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.

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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 [email protected]

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 [email protected]

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 [email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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, [email protected].

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, [email protected].

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, [email protected].

Financial disclosures: None.

From the Office of Science Policy and Communications, National Institute on Drug Abuse, National Institutes of Health, Rockville, MD, and George Washington University, Washington, DC (Dr. Jones), Office of the National Coordinator for Health Information Technology, US Department of Health and Human Services, Washington, DC (Mr. Swain), and Banner Health, Phoenix, AZ (Ms. Burdick).

Abstract

• Objective: Clinical decision support (CDS) can be a useful tool to decrease inappropriate imaging by providing evidence-based information to clinicians at the point of care. The objective of this case study is to highlight lessons from a health care improvement initiative using CDS to encourage use of ultrasound rather than computed tomography (CT) scans as an initial diagnostic tool for suspected appendicitis in pediatric patients.
• Methods: The percentage of suspected pediatric appendicitis cases receiving ultrasounds and CT scans was calculated using electronic health record data. Four steps for implementing health information technology were identified in a literature scan that guided data collection and analysis: planning, software customization and workflow design, training and user support, and optimization.
• Results: During the fourth quarter of 2010, 1 in 7 pediatric patients with suspected appendicitis received an ultrasound and almost half received a CT scan. By the first quarter of 2012, ultrasounds were performed in 40.8% of these cases and the use of CT scans declined to 39.9% of suspected pediatric appendicitis cases.
• Conclusion: Four lessons emerged. First, all levels of staff should be involved in the planning process to make organizational priorities actionable and build buy-in for each healthcare improvement initiative. Second, it takes time to design and test the alert to ensure that clinical guidelines are being properly applied. Third, re-engineering the workflow is critical for usability; in this case, ensuring the availability of ultrasound staff was particularly important. Finally, the effectiveness of CDS depends on applying relevant evidence-based practice guidelines to real-time patient data.

Diagnostic imaging is a useful tool for identifying and guiding the treatment of many health conditions, but evidence indicates that health care providers do not always use imaging appropriately. In fact, a substantial proportion of diagnostic imaging procedures performed in hospital and ambulatory settings are not supported by clinical guideline recommendations [1,2]. Spending on diagnostic imaging is rapidly increasing, and some patients receive unnecessary radiation exposure that can lead to adverse health impacts [3]. Inappropriate imaging falls into 3 broad categories: imaging that does not conform to clinical guidelines, imaging that is contraindicated due to an allergy or implantable medical device, and imaging that might be clinically indicated but is duplicative of prior imaging services.

Clinical decision support (CDS) functionality supports health care improvement initiatives to narrow the gap between evidence-based practices and routine care [4]. CDS merges patient-specific clinical information with relevant information about evidence-based practices, providing health care providers with timely information to guide decisions at the point of care [5]. Decision support is most commonly delivered in the form of alerts and reminders [6]. CDS can be effective in reducing adverse drug events [7], sepsis [8,9], and other conditions in hospital [10–12] and ambulatory settings [13,14].

For the evaluation of suspected appendicitis in children, ultrasound is the preferred initial consideration for imaging examination [15]. Evidence suggests that CDS can increase the use of ultrasound for suspected pediatric appendicitis [16,17] and has affirmed the utility of ultrasound as a first-line diagnostic tool for suspected appendicitis [18,19]. In the Choosing Wisely campaign, the American College of Surgeons and the American College of Radiology have both endorsed ultrasound as an option to consider prior to conducting a CT scan to evaluate suspected appendicitis in children [15].

Banner Health, a large health system headquartered in Phoenix, Arizona, implemented a health care improvement initiative using CDS functionality to encourage providers to use ultrasound instead of CT as a first-line diagnostic tool for suspected pediatric appendicitis. We conducted a site visit to Banner Health, an organization who had had attained a high score on the EMR Adoption Model [20] to examine their implementation process. We sought to build on previous research examining the use of health information technology to improve performance in large health systems [21–23].

Methods

Setting

Banner Health is a large not-for-profit health system that is comprised of 24 acute care hospitals across several states, as well as ambulatory medical practices, behavioral health, home care, and ambulatory surgery centers [24,25]. The health system is the largest employer in Arizona and one of the largest in the United States with over 50,000 employees. Banner Health has been nationally recognized for clinical quality [26], an innovative leadership team [27], and using health IT to improve quality [20]. The health system was also selected as one of the Centers for Medicare & Medicaid Services (CMS) Pioneer Accountable Care Organizations.

Site Visit

The first 2 authors conducted a 2-day site visit to the Banner Health headquarters in Phoenix, Arizona in November 2013. The team conducted discussions with over 20 individuals, including health system leadership, frontline clinicians in several units of an acute care hospital, staff members in 2 telehealth hubs—including a tele-ICU hub—and trainers in a simulation facility that is used for staff training. The discussions were conducted with groups of staff or on an individual basis, as appropriate. At the outset of the project, an environmental scan of relevant grey and peer-reviewed literature was conducted under contract on behalf of the authors to guide data collection and analysis [28]. An interview protocol was created to guide the discussions. The protocol contained modules that were used during each discussion, if relevant. The modules addressed topics such as technical issues with designing and deploying health information technology functionalities such as clinical decision support systems, the organizational processes and structures needed to launch health care improvement initiatives, and using health information technology care coordination. Within each module, questions probed about the challenges that arose and the solutions to these challenges, with a focus on the four phases of implementing a health information technology intervention: functionality planning, software customization and workflow design, training and user support, and optimization. To assist with interpreting the qualitative findings, an evolving outline of the findings was maintained. Salient themes and conceptual categories were tracked, which helped the researchers organize, synthesize, and interpret the information collected during the site visit. Once the authors chose to focus on clinical decision support, summary notes from the discussions were reviewed for relevant information, and this information was compiled and organized under the rubric of the four implementation phases. The findings and key themes from the discussion notes were distilled into key lessons for the field.

Data obtained included the percentage of pediatric patients with suspected appendicitis who received ultrasounds and CT scans each month from 1 October 2010 through 31 March 2012. Banner Health staff originally collected the data to support the implementation of health care improvement initiative; the use of these data in this paper is a secondary use [29].

This manuscript was prepared using the SQUIRE 2.0 guidelines [30]. No patient-identifiable data were used, so institutional review board approval was not sought.

Results

The 4 steps of implementing CDS can be described as functionality planning, software customization and workflow design, training and user support, and optimization [31].

Pre-Implementation

The use of computerized provider order entry (CPOE) is a precursor to using clinical decision support, since orders must be entered electronically to be subject to CDS review. Banner Health deployed CPOE to its various facilities starting in 2008. The deployment was staged in a rolling fashion with one or two facilities going live every few months so that the deployment team was available at each facility.

Phase 1: Planning

In contrast to many large health systems, the organization has a single board of directors that oversees the entire system of over 37,000 employees. Activities and relationships to promote the use of evidence-based practices are built into the organizational structure. For example, Banner Health maintains a Care Management Council, a group comprised of clinical and administrative leadership to provide executive oversight of health care improvement projects. The Council convenes on a quarterly basis to review and approve the adoption of new clinical practice guidelines, policies, and standardized standing orders that have been developed by multidisciplinary groups of physicians and other clinicians. A key focus of the Council is ensuring consistent application of evidence-based guidelines to clinical care and disseminating knowledge of clinical best practices across a large and complex enterprise.

Interdisciplinary clinical consensus groups support the Council’s work. These groups are comprised of administrative and program management staff, physicians and other clinicians, and engineers. Each clinical consensus group focuses on emerging issues and improvement opportunities within a specific clinical domain and leads the implementation of health care improvement initiatives in that domain. Providers and staff at all levels of the organization were involved in planning and implementing the health care improvement initiative in inappropriate imaging. This increased buy-in and staff support, which are associated with successful health care improvement initiatives [32]. Banner Health staff rallied around the idea of addressing inappropriate imaging as a key priority initiative. The teams that implement each initiative include an engineer that focuses on redesigning clinical workflows for each initiative. There is also an organizational unit responsible for project management that provides teams with logistical and operational support.

Phase 2: Software Customization and Workflow Redesign

Once the clinical consensus group selected inappropriate imaging as a priority, the next step was to examine the process flow for imaging ordering. In 2011 Banner Health integrated CDS functionality with CPOE into the electronic health record. Before the use of CDS, inpatient and emergency department imaging orders were simply transmitted to imaging staff after the order was entered. After CDS implementation, the process flow begins with an inpatient imaging order and entailed checking the order against clinical guidelines on the proper use of imaging. If the image order did not conform to guidelines, which in this case indicate that ultrasound should be used before CT scans as a diagnostic tool for suspected pediatric appendicitis, the CDS system triggered an alert [15].

Bringing the perspective and skill sets of engineers to the process of redesigning clinical workflows was particularly valuable [33]. While CDS has the potential to reduce inpatient inappropriate imaging, effectiveness depends on adjusting workflows to ensure that the information provided by CDS alerts and reminders is actionable. To reduce alert fatigue among the clinical staff, the team identified the appropriate level of workflow interruption for each alert and reminder (hard stop, workflow interruption, or informational) [5,6].

The design principles that were used to design the alert include intuitive system development to promote ease of use, one set of screen formats and data definitions, and a set of consistent core reports and standard system output formats across facilities. The alert’s appearance was tailored for maximal impact and covered most of the screen. Color contrast was used, but since some people are color-blind, the meaning of the alert did not depend on the color contrast. The alerts included recommendations for changing the treatment plan to encourage using ultrasound as a first-line diagnostic tool. Minimizing the number of clicks to accept the proposed treatment plan change in the alert is desirable.

Phase 3: Training and User Support

Training and support structures and tools were critical to the rollout of the inappropriate imaging alerts. Providers were reminded about clinical best practices and informed during staff meetings about the new CDS rules. In addition, various types of training and support were available to clinicians and staff during the rollout process. Dedicated time for end-user training provided an opportunity to identify and cultivate super-users. These super-users not only helped provide technical support to their colleagues, but also helped create excitement for the initiative. A centralized support desk provided telephone support for providers in facilities throughout the Banner Health system. Site managers were provided toolkits to support providers and staff throughout the implementation process. The toolkits included frequently asked questions and answers, and were maintained as ‘living documents’ that were updated based on emerging issues and questions.

To keep things on track, project managers from the central project management department were involved in the initiative to provide direct project management services to the initiative. They also worked to instill project management competencies throughout the organization, applying a train-the-trainer approach to disseminate best practices for enhancing communication among team members, implementing workflow changes, and monitoring the results.
 

Phase 4: Optimization

The optimization phase is continuous and continues to the present day. Notably, the success of the CDS rules depends on the availability of current clinical information for each patient, in addition to information about the treatment plan. For this initiative, Banner Health maintained aggregated clinical patient data in the data warehouse that aggregated data from disparate sources, including billing and EHR data from different care settings such as ambulatory offices, inpatient units, the emergency department, home care, and ambulatory surgery centers. The data warehouse is housed in a strategically chosen physical location to minimize the threat of natural disasters, and cloud-based backup is also used. A master patient index and provider credentialing system are integrated with the data warehouse. Query-based health information exchange is used, when possible, to collect information on care received by patients outside of the Banner Health system.

It is important to note that many CDS alerts are over-ridden without changes to clinical care [34]. Previous research indicates that alert fatigue from “false positives” can impede the effectiveness of alerts [35]. Banner Health monitors the rate at which CDS alerts are over-ridden. Figure 1 shows the percentage of all alerts for radiation exposure—including the alert related to using ultrasound as a diagnostic tool for pediatric appendicitis—that led to order cancellations. The percentage of CT orders that generated the alert and were cancelled fell from 18.9% in March 2011 to 13.6% in February 2012. The rate of order cancellations might have declined over time due to a change in provider behavior from the alert. That is, if inappropriate CT scan orders declined over time, then providers would cancel a decreasing percentage of the CT scan orders that prompted an alert.

Imaging Use

In Figure 2, data on the use of the 2 imaging procedures for the diagnosis of pediatric appendicitis is presented. During the fourth quarter of 2010, almost half of pediatric patients with suspected appendicitis received a CT scan and only about 1 in 7 received an ultrasound. After the clinical decision support alert was put in place to remind providers to perform an ultrasound as a first-line diagnostic tool, the use of ultrasounds increased sharply. By the first quarter of 2012, ultrasounds were performed in 40.8% of these cases and the use of CT scans declined to 39.9% of suspected pediatric appendicitis cases.

Discussion

This case study discusses the application of CDS functionality in a health care improvement initiative to address inappropriate imaging in a large health system. Four main implementation lessons emerge for the field. First, it is important to involve all levels of staff in the planning process to ensure that health care improvement activities are prioritized correctly and to build buy-in for the priorities addressed with health care improvement activities. Second, it is necessary to allow time to design the alert or reminder, as well as testing it during the implementation process to ensure that clinical guidelines are being properly applied. Third, re-engineering the workflow and ensuring usability of the alert or reminder are important, and using the skills of trained engineers helps in this process. Ensuring the availability of trained ultrasound staff was particularly important to this initiative. Finally, the effectiveness of CDS depends on having complete data for each patient, as well as up-to-date information on the relevant evidence-based practice guidelines.

These results can help guide the implementation of health care improvement initiatives that use CDS functionality to address inappropriate imaging. The adoption of electronic health records with CDS functionality was incentivized and supported by the Medicare and Medicaid Electronic Health Record Incentive Programs; the Medicare program now exists as part of MACRA. Using CDS to reduce inappropriate imaging is required for Medicare fee-for-service patients in the 2014 Protecting Access to Medicare Act (PAMA), highlighting the critical nature of these results, which can guide implementation of CDS to reduce inappropriate imaging [41].

As noted above, the optimization phase is continuous. Banner Health still encourages use of ultrasounds as a first-line diagnostic tool for pediatric appendicitis. Identifying which patients should immediately receive CT scans is difficult, and sometimes the decision depends on the availability of staff to conduct the ultrasound scans. Ways to maximize the productivity of ultrasound technicians have been explored. Another focus area since the original implementation of this health care improvement initiative has been health information exchange, to ensure that complete, up-to-date information is available for each patient.

Banner Health often implements CDS in conjunction with other health IT functionalities. For example, CDS and telehealth are used together to improve care in the intensive care unit (ICU) for patients with sepsis and delirium. An offsite hub of experienced ICU physicians and nurses remotely monitors ICU patients in facilities across Banner Health, using cameras with zoom capability. The intensive care specialists in the tele-hub act as part of the care team; in addition to receiving video feed, they communicate verbally with patients and ICU staff members. Predictive analytics are used to generate clinical decision support alerts and reminders, with a special focus on early intervention if a patient’s clinical indicators are trending downward. The 4 lessons described in this study were also used in the ICU sepsis and delirium initiative; staff were involved in the planning process, alerts and reminders were thoroughly tested, the workflow was adjusted to accommodate the physicians in the tele-ICU hub, and up-to-date and complete clinical information for each patient is maintained. In addition, the design principles for alerts described in this study, such as covering most of the screen and providing recommendations for changing the treatment plan within the alert itself, were also used in the ICU sepsis and delirium initiative.

One limitation of this study is that it was conducted at a single health system. Thus, the findings might not be generalizable to other health systems, particularly if a robust health IT infrastructure is not in place. The culture of Banner Health values quality and involved providers and staff at all levels in selecting and implementing health care improvement initiatives. In addition, engineers assisted with implementation. Finally, the study design does not permit conclusions about the causality of the decline in CT scans and the increase in ultrasounds for suspected pediatric appendicitis cases; unobserved factors might have contributed to the changes in CT and ultrasound use.

Future research should focus on ways to improve the implementation and organization learning process, particularly through engagement of frontline staff by leadership [36] and explore how to operationalize previous findings indicating that innovations in hospital settings are more likely to be sustained when intrinsically rewarding to staff, either by making clinician and staff jobs easier to perform or more gratifying [37]. Future research should focus on facilitating health information exchange between providers in different health systems.

Disclaimer: The views expressed in the article are solely the views of the authors and do not represent those of the National Institutes of Health or the U.S. Government.

Acknowledgments: The authors wish to thank the Banner Health team for taking time to share their insights on how health information technology can be used for health care improvement initiatives, especially John Hensing. We also thank Michael Furukawa of the Agency for Healthcare Research and Quality, formerly of the Office of the National Coordinator for Health Information Technology, who played a key role in the conceptualization of this study and data collection.

Corresponding author: Emily Jones, PhD, MPP, National Institutes of Health, 6001 Executive Blvd., #5232 Rockville, MD 20852, [email protected].

Financial disclosures: None

From the Office of Science Policy and Communications, National Institute on Drug Abuse, National Institutes of Health, Rockville, MD, and George Washington University, Washington, DC (Dr. Jones), Office of the National Coordinator for Health Information Technology, US Department of Health and Human Services, Washington, DC (Mr. Swain), and Banner Health, Phoenix, AZ (Ms. Burdick).

Abstract

• Objective: Clinical decision support (CDS) can be a useful tool to decrease inappropriate imaging by providing evidence-based information to clinicians at the point of care. The objective of this case study is to highlight lessons from a health care improvement initiative using CDS to encourage use of ultrasound rather than computed tomography (CT) scans as an initial diagnostic tool for suspected appendicitis in pediatric patients.
• Methods: The percentage of suspected pediatric appendicitis cases receiving ultrasounds and CT scans was calculated using electronic health record data. Four steps for implementing health information technology were identified in a literature scan that guided data collection and analysis: planning, software customization and workflow design, training and user support, and optimization.
• Results: During the fourth quarter of 2010, 1 in 7 pediatric patients with suspected appendicitis received an ultrasound and almost half received a CT scan. By the first quarter of 2012, ultrasounds were performed in 40.8% of these cases and the use of CT scans declined to 39.9% of suspected pediatric appendicitis cases.
• Conclusion: Four lessons emerged. First, all levels of staff should be involved in the planning process to make organizational priorities actionable and build buy-in for each healthcare improvement initiative. Second, it takes time to design and test the alert to ensure that clinical guidelines are being properly applied. Third, re-engineering the workflow is critical for usability; in this case, ensuring the availability of ultrasound staff was particularly important. Finally, the effectiveness of CDS depends on applying relevant evidence-based practice guidelines to real-time patient data.

Diagnostic imaging is a useful tool for identifying and guiding the treatment of many health conditions, but evidence indicates that health care providers do not always use imaging appropriately. In fact, a substantial proportion of diagnostic imaging procedures performed in hospital and ambulatory settings are not supported by clinical guideline recommendations [1,2]. Spending on diagnostic imaging is rapidly increasing, and some patients receive unnecessary radiation exposure that can lead to adverse health impacts [3]. Inappropriate imaging falls into 3 broad categories: imaging that does not conform to clinical guidelines, imaging that is contraindicated due to an allergy or implantable medical device, and imaging that might be clinically indicated but is duplicative of prior imaging services.

Clinical decision support (CDS) functionality supports health care improvement initiatives to narrow the gap between evidence-based practices and routine care [4]. CDS merges patient-specific clinical information with relevant information about evidence-based practices, providing health care providers with timely information to guide decisions at the point of care [5]. Decision support is most commonly delivered in the form of alerts and reminders [6]. CDS can be effective in reducing adverse drug events [7], sepsis [8,9], and other conditions in hospital [10–12] and ambulatory settings [13,14].

For the evaluation of suspected appendicitis in children, ultrasound is the preferred initial consideration for imaging examination [15]. Evidence suggests that CDS can increase the use of ultrasound for suspected pediatric appendicitis [16,17] and has affirmed the utility of ultrasound as a first-line diagnostic tool for suspected appendicitis [18,19]. In the Choosing Wisely campaign, the American College of Surgeons and the American College of Radiology have both endorsed ultrasound as an option to consider prior to conducting a CT scan to evaluate suspected appendicitis in children [15].

Banner Health, a large health system headquartered in Phoenix, Arizona, implemented a health care improvement initiative using CDS functionality to encourage providers to use ultrasound instead of CT as a first-line diagnostic tool for suspected pediatric appendicitis. We conducted a site visit to Banner Health, an organization who had had attained a high score on the EMR Adoption Model [20] to examine their implementation process. We sought to build on previous research examining the use of health information technology to improve performance in large health systems [21–23].

Methods

Setting

Banner Health is a large not-for-profit health system that is comprised of 24 acute care hospitals across several states, as well as ambulatory medical practices, behavioral health, home care, and ambulatory surgery centers [24,25]. The health system is the largest employer in Arizona and one of the largest in the United States with over 50,000 employees. Banner Health has been nationally recognized for clinical quality [26], an innovative leadership team [27], and using health IT to improve quality [20]. The health system was also selected as one of the Centers for Medicare & Medicaid Services (CMS) Pioneer Accountable Care Organizations.

Site Visit

The first 2 authors conducted a 2-day site visit to the Banner Health headquarters in Phoenix, Arizona in November 2013. The team conducted discussions with over 20 individuals, including health system leadership, frontline clinicians in several units of an acute care hospital, staff members in 2 telehealth hubs—including a tele-ICU hub—and trainers in a simulation facility that is used for staff training. The discussions were conducted with groups of staff or on an individual basis, as appropriate. At the outset of the project, an environmental scan of relevant grey and peer-reviewed literature was conducted under contract on behalf of the authors to guide data collection and analysis [28]. An interview protocol was created to guide the discussions. The protocol contained modules that were used during each discussion, if relevant. The modules addressed topics such as technical issues with designing and deploying health information technology functionalities such as clinical decision support systems, the organizational processes and structures needed to launch health care improvement initiatives, and using health information technology care coordination. Within each module, questions probed about the challenges that arose and the solutions to these challenges, with a focus on the four phases of implementing a health information technology intervention: functionality planning, software customization and workflow design, training and user support, and optimization. To assist with interpreting the qualitative findings, an evolving outline of the findings was maintained. Salient themes and conceptual categories were tracked, which helped the researchers organize, synthesize, and interpret the information collected during the site visit. Once the authors chose to focus on clinical decision support, summary notes from the discussions were reviewed for relevant information, and this information was compiled and organized under the rubric of the four implementation phases. The findings and key themes from the discussion notes were distilled into key lessons for the field.

Data obtained included the percentage of pediatric patients with suspected appendicitis who received ultrasounds and CT scans each month from 1 October 2010 through 31 March 2012. Banner Health staff originally collected the data to support the implementation of health care improvement initiative; the use of these data in this paper is a secondary use [29].

This manuscript was prepared using the SQUIRE 2.0 guidelines [30]. No patient-identifiable data were used, so institutional review board approval was not sought.

Results

The 4 steps of implementing CDS can be described as functionality planning, software customization and workflow design, training and user support, and optimization [31].

Pre-Implementation

The use of computerized provider order entry (CPOE) is a precursor to using clinical decision support, since orders must be entered electronically to be subject to CDS review. Banner Health deployed CPOE to its various facilities starting in 2008. The deployment was staged in a rolling fashion with one or two facilities going live every few months so that the deployment team was available at each facility.

Phase 1: Planning

In contrast to many large health systems, the organization has a single board of directors that oversees the entire system of over 37,000 employees. Activities and relationships to promote the use of evidence-based practices are built into the organizational structure. For example, Banner Health maintains a Care Management Council, a group comprised of clinical and administrative leadership to provide executive oversight of health care improvement projects. The Council convenes on a quarterly basis to review and approve the adoption of new clinical practice guidelines, policies, and standardized standing orders that have been developed by multidisciplinary groups of physicians and other clinicians. A key focus of the Council is ensuring consistent application of evidence-based guidelines to clinical care and disseminating knowledge of clinical best practices across a large and complex enterprise.

Interdisciplinary clinical consensus groups support the Council’s work. These groups are comprised of administrative and program management staff, physicians and other clinicians, and engineers. Each clinical consensus group focuses on emerging issues and improvement opportunities within a specific clinical domain and leads the implementation of health care improvement initiatives in that domain. Providers and staff at all levels of the organization were involved in planning and implementing the health care improvement initiative in inappropriate imaging. This increased buy-in and staff support, which are associated with successful health care improvement initiatives [32]. Banner Health staff rallied around the idea of addressing inappropriate imaging as a key priority initiative. The teams that implement each initiative include an engineer that focuses on redesigning clinical workflows for each initiative. There is also an organizational unit responsible for project management that provides teams with logistical and operational support.

Phase 2: Software Customization and Workflow Redesign

Once the clinical consensus group selected inappropriate imaging as a priority, the next step was to examine the process flow for imaging ordering. In 2011 Banner Health integrated CDS functionality with CPOE into the electronic health record. Before the use of CDS, inpatient and emergency department imaging orders were simply transmitted to imaging staff after the order was entered. After CDS implementation, the process flow begins with an inpatient imaging order and entailed checking the order against clinical guidelines on the proper use of imaging. If the image order did not conform to guidelines, which in this case indicate that ultrasound should be used before CT scans as a diagnostic tool for suspected pediatric appendicitis, the CDS system triggered an alert [15].

Bringing the perspective and skill sets of engineers to the process of redesigning clinical workflows was particularly valuable [33]. While CDS has the potential to reduce inpatient inappropriate imaging, effectiveness depends on adjusting workflows to ensure that the information provided by CDS alerts and reminders is actionable. To reduce alert fatigue among the clinical staff, the team identified the appropriate level of workflow interruption for each alert and reminder (hard stop, workflow interruption, or informational) [5,6].

The design principles that were used to design the alert include intuitive system development to promote ease of use, one set of screen formats and data definitions, and a set of consistent core reports and standard system output formats across facilities. The alert’s appearance was tailored for maximal impact and covered most of the screen. Color contrast was used, but since some people are color-blind, the meaning of the alert did not depend on the color contrast. The alerts included recommendations for changing the treatment plan to encourage using ultrasound as a first-line diagnostic tool. Minimizing the number of clicks to accept the proposed treatment plan change in the alert is desirable.

Phase 3: Training and User Support

Training and support structures and tools were critical to the rollout of the inappropriate imaging alerts. Providers were reminded about clinical best practices and informed during staff meetings about the new CDS rules. In addition, various types of training and support were available to clinicians and staff during the rollout process. Dedicated time for end-user training provided an opportunity to identify and cultivate super-users. These super-users not only helped provide technical support to their colleagues, but also helped create excitement for the initiative. A centralized support desk provided telephone support for providers in facilities throughout the Banner Health system. Site managers were provided toolkits to support providers and staff throughout the implementation process. The toolkits included frequently asked questions and answers, and were maintained as ‘living documents’ that were updated based on emerging issues and questions.

To keep things on track, project managers from the central project management department were involved in the initiative to provide direct project management services to the initiative. They also worked to instill project management competencies throughout the organization, applying a train-the-trainer approach to disseminate best practices for enhancing communication among team members, implementing workflow changes, and monitoring the results.
 

Phase 4: Optimization

The optimization phase is continuous and continues to the present day. Notably, the success of the CDS rules depends on the availability of current clinical information for each patient, in addition to information about the treatment plan. For this initiative, Banner Health maintained aggregated clinical patient data in the data warehouse that aggregated data from disparate sources, including billing and EHR data from different care settings such as ambulatory offices, inpatient units, the emergency department, home care, and ambulatory surgery centers. The data warehouse is housed in a strategically chosen physical location to minimize the threat of natural disasters, and cloud-based backup is also used. A master patient index and provider credentialing system are integrated with the data warehouse. Query-based health information exchange is used, when possible, to collect information on care received by patients outside of the Banner Health system.

It is important to note that many CDS alerts are over-ridden without changes to clinical care [34]. Previous research indicates that alert fatigue from “false positives” can impede the effectiveness of alerts [35]. Banner Health monitors the rate at which CDS alerts are over-ridden. Figure 1 shows the percentage of all alerts for radiation exposure—including the alert related to using ultrasound as a diagnostic tool for pediatric appendicitis—that led to order cancellations. The percentage of CT orders that generated the alert and were cancelled fell from 18.9% in March 2011 to 13.6% in February 2012. The rate of order cancellations might have declined over time due to a change in provider behavior from the alert. That is, if inappropriate CT scan orders declined over time, then providers would cancel a decreasing percentage of the CT scan orders that prompted an alert.

Imaging Use

In Figure 2, data on the use of the 2 imaging procedures for the diagnosis of pediatric appendicitis is presented. During the fourth quarter of 2010, almost half of pediatric patients with suspected appendicitis received a CT scan and only about 1 in 7 received an ultrasound. After the clinical decision support alert was put in place to remind providers to perform an ultrasound as a first-line diagnostic tool, the use of ultrasounds increased sharply. By the first quarter of 2012, ultrasounds were performed in 40.8% of these cases and the use of CT scans declined to 39.9% of suspected pediatric appendicitis cases.

Discussion

This case study discusses the application of CDS functionality in a health care improvement initiative to address inappropriate imaging in a large health system. Four main implementation lessons emerge for the field. First, it is important to involve all levels of staff in the planning process to ensure that health care improvement activities are prioritized correctly and to build buy-in for the priorities addressed with health care improvement activities. Second, it is necessary to allow time to design the alert or reminder, as well as testing it during the implementation process to ensure that clinical guidelines are being properly applied. Third, re-engineering the workflow and ensuring usability of the alert or reminder are important, and using the skills of trained engineers helps in this process. Ensuring the availability of trained ultrasound staff was particularly important to this initiative. Finally, the effectiveness of CDS depends on having complete data for each patient, as well as up-to-date information on the relevant evidence-based practice guidelines.

These results can help guide the implementation of health care improvement initiatives that use CDS functionality to address inappropriate imaging. The adoption of electronic health records with CDS functionality was incentivized and supported by the Medicare and Medicaid Electronic Health Record Incentive Programs; the Medicare program now exists as part of MACRA. Using CDS to reduce inappropriate imaging is required for Medicare fee-for-service patients in the 2014 Protecting Access to Medicare Act (PAMA), highlighting the critical nature of these results, which can guide implementation of CDS to reduce inappropriate imaging [41].

As noted above, the optimization phase is continuous. Banner Health still encourages use of ultrasounds as a first-line diagnostic tool for pediatric appendicitis. Identifying which patients should immediately receive CT scans is difficult, and sometimes the decision depends on the availability of staff to conduct the ultrasound scans. Ways to maximize the productivity of ultrasound technicians have been explored. Another focus area since the original implementation of this health care improvement initiative has been health information exchange, to ensure that complete, up-to-date information is available for each patient.

Banner Health often implements CDS in conjunction with other health IT functionalities. For example, CDS and telehealth are used together to improve care in the intensive care unit (ICU) for patients with sepsis and delirium. An offsite hub of experienced ICU physicians and nurses remotely monitors ICU patients in facilities across Banner Health, using cameras with zoom capability. The intensive care specialists in the tele-hub act as part of the care team; in addition to receiving video feed, they communicate verbally with patients and ICU staff members. Predictive analytics are used to generate clinical decision support alerts and reminders, with a special focus on early intervention if a patient’s clinical indicators are trending downward. The 4 lessons described in this study were also used in the ICU sepsis and delirium initiative; staff were involved in the planning process, alerts and reminders were thoroughly tested, the workflow was adjusted to accommodate the physicians in the tele-ICU hub, and up-to-date and complete clinical information for each patient is maintained. In addition, the design principles for alerts described in this study, such as covering most of the screen and providing recommendations for changing the treatment plan within the alert itself, were also used in the ICU sepsis and delirium initiative.

One limitation of this study is that it was conducted at a single health system. Thus, the findings might not be generalizable to other health systems, particularly if a robust health IT infrastructure is not in place. The culture of Banner Health values quality and involved providers and staff at all levels in selecting and implementing health care improvement initiatives. In addition, engineers assisted with implementation. Finally, the study design does not permit conclusions about the causality of the decline in CT scans and the increase in ultrasounds for suspected pediatric appendicitis cases; unobserved factors might have contributed to the changes in CT and ultrasound use.

Future research should focus on ways to improve the implementation and organization learning process, particularly through engagement of frontline staff by leadership [36] and explore how to operationalize previous findings indicating that innovations in hospital settings are more likely to be sustained when intrinsically rewarding to staff, either by making clinician and staff jobs easier to perform or more gratifying [37]. Future research should focus on facilitating health information exchange between providers in different health systems.

Disclaimer: The views expressed in the article are solely the views of the authors and do not represent those of the National Institutes of Health or the U.S. Government.

Acknowledgments: The authors wish to thank the Banner Health team for taking time to share their insights on how health information technology can be used for health care improvement initiatives, especially John Hensing. We also thank Michael Furukawa of the Agency for Healthcare Research and Quality, formerly of the Office of the National Coordinator for Health Information Technology, who played a key role in the conceptualization of this study and data collection.

Corresponding author: Emily Jones, PhD, MPP, National Institutes of Health, 6001 Executive Blvd., #5232 Rockville, MD 20852, [email protected].

Financial disclosures: None

From the Office of Science Policy and Communications, National Institute on Drug Abuse, National Institutes of Health, Rockville, MD, and George Washington University, Washington, DC (Dr. Jones), Office of the National Coordinator for Health Information Technology, US Department of Health and Human Services, Washington, DC (Mr. Swain), and Banner Health, Phoenix, AZ (Ms. Burdick).

Abstract

• Objective: Clinical decision support (CDS) can be a useful tool to decrease inappropriate imaging by providing evidence-based information to clinicians at the point of care. The objective of this case study is to highlight lessons from a health care improvement initiative using CDS to encourage use of ultrasound rather than computed tomography (CT) scans as an initial diagnostic tool for suspected appendicitis in pediatric patients.
• Methods: The percentage of suspected pediatric appendicitis cases receiving ultrasounds and CT scans was calculated using electronic health record data. Four steps for implementing health information technology were identified in a literature scan that guided data collection and analysis: planning, software customization and workflow design, training and user support, and optimization.
• Results: During the fourth quarter of 2010, 1 in 7 pediatric patients with suspected appendicitis received an ultrasound and almost half received a CT scan. By the first quarter of 2012, ultrasounds were performed in 40.8% of these cases and the use of CT scans declined to 39.9% of suspected pediatric appendicitis cases.
• Conclusion: Four lessons emerged. First, all levels of staff should be involved in the planning process to make organizational priorities actionable and build buy-in for each healthcare improvement initiative. Second, it takes time to design and test the alert to ensure that clinical guidelines are being properly applied. Third, re-engineering the workflow is critical for usability; in this case, ensuring the availability of ultrasound staff was particularly important. Finally, the effectiveness of CDS depends on applying relevant evidence-based practice guidelines to real-time patient data.

Diagnostic imaging is a useful tool for identifying and guiding the treatment of many health conditions, but evidence indicates that health care providers do not always use imaging appropriately. In fact, a substantial proportion of diagnostic imaging procedures performed in hospital and ambulatory settings are not supported by clinical guideline recommendations [1,2]. Spending on diagnostic imaging is rapidly increasing, and some patients receive unnecessary radiation exposure that can lead to adverse health impacts [3]. Inappropriate imaging falls into 3 broad categories: imaging that does not conform to clinical guidelines, imaging that is contraindicated due to an allergy or implantable medical device, and imaging that might be clinically indicated but is duplicative of prior imaging services.

Clinical decision support (CDS) functionality supports health care improvement initiatives to narrow the gap between evidence-based practices and routine care [4]. CDS merges patient-specific clinical information with relevant information about evidence-based practices, providing health care providers with timely information to guide decisions at the point of care [5]. Decision support is most commonly delivered in the form of alerts and reminders [6]. CDS can be effective in reducing adverse drug events [7], sepsis [8,9], and other conditions in hospital [10–12] and ambulatory settings [13,14].

For the evaluation of suspected appendicitis in children, ultrasound is the preferred initial consideration for imaging examination [15]. Evidence suggests that CDS can increase the use of ultrasound for suspected pediatric appendicitis [16,17] and has affirmed the utility of ultrasound as a first-line diagnostic tool for suspected appendicitis [18,19]. In the Choosing Wisely campaign, the American College of Surgeons and the American College of Radiology have both endorsed ultrasound as an option to consider prior to conducting a CT scan to evaluate suspected appendicitis in children [15].

Banner Health, a large health system headquartered in Phoenix, Arizona, implemented a health care improvement initiative using CDS functionality to encourage providers to use ultrasound instead of CT as a first-line diagnostic tool for suspected pediatric appendicitis. We conducted a site visit to Banner Health, an organization who had had attained a high score on the EMR Adoption Model [20] to examine their implementation process. We sought to build on previous research examining the use of health information technology to improve performance in large health systems [21–23].

Methods

Setting

Banner Health is a large not-for-profit health system that is comprised of 24 acute care hospitals across several states, as well as ambulatory medical practices, behavioral health, home care, and ambulatory surgery centers [24,25]. The health system is the largest employer in Arizona and one of the largest in the United States with over 50,000 employees. Banner Health has been nationally recognized for clinical quality [26], an innovative leadership team [27], and using health IT to improve quality [20]. The health system was also selected as one of the Centers for Medicare & Medicaid Services (CMS) Pioneer Accountable Care Organizations.

Site Visit

The first 2 authors conducted a 2-day site visit to the Banner Health headquarters in Phoenix, Arizona in November 2013. The team conducted discussions with over 20 individuals, including health system leadership, frontline clinicians in several units of an acute care hospital, staff members in 2 telehealth hubs—including a tele-ICU hub—and trainers in a simulation facility that is used for staff training. The discussions were conducted with groups of staff or on an individual basis, as appropriate. At the outset of the project, an environmental scan of relevant grey and peer-reviewed literature was conducted under contract on behalf of the authors to guide data collection and analysis [28]. An interview protocol was created to guide the discussions. The protocol contained modules that were used during each discussion, if relevant. The modules addressed topics such as technical issues with designing and deploying health information technology functionalities such as clinical decision support systems, the organizational processes and structures needed to launch health care improvement initiatives, and using health information technology care coordination. Within each module, questions probed about the challenges that arose and the solutions to these challenges, with a focus on the four phases of implementing a health information technology intervention: functionality planning, software customization and workflow design, training and user support, and optimization. To assist with interpreting the qualitative findings, an evolving outline of the findings was maintained. Salient themes and conceptual categories were tracked, which helped the researchers organize, synthesize, and interpret the information collected during the site visit. Once the authors chose to focus on clinical decision support, summary notes from the discussions were reviewed for relevant information, and this information was compiled and organized under the rubric of the four implementation phases. The findings and key themes from the discussion notes were distilled into key lessons for the field.

Data obtained included the percentage of pediatric patients with suspected appendicitis who received ultrasounds and CT scans each month from 1 October 2010 through 31 March 2012. Banner Health staff originally collected the data to support the implementation of health care improvement initiative; the use of these data in this paper is a secondary use [29].

This manuscript was prepared using the SQUIRE 2.0 guidelines [30]. No patient-identifiable data were used, so institutional review board approval was not sought.

Results

The 4 steps of implementing CDS can be described as functionality planning, software customization and workflow design, training and user support, and optimization [31].

Pre-Implementation

The use of computerized provider order entry (CPOE) is a precursor to using clinical decision support, since orders must be entered electronically to be subject to CDS review. Banner Health deployed CPOE to its various facilities starting in 2008. The deployment was staged in a rolling fashion with one or two facilities going live every few months so that the deployment team was available at each facility.

Phase 1: Planning

In contrast to many large health systems, the organization has a single board of directors that oversees the entire system of over 37,000 employees. Activities and relationships to promote the use of evidence-based practices are built into the organizational structure. For example, Banner Health maintains a Care Management Council, a group comprised of clinical and administrative leadership to provide executive oversight of health care improvement projects. The Council convenes on a quarterly basis to review and approve the adoption of new clinical practice guidelines, policies, and standardized standing orders that have been developed by multidisciplinary groups of physicians and other clinicians. A key focus of the Council is ensuring consistent application of evidence-based guidelines to clinical care and disseminating knowledge of clinical best practices across a large and complex enterprise.

Interdisciplinary clinical consensus groups support the Council’s work. These groups are comprised of administrative and program management staff, physicians and other clinicians, and engineers. Each clinical consensus group focuses on emerging issues and improvement opportunities within a specific clinical domain and leads the implementation of health care improvement initiatives in that domain. Providers and staff at all levels of the organization were involved in planning and implementing the health care improvement initiative in inappropriate imaging. This increased buy-in and staff support, which are associated with successful health care improvement initiatives [32]. Banner Health staff rallied around the idea of addressing inappropriate imaging as a key priority initiative. The teams that implement each initiative include an engineer that focuses on redesigning clinical workflows for each initiative. There is also an organizational unit responsible for project management that provides teams with logistical and operational support.

Phase 2: Software Customization and Workflow Redesign

Once the clinical consensus group selected inappropriate imaging as a priority, the next step was to examine the process flow for imaging ordering. In 2011 Banner Health integrated CDS functionality with CPOE into the electronic health record. Before the use of CDS, inpatient and emergency department imaging orders were simply transmitted to imaging staff after the order was entered. After CDS implementation, the process flow begins with an inpatient imaging order and entailed checking the order against clinical guidelines on the proper use of imaging. If the image order did not conform to guidelines, which in this case indicate that ultrasound should be used before CT scans as a diagnostic tool for suspected pediatric appendicitis, the CDS system triggered an alert [15].

Bringing the perspective and skill sets of engineers to the process of redesigning clinical workflows was particularly valuable [33]. While CDS has the potential to reduce inpatient inappropriate imaging, effectiveness depends on adjusting workflows to ensure that the information provided by CDS alerts and reminders is actionable. To reduce alert fatigue among the clinical staff, the team identified the appropriate level of workflow interruption for each alert and reminder (hard stop, workflow interruption, or informational) [5,6].

The design principles that were used to design the alert include intuitive system development to promote ease of use, one set of screen formats and data definitions, and a set of consistent core reports and standard system output formats across facilities. The alert’s appearance was tailored for maximal impact and covered most of the screen. Color contrast was used, but since some people are color-blind, the meaning of the alert did not depend on the color contrast. The alerts included recommendations for changing the treatment plan to encourage using ultrasound as a first-line diagnostic tool. Minimizing the number of clicks to accept the proposed treatment plan change in the alert is desirable.

Phase 3: Training and User Support

Training and support structures and tools were critical to the rollout of the inappropriate imaging alerts. Providers were reminded about clinical best practices and informed during staff meetings about the new CDS rules. In addition, various types of training and support were available to clinicians and staff during the rollout process. Dedicated time for end-user training provided an opportunity to identify and cultivate super-users. These super-users not only helped provide technical support to their colleagues, but also helped create excitement for the initiative. A centralized support desk provided telephone support for providers in facilities throughout the Banner Health system. Site managers were provided toolkits to support providers and staff throughout the implementation process. The toolkits included frequently asked questions and answers, and were maintained as ‘living documents’ that were updated based on emerging issues and questions.

To keep things on track, project managers from the central project management department were involved in the initiative to provide direct project management services to the initiative. They also worked to instill project management competencies throughout the organization, applying a train-the-trainer approach to disseminate best practices for enhancing communication among team members, implementing workflow changes, and monitoring the results.
 

Phase 4: Optimization

The optimization phase is continuous and continues to the present day. Notably, the success of the CDS rules depends on the availability of current clinical information for each patient, in addition to information about the treatment plan. For this initiative, Banner Health maintained aggregated clinical patient data in the data warehouse that aggregated data from disparate sources, including billing and EHR data from different care settings such as ambulatory offices, inpatient units, the emergency department, home care, and ambulatory surgery centers. The data warehouse is housed in a strategically chosen physical location to minimize the threat of natural disasters, and cloud-based backup is also used. A master patient index and provider credentialing system are integrated with the data warehouse. Query-based health information exchange is used, when possible, to collect information on care received by patients outside of the Banner Health system.

It is important to note that many CDS alerts are over-ridden without changes to clinical care [34]. Previous research indicates that alert fatigue from “false positives” can impede the effectiveness of alerts [35]. Banner Health monitors the rate at which CDS alerts are over-ridden. Figure 1 shows the percentage of all alerts for radiation exposure—including the alert related to using ultrasound as a diagnostic tool for pediatric appendicitis—that led to order cancellations. The percentage of CT orders that generated the alert and were cancelled fell from 18.9% in March 2011 to 13.6% in February 2012. The rate of order cancellations might have declined over time due to a change in provider behavior from the alert. That is, if inappropriate CT scan orders declined over time, then providers would cancel a decreasing percentage of the CT scan orders that prompted an alert.

Imaging Use

In Figure 2, data on the use of the 2 imaging procedures for the diagnosis of pediatric appendicitis is presented. During the fourth quarter of 2010, almost half of pediatric patients with suspected appendicitis received a CT scan and only about 1 in 7 received an ultrasound. After the clinical decision support alert was put in place to remind providers to perform an ultrasound as a first-line diagnostic tool, the use of ultrasounds increased sharply. By the first quarter of 2012, ultrasounds were performed in 40.8% of these cases and the use of CT scans declined to 39.9% of suspected pediatric appendicitis cases.

Discussion

This case study discusses the application of CDS functionality in a health care improvement initiative to address inappropriate imaging in a large health system. Four main implementation lessons emerge for the field. First, it is important to involve all levels of staff in the planning process to ensure that health care improvement activities are prioritized correctly and to build buy-in for the priorities addressed with health care improvement activities. Second, it is necessary to allow time to design the alert or reminder, as well as testing it during the implementation process to ensure that clinical guidelines are being properly applied. Third, re-engineering the workflow and ensuring usability of the alert or reminder are important, and using the skills of trained engineers helps in this process. Ensuring the availability of trained ultrasound staff was particularly important to this initiative. Finally, the effectiveness of CDS depends on having complete data for each patient, as well as up-to-date information on the relevant evidence-based practice guidelines.

These results can help guide the implementation of health care improvement initiatives that use CDS functionality to address inappropriate imaging. The adoption of electronic health records with CDS functionality was incentivized and supported by the Medicare and Medicaid Electronic Health Record Incentive Programs; the Medicare program now exists as part of MACRA. Using CDS to reduce inappropriate imaging is required for Medicare fee-for-service patients in the 2014 Protecting Access to Medicare Act (PAMA), highlighting the critical nature of these results, which can guide implementation of CDS to reduce inappropriate imaging [41].

As noted above, the optimization phase is continuous. Banner Health still encourages use of ultrasounds as a first-line diagnostic tool for pediatric appendicitis. Identifying which patients should immediately receive CT scans is difficult, and sometimes the decision depends on the availability of staff to conduct the ultrasound scans. Ways to maximize the productivity of ultrasound technicians have been explored. Another focus area since the original implementation of this health care improvement initiative has been health information exchange, to ensure that complete, up-to-date information is available for each patient.

Banner Health often implements CDS in conjunction with other health IT functionalities. For example, CDS and telehealth are used together to improve care in the intensive care unit (ICU) for patients with sepsis and delirium. An offsite hub of experienced ICU physicians and nurses remotely monitors ICU patients in facilities across Banner Health, using cameras with zoom capability. The intensive care specialists in the tele-hub act as part of the care team; in addition to receiving video feed, they communicate verbally with patients and ICU staff members. Predictive analytics are used to generate clinical decision support alerts and reminders, with a special focus on early intervention if a patient’s clinical indicators are trending downward. The 4 lessons described in this study were also used in the ICU sepsis and delirium initiative; staff were involved in the planning process, alerts and reminders were thoroughly tested, the workflow was adjusted to accommodate the physicians in the tele-ICU hub, and up-to-date and complete clinical information for each patient is maintained. In addition, the design principles for alerts described in this study, such as covering most of the screen and providing recommendations for changing the treatment plan within the alert itself, were also used in the ICU sepsis and delirium initiative.

One limitation of this study is that it was conducted at a single health system. Thus, the findings might not be generalizable to other health systems, particularly if a robust health IT infrastructure is not in place. The culture of Banner Health values quality and involved providers and staff at all levels in selecting and implementing health care improvement initiatives. In addition, engineers assisted with implementation. Finally, the study design does not permit conclusions about the causality of the decline in CT scans and the increase in ultrasounds for suspected pediatric appendicitis cases; unobserved factors might have contributed to the changes in CT and ultrasound use.

Future research should focus on ways to improve the implementation and organization learning process, particularly through engagement of frontline staff by leadership [36] and explore how to operationalize previous findings indicating that innovations in hospital settings are more likely to be sustained when intrinsically rewarding to staff, either by making clinician and staff jobs easier to perform or more gratifying [37]. Future research should focus on facilitating health information exchange between providers in different health systems.

Disclaimer: The views expressed in the article are solely the views of the authors and do not represent those of the National Institutes of Health or the U.S. Government.

Acknowledgments: The authors wish to thank the Banner Health team for taking time to share their insights on how health information technology can be used for health care improvement initiatives, especially John Hensing. We also thank Michael Furukawa of the Agency for Healthcare Research and Quality, formerly of the Office of the National Coordinator for Health Information Technology, who played a key role in the conceptualization of this study and data collection.

Corresponding author: Emily Jones, PhD, MPP, National Institutes of Health, 6001 Executive Blvd., #5232 Rockville, MD 20852, [email protected].

Financial disclosures: None

Study Overview

Objective. To determine the effectiveness of asthma treatment using fluticasone furoate plus vilanterol in a setting that is closer to usual clinical practice.

Design. Open-label, parallel group, randomised controlled trial.

Setting and participants. The study was conducted at 74 general practice clinics in Salford and South Manchester, UK, between Nov 2012 and Dec 2016. Patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy (either inhaled corticosteroid [ICS] alone or in combination with a long-acting bronchodilator [LABA]) were recruited. Patients with recent history of life-threatening asthma, COPD, or concomitant life-threatening disease were excluded. Participants were randomly assigned through a centralized randomization service and stratified by Asthma Control Test (ACT) score and by previous asthma maintenance therapy (ICS or ICS/LABA). Only those with an ACT score < 20 were included in the study.

Intervention. Patients were randomized to receive either a combination of fluticasone furoate and vilanterol (FF/VI) delivered by novel dry powder inhalation (DPI) (Ellipta) or to continue with their maintenance therapy. General practitioners provided care in their usual manner and could continuously optimize therapy according to their clinical opinion. Treatments were dispensed by community pharmacies in the usual way. Patients could modify their treatment and remain in the study. Those in the FF/VI group were allowed to change to other asthma medications and could stop taking FF/VI. Those in the usual care group were also allowed to alter medications, but could not initiate FF/VI.

Main outcome measures. The primary endpoint was ACT score at week 24 (the percentage of patients at week 24 with either an ACT score of 20 or greater or an increase of 3 or greater in the ACT score from baseline, termed responders). Safety endpoints included the incidence of serious pneumonias. The study utilized the Salford electronic medical record system, which allows near to real-time collection and monitoring of safety data. Secondary endpoints included ACT at various weeks, all asthma-related primary and secondary care contacts, annual rate of severe exacerbations, number of salbutamol inhalers dispensed, and time to modification or initial therapy.

Main results. 4233 patients were randomized, with 2119 patients randomized to usual care and 2114 randomized to the FF/VI group. 605 from the usual care group and 602 from the FF/VI group had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. 306 in the usual care group and 342 in the FF/VI group withdrew for various reasons, including adverse events, or were lost to follow-up or protocol deviations. Mean patient age was 50 years. Within the usual care group, 64% of patients received ICS/LABA combination and 36% received ICS only. Within the FF/VI group, 65% were prescribed 100 μg/25 μg FFI/VI and 35% were prescribed 200 μg/25 μg FF/VI. At week 24, the FF/VI group had 74% responders whereas the usual care group had 60% responders; the odds of being a responder with FF/VI was twice that of being a responder with usual care (OR 1.97; 95% CI 1.71–2.26, P < 0.001). Patients in the FF/VI group had a slightly higher incidence of pneumonia than did the usual care group (23 vs 16; incidence ratio 1.4, 95% CI 0.8–2.7). Also, those in the FF/VI group had an increase in the rate of primary care visits/contacts per year (9.7% increase, 95% CI 4.6%–15.0%).

Conclusion. In patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined FF/VI improved asthma control without increasing the risk of serious adverse events when compared with optimized usual care.

Commentary

Woodcock et al conducted a pragmatic randomized controlled study. This innovative research method prospectively enrolled a large number of patients who were randomized to groups that could involve 1 or more interventions and who were then followed according to the treating physician’s usual practice. The patients’ experience was kept as close to everyday clinical practice care as possible to preserve the real-world nature of the study. The positive aspect of this innovative pragmatic research design is the inclusion of patients with varied disease severity and with comorbidities that are not well represented in conventional double-blind randomized controlled trials, such as patients with smoking history, obesity, or multiple comorbidities. In addition, an electronic health record system was used to track serious adverse events in near real-time and increased the accuracy of the data and minimized data loss.

While the pragmatic study design offers innovation, it also has some limitations. Effectiveness studies using a pragmatic approach are less controlled compared with traditional efficacy RCTs and are more prone to low medication compliance and high rates of follow-up loss. Further, Woodcock et al allowed patients to remain in the FF/VI group even though they may have stopped taking FF/VI. Indeed, in the FF/VI group, 463 (22%) of the 2114 patients changed their medication, and 381 (18%) switched to the usual care group. Patients were analyzed using intention to treat and thus were analyzed in the group to which they were initially randomized. This could have affected results, as a good proportion of patients in the FF/VI group were not actually taking the FF/VI. Within the usual care group, 376 (18%) of 2119 patients altered their medication and 3 (< 1%) switched to FF/VI, though this was prohibited. In routine care, adherence rates are expected to be low (20%–40%) and this is another possible weakness of the study; in closely monitored RCTs, adherence rates are around 80%–90%.

The authors did not include objective measures of the severity or types of asthma, which can be obtained using pulmonary function tests, eosinophil count, or other markers of inflammation. By identifying asthma patients via the general practitioner’s diagnosis, the study is more reflective of real life and primary care–driven; however, one cannot rule out accidental inclusion of patients who do not have asthma (which could include patients with post-infectious cough, vocal cord dysfunction, or anxiety) or patients who would not readily respond to typical asthma therapy (such as those with allergic bronchopulmonary aspergillosis or eosinophilic granulomatosis with polyangitis). In addition, the authors used only subjective measures to define control: ACT score by telephone. Other outcome measures included exacerbation rate, primary care physician visits, and time to exacerbation, which may be insensitive to detecting residual inflammation or severity of asthma. In lieu of objectively measuring the degree of airway obstruction or inflammation, the outcomes measured by the authors may not have comprehensively evaluated efficacy.

The open-label, intention-to-treat, and pragmatic design of the study may have generated major selection bias, despite the randomization. Because general practitioners who directly participated in the recruitment of the patients also monitored their treatment, volunteer or referral bias may have occurred. As the authors admitted, there were differences present in practice and treatment due to variation of training and education of the general practitioners. In addition, the current study was funded by a pharmaceutical company and the trial medication was dispensed free of cost, further generating bias.

Further consideration of the study medication also brings up questions about the study design. Combined therapy with low- to moderate-dose ICS/LABA is currently indicated for asthma patients with moderate persistent or higher severity asthma. The current US insurance system encourages management to begin with low-dose ICS before escalating to a combination of ICS/LABA. Given the previously published evidence of superiority for combined ICS/LABA over ICS alone on asthma control [2,3], inclusion criteria could have been limited only to patients who were already receiving ICS/LABA to more accurately equate the trial medication with the accepted standard medications. By including patients who were on ICS/LABA as well as those only on ICS (in usual care group, 64% were on ICS/LABA and 36% were on ICS) the likelihood of responders in the FF/VI group could have been inflated compared to usual care group. In addition, patients with a low severity of asthma symptoms, such as only intermittent asthma or mild persistent asthma, could have been overtreated by FF/VI per current guidelines. About 30% of the patients initially enrolled in the study had baseline ACT scores greater than 20, and some patients had less severe asthma as indicated by the treatment with ICS alone. The authors also included 2 different doses of fluticasone furoate in their study group.

It is of concern that the incidence of pneumonia with ICS/LABA in this study was slightly higher in the FF/VI than in the usual care group. Although it was not statistically significant in this study, the increased pneumonia risk with ICS has been observed in many other studies [4,5].

Applications for Clinical Practice

Fluticasone furoate plus vilanterol (FF/VI) can be a therapeutic option in patients with asthma, with a small increased risk for pneumonia that is similar to other types of inhaled corticosteroids. However, a stepwise therapeutic approach, following the published asthma treatment strategy [6], should be emphasized when escalating treatment to include FF/VI.

—Minkyung Kwon, MD, Joel Roberson, MD, and Neal Patel, MD, Pulmonary and Critical Care Medicine, Mayo Clinic Florida, Jacksonville, FL (Drs. Kwon and Patel), and Department of Radiology, Oakland University/Beaumont Health, Royal Oak, MI (Dr. Roberson)

Study Overview

Objective. To determine the effectiveness of asthma treatment using fluticasone furoate plus vilanterol in a setting that is closer to usual clinical practice.

Design. Open-label, parallel group, randomised controlled trial.

Setting and participants. The study was conducted at 74 general practice clinics in Salford and South Manchester, UK, between Nov 2012 and Dec 2016. Patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy (either inhaled corticosteroid [ICS] alone or in combination with a long-acting bronchodilator [LABA]) were recruited. Patients with recent history of life-threatening asthma, COPD, or concomitant life-threatening disease were excluded. Participants were randomly assigned through a centralized randomization service and stratified by Asthma Control Test (ACT) score and by previous asthma maintenance therapy (ICS or ICS/LABA). Only those with an ACT score < 20 were included in the study.

Intervention. Patients were randomized to receive either a combination of fluticasone furoate and vilanterol (FF/VI) delivered by novel dry powder inhalation (DPI) (Ellipta) or to continue with their maintenance therapy. General practitioners provided care in their usual manner and could continuously optimize therapy according to their clinical opinion. Treatments were dispensed by community pharmacies in the usual way. Patients could modify their treatment and remain in the study. Those in the FF/VI group were allowed to change to other asthma medications and could stop taking FF/VI. Those in the usual care group were also allowed to alter medications, but could not initiate FF/VI.

Main outcome measures. The primary endpoint was ACT score at week 24 (the percentage of patients at week 24 with either an ACT score of 20 or greater or an increase of 3 or greater in the ACT score from baseline, termed responders). Safety endpoints included the incidence of serious pneumonias. The study utilized the Salford electronic medical record system, which allows near to real-time collection and monitoring of safety data. Secondary endpoints included ACT at various weeks, all asthma-related primary and secondary care contacts, annual rate of severe exacerbations, number of salbutamol inhalers dispensed, and time to modification or initial therapy.

Main results. 4233 patients were randomized, with 2119 patients randomized to usual care and 2114 randomized to the FF/VI group. 605 from the usual care group and 602 from the FF/VI group had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. 306 in the usual care group and 342 in the FF/VI group withdrew for various reasons, including adverse events, or were lost to follow-up or protocol deviations. Mean patient age was 50 years. Within the usual care group, 64% of patients received ICS/LABA combination and 36% received ICS only. Within the FF/VI group, 65% were prescribed 100 μg/25 μg FFI/VI and 35% were prescribed 200 μg/25 μg FF/VI. At week 24, the FF/VI group had 74% responders whereas the usual care group had 60% responders; the odds of being a responder with FF/VI was twice that of being a responder with usual care (OR 1.97; 95% CI 1.71–2.26, P < 0.001). Patients in the FF/VI group had a slightly higher incidence of pneumonia than did the usual care group (23 vs 16; incidence ratio 1.4, 95% CI 0.8–2.7). Also, those in the FF/VI group had an increase in the rate of primary care visits/contacts per year (9.7% increase, 95% CI 4.6%–15.0%).

Conclusion. In patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined FF/VI improved asthma control without increasing the risk of serious adverse events when compared with optimized usual care.

Commentary

Woodcock et al conducted a pragmatic randomized controlled study. This innovative research method prospectively enrolled a large number of patients who were randomized to groups that could involve 1 or more interventions and who were then followed according to the treating physician’s usual practice. The patients’ experience was kept as close to everyday clinical practice care as possible to preserve the real-world nature of the study. The positive aspect of this innovative pragmatic research design is the inclusion of patients with varied disease severity and with comorbidities that are not well represented in conventional double-blind randomized controlled trials, such as patients with smoking history, obesity, or multiple comorbidities. In addition, an electronic health record system was used to track serious adverse events in near real-time and increased the accuracy of the data and minimized data loss.

While the pragmatic study design offers innovation, it also has some limitations. Effectiveness studies using a pragmatic approach are less controlled compared with traditional efficacy RCTs and are more prone to low medication compliance and high rates of follow-up loss. Further, Woodcock et al allowed patients to remain in the FF/VI group even though they may have stopped taking FF/VI. Indeed, in the FF/VI group, 463 (22%) of the 2114 patients changed their medication, and 381 (18%) switched to the usual care group. Patients were analyzed using intention to treat and thus were analyzed in the group to which they were initially randomized. This could have affected results, as a good proportion of patients in the FF/VI group were not actually taking the FF/VI. Within the usual care group, 376 (18%) of 2119 patients altered their medication and 3 (< 1%) switched to FF/VI, though this was prohibited. In routine care, adherence rates are expected to be low (20%–40%) and this is another possible weakness of the study; in closely monitored RCTs, adherence rates are around 80%–90%.

The authors did not include objective measures of the severity or types of asthma, which can be obtained using pulmonary function tests, eosinophil count, or other markers of inflammation. By identifying asthma patients via the general practitioner’s diagnosis, the study is more reflective of real life and primary care–driven; however, one cannot rule out accidental inclusion of patients who do not have asthma (which could include patients with post-infectious cough, vocal cord dysfunction, or anxiety) or patients who would not readily respond to typical asthma therapy (such as those with allergic bronchopulmonary aspergillosis or eosinophilic granulomatosis with polyangitis). In addition, the authors used only subjective measures to define control: ACT score by telephone. Other outcome measures included exacerbation rate, primary care physician visits, and time to exacerbation, which may be insensitive to detecting residual inflammation or severity of asthma. In lieu of objectively measuring the degree of airway obstruction or inflammation, the outcomes measured by the authors may not have comprehensively evaluated efficacy.

The open-label, intention-to-treat, and pragmatic design of the study may have generated major selection bias, despite the randomization. Because general practitioners who directly participated in the recruitment of the patients also monitored their treatment, volunteer or referral bias may have occurred. As the authors admitted, there were differences present in practice and treatment due to variation of training and education of the general practitioners. In addition, the current study was funded by a pharmaceutical company and the trial medication was dispensed free of cost, further generating bias.

Further consideration of the study medication also brings up questions about the study design. Combined therapy with low- to moderate-dose ICS/LABA is currently indicated for asthma patients with moderate persistent or higher severity asthma. The current US insurance system encourages management to begin with low-dose ICS before escalating to a combination of ICS/LABA. Given the previously published evidence of superiority for combined ICS/LABA over ICS alone on asthma control [2,3], inclusion criteria could have been limited only to patients who were already receiving ICS/LABA to more accurately equate the trial medication with the accepted standard medications. By including patients who were on ICS/LABA as well as those only on ICS (in usual care group, 64% were on ICS/LABA and 36% were on ICS) the likelihood of responders in the FF/VI group could have been inflated compared to usual care group. In addition, patients with a low severity of asthma symptoms, such as only intermittent asthma or mild persistent asthma, could have been overtreated by FF/VI per current guidelines. About 30% of the patients initially enrolled in the study had baseline ACT scores greater than 20, and some patients had less severe asthma as indicated by the treatment with ICS alone. The authors also included 2 different doses of fluticasone furoate in their study group.

It is of concern that the incidence of pneumonia with ICS/LABA in this study was slightly higher in the FF/VI than in the usual care group. Although it was not statistically significant in this study, the increased pneumonia risk with ICS has been observed in many other studies [4,5].

Applications for Clinical Practice

Fluticasone furoate plus vilanterol (FF/VI) can be a therapeutic option in patients with asthma, with a small increased risk for pneumonia that is similar to other types of inhaled corticosteroids. However, a stepwise therapeutic approach, following the published asthma treatment strategy [6], should be emphasized when escalating treatment to include FF/VI.

—Minkyung Kwon, MD, Joel Roberson, MD, and Neal Patel, MD, Pulmonary and Critical Care Medicine, Mayo Clinic Florida, Jacksonville, FL (Drs. Kwon and Patel), and Department of Radiology, Oakland University/Beaumont Health, Royal Oak, MI (Dr. Roberson)

Study Overview

Objective. To determine the effectiveness of asthma treatment using fluticasone furoate plus vilanterol in a setting that is closer to usual clinical practice.

Design. Open-label, parallel group, randomised controlled trial.

Setting and participants. The study was conducted at 74 general practice clinics in Salford and South Manchester, UK, between Nov 2012 and Dec 2016. Patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy (either inhaled corticosteroid [ICS] alone or in combination with a long-acting bronchodilator [LABA]) were recruited. Patients with recent history of life-threatening asthma, COPD, or concomitant life-threatening disease were excluded. Participants were randomly assigned through a centralized randomization service and stratified by Asthma Control Test (ACT) score and by previous asthma maintenance therapy (ICS or ICS/LABA). Only those with an ACT score < 20 were included in the study.

Intervention. Patients were randomized to receive either a combination of fluticasone furoate and vilanterol (FF/VI) delivered by novel dry powder inhalation (DPI) (Ellipta) or to continue with their maintenance therapy. General practitioners provided care in their usual manner and could continuously optimize therapy according to their clinical opinion. Treatments were dispensed by community pharmacies in the usual way. Patients could modify their treatment and remain in the study. Those in the FF/VI group were allowed to change to other asthma medications and could stop taking FF/VI. Those in the usual care group were also allowed to alter medications, but could not initiate FF/VI.

Main outcome measures. The primary endpoint was ACT score at week 24 (the percentage of patients at week 24 with either an ACT score of 20 or greater or an increase of 3 or greater in the ACT score from baseline, termed responders). Safety endpoints included the incidence of serious pneumonias. The study utilized the Salford electronic medical record system, which allows near to real-time collection and monitoring of safety data. Secondary endpoints included ACT at various weeks, all asthma-related primary and secondary care contacts, annual rate of severe exacerbations, number of salbutamol inhalers dispensed, and time to modification or initial therapy.

Main results. 4233 patients were randomized, with 2119 patients randomized to usual care and 2114 randomized to the FF/VI group. 605 from the usual care group and 602 from the FF/VI group had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. 306 in the usual care group and 342 in the FF/VI group withdrew for various reasons, including adverse events, or were lost to follow-up or protocol deviations. Mean patient age was 50 years. Within the usual care group, 64% of patients received ICS/LABA combination and 36% received ICS only. Within the FF/VI group, 65% were prescribed 100 μg/25 μg FFI/VI and 35% were prescribed 200 μg/25 μg FF/VI. At week 24, the FF/VI group had 74% responders whereas the usual care group had 60% responders; the odds of being a responder with FF/VI was twice that of being a responder with usual care (OR 1.97; 95% CI 1.71–2.26, P < 0.001). Patients in the FF/VI group had a slightly higher incidence of pneumonia than did the usual care group (23 vs 16; incidence ratio 1.4, 95% CI 0.8–2.7). Also, those in the FF/VI group had an increase in the rate of primary care visits/contacts per year (9.7% increase, 95% CI 4.6%–15.0%).

Conclusion. In patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined FF/VI improved asthma control without increasing the risk of serious adverse events when compared with optimized usual care.

Commentary

Woodcock et al conducted a pragmatic randomized controlled study. This innovative research method prospectively enrolled a large number of patients who were randomized to groups that could involve 1 or more interventions and who were then followed according to the treating physician’s usual practice. The patients’ experience was kept as close to everyday clinical practice care as possible to preserve the real-world nature of the study. The positive aspect of this innovative pragmatic research design is the inclusion of patients with varied disease severity and with comorbidities that are not well represented in conventional double-blind randomized controlled trials, such as patients with smoking history, obesity, or multiple comorbidities. In addition, an electronic health record system was used to track serious adverse events in near real-time and increased the accuracy of the data and minimized data loss.

While the pragmatic study design offers innovation, it also has some limitations. Effectiveness studies using a pragmatic approach are less controlled compared with traditional efficacy RCTs and are more prone to low medication compliance and high rates of follow-up loss. Further, Woodcock et al allowed patients to remain in the FF/VI group even though they may have stopped taking FF/VI. Indeed, in the FF/VI group, 463 (22%) of the 2114 patients changed their medication, and 381 (18%) switched to the usual care group. Patients were analyzed using intention to treat and thus were analyzed in the group to which they were initially randomized. This could have affected results, as a good proportion of patients in the FF/VI group were not actually taking the FF/VI. Within the usual care group, 376 (18%) of 2119 patients altered their medication and 3 (< 1%) switched to FF/VI, though this was prohibited. In routine care, adherence rates are expected to be low (20%–40%) and this is another possible weakness of the study; in closely monitored RCTs, adherence rates are around 80%–90%.

The authors did not include objective measures of the severity or types of asthma, which can be obtained using pulmonary function tests, eosinophil count, or other markers of inflammation. By identifying asthma patients via the general practitioner’s diagnosis, the study is more reflective of real life and primary care–driven; however, one cannot rule out accidental inclusion of patients who do not have asthma (which could include patients with post-infectious cough, vocal cord dysfunction, or anxiety) or patients who would not readily respond to typical asthma therapy (such as those with allergic bronchopulmonary aspergillosis or eosinophilic granulomatosis with polyangitis). In addition, the authors used only subjective measures to define control: ACT score by telephone. Other outcome measures included exacerbation rate, primary care physician visits, and time to exacerbation, which may be insensitive to detecting residual inflammation or severity of asthma. In lieu of objectively measuring the degree of airway obstruction or inflammation, the outcomes measured by the authors may not have comprehensively evaluated efficacy.

The open-label, intention-to-treat, and pragmatic design of the study may have generated major selection bias, despite the randomization. Because general practitioners who directly participated in the recruitment of the patients also monitored their treatment, volunteer or referral bias may have occurred. As the authors admitted, there were differences present in practice and treatment due to variation of training and education of the general practitioners. In addition, the current study was funded by a pharmaceutical company and the trial medication was dispensed free of cost, further generating bias.

Further consideration of the study medication also brings up questions about the study design. Combined therapy with low- to moderate-dose ICS/LABA is currently indicated for asthma patients with moderate persistent or higher severity asthma. The current US insurance system encourages management to begin with low-dose ICS before escalating to a combination of ICS/LABA. Given the previously published evidence of superiority for combined ICS/LABA over ICS alone on asthma control [2,3], inclusion criteria could have been limited only to patients who were already receiving ICS/LABA to more accurately equate the trial medication with the accepted standard medications. By including patients who were on ICS/LABA as well as those only on ICS (in usual care group, 64% were on ICS/LABA and 36% were on ICS) the likelihood of responders in the FF/VI group could have been inflated compared to usual care group. In addition, patients with a low severity of asthma symptoms, such as only intermittent asthma or mild persistent asthma, could have been overtreated by FF/VI per current guidelines. About 30% of the patients initially enrolled in the study had baseline ACT scores greater than 20, and some patients had less severe asthma as indicated by the treatment with ICS alone. The authors also included 2 different doses of fluticasone furoate in their study group.

It is of concern that the incidence of pneumonia with ICS/LABA in this study was slightly higher in the FF/VI than in the usual care group. Although it was not statistically significant in this study, the increased pneumonia risk with ICS has been observed in many other studies [4,5].

Applications for Clinical Practice

Fluticasone furoate plus vilanterol (FF/VI) can be a therapeutic option in patients with asthma, with a small increased risk for pneumonia that is similar to other types of inhaled corticosteroids. However, a stepwise therapeutic approach, following the published asthma treatment strategy [6], should be emphasized when escalating treatment to include FF/VI.

—Minkyung Kwon, MD, Joel Roberson, MD, and Neal Patel, MD, Pulmonary and Critical Care Medicine, Mayo Clinic Florida, Jacksonville, FL (Drs. Kwon and Patel), and Department of Radiology, Oakland University/Beaumont Health, Royal Oak, MI (Dr. Roberson)