for one of those three reasons, so specific data on chronic conditions such as diabetes and asthma are not readily available, Dr. Dziura said.

Still, it’s likely that as rates of childhood obesity continue to skyrocket in the United States, there will be greater demands on the ED and an increased emphasis on the care of chronic conditions.

"Given the numbers that were reported in Pediatrics, ... the types of problems that these children are going into the ED with are totally different than what many people in the ED might have been trained for," he said. "So dealing with chronic conditions is going to be a big part of an ED doctor’s skill set."

The investigators hope to conduct a survey looking at the interaction between BMI and chronic conditions and the types of services given and problems encountered in the ED. Eventually, they hope to design a brief screening and intervention for obesity in the ambulatory setting.

"A lot of these children and parents of these children have never been told by a primary care physician they have a weight problem," he said.

A recent study suggests that despite some progress over the last decade, fewer than a quarter of parents of children with a BMI in the 85th percentile or higher report having been told by a physician or health care provider that their child was overweight (Arch. Pediatr. Adolesc. Med. 2012;166:317-22).

The authors reported having no disclosures.

CHICAGO – Overweight children are 20% more likely to visit the emergency department than are normal-weight children, and they do so for reasons other than injuries and accidents, according to a nationally representative survey.

"I suspect that a big reason we’re seeing this increase in the overweight is that they have chronic conditions that are getting them to the ED," lead author James Dziura, Ph.D., an epidemiologist in the department of emergency medicine and deputy director of the Yale Center for Analytical Sciences in New Haven, Conn., said in an interview.

Dr. James Dziura

That supposition is supported by an alarming new report showing that the prevalence of prediabetes and diabetes among adolescents aged 12-19 years jumped from 9% in 1999 to 23% in 2008 (Pediatrics 2012 May 21 [doi: 10.1542/peds.2011-1082]).

The current analysis used parent-reported weight and height data for 46,707 children, aged 10-17 years, from the cross-sectional, telephone-administered National Survey of Children’s Health. Body mass index was calculated using sex-specific BMI for age growth charts from the Centers for Disease Control and Prevention. Children were categorized as underweight (BMI percentile of 5 or less), normal weight (more than 5 to less than 85), at risk for overweight (85 to less than 95), and overweight (95 or more).

Overall, 15.5% of children were reported to have used the ED in the past year, with the prevalence of at least one ED visit increasing significantly with BMI percentile, from 13% of underweight children to 15% of normal-weight or at-risk children to 19% of overweight children (P less than .001 for overweight vs. all groups or vs. normal weight). Additionally, overweight children were more likely to have more than one visit, Dr. Dziura reported at the annual meeting of the Society for Academic Emergency Medicine.

After adjustment for age, sex, race, ethnicity, insurance type, parent’s education, and parent’s primary language, the odds ratio for ED use was 1.24 in overweight children, compared with those at normal weight. The impact of BMI category was not significantly modified by sex, race, or Hispanic ethnicity.

In all, 49% of overweight children reported an injury, poisoning, or accident as the reason for their ED visit, compared with 61% of at-risk, 62% of normal-weight, and 63% of underweight children (P less than .05; odds ratio, 0.68 for overweight vs. normal weight). The survey asked only if the children came to the ED for one of those three reasons, so specific data on chronic conditions such as diabetes and asthma are not readily available, Dr. Dziura said.

Still, it’s likely that as rates of childhood obesity continue to skyrocket in the United States, there will be greater demands on the ED and an increased emphasis on the care of chronic conditions.

"Given the numbers that were reported in Pediatrics, ... the types of problems that these children are going into the ED with are totally different than what many people in the ED might have been trained for," he said. "So dealing with chronic conditions is going to be a big part of an ED doctor’s skill set."

The investigators hope to conduct a survey looking at the interaction between BMI and chronic conditions and the types of services given and problems encountered in the ED. Eventually, they hope to design a brief screening and intervention for obesity in the ambulatory setting.

"A lot of these children and parents of these children have never been told by a primary care physician they have a weight problem," he said.

A recent study suggests that despite some progress over the last decade, fewer than a quarter of parents of children with a BMI in the 85th percentile or higher report having been told by a physician or health care provider that their child was overweight (Arch. Pediatr. Adolesc. Med. 2012;166:317-22).

The authors reported having no disclosures.

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Revised Sepsis Guidelines to Emphasize Best Practices

What's New for Hospitalists?
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CHICAGO – A move toward crystalloids for initial fluid therapy and away from dopamine as a first-line vasopressor are among the new recommendations in the Surviving Sepsis Campaign consensus guidelines for severe sepsis and septic shock due out later this year.

Efforts were extraordinarily vigorous to ensure the independence of the guideline revision, following controversy that unrestricted industry grant funding of previous guidelines may have influenced which treatments were included and how they were rated, Dr. Alan E. Jones said at the annual meeting of the Society for Academic Emergency Medicine (SAEM). No direct or indirect industry support was used for the 2012 revision, and committee members judged to have financial – or even academic – competing interests on a topic were recused from the closed discussion sessions and from voting on the topic.

Dr. Stephen Trzeciak

The revised guidelines will also take into account the often-litigious issue of standard of care, said Dr. Jones, who represented the SAEM on the guideline-writing committee and is an emergency physician at Carolinas Medical Center in Charlotte, N.C. The authors note that resource limitations in some institutions and countries may prevent physicians from accomplishing particular recommendations, and clearly state that the recommendations are intended to be best practices and were not created with standard of care in mind.

"I can tell you that the use of the Surviving Sepsis Campaign guidelines in medical malpractice cases is unbelievable," he said. "Having this statement in there will really help [stress] the fact that these are guidelines and clinicians should not be held to these as a standard, but rather as best practice.

"I think that’s a huge step forward that the committee did truly recognize the power of the guidelines and how [they are] used by nonmedical personnel."

Dr. Stephen W. Trzeciak, who also served as a SAEM representative during the revision process, said the guidelines are important tools that decrease unnecessary heterogeneity in clinical practice, but they also represent a one-size-fits-all approach.

"We take in a lot of very important information at the bedside, and there are plenty of times that we need to deviate from guidelines because ... in taking care of an individual patient, our clinical judgment will be to do something else," he said. "That’s reasonable. In fact, it’s the right thing to do."

Diagnosis

The diagnostic tests that will allow clinicians to make a diagnosis in real time, including identification of the causative organism, are not yet ready for prime time, although this area of sepsis research is going to accelerate over the next 10 years, said Dr. Trzeciak, a critical care and emergency physician at Cooper University Hospital in Camden, N.J.

The guidance on diagnosis remains relatively unchanged, with at least two blood cultures to be obtained before antimicrobial therapy is administered, as long as doing so does not cause a significant delay. The revised guidelines, however, now define this delay as more than 45 minutes and specify that one of the cultures should be drawn percutaneously and the other drawn through a vascular access device.

Vasopressors

One of the big changes in the guidelines for emergency physicians is that norepinephrine is recommended as the first-choice vasopressor, rather than dopamine. This reflects accumulating evidence that dopamine use in patients with septic shock is associated with an increased risk of death and arrhythmias, compared with norepinephrine (Crit. Care Med. 2012;40:725-30), Dr. Trzeciak said. Phenylephrine was also removed from the guidelines and replaced with epinephrine as the treatment of choice when an additional agent is needed to maintain adequate blood pressure.

Initial Fluid Therapy

The new guidelines recommend that crystalloids be used in the initial fluid resuscitation of severe sepsis, and caution against the use of hydroxyethyl starches with a molecular weight greater than 200 kDa or a degree of substitution exceeding .04 because data show they may not be effective and may actually be detrimental, Dr. Jones said. The committee also suggests albumin in the initial fluid resuscitation, based in large part on a recent meta-analysis of 17 studies showing that use of albumin as a resuscitation fluid was associated with lower mortality (odds ratio 0.82; P = .047) in sepsis patients (Crit. Care Med. 2011;39:386-91).

Fluid Responsiveness

The 2012 guidelines also emphasize using dynamic measures such as delta pulse pressure or stroke volume variation to determine the adequacy of fluid resuscitation, rather than such static measures as central venous pressure. The newer dynamic measures of fluid responsiveness have really taken hold in the critical care community, particularly in Europe, and focus on what the left ventricle does in response to fluids rather than what the central venous pressure is, Dr. Jones said.

 

 

Initial Resuscitation

The guidelines now recommend a quantitative resuscitation protocol for patients with sepsis-induced shock, defined as tissue hypotension persisting after initial fluid challenge or blood lactate concentration of 4 mmol/L or more. The guidelines previously identified central venous pressure of 8-12 mm Hg, mean arterial pressure of at least 65 mm Hg, and urine output of at least 0.5 mL/kg per hour as treatment goals during the first 6 hours of resuscitation, and now add central venous (superior vena cava) or mixed venous oxygen saturation of at least 70% or at least 65%, respectively, as a fourth goal.

In patients with elevated lactate levels as a marker of tissue hypoperfusion, the guidelines for the first time suggest targeting resuscitation to normalize lactate as rapidly as possible. Several studies have recently looked at lactate clearance using a target of less than 10%, but in the absence of data on other lactate levels, the committee thought it made more sense to suggest lactate be normalized rather than to shoot for a specific level of clearance, Dr. Jones said.

The Surviving Sepsis Campaign guidelines for severe sepsis and septic shock were last updated in 2008 (Crit. Care Med. 2008;36:296-327). More than 25 international professional medical societies were represented in the review and revision process.

The Gordon and Betty Moore Foundation provides grant support for the Surviving Sepsis Campaign.

Body

Dr. Ian Jenkins of the department of medicine at University of California, San Diego, represented the Society of Hospital Medicine on the revision committee, and shared these observations:

Issues with particular resonance to hospitalists include glycemic control and venous thromboembolism prophylaxis.

Recently the ACP and ACCP have issued guidelines that are less enthusiastic about VTE prophy, and indicate no mortality benefit should be expected. The Surviving Sepsis Campaign guidelines committee draft was very enthusiastic about VTE prophy and implied a potential mortality benefit. It clearly endorsed low-molecular-weight heparin over unfractionated heparin as the agent of choice. This requires some thought and caution because it is based on the PROTECT study (in which the dalteparin group had less pulmonary embolism than the UFH group). PROTECT [Prophylaxis of Thromboembolism in Critical Care Trial] enrolled patients without regard to renal function, but many hospitals use enoxaparin instead of dalteparin, and enoxaparin has significantly more renal clearance than does dalteparin.

Additional evolution in the guidelines includes the backing away from intensive insulin therapy to a more cautious approach after the NICE-SUGAR trial, which found an absolute risk increase in mortality of 2.6%, and the subsequent Endocrine Society guidelines, which now advise a target of less than 180 mg/dL instead of less than 110 mg/dL.

Hospitalists also consider stress ulcer prophylaxis on many patients and the draft includes a 2C (weak) recommendation for proton pump inhibitors (PPIs) over H2-blockers for this purpose. Hospitalists should exercise caution particularly for ward patients in whom stress ulcer prophylaxis is rarely needed because PPI may increase pneumonia and Clostridium difficile rates.

Another major development for this is that Xigris is off the market. Hospitalists don't usually give it, but what is remarkable to me is that this once-promoted therapy has been found ineffective and is unavailable. Over time, the recommendations for intensive insulin and to test for adrenal insufficiency with adrenocorticotropic hormone have been reversed, and the target population for stress-dose steroids has shrunk considerably. Changes like this make me wonder if other recommendations (for example, the resuscitation protocol) might evolve as well.

Lastly, many hospitalists would like to further explore the issue of identification of sepsis on the wards for urgent intervention.

Dr. Jenkins said that he had no relevant conflicts of interest.

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Body

Dr. Ian Jenkins of the department of medicine at University of California, San Diego, represented the Society of Hospital Medicine on the revision committee, and shared these observations:

Issues with particular resonance to hospitalists include glycemic control and venous thromboembolism prophylaxis.

Recently the ACP and ACCP have issued guidelines that are less enthusiastic about VTE prophy, and indicate no mortality benefit should be expected. The Surviving Sepsis Campaign guidelines committee draft was very enthusiastic about VTE prophy and implied a potential mortality benefit. It clearly endorsed low-molecular-weight heparin over unfractionated heparin as the agent of choice. This requires some thought and caution because it is based on the PROTECT study (in which the dalteparin group had less pulmonary embolism than the UFH group). PROTECT [Prophylaxis of Thromboembolism in Critical Care Trial] enrolled patients without regard to renal function, but many hospitals use enoxaparin instead of dalteparin, and enoxaparin has significantly more renal clearance than does dalteparin.

Additional evolution in the guidelines includes the backing away from intensive insulin therapy to a more cautious approach after the NICE-SUGAR trial, which found an absolute risk increase in mortality of 2.6%, and the subsequent Endocrine Society guidelines, which now advise a target of less than 180 mg/dL instead of less than 110 mg/dL.

Hospitalists also consider stress ulcer prophylaxis on many patients and the draft includes a 2C (weak) recommendation for proton pump inhibitors (PPIs) over H2-blockers for this purpose. Hospitalists should exercise caution particularly for ward patients in whom stress ulcer prophylaxis is rarely needed because PPI may increase pneumonia and Clostridium difficile rates.

Another major development for this is that Xigris is off the market. Hospitalists don't usually give it, but what is remarkable to me is that this once-promoted therapy has been found ineffective and is unavailable. Over time, the recommendations for intensive insulin and to test for adrenal insufficiency with adrenocorticotropic hormone have been reversed, and the target population for stress-dose steroids has shrunk considerably. Changes like this make me wonder if other recommendations (for example, the resuscitation protocol) might evolve as well.

Lastly, many hospitalists would like to further explore the issue of identification of sepsis on the wards for urgent intervention.

Dr. Jenkins said that he had no relevant conflicts of interest.

Body

Dr. Ian Jenkins of the department of medicine at University of California, San Diego, represented the Society of Hospital Medicine on the revision committee, and shared these observations:

Issues with particular resonance to hospitalists include glycemic control and venous thromboembolism prophylaxis.

Recently the ACP and ACCP have issued guidelines that are less enthusiastic about VTE prophy, and indicate no mortality benefit should be expected. The Surviving Sepsis Campaign guidelines committee draft was very enthusiastic about VTE prophy and implied a potential mortality benefit. It clearly endorsed low-molecular-weight heparin over unfractionated heparin as the agent of choice. This requires some thought and caution because it is based on the PROTECT study (in which the dalteparin group had less pulmonary embolism than the UFH group). PROTECT [Prophylaxis of Thromboembolism in Critical Care Trial] enrolled patients without regard to renal function, but many hospitals use enoxaparin instead of dalteparin, and enoxaparin has significantly more renal clearance than does dalteparin.

Additional evolution in the guidelines includes the backing away from intensive insulin therapy to a more cautious approach after the NICE-SUGAR trial, which found an absolute risk increase in mortality of 2.6%, and the subsequent Endocrine Society guidelines, which now advise a target of less than 180 mg/dL instead of less than 110 mg/dL.

Hospitalists also consider stress ulcer prophylaxis on many patients and the draft includes a 2C (weak) recommendation for proton pump inhibitors (PPIs) over H2-blockers for this purpose. Hospitalists should exercise caution particularly for ward patients in whom stress ulcer prophylaxis is rarely needed because PPI may increase pneumonia and Clostridium difficile rates.

Another major development for this is that Xigris is off the market. Hospitalists don't usually give it, but what is remarkable to me is that this once-promoted therapy has been found ineffective and is unavailable. Over time, the recommendations for intensive insulin and to test for adrenal insufficiency with adrenocorticotropic hormone have been reversed, and the target population for stress-dose steroids has shrunk considerably. Changes like this make me wonder if other recommendations (for example, the resuscitation protocol) might evolve as well.

Lastly, many hospitalists would like to further explore the issue of identification of sepsis on the wards for urgent intervention.

Dr. Jenkins said that he had no relevant conflicts of interest.

Title
What's New for Hospitalists?
What's New for Hospitalists?

CHICAGO – A move toward crystalloids for initial fluid therapy and away from dopamine as a first-line vasopressor are among the new recommendations in the Surviving Sepsis Campaign consensus guidelines for severe sepsis and septic shock due out later this year.

Efforts were extraordinarily vigorous to ensure the independence of the guideline revision, following controversy that unrestricted industry grant funding of previous guidelines may have influenced which treatments were included and how they were rated, Dr. Alan E. Jones said at the annual meeting of the Society for Academic Emergency Medicine (SAEM). No direct or indirect industry support was used for the 2012 revision, and committee members judged to have financial – or even academic – competing interests on a topic were recused from the closed discussion sessions and from voting on the topic.

Dr. Stephen Trzeciak

The revised guidelines will also take into account the often-litigious issue of standard of care, said Dr. Jones, who represented the SAEM on the guideline-writing committee and is an emergency physician at Carolinas Medical Center in Charlotte, N.C. The authors note that resource limitations in some institutions and countries may prevent physicians from accomplishing particular recommendations, and clearly state that the recommendations are intended to be best practices and were not created with standard of care in mind.

"I can tell you that the use of the Surviving Sepsis Campaign guidelines in medical malpractice cases is unbelievable," he said. "Having this statement in there will really help [stress] the fact that these are guidelines and clinicians should not be held to these as a standard, but rather as best practice.

"I think that’s a huge step forward that the committee did truly recognize the power of the guidelines and how [they are] used by nonmedical personnel."

Dr. Stephen W. Trzeciak, who also served as a SAEM representative during the revision process, said the guidelines are important tools that decrease unnecessary heterogeneity in clinical practice, but they also represent a one-size-fits-all approach.

"We take in a lot of very important information at the bedside, and there are plenty of times that we need to deviate from guidelines because ... in taking care of an individual patient, our clinical judgment will be to do something else," he said. "That’s reasonable. In fact, it’s the right thing to do."

Diagnosis

The diagnostic tests that will allow clinicians to make a diagnosis in real time, including identification of the causative organism, are not yet ready for prime time, although this area of sepsis research is going to accelerate over the next 10 years, said Dr. Trzeciak, a critical care and emergency physician at Cooper University Hospital in Camden, N.J.

The guidance on diagnosis remains relatively unchanged, with at least two blood cultures to be obtained before antimicrobial therapy is administered, as long as doing so does not cause a significant delay. The revised guidelines, however, now define this delay as more than 45 minutes and specify that one of the cultures should be drawn percutaneously and the other drawn through a vascular access device.

Vasopressors

One of the big changes in the guidelines for emergency physicians is that norepinephrine is recommended as the first-choice vasopressor, rather than dopamine. This reflects accumulating evidence that dopamine use in patients with septic shock is associated with an increased risk of death and arrhythmias, compared with norepinephrine (Crit. Care Med. 2012;40:725-30), Dr. Trzeciak said. Phenylephrine was also removed from the guidelines and replaced with epinephrine as the treatment of choice when an additional agent is needed to maintain adequate blood pressure.

Initial Fluid Therapy

The new guidelines recommend that crystalloids be used in the initial fluid resuscitation of severe sepsis, and caution against the use of hydroxyethyl starches with a molecular weight greater than 200 kDa or a degree of substitution exceeding .04 because data show they may not be effective and may actually be detrimental, Dr. Jones said. The committee also suggests albumin in the initial fluid resuscitation, based in large part on a recent meta-analysis of 17 studies showing that use of albumin as a resuscitation fluid was associated with lower mortality (odds ratio 0.82; P = .047) in sepsis patients (Crit. Care Med. 2011;39:386-91).

Fluid Responsiveness

The 2012 guidelines also emphasize using dynamic measures such as delta pulse pressure or stroke volume variation to determine the adequacy of fluid resuscitation, rather than such static measures as central venous pressure. The newer dynamic measures of fluid responsiveness have really taken hold in the critical care community, particularly in Europe, and focus on what the left ventricle does in response to fluids rather than what the central venous pressure is, Dr. Jones said.

 

 

Initial Resuscitation

The guidelines now recommend a quantitative resuscitation protocol for patients with sepsis-induced shock, defined as tissue hypotension persisting after initial fluid challenge or blood lactate concentration of 4 mmol/L or more. The guidelines previously identified central venous pressure of 8-12 mm Hg, mean arterial pressure of at least 65 mm Hg, and urine output of at least 0.5 mL/kg per hour as treatment goals during the first 6 hours of resuscitation, and now add central venous (superior vena cava) or mixed venous oxygen saturation of at least 70% or at least 65%, respectively, as a fourth goal.

In patients with elevated lactate levels as a marker of tissue hypoperfusion, the guidelines for the first time suggest targeting resuscitation to normalize lactate as rapidly as possible. Several studies have recently looked at lactate clearance using a target of less than 10%, but in the absence of data on other lactate levels, the committee thought it made more sense to suggest lactate be normalized rather than to shoot for a specific level of clearance, Dr. Jones said.

The Surviving Sepsis Campaign guidelines for severe sepsis and septic shock were last updated in 2008 (Crit. Care Med. 2008;36:296-327). More than 25 international professional medical societies were represented in the review and revision process.

The Gordon and Betty Moore Foundation provides grant support for the Surviving Sepsis Campaign.

CHICAGO – A move toward crystalloids for initial fluid therapy and away from dopamine as a first-line vasopressor are among the new recommendations in the Surviving Sepsis Campaign consensus guidelines for severe sepsis and septic shock due out later this year.

Efforts were extraordinarily vigorous to ensure the independence of the guideline revision, following controversy that unrestricted industry grant funding of previous guidelines may have influenced which treatments were included and how they were rated, Dr. Alan E. Jones said at the annual meeting of the Society for Academic Emergency Medicine (SAEM). No direct or indirect industry support was used for the 2012 revision, and committee members judged to have financial – or even academic – competing interests on a topic were recused from the closed discussion sessions and from voting on the topic.

Dr. Stephen Trzeciak

The revised guidelines will also take into account the often-litigious issue of standard of care, said Dr. Jones, who represented the SAEM on the guideline-writing committee and is an emergency physician at Carolinas Medical Center in Charlotte, N.C. The authors note that resource limitations in some institutions and countries may prevent physicians from accomplishing particular recommendations, and clearly state that the recommendations are intended to be best practices and were not created with standard of care in mind.

"I can tell you that the use of the Surviving Sepsis Campaign guidelines in medical malpractice cases is unbelievable," he said. "Having this statement in there will really help [stress] the fact that these are guidelines and clinicians should not be held to these as a standard, but rather as best practice.

"I think that’s a huge step forward that the committee did truly recognize the power of the guidelines and how [they are] used by nonmedical personnel."

Dr. Stephen W. Trzeciak, who also served as a SAEM representative during the revision process, said the guidelines are important tools that decrease unnecessary heterogeneity in clinical practice, but they also represent a one-size-fits-all approach.

"We take in a lot of very important information at the bedside, and there are plenty of times that we need to deviate from guidelines because ... in taking care of an individual patient, our clinical judgment will be to do something else," he said. "That’s reasonable. In fact, it’s the right thing to do."

Diagnosis

The diagnostic tests that will allow clinicians to make a diagnosis in real time, including identification of the causative organism, are not yet ready for prime time, although this area of sepsis research is going to accelerate over the next 10 years, said Dr. Trzeciak, a critical care and emergency physician at Cooper University Hospital in Camden, N.J.

The guidance on diagnosis remains relatively unchanged, with at least two blood cultures to be obtained before antimicrobial therapy is administered, as long as doing so does not cause a significant delay. The revised guidelines, however, now define this delay as more than 45 minutes and specify that one of the cultures should be drawn percutaneously and the other drawn through a vascular access device.

Vasopressors

One of the big changes in the guidelines for emergency physicians is that norepinephrine is recommended as the first-choice vasopressor, rather than dopamine. This reflects accumulating evidence that dopamine use in patients with septic shock is associated with an increased risk of death and arrhythmias, compared with norepinephrine (Crit. Care Med. 2012;40:725-30), Dr. Trzeciak said. Phenylephrine was also removed from the guidelines and replaced with epinephrine as the treatment of choice when an additional agent is needed to maintain adequate blood pressure.

Initial Fluid Therapy

The new guidelines recommend that crystalloids be used in the initial fluid resuscitation of severe sepsis, and caution against the use of hydroxyethyl starches with a molecular weight greater than 200 kDa or a degree of substitution exceeding .04 because data show they may not be effective and may actually be detrimental, Dr. Jones said. The committee also suggests albumin in the initial fluid resuscitation, based in large part on a recent meta-analysis of 17 studies showing that use of albumin as a resuscitation fluid was associated with lower mortality (odds ratio 0.82; P = .047) in sepsis patients (Crit. Care Med. 2011;39:386-91).

Fluid Responsiveness

The 2012 guidelines also emphasize using dynamic measures such as delta pulse pressure or stroke volume variation to determine the adequacy of fluid resuscitation, rather than such static measures as central venous pressure. The newer dynamic measures of fluid responsiveness have really taken hold in the critical care community, particularly in Europe, and focus on what the left ventricle does in response to fluids rather than what the central venous pressure is, Dr. Jones said.

 

 

Initial Resuscitation

The guidelines now recommend a quantitative resuscitation protocol for patients with sepsis-induced shock, defined as tissue hypotension persisting after initial fluid challenge or blood lactate concentration of 4 mmol/L or more. The guidelines previously identified central venous pressure of 8-12 mm Hg, mean arterial pressure of at least 65 mm Hg, and urine output of at least 0.5 mL/kg per hour as treatment goals during the first 6 hours of resuscitation, and now add central venous (superior vena cava) or mixed venous oxygen saturation of at least 70% or at least 65%, respectively, as a fourth goal.

In patients with elevated lactate levels as a marker of tissue hypoperfusion, the guidelines for the first time suggest targeting resuscitation to normalize lactate as rapidly as possible. Several studies have recently looked at lactate clearance using a target of less than 10%, but in the absence of data on other lactate levels, the committee thought it made more sense to suggest lactate be normalized rather than to shoot for a specific level of clearance, Dr. Jones said.

The Surviving Sepsis Campaign guidelines for severe sepsis and septic shock were last updated in 2008 (Crit. Care Med. 2008;36:296-327). More than 25 international professional medical societies were represented in the review and revision process.

The Gordon and Betty Moore Foundation provides grant support for the Surviving Sepsis Campaign.

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Extra ED Physician Shift Fails to Cut LOS

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Extra ED Physician Shift Fails to Cut LOS

CHICAGO – Adding an additional physician shift in the ambulatory pod of a typical, high-volume academic center with severe emergency department overcrowding did not reduce overall length of stay in the randomized, controlled PICO-D trial.

"Despite the fact you could say this is a negative trial, the physician group almost unanimously voted to keep this intervention because they were seeing fewer patients, but their quality of life was improved," Dr. Brian H. Rowe said at the annual meeting of the Society for Academic Emergency Medicine. "There was more overlap, more discussion, and less staying 3, 4 hours after the end of their shift."

Patrice Wendling/IMNG Medical Media
Dr. Brian H. Rowe

The unblinded, parallel-group trial compared the traditional schedule of three emergency physician shifts per day (9 a.m. to 5 p.m., 2 p.m. to 10 p.m., and 7 p.m. to 3 a.m.) with four physician shifts per day (9 a.m. to 5 p.m., 1 p.m. to 9 p.m., 5 p.m. to 1 a.m., and 9 p.m. to 5 a.m.) in the ambulatory pod at the University of Alberta Hospital in Edmonton. The schedules were computer generated in 2-week blocks for a total of 12 weeks during mid-2011.

The tertiary care center ED has about 60,000 adult and 30,000 pediatric visits per year, static 8-hour shifts that are similar on weekdays and weekends, and no on-call system. It is the last fee-for-service ED in Canada and has serious overcrowding issues, said Dr. Rowe, a clinical emergency physician at the hospital and professor and research director of emergency medicine at the University of Alberta.

In the 3 months prior to and during the intervention, patient volumes were similar at 15,135 vs. 14,005, as was median patient age (both 46 years) and CTAS (Canadian Triage and Acuity Scale) status (23.8% vs. 22.5% levels 1, 2 [highest acuity]).

Physician initial assessment times decreased significantly from a median of 76 minutes on control days to 69 minutes on intervention days (P less than .001), Dr. Rowe said.

The median length of stay was not significantly decreased by the intervention for admitted patients (10.5 hours to 10.2 hours; P = .27) or for discharged patients (4.1 hours to 3.9 hours; P = .06).

In multiple linear regression modeling that adjusted for confounders such as age, sex, CTAS status, and consultations, the intervention did provide a statistically significant influence on overall length of stay (P = .003), he said.

In addition, the left-without-being-seen rate dropped significantly, from 5.1% on control days to 3.7% on intervention days (P less than .001). The proportion of patients leaving against medical advice was similar during both periods (0.7% vs. 0.5%; P = .08).

Although physicians saw five fewer patients per shift in the ambulatory pod on the intervention days (decreasing from 27 to 22 patients), the ED physicians rated their satisfaction higher, Dr. Rowe observed.

He said that this is the third randomized, controlled trial to be conducted in his institution’s ED, and that the physician group was particularly resistant to changes in the staffing model. Although there has been considerable research on throughput interventions to reduce ED overcrowding, volume-based staffing has been infrequently described in the literature.

Dr. Robert A. Lowe

Session moderator and emergency physician Dr. Robert A. Lowe of Oregon Health and Science University in Portland asked whether the lack of substantial change in length of stay is an argument that the problem of ED overcrowding is really due to a shortage of inpatient beds.

Dr. Rowe agreed, and said the physician group was able to demonstrate to the administration that despite their efforts, the problem remained.

"So it’s a good argument to administrations to stop blaming us," Dr. Lowe added.

Dr. Rowe reported no relevant conflicts of interest.

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CHICAGO – Adding an additional physician shift in the ambulatory pod of a typical, high-volume academic center with severe emergency department overcrowding did not reduce overall length of stay in the randomized, controlled PICO-D trial.

"Despite the fact you could say this is a negative trial, the physician group almost unanimously voted to keep this intervention because they were seeing fewer patients, but their quality of life was improved," Dr. Brian H. Rowe said at the annual meeting of the Society for Academic Emergency Medicine. "There was more overlap, more discussion, and less staying 3, 4 hours after the end of their shift."

Patrice Wendling/IMNG Medical Media
Dr. Brian H. Rowe

The unblinded, parallel-group trial compared the traditional schedule of three emergency physician shifts per day (9 a.m. to 5 p.m., 2 p.m. to 10 p.m., and 7 p.m. to 3 a.m.) with four physician shifts per day (9 a.m. to 5 p.m., 1 p.m. to 9 p.m., 5 p.m. to 1 a.m., and 9 p.m. to 5 a.m.) in the ambulatory pod at the University of Alberta Hospital in Edmonton. The schedules were computer generated in 2-week blocks for a total of 12 weeks during mid-2011.

The tertiary care center ED has about 60,000 adult and 30,000 pediatric visits per year, static 8-hour shifts that are similar on weekdays and weekends, and no on-call system. It is the last fee-for-service ED in Canada and has serious overcrowding issues, said Dr. Rowe, a clinical emergency physician at the hospital and professor and research director of emergency medicine at the University of Alberta.

In the 3 months prior to and during the intervention, patient volumes were similar at 15,135 vs. 14,005, as was median patient age (both 46 years) and CTAS (Canadian Triage and Acuity Scale) status (23.8% vs. 22.5% levels 1, 2 [highest acuity]).

Physician initial assessment times decreased significantly from a median of 76 minutes on control days to 69 minutes on intervention days (P less than .001), Dr. Rowe said.

The median length of stay was not significantly decreased by the intervention for admitted patients (10.5 hours to 10.2 hours; P = .27) or for discharged patients (4.1 hours to 3.9 hours; P = .06).

In multiple linear regression modeling that adjusted for confounders such as age, sex, CTAS status, and consultations, the intervention did provide a statistically significant influence on overall length of stay (P = .003), he said.

In addition, the left-without-being-seen rate dropped significantly, from 5.1% on control days to 3.7% on intervention days (P less than .001). The proportion of patients leaving against medical advice was similar during both periods (0.7% vs. 0.5%; P = .08).

Although physicians saw five fewer patients per shift in the ambulatory pod on the intervention days (decreasing from 27 to 22 patients), the ED physicians rated their satisfaction higher, Dr. Rowe observed.

He said that this is the third randomized, controlled trial to be conducted in his institution’s ED, and that the physician group was particularly resistant to changes in the staffing model. Although there has been considerable research on throughput interventions to reduce ED overcrowding, volume-based staffing has been infrequently described in the literature.

Dr. Robert A. Lowe

Session moderator and emergency physician Dr. Robert A. Lowe of Oregon Health and Science University in Portland asked whether the lack of substantial change in length of stay is an argument that the problem of ED overcrowding is really due to a shortage of inpatient beds.

Dr. Rowe agreed, and said the physician group was able to demonstrate to the administration that despite their efforts, the problem remained.

"So it’s a good argument to administrations to stop blaming us," Dr. Lowe added.

Dr. Rowe reported no relevant conflicts of interest.

CHICAGO – Adding an additional physician shift in the ambulatory pod of a typical, high-volume academic center with severe emergency department overcrowding did not reduce overall length of stay in the randomized, controlled PICO-D trial.

"Despite the fact you could say this is a negative trial, the physician group almost unanimously voted to keep this intervention because they were seeing fewer patients, but their quality of life was improved," Dr. Brian H. Rowe said at the annual meeting of the Society for Academic Emergency Medicine. "There was more overlap, more discussion, and less staying 3, 4 hours after the end of their shift."

Patrice Wendling/IMNG Medical Media
Dr. Brian H. Rowe

The unblinded, parallel-group trial compared the traditional schedule of three emergency physician shifts per day (9 a.m. to 5 p.m., 2 p.m. to 10 p.m., and 7 p.m. to 3 a.m.) with four physician shifts per day (9 a.m. to 5 p.m., 1 p.m. to 9 p.m., 5 p.m. to 1 a.m., and 9 p.m. to 5 a.m.) in the ambulatory pod at the University of Alberta Hospital in Edmonton. The schedules were computer generated in 2-week blocks for a total of 12 weeks during mid-2011.

The tertiary care center ED has about 60,000 adult and 30,000 pediatric visits per year, static 8-hour shifts that are similar on weekdays and weekends, and no on-call system. It is the last fee-for-service ED in Canada and has serious overcrowding issues, said Dr. Rowe, a clinical emergency physician at the hospital and professor and research director of emergency medicine at the University of Alberta.

In the 3 months prior to and during the intervention, patient volumes were similar at 15,135 vs. 14,005, as was median patient age (both 46 years) and CTAS (Canadian Triage and Acuity Scale) status (23.8% vs. 22.5% levels 1, 2 [highest acuity]).

Physician initial assessment times decreased significantly from a median of 76 minutes on control days to 69 minutes on intervention days (P less than .001), Dr. Rowe said.

The median length of stay was not significantly decreased by the intervention for admitted patients (10.5 hours to 10.2 hours; P = .27) or for discharged patients (4.1 hours to 3.9 hours; P = .06).

In multiple linear regression modeling that adjusted for confounders such as age, sex, CTAS status, and consultations, the intervention did provide a statistically significant influence on overall length of stay (P = .003), he said.

In addition, the left-without-being-seen rate dropped significantly, from 5.1% on control days to 3.7% on intervention days (P less than .001). The proportion of patients leaving against medical advice was similar during both periods (0.7% vs. 0.5%; P = .08).

Although physicians saw five fewer patients per shift in the ambulatory pod on the intervention days (decreasing from 27 to 22 patients), the ED physicians rated their satisfaction higher, Dr. Rowe observed.

He said that this is the third randomized, controlled trial to be conducted in his institution’s ED, and that the physician group was particularly resistant to changes in the staffing model. Although there has been considerable research on throughput interventions to reduce ED overcrowding, volume-based staffing has been infrequently described in the literature.

Dr. Robert A. Lowe

Session moderator and emergency physician Dr. Robert A. Lowe of Oregon Health and Science University in Portland asked whether the lack of substantial change in length of stay is an argument that the problem of ED overcrowding is really due to a shortage of inpatient beds.

Dr. Rowe agreed, and said the physician group was able to demonstrate to the administration that despite their efforts, the problem remained.

"So it’s a good argument to administrations to stop blaming us," Dr. Lowe added.

Dr. Rowe reported no relevant conflicts of interest.

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