The outbreak of Ebola in West Africa in 2014 provided a wake-up call for global health care experts. Responding to the next global health care crisis will require a more coherent and strategic response, and U.S. leadership, to protect both U.S. and global health security. The Ebola crisis “raised consciousness generally that health and security have become more directly linked,” said CAPT Paul Reed, MD, USPHS, interim director of the Center for Global Health Engagement (CGHE) at the Uniformed Services University.

According to CAPT Reed, global health engagement is an essential part of force preparedness and a key part of U.S. dialogue with global partners. The CGHE will host a series of sessions at the upcoming AMSUS meeting on November 28, outside Washington, DC, that will focus on global health strategies, the importance of global health engagement to combat commands, and projects underway to expand global health engagement.

The CGHE mission is to lead, integrate, and bring together thought leadership, research, and advocacy from public health experts, Uniformed Services University faculty, combatant commands, and the Military Health System to national security objectives. The CGHE is focused on developing partnerships to build global capacity and increase resiliency for disaster preparation. In addition, the center is engaged in research studies, including the Measures Of Effectiveness in Defense Engagement and Learning (MODEL) and the Improving Processes and Coordination in Theater (IMPACT) studies.

As the Ebola outbreak made clear, global health threats can impact both military and domestic operations. “There is not distinction between global and domestic health issues,” Dr. Reed told Federal Practitioner. “Global health engagement is a unique aspects of public health. We need to develop a new doctrine. We have to do it collectively and we can't do that in silos. We can't even do it within a federal government silo.”

The outbreak of Ebola in West Africa in 2014 provided a wake-up call for global health care experts. Responding to the next global health care crisis will require a more coherent and strategic response, and U.S. leadership, to protect both U.S. and global health security. The Ebola crisis “raised consciousness generally that health and security have become more directly linked,” said CAPT Paul Reed, MD, USPHS, interim director of the Center for Global Health Engagement (CGHE) at the Uniformed Services University.

According to CAPT Reed, global health engagement is an essential part of force preparedness and a key part of U.S. dialogue with global partners. The CGHE will host a series of sessions at the upcoming AMSUS meeting on November 28, outside Washington, DC, that will focus on global health strategies, the importance of global health engagement to combat commands, and projects underway to expand global health engagement.

The CGHE mission is to lead, integrate, and bring together thought leadership, research, and advocacy from public health experts, Uniformed Services University faculty, combatant commands, and the Military Health System to national security objectives. The CGHE is focused on developing partnerships to build global capacity and increase resiliency for disaster preparation. In addition, the center is engaged in research studies, including the Measures Of Effectiveness in Defense Engagement and Learning (MODEL) and the Improving Processes and Coordination in Theater (IMPACT) studies.

As the Ebola outbreak made clear, global health threats can impact both military and domestic operations. “There is not distinction between global and domestic health issues,” Dr. Reed told Federal Practitioner. “Global health engagement is a unique aspects of public health. We need to develop a new doctrine. We have to do it collectively and we can't do that in silos. We can't even do it within a federal government silo.”

The outbreak of Ebola in West Africa in 2014 provided a wake-up call for global health care experts. Responding to the next global health care crisis will require a more coherent and strategic response, and U.S. leadership, to protect both U.S. and global health security. The Ebola crisis “raised consciousness generally that health and security have become more directly linked,” said CAPT Paul Reed, MD, USPHS, interim director of the Center for Global Health Engagement (CGHE) at the Uniformed Services University.

According to CAPT Reed, global health engagement is an essential part of force preparedness and a key part of U.S. dialogue with global partners. The CGHE will host a series of sessions at the upcoming AMSUS meeting on November 28, outside Washington, DC, that will focus on global health strategies, the importance of global health engagement to combat commands, and projects underway to expand global health engagement.

The CGHE mission is to lead, integrate, and bring together thought leadership, research, and advocacy from public health experts, Uniformed Services University faculty, combatant commands, and the Military Health System to national security objectives. The CGHE is focused on developing partnerships to build global capacity and increase resiliency for disaster preparation. In addition, the center is engaged in research studies, including the Measures Of Effectiveness in Defense Engagement and Learning (MODEL) and the Improving Processes and Coordination in Theater (IMPACT) studies.

As the Ebola outbreak made clear, global health threats can impact both military and domestic operations. “There is not distinction between global and domestic health issues,” Dr. Reed told Federal Practitioner. “Global health engagement is a unique aspects of public health. We need to develop a new doctrine. We have to do it collectively and we can't do that in silos. We can't even do it within a federal government silo.”

Which method is better for breast cancer screening: 3-D mammography or 2-D mammography? Researchers from the ECOG-ACRIN Cancer Research Group and the National Cancer Institute are hoping to find out, with the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).

It has been decades since the last large-scale randomized trial of mammography, points out Worta McCaskill-Stevens, MD, director of the NCI Community Oncology Research Program. In the meantime, mammography technology has evolved, from “conventional” 2-D mammography to tomosynthesis, also known as 3-D mammography.

However, although 3-D mammography is more likely to detect more findings that require follow-up, it is also likely to lead to more procedures and treatments. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” said Etta Pisano, MD, ECOG-ACRIN study chair.

Researchers plan to enroll 165,000 participants aged between 45 and 74 years who already are scheduled for routine mammograms. They will follow all participants for breast cancer status, treatment, and outcomes until at least 2025. About 100 mammography clinics are expected to take part.

Which method is better for breast cancer screening: 3-D mammography or 2-D mammography? Researchers from the ECOG-ACRIN Cancer Research Group and the National Cancer Institute are hoping to find out, with the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).

It has been decades since the last large-scale randomized trial of mammography, points out Worta McCaskill-Stevens, MD, director of the NCI Community Oncology Research Program. In the meantime, mammography technology has evolved, from “conventional” 2-D mammography to tomosynthesis, also known as 3-D mammography.

However, although 3-D mammography is more likely to detect more findings that require follow-up, it is also likely to lead to more procedures and treatments. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” said Etta Pisano, MD, ECOG-ACRIN study chair.

Researchers plan to enroll 165,000 participants aged between 45 and 74 years who already are scheduled for routine mammograms. They will follow all participants for breast cancer status, treatment, and outcomes until at least 2025. About 100 mammography clinics are expected to take part.

Which method is better for breast cancer screening: 3-D mammography or 2-D mammography? Researchers from the ECOG-ACRIN Cancer Research Group and the National Cancer Institute are hoping to find out, with the Tomosynthesis Mammographic Imaging Screening Trial (TMIST).

It has been decades since the last large-scale randomized trial of mammography, points out Worta McCaskill-Stevens, MD, director of the NCI Community Oncology Research Program. In the meantime, mammography technology has evolved, from “conventional” 2-D mammography to tomosynthesis, also known as 3-D mammography.

However, although 3-D mammography is more likely to detect more findings that require follow-up, it is also likely to lead to more procedures and treatments. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” said Etta Pisano, MD, ECOG-ACRIN study chair.

Researchers plan to enroll 165,000 participants aged between 45 and 74 years who already are scheduled for routine mammograms. They will follow all participants for breast cancer status, treatment, and outcomes until at least 2025. About 100 mammography clinics are expected to take part.

Photo by Elise Amendola

ANAHEIM, CA—Results of a large study suggest a restrictive transfusion strategy is safe for moderate- to high-risk patients undergoing cardiac surgery.

Researchers found that patients had similar rates of various outcomes—death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis—whether they received red blood cell (RBC) transfusions according to a restrictive strategy or a liberal one.

C. David Mazer, MD, of St. Michael’s Hospital in Toronto, Ontario, Canada, presented these results at the American Heart Association’s Scientific Sessions 2017.

Results were simultaneously published in NEJM.

Dr Mazer and his colleagues studied 5243 adults undergoing cardiac surgery. They all had a European System for Cardiac Operative Risk Evaluation I score of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery).

Patients were randomized to receive RBC transfusions according to a restrictive strategy or a liberal one.

With the restrictive strategy, patients received transfusions if their hemoglobin level was below 7.5 g/dL, starting from induction of anesthesia.

With the liberal strategy, patients were transfused if their hemoglobin level was less than 9.5 g/dL in the operating room or intensive care unit (ICU) or was less than 8.5 g/dL in the non-ICU ward.

Results

There were 4860 patients in the per-protocol analysis—2430 in each transfusion group. Baseline characteristics were similar between the groups.

The rate of RBC transfusion was 52.3% in the restrictive group and 72.6% in the liberal group. The odds ratio (OR) was 0.41 (95% confidence interval [CI], 0.37 to 0.47).

Transfused patients received a median of 2 RBC units (interquartile range [IQR], 1 to 4) in the restrictive group and 3 units (IQR, 2 to 5) in the liberal group.

The study’s primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first.

This outcome occurred in 11.4% of patients in the restrictive group and 12.5% of those in the liberal group. The absolute risk difference was −1.11 percentage points (95% CI, −2.93 to 0.72), and the odds ratio was 0.90 (95% CI, 0.76 to 1.07; P<0.001 for noninferiority).

There were no significant differences between the groups when it came to the individual components of the composite outcome.

“We have shown that this [restrictive] approach to transfusion is safe in moderate- to high-risk patients undergoing cardiac surgery,” Dr Mazer said.

“Such practices can also reduce the number of patients transfused, the amount of blood transfused, the impact on blood supply, and costs to the healthcare system.”

Photo by Elise Amendola

ANAHEIM, CA—Results of a large study suggest a restrictive transfusion strategy is safe for moderate- to high-risk patients undergoing cardiac surgery.

Researchers found that patients had similar rates of various outcomes—death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis—whether they received red blood cell (RBC) transfusions according to a restrictive strategy or a liberal one.

C. David Mazer, MD, of St. Michael’s Hospital in Toronto, Ontario, Canada, presented these results at the American Heart Association’s Scientific Sessions 2017.

Results were simultaneously published in NEJM.

Dr Mazer and his colleagues studied 5243 adults undergoing cardiac surgery. They all had a European System for Cardiac Operative Risk Evaluation I score of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery).

Patients were randomized to receive RBC transfusions according to a restrictive strategy or a liberal one.

With the restrictive strategy, patients received transfusions if their hemoglobin level was below 7.5 g/dL, starting from induction of anesthesia.

With the liberal strategy, patients were transfused if their hemoglobin level was less than 9.5 g/dL in the operating room or intensive care unit (ICU) or was less than 8.5 g/dL in the non-ICU ward.

Results

There were 4860 patients in the per-protocol analysis—2430 in each transfusion group. Baseline characteristics were similar between the groups.

The rate of RBC transfusion was 52.3% in the restrictive group and 72.6% in the liberal group. The odds ratio (OR) was 0.41 (95% confidence interval [CI], 0.37 to 0.47).

Transfused patients received a median of 2 RBC units (interquartile range [IQR], 1 to 4) in the restrictive group and 3 units (IQR, 2 to 5) in the liberal group.

The study’s primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first.

This outcome occurred in 11.4% of patients in the restrictive group and 12.5% of those in the liberal group. The absolute risk difference was −1.11 percentage points (95% CI, −2.93 to 0.72), and the odds ratio was 0.90 (95% CI, 0.76 to 1.07; P<0.001 for noninferiority).

There were no significant differences between the groups when it came to the individual components of the composite outcome.

“We have shown that this [restrictive] approach to transfusion is safe in moderate- to high-risk patients undergoing cardiac surgery,” Dr Mazer said.

“Such practices can also reduce the number of patients transfused, the amount of blood transfused, the impact on blood supply, and costs to the healthcare system.”

Photo by Elise Amendola

ANAHEIM, CA—Results of a large study suggest a restrictive transfusion strategy is safe for moderate- to high-risk patients undergoing cardiac surgery.

Researchers found that patients had similar rates of various outcomes—death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis—whether they received red blood cell (RBC) transfusions according to a restrictive strategy or a liberal one.

C. David Mazer, MD, of St. Michael’s Hospital in Toronto, Ontario, Canada, presented these results at the American Heart Association’s Scientific Sessions 2017.

Results were simultaneously published in NEJM.

Dr Mazer and his colleagues studied 5243 adults undergoing cardiac surgery. They all had a European System for Cardiac Operative Risk Evaluation I score of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery).

Patients were randomized to receive RBC transfusions according to a restrictive strategy or a liberal one.

With the restrictive strategy, patients received transfusions if their hemoglobin level was below 7.5 g/dL, starting from induction of anesthesia.

With the liberal strategy, patients were transfused if their hemoglobin level was less than 9.5 g/dL in the operating room or intensive care unit (ICU) or was less than 8.5 g/dL in the non-ICU ward.

Results

There were 4860 patients in the per-protocol analysis—2430 in each transfusion group. Baseline characteristics were similar between the groups.

The rate of RBC transfusion was 52.3% in the restrictive group and 72.6% in the liberal group. The odds ratio (OR) was 0.41 (95% confidence interval [CI], 0.37 to 0.47).

Transfused patients received a median of 2 RBC units (interquartile range [IQR], 1 to 4) in the restrictive group and 3 units (IQR, 2 to 5) in the liberal group.

The study’s primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first.

This outcome occurred in 11.4% of patients in the restrictive group and 12.5% of those in the liberal group. The absolute risk difference was −1.11 percentage points (95% CI, −2.93 to 0.72), and the odds ratio was 0.90 (95% CI, 0.76 to 1.07; P<0.001 for noninferiority).

There were no significant differences between the groups when it came to the individual components of the composite outcome.

“We have shown that this [restrictive] approach to transfusion is safe in moderate- to high-risk patients undergoing cardiac surgery,” Dr Mazer said.

“Such practices can also reduce the number of patients transfused, the amount of blood transfused, the impact on blood supply, and costs to the healthcare system.”

Photo by Aaron Logan

Preclinical research suggests PRO 140, a humanized anti-CCR5 monoclonal antibody, can prevent graft-versus-host disease (GVHD) in mice.

Mice that received 2 mg of PRO 140 twice weekly showed no signs of GVHD throughout the study period.

On the other hand, all control mice exhibited signs of GVHD, starting 25 days after engraftment, and had to be sacrificed early.

Researchers reported these results in Biology of Blood and Marrow Transplantation.

The study’s lead author, Denis R. Burger, PhD, is chief science officer of CytoDyn, the company developing PRO 140.

PRO 140 targets the CCR5 receptor, a molecule that modulates the immune cell trafficking crucial for the development of acute GVHD.

Previous clinical studies have shown that inhibiting CCR5 can reduce the clinical impact of acute GVHD without significantly affecting the engraftment of transplanted hematopoietic stem cells (HSCs).

This new study supports the idea that the CCR5 receptor on engrafted cells is critical for the development of acute GVHD and that preventing this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GVHD.

Dr Burger and his colleagues tested PRO 140 in NOD-scid IL-2Ry^null mice transplanted with human HSCs.

Mice received 2 different doses of PRO 140 or a control antibody—2 mg or 0.2 mg—twice weekly and were followed for a maximum of 75 days.

Engraftment at the higher dose

Mice that received the 2 mg dose of PRO 140 or the control antibody had received HSCs from a 56-year-old donor.

Engraftment was similar between control and PRO 140-treated mice for the first 30+ days. However, at day 50, there were significantly fewer human CD45+ cells in the PRO 140-treated mice (P=0.034).

At 54 days, control mice had greater engraftment of mature T cells than treated mice in the peripheral blood (63.2% vs 49.8%) and bone marrow (40.2% vs 26.4%).

GVHD at the higher dose

Throughout the study period, there were no physical signs of GVHD in the PRO 140-treated mice.

However, control mice exhibited signs of GVHD starting at day 25 after bone marrow engraftment. Signs included ruffled fur, lethargy, hunching, and weight loss.

There was a significant difference in survival between the 2 groups (P<0.01). All of the control mice had to be sacrificed early, by day 56, whereas all of the PRO 140-treated animals were alive until planned sacrifice at day 75.

Engraftment at the low dose

Mice that received the 0.2 mg dose of PRO 140 or the control antibody had received HSCs from a 26-year-old donor.

Mice in the treatment and control groups achieved the same percentage of CD45+ engraftment. However, PRO 140-treated mice achieved engraftment about 20 days later than control mice (P<0.01).

GVHD at the low dose

Both control and PRO 140-treated mice showed signs of GVHD. However, weight loss was significantly greater among control mice (P<0.05).

Survival was significantly worse among control mice as well (P<0.05). All control mice were dead by 31 days, and all PRO 140-treated mice were dead by 54 days.

The researchers said the difference in survival times between these mice and the mice treated with the higher dose of antibody suggest the younger HSC donor produced more aggressive GVHD.

“This research provided CytoDyn with strong rationale for exploring the use of PRO 140 in . . . the prevention of GVHD,” Dr Burger said.

“The potential of PRO 140 to prevent this life-threatening condition could help extend the use of [HSC] transplantation, an important and effective therapy, to more patients.”

CytoDyn is currently enrolling patients in a phase 2 trial of PRO 140 in leukemia patients undergoing transplant.

Photo by Aaron Logan

Preclinical research suggests PRO 140, a humanized anti-CCR5 monoclonal antibody, can prevent graft-versus-host disease (GVHD) in mice.

Mice that received 2 mg of PRO 140 twice weekly showed no signs of GVHD throughout the study period.

On the other hand, all control mice exhibited signs of GVHD, starting 25 days after engraftment, and had to be sacrificed early.

Researchers reported these results in Biology of Blood and Marrow Transplantation.

The study’s lead author, Denis R. Burger, PhD, is chief science officer of CytoDyn, the company developing PRO 140.

PRO 140 targets the CCR5 receptor, a molecule that modulates the immune cell trafficking crucial for the development of acute GVHD.

Previous clinical studies have shown that inhibiting CCR5 can reduce the clinical impact of acute GVHD without significantly affecting the engraftment of transplanted hematopoietic stem cells (HSCs).

This new study supports the idea that the CCR5 receptor on engrafted cells is critical for the development of acute GVHD and that preventing this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GVHD.

Dr Burger and his colleagues tested PRO 140 in NOD-scid IL-2Ry^null mice transplanted with human HSCs.

Mice received 2 different doses of PRO 140 or a control antibody—2 mg or 0.2 mg—twice weekly and were followed for a maximum of 75 days.

Engraftment at the higher dose

Mice that received the 2 mg dose of PRO 140 or the control antibody had received HSCs from a 56-year-old donor.

Engraftment was similar between control and PRO 140-treated mice for the first 30+ days. However, at day 50, there were significantly fewer human CD45+ cells in the PRO 140-treated mice (P=0.034).

At 54 days, control mice had greater engraftment of mature T cells than treated mice in the peripheral blood (63.2% vs 49.8%) and bone marrow (40.2% vs 26.4%).

GVHD at the higher dose

Throughout the study period, there were no physical signs of GVHD in the PRO 140-treated mice.

However, control mice exhibited signs of GVHD starting at day 25 after bone marrow engraftment. Signs included ruffled fur, lethargy, hunching, and weight loss.

There was a significant difference in survival between the 2 groups (P<0.01). All of the control mice had to be sacrificed early, by day 56, whereas all of the PRO 140-treated animals were alive until planned sacrifice at day 75.

Engraftment at the low dose

Mice that received the 0.2 mg dose of PRO 140 or the control antibody had received HSCs from a 26-year-old donor.

Mice in the treatment and control groups achieved the same percentage of CD45+ engraftment. However, PRO 140-treated mice achieved engraftment about 20 days later than control mice (P<0.01).

GVHD at the low dose

Both control and PRO 140-treated mice showed signs of GVHD. However, weight loss was significantly greater among control mice (P<0.05).

Survival was significantly worse among control mice as well (P<0.05). All control mice were dead by 31 days, and all PRO 140-treated mice were dead by 54 days.

The researchers said the difference in survival times between these mice and the mice treated with the higher dose of antibody suggest the younger HSC donor produced more aggressive GVHD.

“This research provided CytoDyn with strong rationale for exploring the use of PRO 140 in . . . the prevention of GVHD,” Dr Burger said.

“The potential of PRO 140 to prevent this life-threatening condition could help extend the use of [HSC] transplantation, an important and effective therapy, to more patients.”

CytoDyn is currently enrolling patients in a phase 2 trial of PRO 140 in leukemia patients undergoing transplant.

Photo by Aaron Logan

Preclinical research suggests PRO 140, a humanized anti-CCR5 monoclonal antibody, can prevent graft-versus-host disease (GVHD) in mice.

Mice that received 2 mg of PRO 140 twice weekly showed no signs of GVHD throughout the study period.

On the other hand, all control mice exhibited signs of GVHD, starting 25 days after engraftment, and had to be sacrificed early.

Researchers reported these results in Biology of Blood and Marrow Transplantation.

The study’s lead author, Denis R. Burger, PhD, is chief science officer of CytoDyn, the company developing PRO 140.

PRO 140 targets the CCR5 receptor, a molecule that modulates the immune cell trafficking crucial for the development of acute GVHD.

Previous clinical studies have shown that inhibiting CCR5 can reduce the clinical impact of acute GVHD without significantly affecting the engraftment of transplanted hematopoietic stem cells (HSCs).

This new study supports the idea that the CCR5 receptor on engrafted cells is critical for the development of acute GVHD and that preventing this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GVHD.

Dr Burger and his colleagues tested PRO 140 in NOD-scid IL-2Ry^null mice transplanted with human HSCs.

Mice received 2 different doses of PRO 140 or a control antibody—2 mg or 0.2 mg—twice weekly and were followed for a maximum of 75 days.

Engraftment at the higher dose

Mice that received the 2 mg dose of PRO 140 or the control antibody had received HSCs from a 56-year-old donor.

Engraftment was similar between control and PRO 140-treated mice for the first 30+ days. However, at day 50, there were significantly fewer human CD45+ cells in the PRO 140-treated mice (P=0.034).

At 54 days, control mice had greater engraftment of mature T cells than treated mice in the peripheral blood (63.2% vs 49.8%) and bone marrow (40.2% vs 26.4%).

GVHD at the higher dose

Throughout the study period, there were no physical signs of GVHD in the PRO 140-treated mice.

However, control mice exhibited signs of GVHD starting at day 25 after bone marrow engraftment. Signs included ruffled fur, lethargy, hunching, and weight loss.

There was a significant difference in survival between the 2 groups (P<0.01). All of the control mice had to be sacrificed early, by day 56, whereas all of the PRO 140-treated animals were alive until planned sacrifice at day 75.

Engraftment at the low dose

Mice that received the 0.2 mg dose of PRO 140 or the control antibody had received HSCs from a 26-year-old donor.

Mice in the treatment and control groups achieved the same percentage of CD45+ engraftment. However, PRO 140-treated mice achieved engraftment about 20 days later than control mice (P<0.01).

GVHD at the low dose

Both control and PRO 140-treated mice showed signs of GVHD. However, weight loss was significantly greater among control mice (P<0.05).

Survival was significantly worse among control mice as well (P<0.05). All control mice were dead by 31 days, and all PRO 140-treated mice were dead by 54 days.

The researchers said the difference in survival times between these mice and the mice treated with the higher dose of antibody suggest the younger HSC donor produced more aggressive GVHD.

“This research provided CytoDyn with strong rationale for exploring the use of PRO 140 in . . . the prevention of GVHD,” Dr Burger said.

“The potential of PRO 140 to prevent this life-threatening condition could help extend the use of [HSC] transplantation, an important and effective therapy, to more patients.”

CytoDyn is currently enrolling patients in a phase 2 trial of PRO 140 in leukemia patients undergoing transplant.

Photo by Steven Harbour

US state laws intended to ensure fair prices for oral cancer drugs have had a mixed impact on patients’ pocketbooks, according to a study published in JAMA Oncology.

A total of 43 states and Washington, DC, have enacted parity laws, which require that patients pay no more for an oral cancer treatment than they would for an infusion of the same treatment.

Researchers analyzed the impact of these laws and observed modest improvements in costs for some patients.

However, patients who were already paying the most for their medications saw their monthly costs go up.

“Although parity laws appear to help reduce out-of-pocket spending for some patients, they may not fully address affordability for patients needing cancer drugs,” said study author Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill.

“We need to consider ways to address drug pricing directly and to improve benefit design to make sure that all patients can access prescribed drugs.”

To gauge the impact of parity laws on treatment costs, Dr Dusetzina and her colleagues analyzed health claims data for 63,780 adults from 3 large, nationwide insurance companies before and after the laws were enacted, from 2008 to 2012.

The team compared the cost of filling an oral cancer drug prescription for patients with health insurance plans that were covered by the state laws (fully insured) and patients whose plans were not (self-funded). All patients lived in 1 of 16 states that had passed parity laws at the time of the study.

About half of patients (51.4%) had fully insured plans, and the other half (48.6%) had self-funded plans.

For the entire cohort, the use of oral cancer drugs increased from 18% in the months before parity laws were passed to 22% in the months after (adjusted difference-in-differences risk ratio [aDDRR], 1.04; 95% confidence interval [CI], 0.96-1.13; P=0.34).

The proportion of prescription fills for oral drugs without copayment increased from 15.0% to 53.0% for patients with fully insured plans and from 12.3% to 18.0% in patients with self-funded plans (aDDRR, 2.36; 95% CI, 2.00-2.79; P<0.001).

“From our results, it looks like many plans decided they would just set the co-pay for oral drugs to $0,” Dr Dusetzina said. “Instead of $30 per month, those fills were now $0.”

The proportion of prescription fills with out-of-pocket cost of more than $100 per month increased from 8.4% to 11.1% for patients with fully insured plans but decreased from 12.0% to 11.7% for those with self-funded plans (aDDRR, 1.36; 95% CI, 1.11-1.68; P=0.004).

Patients paying the most for their oral cancer drug prescriptions experienced increases in their monthly out-of-pocket costs after parity laws were passed.

For patients whose costs were more expensive than 95% of other patients, their out-of-pocket costs increased an estimated $143.25 per month. Those paying more than 90% of what other patients paid saw their costs increase by $37.19 per month.

“One of the biggest problems with parity laws as they are written is that they don’t address the prices of these medications, which can be very high,” Dr Dusetzina noted.

“Parity can be reached as long as the coverage is the same for both oral and infused cancer therapies. Because we’re now seeing more people insured by plans with high deductibles or plans that require them to pay a percentage of their drug costs, parity may not reduce spending for some patients.”

However, Dr Dusetzina and her colleagues did find that patients who paid the least for their oral cancer treatments saw their estimated monthly out-of-pocket spending decrease.

Patients in the 25th percentile saw an estimated decrease of $19.44 per month, those in the 50th percentile saw a $32.13 decrease, and patients in the 75th percentile saw a decrease of $10.83.

On the other hand, the researchers also found that average 6-month healthcare costs—including what was paid by insurance companies and patients—did not change significantly as a result of parity laws.

The aDDRR was 0.96 (95% CI, 0.90-1.02; P=0.09) for all cancer treatments and 1.06 (95% CI, 0.93-1.20; P=0.40) for oral cancer drugs.

“One of the key arguments against passing parity, both for states that haven’t passed it and for legislation at the federal level, has been that it may increase costs to health plans,” Dr Dusetzina said. “But we didn’t find evidence of that.”

Photo by Steven Harbour

US state laws intended to ensure fair prices for oral cancer drugs have had a mixed impact on patients’ pocketbooks, according to a study published in JAMA Oncology.

A total of 43 states and Washington, DC, have enacted parity laws, which require that patients pay no more for an oral cancer treatment than they would for an infusion of the same treatment.

Researchers analyzed the impact of these laws and observed modest improvements in costs for some patients.

However, patients who were already paying the most for their medications saw their monthly costs go up.

“Although parity laws appear to help reduce out-of-pocket spending for some patients, they may not fully address affordability for patients needing cancer drugs,” said study author Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill.

“We need to consider ways to address drug pricing directly and to improve benefit design to make sure that all patients can access prescribed drugs.”

To gauge the impact of parity laws on treatment costs, Dr Dusetzina and her colleagues analyzed health claims data for 63,780 adults from 3 large, nationwide insurance companies before and after the laws were enacted, from 2008 to 2012.

The team compared the cost of filling an oral cancer drug prescription for patients with health insurance plans that were covered by the state laws (fully insured) and patients whose plans were not (self-funded). All patients lived in 1 of 16 states that had passed parity laws at the time of the study.

About half of patients (51.4%) had fully insured plans, and the other half (48.6%) had self-funded plans.

For the entire cohort, the use of oral cancer drugs increased from 18% in the months before parity laws were passed to 22% in the months after (adjusted difference-in-differences risk ratio [aDDRR], 1.04; 95% confidence interval [CI], 0.96-1.13; P=0.34).

The proportion of prescription fills for oral drugs without copayment increased from 15.0% to 53.0% for patients with fully insured plans and from 12.3% to 18.0% in patients with self-funded plans (aDDRR, 2.36; 95% CI, 2.00-2.79; P<0.001).

“From our results, it looks like many plans decided they would just set the co-pay for oral drugs to $0,” Dr Dusetzina said. “Instead of $30 per month, those fills were now $0.”

The proportion of prescription fills with out-of-pocket cost of more than $100 per month increased from 8.4% to 11.1% for patients with fully insured plans but decreased from 12.0% to 11.7% for those with self-funded plans (aDDRR, 1.36; 95% CI, 1.11-1.68; P=0.004).

Patients paying the most for their oral cancer drug prescriptions experienced increases in their monthly out-of-pocket costs after parity laws were passed.

For patients whose costs were more expensive than 95% of other patients, their out-of-pocket costs increased an estimated $143.25 per month. Those paying more than 90% of what other patients paid saw their costs increase by $37.19 per month.

“One of the biggest problems with parity laws as they are written is that they don’t address the prices of these medications, which can be very high,” Dr Dusetzina noted.

“Parity can be reached as long as the coverage is the same for both oral and infused cancer therapies. Because we’re now seeing more people insured by plans with high deductibles or plans that require them to pay a percentage of their drug costs, parity may not reduce spending for some patients.”

However, Dr Dusetzina and her colleagues did find that patients who paid the least for their oral cancer treatments saw their estimated monthly out-of-pocket spending decrease.

Patients in the 25th percentile saw an estimated decrease of $19.44 per month, those in the 50th percentile saw a $32.13 decrease, and patients in the 75th percentile saw a decrease of $10.83.

On the other hand, the researchers also found that average 6-month healthcare costs—including what was paid by insurance companies and patients—did not change significantly as a result of parity laws.

The aDDRR was 0.96 (95% CI, 0.90-1.02; P=0.09) for all cancer treatments and 1.06 (95% CI, 0.93-1.20; P=0.40) for oral cancer drugs.

“One of the key arguments against passing parity, both for states that haven’t passed it and for legislation at the federal level, has been that it may increase costs to health plans,” Dr Dusetzina said. “But we didn’t find evidence of that.”

Photo by Steven Harbour

US state laws intended to ensure fair prices for oral cancer drugs have had a mixed impact on patients’ pocketbooks, according to a study published in JAMA Oncology.

A total of 43 states and Washington, DC, have enacted parity laws, which require that patients pay no more for an oral cancer treatment than they would for an infusion of the same treatment.

Researchers analyzed the impact of these laws and observed modest improvements in costs for some patients.

However, patients who were already paying the most for their medications saw their monthly costs go up.

“Although parity laws appear to help reduce out-of-pocket spending for some patients, they may not fully address affordability for patients needing cancer drugs,” said study author Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill.

“We need to consider ways to address drug pricing directly and to improve benefit design to make sure that all patients can access prescribed drugs.”

To gauge the impact of parity laws on treatment costs, Dr Dusetzina and her colleagues analyzed health claims data for 63,780 adults from 3 large, nationwide insurance companies before and after the laws were enacted, from 2008 to 2012.

The team compared the cost of filling an oral cancer drug prescription for patients with health insurance plans that were covered by the state laws (fully insured) and patients whose plans were not (self-funded). All patients lived in 1 of 16 states that had passed parity laws at the time of the study.

About half of patients (51.4%) had fully insured plans, and the other half (48.6%) had self-funded plans.

For the entire cohort, the use of oral cancer drugs increased from 18% in the months before parity laws were passed to 22% in the months after (adjusted difference-in-differences risk ratio [aDDRR], 1.04; 95% confidence interval [CI], 0.96-1.13; P=0.34).

The proportion of prescription fills for oral drugs without copayment increased from 15.0% to 53.0% for patients with fully insured plans and from 12.3% to 18.0% in patients with self-funded plans (aDDRR, 2.36; 95% CI, 2.00-2.79; P<0.001).

“From our results, it looks like many plans decided they would just set the co-pay for oral drugs to $0,” Dr Dusetzina said. “Instead of $30 per month, those fills were now $0.”

The proportion of prescription fills with out-of-pocket cost of more than $100 per month increased from 8.4% to 11.1% for patients with fully insured plans but decreased from 12.0% to 11.7% for those with self-funded plans (aDDRR, 1.36; 95% CI, 1.11-1.68; P=0.004).

Patients paying the most for their oral cancer drug prescriptions experienced increases in their monthly out-of-pocket costs after parity laws were passed.

For patients whose costs were more expensive than 95% of other patients, their out-of-pocket costs increased an estimated $143.25 per month. Those paying more than 90% of what other patients paid saw their costs increase by $37.19 per month.

“One of the biggest problems with parity laws as they are written is that they don’t address the prices of these medications, which can be very high,” Dr Dusetzina noted.

“Parity can be reached as long as the coverage is the same for both oral and infused cancer therapies. Because we’re now seeing more people insured by plans with high deductibles or plans that require them to pay a percentage of their drug costs, parity may not reduce spending for some patients.”

However, Dr Dusetzina and her colleagues did find that patients who paid the least for their oral cancer treatments saw their estimated monthly out-of-pocket spending decrease.

Patients in the 25th percentile saw an estimated decrease of $19.44 per month, those in the 50th percentile saw a $32.13 decrease, and patients in the 75th percentile saw a decrease of $10.83.

On the other hand, the researchers also found that average 6-month healthcare costs—including what was paid by insurance companies and patients—did not change significantly as a result of parity laws.

The aDDRR was 0.96 (95% CI, 0.90-1.02; P=0.09) for all cancer treatments and 1.06 (95% CI, 0.93-1.20; P=0.40) for oral cancer drugs.

“One of the key arguments against passing parity, both for states that haven’t passed it and for legislation at the federal level, has been that it may increase costs to health plans,” Dr Dusetzina said. “But we didn’t find evidence of that.”

Philip R. Schauer, MD, FACS, discusses innovations, hot topics, and controversies covered in the sessions of this year’s Minimally Invasive Surgery Symposium, held in Las Vegas. In addition to highlighting what’s new this year, Dr. Schauer also spoke about plans for next year’s meeting and what makes the MISS unique and valuable to attendees.

Vidyard Video

Philip R. Schauer, MD, FACS, discusses innovations, hot topics, and controversies covered in the sessions of this year’s Minimally Invasive Surgery Symposium, held in Las Vegas. In addition to highlighting what’s new this year, Dr. Schauer also spoke about plans for next year’s meeting and what makes the MISS unique and valuable to attendees.

Vidyard Video

Philip R. Schauer, MD, FACS, discusses innovations, hot topics, and controversies covered in the sessions of this year’s Minimally Invasive Surgery Symposium, held in Las Vegas. In addition to highlighting what’s new this year, Dr. Schauer also spoke about plans for next year’s meeting and what makes the MISS unique and valuable to attendees.

Vidyard Video

My chest and back are sore this week because I was on call last week. It’s my secret to beating burnout. Just keep reading.

The phrase “dermatologist burnout” may seem as oxymoronic as jumbo shrimp, yet both are real. Our work is easier than some other physicians’. Dermatologists don’t sleep in the hospital, and we have many fewer dope-seeking or dying patients. Yet we suffer the same EHR frustrations as any physician. We struggle with an ever-increasing volume of patients and regulations which stultify our ability to care for patients.

[polldaddy:9875293]

Challenges

First, I mark difficult weeks on my calendar in red. Do I have extra clinics? Is it post vacation? Am I giving a talk? Then, I set up challenges. For example, I knew last week’s call was going to be tough. So, each morning I challenged myself to do 100 push-ups in 2 minutes, 12 pull-ups, and run 2 miles. I also set goals of plowing through my backlog of journals and upgrading my EHR shortcuts and order sets.

Colleagues

A Navy SEAL training instructor once told me the key to success in BUD/S (the grueling 6-month SEAL training course), is to take care of your teammates:“When you’re focused on the guy to your right and the guy to your left, you find inner strength to endure suffering.” No matter how busy I am, when my phone rings or I get a text, I think to myself, Good, one of my partners needs my help. Framing it that way makes any added work feel lighter.

(Re)Charging

Lastly, I schedule time to recharge and recover. For example, this morning instead of going to the gym, I had a cappuccino and read the entire Sunday New York Times. Later today, my wife and I are going to see Thor: Ragnarok. In reclining seats. With a craft beer.

My call week was sometimes easy and occasionally arduous. Yet, I taught an ER resident how to recognize zoster in its very early stages. I learned the difference between erythema multiforme major and mycoplasma-induced rash with mucositis, and I reassured a family that their hospitalized 9-year-old was going to be just fine. I didn’t miss a workout (however, no SEAL instructor would have credited my pathetic pull-ups #11 and #12).

My next call isn’t long off, and soon, I must work on a big presentation. Medicine is a marathon, punctuated by sprinting. During stressful periods, I challenge myself physically and mentally, focus on helping others, and take the time to rest and recharge after. I think it has helped me beat burnout, I hope it helps you too.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@frontlinemedcom.com

My chest and back are sore this week because I was on call last week. It’s my secret to beating burnout. Just keep reading.

The phrase “dermatologist burnout” may seem as oxymoronic as jumbo shrimp, yet both are real. Our work is easier than some other physicians’. Dermatologists don’t sleep in the hospital, and we have many fewer dope-seeking or dying patients. Yet we suffer the same EHR frustrations as any physician. We struggle with an ever-increasing volume of patients and regulations which stultify our ability to care for patients.

[polldaddy:9875293]

Challenges

First, I mark difficult weeks on my calendar in red. Do I have extra clinics? Is it post vacation? Am I giving a talk? Then, I set up challenges. For example, I knew last week’s call was going to be tough. So, each morning I challenged myself to do 100 push-ups in 2 minutes, 12 pull-ups, and run 2 miles. I also set goals of plowing through my backlog of journals and upgrading my EHR shortcuts and order sets.

Colleagues

A Navy SEAL training instructor once told me the key to success in BUD/S (the grueling 6-month SEAL training course), is to take care of your teammates:“When you’re focused on the guy to your right and the guy to your left, you find inner strength to endure suffering.” No matter how busy I am, when my phone rings or I get a text, I think to myself, Good, one of my partners needs my help. Framing it that way makes any added work feel lighter.

(Re)Charging

Lastly, I schedule time to recharge and recover. For example, this morning instead of going to the gym, I had a cappuccino and read the entire Sunday New York Times. Later today, my wife and I are going to see Thor: Ragnarok. In reclining seats. With a craft beer.

My call week was sometimes easy and occasionally arduous. Yet, I taught an ER resident how to recognize zoster in its very early stages. I learned the difference between erythema multiforme major and mycoplasma-induced rash with mucositis, and I reassured a family that their hospitalized 9-year-old was going to be just fine. I didn’t miss a workout (however, no SEAL instructor would have credited my pathetic pull-ups #11 and #12).

My next call isn’t long off, and soon, I must work on a big presentation. Medicine is a marathon, punctuated by sprinting. During stressful periods, I challenge myself physically and mentally, focus on helping others, and take the time to rest and recharge after. I think it has helped me beat burnout, I hope it helps you too.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@frontlinemedcom.com

My chest and back are sore this week because I was on call last week. It’s my secret to beating burnout. Just keep reading.

The phrase “dermatologist burnout” may seem as oxymoronic as jumbo shrimp, yet both are real. Our work is easier than some other physicians’. Dermatologists don’t sleep in the hospital, and we have many fewer dope-seeking or dying patients. Yet we suffer the same EHR frustrations as any physician. We struggle with an ever-increasing volume of patients and regulations which stultify our ability to care for patients.

[polldaddy:9875293]

Challenges

First, I mark difficult weeks on my calendar in red. Do I have extra clinics? Is it post vacation? Am I giving a talk? Then, I set up challenges. For example, I knew last week’s call was going to be tough. So, each morning I challenged myself to do 100 push-ups in 2 minutes, 12 pull-ups, and run 2 miles. I also set goals of plowing through my backlog of journals and upgrading my EHR shortcuts and order sets.

Colleagues

A Navy SEAL training instructor once told me the key to success in BUD/S (the grueling 6-month SEAL training course), is to take care of your teammates:“When you’re focused on the guy to your right and the guy to your left, you find inner strength to endure suffering.” No matter how busy I am, when my phone rings or I get a text, I think to myself, Good, one of my partners needs my help. Framing it that way makes any added work feel lighter.

(Re)Charging

Lastly, I schedule time to recharge and recover. For example, this morning instead of going to the gym, I had a cappuccino and read the entire Sunday New York Times. Later today, my wife and I are going to see Thor: Ragnarok. In reclining seats. With a craft beer.

My call week was sometimes easy and occasionally arduous. Yet, I taught an ER resident how to recognize zoster in its very early stages. I learned the difference between erythema multiforme major and mycoplasma-induced rash with mucositis, and I reassured a family that their hospitalized 9-year-old was going to be just fine. I didn’t miss a workout (however, no SEAL instructor would have credited my pathetic pull-ups #11 and #12).

My next call isn’t long off, and soon, I must work on a big presentation. Medicine is a marathon, punctuated by sprinting. During stressful periods, I challenge myself physically and mentally, focus on helping others, and take the time to rest and recharge after. I think it has helped me beat burnout, I hope it helps you too.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@frontlinemedcom.com

BOSTON – Pimavanserin, an atypical antipsychotic approved for use in psychosis associated with Parkinson’s disease, was modestly effective in treating psychosis associated with Alzheimer’s dementia in a phase 2 study.

The study of 181 patients showed that pimavanserin (Nuplazid) was associated with a statistically significant 3.76-point improvement on the Neuropsychiatric Inventory–Nursing Home Version (NPI-NH) psychosis score, Clive Ballard, MD, reported at the Clinical Trials on Alzheimer’s Disease conference. But although pimavanserin was significantly more effective than placebo at 6 weeks, it lost its statistical edge by the trial’s end at 12 weeks, largely because the placebo group improved over the study period.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal

BOSTON – Pimavanserin, an atypical antipsychotic approved for use in psychosis associated with Parkinson’s disease, was modestly effective in treating psychosis associated with Alzheimer’s dementia in a phase 2 study.

The study of 181 patients showed that pimavanserin (Nuplazid) was associated with a statistically significant 3.76-point improvement on the Neuropsychiatric Inventory–Nursing Home Version (NPI-NH) psychosis score, Clive Ballard, MD, reported at the Clinical Trials on Alzheimer’s Disease conference. But although pimavanserin was significantly more effective than placebo at 6 weeks, it lost its statistical edge by the trial’s end at 12 weeks, largely because the placebo group improved over the study period.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal

BOSTON – Pimavanserin, an atypical antipsychotic approved for use in psychosis associated with Parkinson’s disease, was modestly effective in treating psychosis associated with Alzheimer’s dementia in a phase 2 study.

The study of 181 patients showed that pimavanserin (Nuplazid) was associated with a statistically significant 3.76-point improvement on the Neuropsychiatric Inventory–Nursing Home Version (NPI-NH) psychosis score, Clive Ballard, MD, reported at the Clinical Trials on Alzheimer’s Disease conference. But although pimavanserin was significantly more effective than placebo at 6 weeks, it lost its statistical edge by the trial’s end at 12 weeks, largely because the placebo group improved over the study period.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal

From RTI International, Waltham, MA, and Brown University School of Public Health, Providence, RI.

Abstract

• Objective: To review the nursing home culture change literature and identify common barriers to and facilitators of nursing home culture change adoption. Nursing home culture change aims to make nursing homes less institutional by providing more resident-centered care, making environments more homelike, and empowering direct care staff.
• Methods: We reviewed the research literature on nursing home culture change, especially as related to implementation and outcomes.
• Results: Adoption of nursing home culture change practices has been steadily increasing in the past decade, but some practices are more likely to be adopted than others. A commonly reported barrier to culture change adoption is staff resistance to change. Studies suggest that this resistance can be overcome by changes to management practices, including good communication, providing training and education, and leadership support.
• Conclusion: The numerous benefits of nursing home culture change are apparent in the literature. Barriers to its adoption may be overcome by making improvements to nursing home management practices.

Key words: nursing homes; culture change; resident-centered care.

Nursing home culture change is a philosophy and combination of diverse practices aimed at making nursing homes less institutional and more resident-centered [1]. Nursing homes have been depicted as dehumanizing “total institutions” [2–4] in which the quality of residents’ lives and the quality of care are generally poor, daily life is medically regimented, only residents’ basic physical needs receive attention [5–8], and direct care workers are subject to poor working conditions for the lowest possible pay [9,10]. Since the 1980s, transforming the culture of nursing homes to be more humanizing, resident-centered, empowering, and homelike has been a primary mission of many stakeholder groups, including nursing home residents and care workers and their advocates [11].

Comprehensive culture change requires transformation of the nursing home environment from that of an institution to that of a home, implementation of more resident-centered care practices, empowerment of direct care staff, and flattening of the traditional organizational hierarchy so that residents and direct-care workers are actively involved in planning and implementing changes that empower them [12,13]. Culture change requires both technical changes, which are relatively straightforward efforts to address issues within a system while fundamentally keeping the system intact, and adaptive changes, which are more complex and entail reforming fundamental values that underlie the system and demand changes to the system itself [14,15].

Over time, nursing home culture change has gained widespread mainstream support. In 2009, the federal government issued new interpretive guidelines for use by nursing home inspectors that call for nursing homes to have more homelike environments and to support more resident-centered care [16]. The Centers for Medicare & Medicaid Services also required state quality improvement organizations to work with nursing homes on culture change efforts [1]. Some states effectively incentivize culture change by tying nursing home reimbursement rates and pay-for-performance policies to the implementation of culture change practices [17]. In addition to federal and state regulations, some nursing home corporations encourage or require facility administrators to implement culture change practices [18]. Overall, nursing homes are pushed to implement culture change practices on many fronts. The promise of beneficial outcomes of culture change also motivates implementation of some culture change practices [19].

In this article, we discuss the key elements of culture change, review the research examining the association between culture change and outcomes, identify key barriers to culture change, and offer suggestions from the literature for overcoming resistance to culture change.

Elements of Culture Change

Changing the Physical Environment

Changing the physical environment of nursing homes to be less institutional and more homelike is a core component of culture change [1]. These include both exterior and interior changes. Exterior changes can include adding walkways, patios, and gardens; interior changes include replacing nurses’ stations with desks, creating resident common areas, introducing the use of linens in dining areas, personalizing mailboxes outside of resident rooms, and adding small kitchens on units [20]. Other ideas for making environments more homelike include providing residents with the choice of colors for painting rooms and the choice of corridor/unit names and replacing public announcement systems with staff pagers [20].

Although changes to the physical environment may be considered cost-prohibitive, many of these changes entail minor and inexpensive enhancements that can help make environments more intimate and reminiscent of home than are traditional nursing homes [21,22]. Additionally, some environmental changes, such as adding raised gardens and walkways, can be designed not only to make the environment more homelike but also to help residents to engage in meaningful activities and connect to former roles, such as those of a homemaker, gardener, or farmer [21–23].

Providing Resident-Centered Care

Making care resident-centered entails enhancing resident choice and decision making and focusing the delivery of services on residents’ needs and preferences. According to Banaszak-Holl and colleagues [24], resident-centered approaches often emphasize the importance of shifting institutional norms and values and drawing employees’ attention to the needs of residents. This cultural shift in values and norms may be signaled by the implementation of practices that strengthen residents’ autonomy regarding everyday decisions. For example, as part of a resident-centered approach, residents would be offered choices and encouraged to make their own decisions about things personally affecting them, such as what to wear or when to go to bed, eating schedules, and menus [1,17,25].

Empowering Care Aides

Nursing home staff empowerment, particularly the empowerment of nursing assistants and other “hands-on” care aides—who are the predominant workforce in nursing homes and provide the vast bulk of care [26]—is a core component of culture change [1]. Such staff empowerment generally entails enhanced participation in decision making and increased autonomy. Staff empowerment practices that were examined in a national survey of nursing home directors [17] included:

• Staff work together to cover shifts when someone cannot come to work
• Staff cross-trained to perform tasks outside of their assigned job duties
• Staff involved in planning social events
• Nursing assistants take part in quality improvement teams
• Nursing assistants know when a resident’s care plan has changed
• Nursing assistants who receive extra training or education receive bonuses or raises
• Nursing assistants can choose which the residents for whom they provide care

We found that the staff empowerment practices most commonly implemented by nursing homes included nursing assistants knowing when a resident’s care plan has changed and staff working together to cover shifts when someone can’t come to work, but it was uncommon for nursing homes to permit nursing assistants to choose which residents they care for [17].

Outcomes of Culture Change

Research over the past 2 decades has examined the outcomes of culture change and the challenges involved in its implementation. Culture change is intended to improve the quality of life for nursing home residents, but the impact of culture change interventions is not clear. Shier and colleagues [27] conducted a comprehensive review of the peer-reviewed and gray literature on culture change published between 2005 and 2012 and found that studies varied widely in scope and evidence was inconsistent. They concluded that there is not yet sufficient evidence to provide specific guidance to nursing homes interested in implementing culture change [27]. The reviewed studies (27 peer-reviewed and 9 gray literature) also were noted to include small sample sizes and restricted geographic coverage, which both limit generalizability.

Although the literature had substantial limitations, Shier and colleagues [27] found numerous beneficial outcomes of culture change. Statistically significant improvements in numerous resident outcome measures were found to be associated with the implementation of culture change practices, including measures of resident quality of life/well-being, engagement and activities, functional status, satisfaction, mood (depression), anxiety/behavior/agitation, and pain/comfort. Two quality of care and services outcome measures also showed significant improvement associated with culture change practices, including increased completion of advance care plans and improved quality of workers’ approach to residents. Various staff outcome measures also showed significant improvement associated with culture change, including improvements in staff turnover/retention, satisfaction/well-being/burnout, absenteeism, knowledge, and attitude. Additionally, studies have shown culture change to be associated with improvements in select organizational outcome measures including operations costs, occupancy rates, revenue/profits, and family satisfaction. Four of the 36 studies reported negative outcomes of culture change. These negative outcomes included increased resident fear/anxiety [28], increased resident incontinence, decreased resident engagement in activities, decreased family engagement [29,30], decreased resident well-being [31], and increased physical incidents [32]. Notably, negative outcomes often co-occurred with positive outcomes [27,28].

To address the limitations of previous culture change research, such as small sample sizes and limited geographic coverage, and to explain some of the previous equivocal findings from quality studies when the extent of culture change practice implementation was not considered or measured, we collaborated on a national study to understand whether nursing home introduction of culture change practices is associated with improved quality [33]. We identified 824 U.S. nursing homes that had implemented some culture change practices, and we classified them by level of culture change practice implementation (high versus low). In nursing homes with high levels of culture change practice implementation, the introduction of nursing home culture change was associated with significant improvements in some care processes (eg, decreased prevalence of restraints, tube feeding, and pressure ulcers; increased proportion of residents on bladder training programs) and improvements in some resident outcomes, including slightly fewer hospitalizations. Among nursing homes with lower levels of culture change practice implementation, the introduction of culture change was associated with fewer health-related and quality-of-life survey deficiencies, but also with a significant increase in the number of resident hospitalizations [33]. Conclusive evidence regarding the impact of nursing homes implementing specific culture change practices or a comprehensive array of culture change practices on resident outcomes and quality of life remains needed, but numerous benefits of culture change are apparent in the literature.

Diffusion of Culture Change Practices

As culture change is widely supported and shows promise for beneficial outcomes, culture change practices are increasingly being implemented in nursing homes nationally. In 2007, a Commonwealth Fund survey found 56% of directors of nursing in U.S. nursing homes reported any culture change implementation or leadership commitment to implementation, but only 5% reported that culture change had completely changed the way the nursing home cared for residents in all areas of the nursing home [34]. In contrast, by 2010, 85% of directors of nursing reported at least partial culture change implementation and 13% reported that culture change had completely changed the way the nursing home cared for residents in all areas [14]. In a more recent survey of nursing home administrators, 16% reported that culture change had completely changed the way the nursing home cared for residents in all areas [35].

Barriers to Culture Change Implementation

Although the growth of culture change in the nursing home industry in the past decade has been impressive, implementation of comprehensive culture change has lagged behind. This is because one notable feature of nursing home culture change is that it is a philosophy that consists of many related practices. As noted above, implementing culture change can involve changes to physical environments, resident-centered care practices, and staff empowerment. This means that facilities can choose to implement as many or as few changes as they would like, and research has shown that there has been a lot of variation in which culture change practices are implemented. For example, in previous research we found that facilities interested in attracting highly reimbursed Medicare rehabilitation patients were more likely to implement hotel-style changes to their physical environments than they were to implement resident-centered care practices or forms of staff empowerment [19]. Sterns and colleagues [36] found that facilities were more likely to implement less complex practices (eg, allowing residents to choose when they go to bed) than more complex practices (eg, involving staff and residents in organizational decision making). The authors suggest that differences in commitment of facility leaders to comprehensive culture change may have contributed to these differences.

Attributes of facility leaders and other aspects of organizational context have been shown to contribute to more and less successful culture change implementation. For example, Scalzi and colleagues [37] found that some important barriers to culture change implementation were not involving all staff in culture change activities and a lack of corporate level support for these efforts. Schuldheis [38] examined differences in organizational context and its role in culture change among 9 Oregon facilities; 3 facilities successfully implemented culture change practices and 6 facilities did not. Results showed that a facility’s existing organizational culture, attention to sustainability, management practices, and staff involvement were important to the success of the initiative. Similarly, Rosemond and colleagues [39] conducted a study involving 8 North Carolina nursing homes. They determined that unsuccessful culture change initiatives could be attributed to the organizations’ readiness for change, a lack of high quality management communications, and unfavorable perceptions of culture change by direct-care workers. A study conducted in 4 nursing homes by Munroe et al [40] found that formal culture change training provided by professional trainers produced better outcomes than informal “train the trainer” sessions provided by other facility managers. Bowers and colleagues [41] also found that unsuccessful implementation of the Green House model of culture change was likely related to a lack of training resources for staff. Similarly, after an in-depth ethnographic study of culture change implementation, Lopez [42] found that it was unrealistic to expect direct-care workers to perform their jobs in radically new ways without being provided with ongoing support from management.

Resistance to Change: A Key Barrier

Our own research sought to understand the barriers and challenges nursing home administrators faced when implementing culture change in their facilities and the strategies they used to overcome them. In interviews conducted with 64 administrators who had participated in a previous nationally representative survey about culture change implementation, administrators reported a wide variety of barriers, including old and outdated physical plants, the costs of some changes, and issues with unions [18]. A key barrier that administrators reported facing was resistance to change on the part of nursing facility staff, residents, and residents’ family members [43]. Administrators reported that residents were resistant to change primarily because they had been institutionalized in their thinking. In other words, nursing homes had essentially trained residents to expect things to be done at certain times and in certain ways. Resistance among staff reportedly included resistance to the overall concept of culture change and to specific culture change practices. Often, staff perceived that changes related to culture change implementation involved additional work or effort on their part without additional resources, but this was not the only reason for resistance. Most often staff, especially longer-term staff, simply were resistant to making any changes to their usual routines or duties.

This type of resistance to change among staff is not unique to culture change implementation and has long been a commonly cited barrier in the organizational change literature. For example, in a 1954 Harvard Business Review article, Lawrence [44] stated that resistance to change was “the most baffling and recalcitrant of the problems which business executives face.” Since that time, resistance to change has been extensively studied as have methods for overcoming such resistance.

Recommendations for Overcoming Resistance to Culture Change

In seminal work on employee resistance to change conducted shortly after World War II, Coch and French [45] challenged the concept that resistance to change was the result of flaws or inadequacies on the part of staff, which would make addressing resistance difficult. Instead, they proposed, and proved through experimental methods, that resistance arose primarily from the context within which the changes were taking place. In other words, they found that managers could ameliorate resistance to change through changes to management and leadership practices. In their experiment, resistance to change in a manufacturing plant was overcome when management effectively communicated to staff the reasons for the change and engaged staff in planning for the desired changes. Studies on the barriers and facilitators of culture change implementation in nursing facilities have similarly found that facility leaders can take steps to address, or even avoid, staff resistance to change.

In our own research, we have found that resistance to change is a common barrier faced by facility leaders. We also found that resistance to change was unique among barriers in that, although strategies used to address other types of barriers varied widely, administrators consistently reported using the same strategies to address and overcome resistance to change. These strategies all involved management and leadership activities, including education and training and improved communication. In addition, administrators discussed in detail the ways they tailored education and communication to their facility’s unique needs. They also indicated that these efforts should be ongoing, communication should be two-way, and that all staff should be included [43].

Good Communication

One important tool for avoiding or overcoming resistance to culture change that facility administrators reported was good communication. They reported that open and bidirectional communication fostered feedback about ongoing culture change efforts and encouraged engagement and buy-in from staff. They also suggested that it is important that this type of communication be ongoing. Good communication about culture change, in particular, included providing a strong rationale for the changes and involved getting input from staff before and during implementation [43].

These findings are similar to other studies of culture change which have found that culture change implementation should involve staff at all levels [37] and that facility leaders should follow through on the plans that have been communicated [39]. Interestingly, the importance of good and open communication has also been identified as important to other forms of nursing facility quality improvement [46].

Training and Education

The facility administrators we interviewed also reported providing education and training for staff about culture change in a variety of ways, including as part of regular in-service training and as a component of new employee orientation. The training materials used were often obtained from the leading culture change organizations. However, importantly, administrators reported tailoring these trainings to the specific needs of their employees or unique context of their facility. For example, administrators reported breaking up long training sessions into shorter segments provided over a longer period of time or organizing trainings to be provided to small groups on the units rather than in more didactic conference-style settings [43]. Administrators explained that providing training in this way was more palatable to staff and helped incorporate learning into everyday care.

Other studies of nursing home culture change have also found training and education to be important to implementation. For example, in a study of a labor-management partnership for culture change implementation, Leutz and colleagues [47] found training of staff from all disciplines by culture change experts to be an important element of successful implementation. Training topics included those that were very general, such as gerontology, and very specific, including person-centered care. Staff were paid for their time participating in training, which took place at their facilities to make participation easier. The trainings were also staggered over the course of several months, so that staff had time to use what they had learned between sessions and could discuss their experiences at the later sessions.

Munroe and colleagues [40] conducted a study of culture change training using pre-post test survey methods and found that formal training had more of an effect on staff than informal training. In the study, staff at 2 facilities received formal education from a consulting group while staff at 2 other facilities then received informal training from the staff of one of the formally trained facilities. An important conclusion of the authors was that the formal training did a better job than the informal training of helping facility leaders and managers view their relationships with staff differently. This suggests that facility leaders and managers may have to alter their management styles to create the supportive context within which culture change efforts can succeed [48].

Leadership Support

Good communication and training/education can be thought of as 2 examples of leadership support, and support from facility leaders and managers has been found, in multiple studies, to be critical to successful culture change efforts. For example, in a recent study of nursing facility culture change in the Netherlands, Snoeren and colleagues [49] found that facility managers can facilitate culture change implementation by supporting a variety of staff needs and promoting the facilities’ new desired values. Another study found that facilities with leaders who are supportive and foster staff flexibility, such as allowing staff to be creative in their problem-solving and have decentralized decision-making, were more likely to report having implemented culture change [24].

In a study focused specifically on facility leadership style and its relation to culture change implementation, Corazzini and colleagues [50] found an adaptive leadership style to be important to culture change implementation. Adaptive leadership styles are ones that acknowledge the importance of staff relationships and recognize that complex changes, like those often implemented in culture change efforts, require complex solutions that will likely evolve over time. These authors conclude that culture change implementation necessitates development of new normative values and behaviors and can, therefore, not be accomplished by simply generating new rules and procedures [50].

Of course, not all nursing facility leaders have the management skills needed to perform in these adaptive and flexible ways. Therefore, management training for facility leaders may be an important first step in a facility’s culture change efforts [51]. This type of training may help improve communication skills and allow facility leaders to perform in more adaptive and flexible ways to better meet the needs of their particular facility and staff. Research also suggests that culture change training for facility leaders may help them to form new and better relationships with staff [40], an important element of culture change.

Conclusion

Nursing home culture change aims to improve care quality and resident satisfaction through changes to physical environments, resident care practices, and staff empowerment. These include both relatively simple technical changes and more complex changes. Nursing home managers and leaders have reported a variety of barriers to implementing nursing home culture change. A common barrier cited is staff resistance to change. Many decades of research in the organizational change literature and more recent research on culture change implementation suggest steps that facility managers and leaders can take to avoid or overcome this resistance. These steps include providing management support, especially in the form of good communication and training and education.

Corresponding author: Denise A. Tyler, PhD, RTI International, 307 Waverly Oaks Rd., Waltham, MA 02452, dtyler@rti.org.

Financial disclosures: None.

From RTI International, Waltham, MA, and Brown University School of Public Health, Providence, RI.

Abstract

• Objective: To review the nursing home culture change literature and identify common barriers to and facilitators of nursing home culture change adoption. Nursing home culture change aims to make nursing homes less institutional by providing more resident-centered care, making environments more homelike, and empowering direct care staff.
• Methods: We reviewed the research literature on nursing home culture change, especially as related to implementation and outcomes.
• Results: Adoption of nursing home culture change practices has been steadily increasing in the past decade, but some practices are more likely to be adopted than others. A commonly reported barrier to culture change adoption is staff resistance to change. Studies suggest that this resistance can be overcome by changes to management practices, including good communication, providing training and education, and leadership support.
• Conclusion: The numerous benefits of nursing home culture change are apparent in the literature. Barriers to its adoption may be overcome by making improvements to nursing home management practices.

Key words: nursing homes; culture change; resident-centered care.

Nursing home culture change is a philosophy and combination of diverse practices aimed at making nursing homes less institutional and more resident-centered [1]. Nursing homes have been depicted as dehumanizing “total institutions” [2–4] in which the quality of residents’ lives and the quality of care are generally poor, daily life is medically regimented, only residents’ basic physical needs receive attention [5–8], and direct care workers are subject to poor working conditions for the lowest possible pay [9,10]. Since the 1980s, transforming the culture of nursing homes to be more humanizing, resident-centered, empowering, and homelike has been a primary mission of many stakeholder groups, including nursing home residents and care workers and their advocates [11].

Comprehensive culture change requires transformation of the nursing home environment from that of an institution to that of a home, implementation of more resident-centered care practices, empowerment of direct care staff, and flattening of the traditional organizational hierarchy so that residents and direct-care workers are actively involved in planning and implementing changes that empower them [12,13]. Culture change requires both technical changes, which are relatively straightforward efforts to address issues within a system while fundamentally keeping the system intact, and adaptive changes, which are more complex and entail reforming fundamental values that underlie the system and demand changes to the system itself [14,15].

Over time, nursing home culture change has gained widespread mainstream support. In 2009, the federal government issued new interpretive guidelines for use by nursing home inspectors that call for nursing homes to have more homelike environments and to support more resident-centered care [16]. The Centers for Medicare & Medicaid Services also required state quality improvement organizations to work with nursing homes on culture change efforts [1]. Some states effectively incentivize culture change by tying nursing home reimbursement rates and pay-for-performance policies to the implementation of culture change practices [17]. In addition to federal and state regulations, some nursing home corporations encourage or require facility administrators to implement culture change practices [18]. Overall, nursing homes are pushed to implement culture change practices on many fronts. The promise of beneficial outcomes of culture change also motivates implementation of some culture change practices [19].

In this article, we discuss the key elements of culture change, review the research examining the association between culture change and outcomes, identify key barriers to culture change, and offer suggestions from the literature for overcoming resistance to culture change.

Elements of Culture Change

Changing the Physical Environment

Changing the physical environment of nursing homes to be less institutional and more homelike is a core component of culture change [1]. These include both exterior and interior changes. Exterior changes can include adding walkways, patios, and gardens; interior changes include replacing nurses’ stations with desks, creating resident common areas, introducing the use of linens in dining areas, personalizing mailboxes outside of resident rooms, and adding small kitchens on units [20]. Other ideas for making environments more homelike include providing residents with the choice of colors for painting rooms and the choice of corridor/unit names and replacing public announcement systems with staff pagers [20].

Although changes to the physical environment may be considered cost-prohibitive, many of these changes entail minor and inexpensive enhancements that can help make environments more intimate and reminiscent of home than are traditional nursing homes [21,22]. Additionally, some environmental changes, such as adding raised gardens and walkways, can be designed not only to make the environment more homelike but also to help residents to engage in meaningful activities and connect to former roles, such as those of a homemaker, gardener, or farmer [21–23].

Providing Resident-Centered Care

Making care resident-centered entails enhancing resident choice and decision making and focusing the delivery of services on residents’ needs and preferences. According to Banaszak-Holl and colleagues [24], resident-centered approaches often emphasize the importance of shifting institutional norms and values and drawing employees’ attention to the needs of residents. This cultural shift in values and norms may be signaled by the implementation of practices that strengthen residents’ autonomy regarding everyday decisions. For example, as part of a resident-centered approach, residents would be offered choices and encouraged to make their own decisions about things personally affecting them, such as what to wear or when to go to bed, eating schedules, and menus [1,17,25].

Empowering Care Aides

Nursing home staff empowerment, particularly the empowerment of nursing assistants and other “hands-on” care aides—who are the predominant workforce in nursing homes and provide the vast bulk of care [26]—is a core component of culture change [1]. Such staff empowerment generally entails enhanced participation in decision making and increased autonomy. Staff empowerment practices that were examined in a national survey of nursing home directors [17] included:

• Staff work together to cover shifts when someone cannot come to work
• Staff cross-trained to perform tasks outside of their assigned job duties
• Staff involved in planning social events
• Nursing assistants take part in quality improvement teams
• Nursing assistants know when a resident’s care plan has changed
• Nursing assistants who receive extra training or education receive bonuses or raises
• Nursing assistants can choose which the residents for whom they provide care

We found that the staff empowerment practices most commonly implemented by nursing homes included nursing assistants knowing when a resident’s care plan has changed and staff working together to cover shifts when someone can’t come to work, but it was uncommon for nursing homes to permit nursing assistants to choose which residents they care for [17].

Outcomes of Culture Change

Research over the past 2 decades has examined the outcomes of culture change and the challenges involved in its implementation. Culture change is intended to improve the quality of life for nursing home residents, but the impact of culture change interventions is not clear. Shier and colleagues [27] conducted a comprehensive review of the peer-reviewed and gray literature on culture change published between 2005 and 2012 and found that studies varied widely in scope and evidence was inconsistent. They concluded that there is not yet sufficient evidence to provide specific guidance to nursing homes interested in implementing culture change [27]. The reviewed studies (27 peer-reviewed and 9 gray literature) also were noted to include small sample sizes and restricted geographic coverage, which both limit generalizability.

Although the literature had substantial limitations, Shier and colleagues [27] found numerous beneficial outcomes of culture change. Statistically significant improvements in numerous resident outcome measures were found to be associated with the implementation of culture change practices, including measures of resident quality of life/well-being, engagement and activities, functional status, satisfaction, mood (depression), anxiety/behavior/agitation, and pain/comfort. Two quality of care and services outcome measures also showed significant improvement associated with culture change practices, including increased completion of advance care plans and improved quality of workers’ approach to residents. Various staff outcome measures also showed significant improvement associated with culture change, including improvements in staff turnover/retention, satisfaction/well-being/burnout, absenteeism, knowledge, and attitude. Additionally, studies have shown culture change to be associated with improvements in select organizational outcome measures including operations costs, occupancy rates, revenue/profits, and family satisfaction. Four of the 36 studies reported negative outcomes of culture change. These negative outcomes included increased resident fear/anxiety [28], increased resident incontinence, decreased resident engagement in activities, decreased family engagement [29,30], decreased resident well-being [31], and increased physical incidents [32]. Notably, negative outcomes often co-occurred with positive outcomes [27,28].

To address the limitations of previous culture change research, such as small sample sizes and limited geographic coverage, and to explain some of the previous equivocal findings from quality studies when the extent of culture change practice implementation was not considered or measured, we collaborated on a national study to understand whether nursing home introduction of culture change practices is associated with improved quality [33]. We identified 824 U.S. nursing homes that had implemented some culture change practices, and we classified them by level of culture change practice implementation (high versus low). In nursing homes with high levels of culture change practice implementation, the introduction of nursing home culture change was associated with significant improvements in some care processes (eg, decreased prevalence of restraints, tube feeding, and pressure ulcers; increased proportion of residents on bladder training programs) and improvements in some resident outcomes, including slightly fewer hospitalizations. Among nursing homes with lower levels of culture change practice implementation, the introduction of culture change was associated with fewer health-related and quality-of-life survey deficiencies, but also with a significant increase in the number of resident hospitalizations [33]. Conclusive evidence regarding the impact of nursing homes implementing specific culture change practices or a comprehensive array of culture change practices on resident outcomes and quality of life remains needed, but numerous benefits of culture change are apparent in the literature.

Diffusion of Culture Change Practices

As culture change is widely supported and shows promise for beneficial outcomes, culture change practices are increasingly being implemented in nursing homes nationally. In 2007, a Commonwealth Fund survey found 56% of directors of nursing in U.S. nursing homes reported any culture change implementation or leadership commitment to implementation, but only 5% reported that culture change had completely changed the way the nursing home cared for residents in all areas of the nursing home [34]. In contrast, by 2010, 85% of directors of nursing reported at least partial culture change implementation and 13% reported that culture change had completely changed the way the nursing home cared for residents in all areas [14]. In a more recent survey of nursing home administrators, 16% reported that culture change had completely changed the way the nursing home cared for residents in all areas [35].

Barriers to Culture Change Implementation

Although the growth of culture change in the nursing home industry in the past decade has been impressive, implementation of comprehensive culture change has lagged behind. This is because one notable feature of nursing home culture change is that it is a philosophy that consists of many related practices. As noted above, implementing culture change can involve changes to physical environments, resident-centered care practices, and staff empowerment. This means that facilities can choose to implement as many or as few changes as they would like, and research has shown that there has been a lot of variation in which culture change practices are implemented. For example, in previous research we found that facilities interested in attracting highly reimbursed Medicare rehabilitation patients were more likely to implement hotel-style changes to their physical environments than they were to implement resident-centered care practices or forms of staff empowerment [19]. Sterns and colleagues [36] found that facilities were more likely to implement less complex practices (eg, allowing residents to choose when they go to bed) than more complex practices (eg, involving staff and residents in organizational decision making). The authors suggest that differences in commitment of facility leaders to comprehensive culture change may have contributed to these differences.

Attributes of facility leaders and other aspects of organizational context have been shown to contribute to more and less successful culture change implementation. For example, Scalzi and colleagues [37] found that some important barriers to culture change implementation were not involving all staff in culture change activities and a lack of corporate level support for these efforts. Schuldheis [38] examined differences in organizational context and its role in culture change among 9 Oregon facilities; 3 facilities successfully implemented culture change practices and 6 facilities did not. Results showed that a facility’s existing organizational culture, attention to sustainability, management practices, and staff involvement were important to the success of the initiative. Similarly, Rosemond and colleagues [39] conducted a study involving 8 North Carolina nursing homes. They determined that unsuccessful culture change initiatives could be attributed to the organizations’ readiness for change, a lack of high quality management communications, and unfavorable perceptions of culture change by direct-care workers. A study conducted in 4 nursing homes by Munroe et al [40] found that formal culture change training provided by professional trainers produced better outcomes than informal “train the trainer” sessions provided by other facility managers. Bowers and colleagues [41] also found that unsuccessful implementation of the Green House model of culture change was likely related to a lack of training resources for staff. Similarly, after an in-depth ethnographic study of culture change implementation, Lopez [42] found that it was unrealistic to expect direct-care workers to perform their jobs in radically new ways without being provided with ongoing support from management.

Resistance to Change: A Key Barrier

Our own research sought to understand the barriers and challenges nursing home administrators faced when implementing culture change in their facilities and the strategies they used to overcome them. In interviews conducted with 64 administrators who had participated in a previous nationally representative survey about culture change implementation, administrators reported a wide variety of barriers, including old and outdated physical plants, the costs of some changes, and issues with unions [18]. A key barrier that administrators reported facing was resistance to change on the part of nursing facility staff, residents, and residents’ family members [43]. Administrators reported that residents were resistant to change primarily because they had been institutionalized in their thinking. In other words, nursing homes had essentially trained residents to expect things to be done at certain times and in certain ways. Resistance among staff reportedly included resistance to the overall concept of culture change and to specific culture change practices. Often, staff perceived that changes related to culture change implementation involved additional work or effort on their part without additional resources, but this was not the only reason for resistance. Most often staff, especially longer-term staff, simply were resistant to making any changes to their usual routines or duties.

This type of resistance to change among staff is not unique to culture change implementation and has long been a commonly cited barrier in the organizational change literature. For example, in a 1954 Harvard Business Review article, Lawrence [44] stated that resistance to change was “the most baffling and recalcitrant of the problems which business executives face.” Since that time, resistance to change has been extensively studied as have methods for overcoming such resistance.

Recommendations for Overcoming Resistance to Culture Change

In seminal work on employee resistance to change conducted shortly after World War II, Coch and French [45] challenged the concept that resistance to change was the result of flaws or inadequacies on the part of staff, which would make addressing resistance difficult. Instead, they proposed, and proved through experimental methods, that resistance arose primarily from the context within which the changes were taking place. In other words, they found that managers could ameliorate resistance to change through changes to management and leadership practices. In their experiment, resistance to change in a manufacturing plant was overcome when management effectively communicated to staff the reasons for the change and engaged staff in planning for the desired changes. Studies on the barriers and facilitators of culture change implementation in nursing facilities have similarly found that facility leaders can take steps to address, or even avoid, staff resistance to change.

In our own research, we have found that resistance to change is a common barrier faced by facility leaders. We also found that resistance to change was unique among barriers in that, although strategies used to address other types of barriers varied widely, administrators consistently reported using the same strategies to address and overcome resistance to change. These strategies all involved management and leadership activities, including education and training and improved communication. In addition, administrators discussed in detail the ways they tailored education and communication to their facility’s unique needs. They also indicated that these efforts should be ongoing, communication should be two-way, and that all staff should be included [43].

Good Communication

One important tool for avoiding or overcoming resistance to culture change that facility administrators reported was good communication. They reported that open and bidirectional communication fostered feedback about ongoing culture change efforts and encouraged engagement and buy-in from staff. They also suggested that it is important that this type of communication be ongoing. Good communication about culture change, in particular, included providing a strong rationale for the changes and involved getting input from staff before and during implementation [43].

These findings are similar to other studies of culture change which have found that culture change implementation should involve staff at all levels [37] and that facility leaders should follow through on the plans that have been communicated [39]. Interestingly, the importance of good and open communication has also been identified as important to other forms of nursing facility quality improvement [46].

Training and Education

The facility administrators we interviewed also reported providing education and training for staff about culture change in a variety of ways, including as part of regular in-service training and as a component of new employee orientation. The training materials used were often obtained from the leading culture change organizations. However, importantly, administrators reported tailoring these trainings to the specific needs of their employees or unique context of their facility. For example, administrators reported breaking up long training sessions into shorter segments provided over a longer period of time or organizing trainings to be provided to small groups on the units rather than in more didactic conference-style settings [43]. Administrators explained that providing training in this way was more palatable to staff and helped incorporate learning into everyday care.

Other studies of nursing home culture change have also found training and education to be important to implementation. For example, in a study of a labor-management partnership for culture change implementation, Leutz and colleagues [47] found training of staff from all disciplines by culture change experts to be an important element of successful implementation. Training topics included those that were very general, such as gerontology, and very specific, including person-centered care. Staff were paid for their time participating in training, which took place at their facilities to make participation easier. The trainings were also staggered over the course of several months, so that staff had time to use what they had learned between sessions and could discuss their experiences at the later sessions.

Munroe and colleagues [40] conducted a study of culture change training using pre-post test survey methods and found that formal training had more of an effect on staff than informal training. In the study, staff at 2 facilities received formal education from a consulting group while staff at 2 other facilities then received informal training from the staff of one of the formally trained facilities. An important conclusion of the authors was that the formal training did a better job than the informal training of helping facility leaders and managers view their relationships with staff differently. This suggests that facility leaders and managers may have to alter their management styles to create the supportive context within which culture change efforts can succeed [48].

Leadership Support

Good communication and training/education can be thought of as 2 examples of leadership support, and support from facility leaders and managers has been found, in multiple studies, to be critical to successful culture change efforts. For example, in a recent study of nursing facility culture change in the Netherlands, Snoeren and colleagues [49] found that facility managers can facilitate culture change implementation by supporting a variety of staff needs and promoting the facilities’ new desired values. Another study found that facilities with leaders who are supportive and foster staff flexibility, such as allowing staff to be creative in their problem-solving and have decentralized decision-making, were more likely to report having implemented culture change [24].

In a study focused specifically on facility leadership style and its relation to culture change implementation, Corazzini and colleagues [50] found an adaptive leadership style to be important to culture change implementation. Adaptive leadership styles are ones that acknowledge the importance of staff relationships and recognize that complex changes, like those often implemented in culture change efforts, require complex solutions that will likely evolve over time. These authors conclude that culture change implementation necessitates development of new normative values and behaviors and can, therefore, not be accomplished by simply generating new rules and procedures [50].

Of course, not all nursing facility leaders have the management skills needed to perform in these adaptive and flexible ways. Therefore, management training for facility leaders may be an important first step in a facility’s culture change efforts [51]. This type of training may help improve communication skills and allow facility leaders to perform in more adaptive and flexible ways to better meet the needs of their particular facility and staff. Research also suggests that culture change training for facility leaders may help them to form new and better relationships with staff [40], an important element of culture change.

Conclusion

Nursing home culture change aims to improve care quality and resident satisfaction through changes to physical environments, resident care practices, and staff empowerment. These include both relatively simple technical changes and more complex changes. Nursing home managers and leaders have reported a variety of barriers to implementing nursing home culture change. A common barrier cited is staff resistance to change. Many decades of research in the organizational change literature and more recent research on culture change implementation suggest steps that facility managers and leaders can take to avoid or overcome this resistance. These steps include providing management support, especially in the form of good communication and training and education.

Corresponding author: Denise A. Tyler, PhD, RTI International, 307 Waverly Oaks Rd., Waltham, MA 02452, dtyler@rti.org.

Financial disclosures: None.

From RTI International, Waltham, MA, and Brown University School of Public Health, Providence, RI.

Abstract

• Objective: To review the nursing home culture change literature and identify common barriers to and facilitators of nursing home culture change adoption. Nursing home culture change aims to make nursing homes less institutional by providing more resident-centered care, making environments more homelike, and empowering direct care staff.
• Methods: We reviewed the research literature on nursing home culture change, especially as related to implementation and outcomes.
• Results: Adoption of nursing home culture change practices has been steadily increasing in the past decade, but some practices are more likely to be adopted than others. A commonly reported barrier to culture change adoption is staff resistance to change. Studies suggest that this resistance can be overcome by changes to management practices, including good communication, providing training and education, and leadership support.
• Conclusion: The numerous benefits of nursing home culture change are apparent in the literature. Barriers to its adoption may be overcome by making improvements to nursing home management practices.

Key words: nursing homes; culture change; resident-centered care.

Nursing home culture change is a philosophy and combination of diverse practices aimed at making nursing homes less institutional and more resident-centered [1]. Nursing homes have been depicted as dehumanizing “total institutions” [2–4] in which the quality of residents’ lives and the quality of care are generally poor, daily life is medically regimented, only residents’ basic physical needs receive attention [5–8], and direct care workers are subject to poor working conditions for the lowest possible pay [9,10]. Since the 1980s, transforming the culture of nursing homes to be more humanizing, resident-centered, empowering, and homelike has been a primary mission of many stakeholder groups, including nursing home residents and care workers and their advocates [11].

Comprehensive culture change requires transformation of the nursing home environment from that of an institution to that of a home, implementation of more resident-centered care practices, empowerment of direct care staff, and flattening of the traditional organizational hierarchy so that residents and direct-care workers are actively involved in planning and implementing changes that empower them [12,13]. Culture change requires both technical changes, which are relatively straightforward efforts to address issues within a system while fundamentally keeping the system intact, and adaptive changes, which are more complex and entail reforming fundamental values that underlie the system and demand changes to the system itself [14,15].

Over time, nursing home culture change has gained widespread mainstream support. In 2009, the federal government issued new interpretive guidelines for use by nursing home inspectors that call for nursing homes to have more homelike environments and to support more resident-centered care [16]. The Centers for Medicare & Medicaid Services also required state quality improvement organizations to work with nursing homes on culture change efforts [1]. Some states effectively incentivize culture change by tying nursing home reimbursement rates and pay-for-performance policies to the implementation of culture change practices [17]. In addition to federal and state regulations, some nursing home corporations encourage or require facility administrators to implement culture change practices [18]. Overall, nursing homes are pushed to implement culture change practices on many fronts. The promise of beneficial outcomes of culture change also motivates implementation of some culture change practices [19].

In this article, we discuss the key elements of culture change, review the research examining the association between culture change and outcomes, identify key barriers to culture change, and offer suggestions from the literature for overcoming resistance to culture change.

Elements of Culture Change

Changing the Physical Environment

Changing the physical environment of nursing homes to be less institutional and more homelike is a core component of culture change [1]. These include both exterior and interior changes. Exterior changes can include adding walkways, patios, and gardens; interior changes include replacing nurses’ stations with desks, creating resident common areas, introducing the use of linens in dining areas, personalizing mailboxes outside of resident rooms, and adding small kitchens on units [20]. Other ideas for making environments more homelike include providing residents with the choice of colors for painting rooms and the choice of corridor/unit names and replacing public announcement systems with staff pagers [20].

Although changes to the physical environment may be considered cost-prohibitive, many of these changes entail minor and inexpensive enhancements that can help make environments more intimate and reminiscent of home than are traditional nursing homes [21,22]. Additionally, some environmental changes, such as adding raised gardens and walkways, can be designed not only to make the environment more homelike but also to help residents to engage in meaningful activities and connect to former roles, such as those of a homemaker, gardener, or farmer [21–23].

Providing Resident-Centered Care

Making care resident-centered entails enhancing resident choice and decision making and focusing the delivery of services on residents’ needs and preferences. According to Banaszak-Holl and colleagues [24], resident-centered approaches often emphasize the importance of shifting institutional norms and values and drawing employees’ attention to the needs of residents. This cultural shift in values and norms may be signaled by the implementation of practices that strengthen residents’ autonomy regarding everyday decisions. For example, as part of a resident-centered approach, residents would be offered choices and encouraged to make their own decisions about things personally affecting them, such as what to wear or when to go to bed, eating schedules, and menus [1,17,25].

Empowering Care Aides

Nursing home staff empowerment, particularly the empowerment of nursing assistants and other “hands-on” care aides—who are the predominant workforce in nursing homes and provide the vast bulk of care [26]—is a core component of culture change [1]. Such staff empowerment generally entails enhanced participation in decision making and increased autonomy. Staff empowerment practices that were examined in a national survey of nursing home directors [17] included:

• Staff work together to cover shifts when someone cannot come to work
• Staff cross-trained to perform tasks outside of their assigned job duties
• Staff involved in planning social events
• Nursing assistants take part in quality improvement teams
• Nursing assistants know when a resident’s care plan has changed
• Nursing assistants who receive extra training or education receive bonuses or raises
• Nursing assistants can choose which the residents for whom they provide care

We found that the staff empowerment practices most commonly implemented by nursing homes included nursing assistants knowing when a resident’s care plan has changed and staff working together to cover shifts when someone can’t come to work, but it was uncommon for nursing homes to permit nursing assistants to choose which residents they care for [17].

Outcomes of Culture Change

Research over the past 2 decades has examined the outcomes of culture change and the challenges involved in its implementation. Culture change is intended to improve the quality of life for nursing home residents, but the impact of culture change interventions is not clear. Shier and colleagues [27] conducted a comprehensive review of the peer-reviewed and gray literature on culture change published between 2005 and 2012 and found that studies varied widely in scope and evidence was inconsistent. They concluded that there is not yet sufficient evidence to provide specific guidance to nursing homes interested in implementing culture change [27]. The reviewed studies (27 peer-reviewed and 9 gray literature) also were noted to include small sample sizes and restricted geographic coverage, which both limit generalizability.

Although the literature had substantial limitations, Shier and colleagues [27] found numerous beneficial outcomes of culture change. Statistically significant improvements in numerous resident outcome measures were found to be associated with the implementation of culture change practices, including measures of resident quality of life/well-being, engagement and activities, functional status, satisfaction, mood (depression), anxiety/behavior/agitation, and pain/comfort. Two quality of care and services outcome measures also showed significant improvement associated with culture change practices, including increased completion of advance care plans and improved quality of workers’ approach to residents. Various staff outcome measures also showed significant improvement associated with culture change, including improvements in staff turnover/retention, satisfaction/well-being/burnout, absenteeism, knowledge, and attitude. Additionally, studies have shown culture change to be associated with improvements in select organizational outcome measures including operations costs, occupancy rates, revenue/profits, and family satisfaction. Four of the 36 studies reported negative outcomes of culture change. These negative outcomes included increased resident fear/anxiety [28], increased resident incontinence, decreased resident engagement in activities, decreased family engagement [29,30], decreased resident well-being [31], and increased physical incidents [32]. Notably, negative outcomes often co-occurred with positive outcomes [27,28].

To address the limitations of previous culture change research, such as small sample sizes and limited geographic coverage, and to explain some of the previous equivocal findings from quality studies when the extent of culture change practice implementation was not considered or measured, we collaborated on a national study to understand whether nursing home introduction of culture change practices is associated with improved quality [33]. We identified 824 U.S. nursing homes that had implemented some culture change practices, and we classified them by level of culture change practice implementation (high versus low). In nursing homes with high levels of culture change practice implementation, the introduction of nursing home culture change was associated with significant improvements in some care processes (eg, decreased prevalence of restraints, tube feeding, and pressure ulcers; increased proportion of residents on bladder training programs) and improvements in some resident outcomes, including slightly fewer hospitalizations. Among nursing homes with lower levels of culture change practice implementation, the introduction of culture change was associated with fewer health-related and quality-of-life survey deficiencies, but also with a significant increase in the number of resident hospitalizations [33]. Conclusive evidence regarding the impact of nursing homes implementing specific culture change practices or a comprehensive array of culture change practices on resident outcomes and quality of life remains needed, but numerous benefits of culture change are apparent in the literature.

Diffusion of Culture Change Practices

As culture change is widely supported and shows promise for beneficial outcomes, culture change practices are increasingly being implemented in nursing homes nationally. In 2007, a Commonwealth Fund survey found 56% of directors of nursing in U.S. nursing homes reported any culture change implementation or leadership commitment to implementation, but only 5% reported that culture change had completely changed the way the nursing home cared for residents in all areas of the nursing home [34]. In contrast, by 2010, 85% of directors of nursing reported at least partial culture change implementation and 13% reported that culture change had completely changed the way the nursing home cared for residents in all areas [14]. In a more recent survey of nursing home administrators, 16% reported that culture change had completely changed the way the nursing home cared for residents in all areas [35].

Barriers to Culture Change Implementation

Although the growth of culture change in the nursing home industry in the past decade has been impressive, implementation of comprehensive culture change has lagged behind. This is because one notable feature of nursing home culture change is that it is a philosophy that consists of many related practices. As noted above, implementing culture change can involve changes to physical environments, resident-centered care practices, and staff empowerment. This means that facilities can choose to implement as many or as few changes as they would like, and research has shown that there has been a lot of variation in which culture change practices are implemented. For example, in previous research we found that facilities interested in attracting highly reimbursed Medicare rehabilitation patients were more likely to implement hotel-style changes to their physical environments than they were to implement resident-centered care practices or forms of staff empowerment [19]. Sterns and colleagues [36] found that facilities were more likely to implement less complex practices (eg, allowing residents to choose when they go to bed) than more complex practices (eg, involving staff and residents in organizational decision making). The authors suggest that differences in commitment of facility leaders to comprehensive culture change may have contributed to these differences.

Attributes of facility leaders and other aspects of organizational context have been shown to contribute to more and less successful culture change implementation. For example, Scalzi and colleagues [37] found that some important barriers to culture change implementation were not involving all staff in culture change activities and a lack of corporate level support for these efforts. Schuldheis [38] examined differences in organizational context and its role in culture change among 9 Oregon facilities; 3 facilities successfully implemented culture change practices and 6 facilities did not. Results showed that a facility’s existing organizational culture, attention to sustainability, management practices, and staff involvement were important to the success of the initiative. Similarly, Rosemond and colleagues [39] conducted a study involving 8 North Carolina nursing homes. They determined that unsuccessful culture change initiatives could be attributed to the organizations’ readiness for change, a lack of high quality management communications, and unfavorable perceptions of culture change by direct-care workers. A study conducted in 4 nursing homes by Munroe et al [40] found that formal culture change training provided by professional trainers produced better outcomes than informal “train the trainer” sessions provided by other facility managers. Bowers and colleagues [41] also found that unsuccessful implementation of the Green House model of culture change was likely related to a lack of training resources for staff. Similarly, after an in-depth ethnographic study of culture change implementation, Lopez [42] found that it was unrealistic to expect direct-care workers to perform their jobs in radically new ways without being provided with ongoing support from management.

Resistance to Change: A Key Barrier

Our own research sought to understand the barriers and challenges nursing home administrators faced when implementing culture change in their facilities and the strategies they used to overcome them. In interviews conducted with 64 administrators who had participated in a previous nationally representative survey about culture change implementation, administrators reported a wide variety of barriers, including old and outdated physical plants, the costs of some changes, and issues with unions [18]. A key barrier that administrators reported facing was resistance to change on the part of nursing facility staff, residents, and residents’ family members [43]. Administrators reported that residents were resistant to change primarily because they had been institutionalized in their thinking. In other words, nursing homes had essentially trained residents to expect things to be done at certain times and in certain ways. Resistance among staff reportedly included resistance to the overall concept of culture change and to specific culture change practices. Often, staff perceived that changes related to culture change implementation involved additional work or effort on their part without additional resources, but this was not the only reason for resistance. Most often staff, especially longer-term staff, simply were resistant to making any changes to their usual routines or duties.

This type of resistance to change among staff is not unique to culture change implementation and has long been a commonly cited barrier in the organizational change literature. For example, in a 1954 Harvard Business Review article, Lawrence [44] stated that resistance to change was “the most baffling and recalcitrant of the problems which business executives face.” Since that time, resistance to change has been extensively studied as have methods for overcoming such resistance.

Recommendations for Overcoming Resistance to Culture Change

In seminal work on employee resistance to change conducted shortly after World War II, Coch and French [45] challenged the concept that resistance to change was the result of flaws or inadequacies on the part of staff, which would make addressing resistance difficult. Instead, they proposed, and proved through experimental methods, that resistance arose primarily from the context within which the changes were taking place. In other words, they found that managers could ameliorate resistance to change through changes to management and leadership practices. In their experiment, resistance to change in a manufacturing plant was overcome when management effectively communicated to staff the reasons for the change and engaged staff in planning for the desired changes. Studies on the barriers and facilitators of culture change implementation in nursing facilities have similarly found that facility leaders can take steps to address, or even avoid, staff resistance to change.

In our own research, we have found that resistance to change is a common barrier faced by facility leaders. We also found that resistance to change was unique among barriers in that, although strategies used to address other types of barriers varied widely, administrators consistently reported using the same strategies to address and overcome resistance to change. These strategies all involved management and leadership activities, including education and training and improved communication. In addition, administrators discussed in detail the ways they tailored education and communication to their facility’s unique needs. They also indicated that these efforts should be ongoing, communication should be two-way, and that all staff should be included [43].

Good Communication

One important tool for avoiding or overcoming resistance to culture change that facility administrators reported was good communication. They reported that open and bidirectional communication fostered feedback about ongoing culture change efforts and encouraged engagement and buy-in from staff. They also suggested that it is important that this type of communication be ongoing. Good communication about culture change, in particular, included providing a strong rationale for the changes and involved getting input from staff before and during implementation [43].

These findings are similar to other studies of culture change which have found that culture change implementation should involve staff at all levels [37] and that facility leaders should follow through on the plans that have been communicated [39]. Interestingly, the importance of good and open communication has also been identified as important to other forms of nursing facility quality improvement [46].

Training and Education

The facility administrators we interviewed also reported providing education and training for staff about culture change in a variety of ways, including as part of regular in-service training and as a component of new employee orientation. The training materials used were often obtained from the leading culture change organizations. However, importantly, administrators reported tailoring these trainings to the specific needs of their employees or unique context of their facility. For example, administrators reported breaking up long training sessions into shorter segments provided over a longer period of time or organizing trainings to be provided to small groups on the units rather than in more didactic conference-style settings [43]. Administrators explained that providing training in this way was more palatable to staff and helped incorporate learning into everyday care.

Other studies of nursing home culture change have also found training and education to be important to implementation. For example, in a study of a labor-management partnership for culture change implementation, Leutz and colleagues [47] found training of staff from all disciplines by culture change experts to be an important element of successful implementation. Training topics included those that were very general, such as gerontology, and very specific, including person-centered care. Staff were paid for their time participating in training, which took place at their facilities to make participation easier. The trainings were also staggered over the course of several months, so that staff had time to use what they had learned between sessions and could discuss their experiences at the later sessions.

Munroe and colleagues [40] conducted a study of culture change training using pre-post test survey methods and found that formal training had more of an effect on staff than informal training. In the study, staff at 2 facilities received formal education from a consulting group while staff at 2 other facilities then received informal training from the staff of one of the formally trained facilities. An important conclusion of the authors was that the formal training did a better job than the informal training of helping facility leaders and managers view their relationships with staff differently. This suggests that facility leaders and managers may have to alter their management styles to create the supportive context within which culture change efforts can succeed [48].

Leadership Support

Good communication and training/education can be thought of as 2 examples of leadership support, and support from facility leaders and managers has been found, in multiple studies, to be critical to successful culture change efforts. For example, in a recent study of nursing facility culture change in the Netherlands, Snoeren and colleagues [49] found that facility managers can facilitate culture change implementation by supporting a variety of staff needs and promoting the facilities’ new desired values. Another study found that facilities with leaders who are supportive and foster staff flexibility, such as allowing staff to be creative in their problem-solving and have decentralized decision-making, were more likely to report having implemented culture change [24].

In a study focused specifically on facility leadership style and its relation to culture change implementation, Corazzini and colleagues [50] found an adaptive leadership style to be important to culture change implementation. Adaptive leadership styles are ones that acknowledge the importance of staff relationships and recognize that complex changes, like those often implemented in culture change efforts, require complex solutions that will likely evolve over time. These authors conclude that culture change implementation necessitates development of new normative values and behaviors and can, therefore, not be accomplished by simply generating new rules and procedures [50].

Of course, not all nursing facility leaders have the management skills needed to perform in these adaptive and flexible ways. Therefore, management training for facility leaders may be an important first step in a facility’s culture change efforts [51]. This type of training may help improve communication skills and allow facility leaders to perform in more adaptive and flexible ways to better meet the needs of their particular facility and staff. Research also suggests that culture change training for facility leaders may help them to form new and better relationships with staff [40], an important element of culture change.

Conclusion

Nursing home culture change aims to improve care quality and resident satisfaction through changes to physical environments, resident care practices, and staff empowerment. These include both relatively simple technical changes and more complex changes. Nursing home managers and leaders have reported a variety of barriers to implementing nursing home culture change. A common barrier cited is staff resistance to change. Many decades of research in the organizational change literature and more recent research on culture change implementation suggest steps that facility managers and leaders can take to avoid or overcome this resistance. These steps include providing management support, especially in the form of good communication and training and education.

Corresponding author: Denise A. Tyler, PhD, RTI International, 307 Waverly Oaks Rd., Waltham, MA 02452, dtyler@rti.org.

Financial disclosures: None.