Federal Practitioner

Cognitive-behavioral therapies (CBTs) can provide relief from comorbid, persistent posttraumatic headache and posttraumatic stress disorder, new research suggests.

Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.

Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.

That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.

The findings were published online in JAMA Neurology.
 

Signature wounds

Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.

To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.

All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.

They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.

CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.

CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.

Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.

The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.

At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
 

Significant improvement

Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).

CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).

“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”

Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.

The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.

“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
 

A step forward

Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.

“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.

Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.

The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cognitive-behavioral therapies (CBTs) can provide relief from comorbid, persistent posttraumatic headache and posttraumatic stress disorder, new research suggests.

Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.

Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.

That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.

The findings were published online in JAMA Neurology.
 

Signature wounds

Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.

To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.

All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.

They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.

CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.

CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.

Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.

The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.

At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
 

Significant improvement

Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).

CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).

“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”

Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.

The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.

“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
 

A step forward

Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.

“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.

Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.

The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cognitive-behavioral therapies (CBTs) can provide relief from comorbid, persistent posttraumatic headache and posttraumatic stress disorder, new research suggests.

Results from a randomized clinical trial of almost 200 military veterans showed that, compared with usual care, CBT for headache led to significant improvement in both headache disability and PTSD symptoms. Cognitive-processing therapy (CPT) also led to significant improvement in PTSD symptoms, but it did not improve headache disability.

Lead author Donald McGeary, PhD, department of rehabilitation medicine, the University of Texas Health Science Center,San Antonio, noted the improvements shown in headache disability after CBT were likely caused by its building of patients’ confidence that they could control or manage their headaches themselves.

That sense of control was key to helping patients “get their lives back. If you can improve a person’s belief that they can control their headache, they function better,” Dr. McGeary said in a news release.

The findings were published online in JAMA Neurology.
 

Signature wounds

Both mild traumatic brain injury (TBI) and PTSD are signature wounds of post-9/11 military conflicts. The two conditions commonly occur together and can harm quality of life and functioning, the investigators noted. Following mild TBI, many veterans experience persistent posttraumatic headache, which often co-occurs with PTSD.

To gauge the impact of CBTs for this patient population, researchers recruited 193 post-9/11 combat veterans (mean age, 39.7 years) with clinically significant PTSD symptoms and posttraumatic headache that had persisted more than 3 months after TBI. Of these, 167 were men.

All participants were receiving care at the Polytrauma Rehabilitation Center of the South Texas Veterans Health Care System in Houston.

They were randomly allocated to undergo 8 sessions of manualized CBT for headache, 12 sessions of manualized CPT for PTSD, or usual headache treatment.

CBT for headache uses CBT concepts to reduce headache disability and improve mood – and includes key components, such as relaxation, setting goals for activities patients want to resume, and planning for those situations.

CPT is a leading psychotherapy for PTSD. It teaches patients how to evaluate and change upsetting and maladaptive thoughts related to their trauma. The idea is that, by changing thoughts, patients can change the way they feel.

Treatment as usual was consistent with multidisciplinary treatment in a large Veterans Affairs multiple-trauma center and could include pharmacotherapies, physical and occupational therapies, pain medications, acupuncture, and massage.

The coprimary outcomes were headache-related disability on the six-item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), assessed from end of treatment to 6 months post treatment.

At baseline, all participants reported severe headache-related disability (mean HIT-6 score, 65.8 points) and severe PTSD symptoms (mean PCL-5 score, 48.4 points).
 

Significant improvement

Compared with usual care, CBT for headache led to significant improvement in headache disability (posttreatment mean change in HIT-6 score, –3.4 points; P < .01) and PTSD symptoms (posttreatment change in PCL-5, –6.5 points; P = .04).

CPT also led to significant improvement in PTSD symptoms (8.9 points lower on the PCL-5 after treatment; P = .01), but it had only a modest effect on headache disability (1.4 points lower after treatment; P = .21).

“This was a surprise,” Dr. McGeary said. “If theories about PTSD driving posttraumatic headache are correct, you’d expect CPT to help both PTSD and headache. Our findings call that into question.”

Despite improvements in headache disability, CBT for headache did not significantly reduce headache frequency or intensity.

The researchers are now hoping to replicate their findings in a larger trial at multiple military and VA sites around the United States.

“We need more women, more racial and ethnic diversity, veterans as well as active military of different branches with varying comorbidities in different geographic regions attached to different hospitals and medical systems, because we’re comparing to usual care,” Dr. McGeary said.
 

A step forward

Commenting on the study, retired Col. Elspeth Cameron Ritchie, MD, chair of psychiatry, MedStar Washington Hospital Center, Washington, said she was “pleased” to see that this study was conducted and that she was pleased with the results.

“It’s been 20 years since 9/11, and wars are pretty much forgotten, but people are still suffering from the effects of traumatic brain injury and posttraumatic stress disorder. These are not conditions that go away quickly or lightly. They do take work,” said Dr. Ritchie, who was not involved with the research.

Finding therapies besides medication that are helpful is “good and is a step forward. The more alternatives we have, the better,” she concluded.

The study was supported in part by the Department of Defense and the Department of Veterans Affairs. Dr. McGeary and Dr. Ritchie have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LONDON – Substantial reductions in liver fat and fibrosis can be achieved with statin therapy, according to research presented at the annual International Liver Congress sponsored by the European Association for the Study of the Liver.

Statins are thought to have multiple beneficial actions in people with fatty liver disease, but there has been little insight into how they may be exerting such effects.

Now, data from the Rotterdam Study and others suggest that statins may be reducing the formation of lipid droplets as well as influencing the expression of important inflammatory genes.

The results “require further confirmation,” the team behind the work said, which was done at Erasmus Medical Center in Rotterdam, the Netherlands, in collaboration with researchers at The First Affiliated Hospital of Wenzhou (China) Medical University.

Sara Freeman/MDedge News

“Statins are inversely associated with multiple components of the NAFLD [nonalcoholic fatty liver disease] spectrum,” said Ibrahim Ayada, a PhD student in the department of gastroenterology and hepatology at Erasmus MC.

“Statins can inhibit lipid synthesis in organoids and statins also exhibit healthy inflammatory effects, which might contribute to the hepatoprotective effects that we observe in our population studies,” Mr. Ayada said.
 

A rising problem that needs addressing

Together NAFLD and NASH constitute a significant and increasing health burden, Mr. Ayada observed, noting that there were an estimated 64 million people in the United States and 52 million people in Europe, at least, with the rise mirroring the obesity pandemic.

“The number of patients visiting outpatient clinics has nearly doubled within a study period of 5 years,” he said.

“There is no pharmacologic therapy,” he reminded his audience, observing that fatty liver disease was a major indication for liver transplantation.

Statins are a long-standing staple of cardiovascular disease management and are known to have pleiotropic effects, Mr. Ayada explained. Their use in NAFLD and non-alcoholic steatohepatitis (NASH) has been purported but is supported by inconclusive evidence.

Indeed, a prior Cochrane review performed in 2013 found only two studies that were eligible for analysis and had “high risk of bias and a small numbers of participants,” according to the review’s authors.
 

Examining the connection

To look at the possible benefits of statins in people with NASH and examine how these effects might be occurring, Mr. Ayada and collaborators first took data from the Rotterdam Study, a large population-based prospective cohort that has been collecting data on its participants since the early 90s.

Data on over 4,500 participants were examined and of these, just over 1,000 had NAFLD. Statin versus no statin use was found to be associated with around a 30% reduction in fatty liver disease, with an odds ratio or 0.72 for NAFLD.

Then, looking only at a subset of patients with biopsy-proven NAFLD, statin use was associated with a 45% reduction in NASH (OR, 0.55) and a 24% reduction in fibrosis, although only the NASH reduction was significant (P = .031). The purpose of this cohort is to look at potential biomarkers and all participants had donated blood, urine, and stool samples; all were of Chinese descent, Mr. Ayada said.

“We then pooled our results with existing evidence in a meta-analysis,” said Mr. Ayada, including 16 studies. While results showed an overall inverse association, only the findings for a reduction in NAFLD and fibrosis were significant; the relationship between statins and NASH was not significant.
 

Investigating mechanistic effects

Then, for the second part of their work, Mr. Ayada and associates looked at potential mechanistic effects of statins.

“We did part two because we knew part one was going to be cross-sectional and we could only show the association and not causality, so we tried to shed some light on possible pathways,” he said.

To do this they used a novel model of liver organoids developed to study fatty liver disease and test potential therapeutics. In this model human liver organoids are exposed to sodium lactate, sodium pyruvate, and octanoic acid, which induce the formation of lipid droplets. Exposing the organoids to statins – simvastatin and lovastatin were used in the experiments – resulted in a reduced number of the induced lipid droplets.

“Although all concentrations of statins significantly inhibited the lipid size versus the control, the major effect was quite modest,” observed Mr. Ayada. The effect was most noticeable at the highest dose used (10 micromolar), and what they think might be happening is that the statins are clearing the smaller droplets first, leaving the larger ones behind.

Next, they looked at the effect of statin treatment on inflammatory gene expression in liver-derived monocytes. These will turn into macrophages and play a key role in chronic inflammation, Mr. Ayada explained. Initial results suggest that several proinflammatory cytokines such as interleukin-1 beta, IL-6, and IL-8 may be downplayed by statin therapy.

An anti-inflammatory effect of statins was also reported in unrelated poster presentations at the congress. While researchers Seul Ki Han and associated from South Korea showed an anti-inflammatory effect of a combination of simvastatin and ezetimibe (SAT083), a Dutch team found that atorvastatin reduced the infiltration of hepatic macrophages, neutrophils, and monocytes, as well as lowering levels of proinflammatory cytokines (SAT033).
 

Statins for NASH – a missed opportunity?

“As far as I am aware there is no robust evidence from large, randomized trials to suggest statins lessen chances of NAFLD, or improve its surrogate markers such as ALT or GGT [gamma-glutamyltransferase] levels,” Naveed Sattar, PhD, FRCP, FRCPath, FRSE, FMedSci, commented in an interview.

“The Rotterdam study is merely cross-sectional and cannot answer the question of causality,” added Dr. Sattar, who is professor of metabolic medicine and Honorary Consultant in Cardiovascular & Medical Science at the University of Glasgow. “It may be people who have less NAFLD are more likely to be prescribed statins, perhaps because doctors are wary of prescribing statins to those with slightly deranged liver tests,” he qualified.

Moreover, said Dr. Sattar, “prior evidence shows statins are underused in people with heart disease but who have NAFLD, which represents a missed opportunity to prevent heart disease.

“If statins had positive effects for preventing conversion of NAFLD to NASH or lessening fibrosis, I believe we would have known that by now.”

As for use of statins in future treatments of fatty liver disease, Dr. Sattar said: “I would not pin my hopes on statins to improve liver health, but doctors need to remember statins are safe in people with NAFLD or NASH and they should not be withheld in those who have existing cardiovascular disease or at elevated risk.” 

The study received no commercial funding. Mr. Ayada and Dr. Sattar had no relevant conflicts of interest.
 

LONDON – Substantial reductions in liver fat and fibrosis can be achieved with statin therapy, according to research presented at the annual International Liver Congress sponsored by the European Association for the Study of the Liver.

Statins are thought to have multiple beneficial actions in people with fatty liver disease, but there has been little insight into how they may be exerting such effects.

Now, data from the Rotterdam Study and others suggest that statins may be reducing the formation of lipid droplets as well as influencing the expression of important inflammatory genes.

The results “require further confirmation,” the team behind the work said, which was done at Erasmus Medical Center in Rotterdam, the Netherlands, in collaboration with researchers at The First Affiliated Hospital of Wenzhou (China) Medical University.

Sara Freeman/MDedge News

“Statins are inversely associated with multiple components of the NAFLD [nonalcoholic fatty liver disease] spectrum,” said Ibrahim Ayada, a PhD student in the department of gastroenterology and hepatology at Erasmus MC.

“Statins can inhibit lipid synthesis in organoids and statins also exhibit healthy inflammatory effects, which might contribute to the hepatoprotective effects that we observe in our population studies,” Mr. Ayada said.
 

A rising problem that needs addressing

Together NAFLD and NASH constitute a significant and increasing health burden, Mr. Ayada observed, noting that there were an estimated 64 million people in the United States and 52 million people in Europe, at least, with the rise mirroring the obesity pandemic.

“The number of patients visiting outpatient clinics has nearly doubled within a study period of 5 years,” he said.

“There is no pharmacologic therapy,” he reminded his audience, observing that fatty liver disease was a major indication for liver transplantation.

Statins are a long-standing staple of cardiovascular disease management and are known to have pleiotropic effects, Mr. Ayada explained. Their use in NAFLD and non-alcoholic steatohepatitis (NASH) has been purported but is supported by inconclusive evidence.

Indeed, a prior Cochrane review performed in 2013 found only two studies that were eligible for analysis and had “high risk of bias and a small numbers of participants,” according to the review’s authors.
 

Examining the connection

To look at the possible benefits of statins in people with NASH and examine how these effects might be occurring, Mr. Ayada and collaborators first took data from the Rotterdam Study, a large population-based prospective cohort that has been collecting data on its participants since the early 90s.

Data on over 4,500 participants were examined and of these, just over 1,000 had NAFLD. Statin versus no statin use was found to be associated with around a 30% reduction in fatty liver disease, with an odds ratio or 0.72 for NAFLD.

Then, looking only at a subset of patients with biopsy-proven NAFLD, statin use was associated with a 45% reduction in NASH (OR, 0.55) and a 24% reduction in fibrosis, although only the NASH reduction was significant (P = .031). The purpose of this cohort is to look at potential biomarkers and all participants had donated blood, urine, and stool samples; all were of Chinese descent, Mr. Ayada said.

“We then pooled our results with existing evidence in a meta-analysis,” said Mr. Ayada, including 16 studies. While results showed an overall inverse association, only the findings for a reduction in NAFLD and fibrosis were significant; the relationship between statins and NASH was not significant.
 

Investigating mechanistic effects

Then, for the second part of their work, Mr. Ayada and associates looked at potential mechanistic effects of statins.

“We did part two because we knew part one was going to be cross-sectional and we could only show the association and not causality, so we tried to shed some light on possible pathways,” he said.

To do this they used a novel model of liver organoids developed to study fatty liver disease and test potential therapeutics. In this model human liver organoids are exposed to sodium lactate, sodium pyruvate, and octanoic acid, which induce the formation of lipid droplets. Exposing the organoids to statins – simvastatin and lovastatin were used in the experiments – resulted in a reduced number of the induced lipid droplets.

“Although all concentrations of statins significantly inhibited the lipid size versus the control, the major effect was quite modest,” observed Mr. Ayada. The effect was most noticeable at the highest dose used (10 micromolar), and what they think might be happening is that the statins are clearing the smaller droplets first, leaving the larger ones behind.

Next, they looked at the effect of statin treatment on inflammatory gene expression in liver-derived monocytes. These will turn into macrophages and play a key role in chronic inflammation, Mr. Ayada explained. Initial results suggest that several proinflammatory cytokines such as interleukin-1 beta, IL-6, and IL-8 may be downplayed by statin therapy.

An anti-inflammatory effect of statins was also reported in unrelated poster presentations at the congress. While researchers Seul Ki Han and associated from South Korea showed an anti-inflammatory effect of a combination of simvastatin and ezetimibe (SAT083), a Dutch team found that atorvastatin reduced the infiltration of hepatic macrophages, neutrophils, and monocytes, as well as lowering levels of proinflammatory cytokines (SAT033).
 

Statins for NASH – a missed opportunity?

“As far as I am aware there is no robust evidence from large, randomized trials to suggest statins lessen chances of NAFLD, or improve its surrogate markers such as ALT or GGT [gamma-glutamyltransferase] levels,” Naveed Sattar, PhD, FRCP, FRCPath, FRSE, FMedSci, commented in an interview.

“The Rotterdam study is merely cross-sectional and cannot answer the question of causality,” added Dr. Sattar, who is professor of metabolic medicine and Honorary Consultant in Cardiovascular & Medical Science at the University of Glasgow. “It may be people who have less NAFLD are more likely to be prescribed statins, perhaps because doctors are wary of prescribing statins to those with slightly deranged liver tests,” he qualified.

Moreover, said Dr. Sattar, “prior evidence shows statins are underused in people with heart disease but who have NAFLD, which represents a missed opportunity to prevent heart disease.

“If statins had positive effects for preventing conversion of NAFLD to NASH or lessening fibrosis, I believe we would have known that by now.”

As for use of statins in future treatments of fatty liver disease, Dr. Sattar said: “I would not pin my hopes on statins to improve liver health, but doctors need to remember statins are safe in people with NAFLD or NASH and they should not be withheld in those who have existing cardiovascular disease or at elevated risk.” 

The study received no commercial funding. Mr. Ayada and Dr. Sattar had no relevant conflicts of interest.
 

LONDON – Substantial reductions in liver fat and fibrosis can be achieved with statin therapy, according to research presented at the annual International Liver Congress sponsored by the European Association for the Study of the Liver.

Statins are thought to have multiple beneficial actions in people with fatty liver disease, but there has been little insight into how they may be exerting such effects.

Now, data from the Rotterdam Study and others suggest that statins may be reducing the formation of lipid droplets as well as influencing the expression of important inflammatory genes.

The results “require further confirmation,” the team behind the work said, which was done at Erasmus Medical Center in Rotterdam, the Netherlands, in collaboration with researchers at The First Affiliated Hospital of Wenzhou (China) Medical University.

Sara Freeman/MDedge News

“Statins are inversely associated with multiple components of the NAFLD [nonalcoholic fatty liver disease] spectrum,” said Ibrahim Ayada, a PhD student in the department of gastroenterology and hepatology at Erasmus MC.

“Statins can inhibit lipid synthesis in organoids and statins also exhibit healthy inflammatory effects, which might contribute to the hepatoprotective effects that we observe in our population studies,” Mr. Ayada said.
 

A rising problem that needs addressing

Together NAFLD and NASH constitute a significant and increasing health burden, Mr. Ayada observed, noting that there were an estimated 64 million people in the United States and 52 million people in Europe, at least, with the rise mirroring the obesity pandemic.

“The number of patients visiting outpatient clinics has nearly doubled within a study period of 5 years,” he said.

“There is no pharmacologic therapy,” he reminded his audience, observing that fatty liver disease was a major indication for liver transplantation.

Statins are a long-standing staple of cardiovascular disease management and are known to have pleiotropic effects, Mr. Ayada explained. Their use in NAFLD and non-alcoholic steatohepatitis (NASH) has been purported but is supported by inconclusive evidence.

Indeed, a prior Cochrane review performed in 2013 found only two studies that were eligible for analysis and had “high risk of bias and a small numbers of participants,” according to the review’s authors.
 

Examining the connection

To look at the possible benefits of statins in people with NASH and examine how these effects might be occurring, Mr. Ayada and collaborators first took data from the Rotterdam Study, a large population-based prospective cohort that has been collecting data on its participants since the early 90s.

Data on over 4,500 participants were examined and of these, just over 1,000 had NAFLD. Statin versus no statin use was found to be associated with around a 30% reduction in fatty liver disease, with an odds ratio or 0.72 for NAFLD.

Then, looking only at a subset of patients with biopsy-proven NAFLD, statin use was associated with a 45% reduction in NASH (OR, 0.55) and a 24% reduction in fibrosis, although only the NASH reduction was significant (P = .031). The purpose of this cohort is to look at potential biomarkers and all participants had donated blood, urine, and stool samples; all were of Chinese descent, Mr. Ayada said.

“We then pooled our results with existing evidence in a meta-analysis,” said Mr. Ayada, including 16 studies. While results showed an overall inverse association, only the findings for a reduction in NAFLD and fibrosis were significant; the relationship between statins and NASH was not significant.
 

Investigating mechanistic effects

Then, for the second part of their work, Mr. Ayada and associates looked at potential mechanistic effects of statins.

“We did part two because we knew part one was going to be cross-sectional and we could only show the association and not causality, so we tried to shed some light on possible pathways,” he said.

To do this they used a novel model of liver organoids developed to study fatty liver disease and test potential therapeutics. In this model human liver organoids are exposed to sodium lactate, sodium pyruvate, and octanoic acid, which induce the formation of lipid droplets. Exposing the organoids to statins – simvastatin and lovastatin were used in the experiments – resulted in a reduced number of the induced lipid droplets.

“Although all concentrations of statins significantly inhibited the lipid size versus the control, the major effect was quite modest,” observed Mr. Ayada. The effect was most noticeable at the highest dose used (10 micromolar), and what they think might be happening is that the statins are clearing the smaller droplets first, leaving the larger ones behind.

Next, they looked at the effect of statin treatment on inflammatory gene expression in liver-derived monocytes. These will turn into macrophages and play a key role in chronic inflammation, Mr. Ayada explained. Initial results suggest that several proinflammatory cytokines such as interleukin-1 beta, IL-6, and IL-8 may be downplayed by statin therapy.

An anti-inflammatory effect of statins was also reported in unrelated poster presentations at the congress. While researchers Seul Ki Han and associated from South Korea showed an anti-inflammatory effect of a combination of simvastatin and ezetimibe (SAT083), a Dutch team found that atorvastatin reduced the infiltration of hepatic macrophages, neutrophils, and monocytes, as well as lowering levels of proinflammatory cytokines (SAT033).
 

Statins for NASH – a missed opportunity?

“As far as I am aware there is no robust evidence from large, randomized trials to suggest statins lessen chances of NAFLD, or improve its surrogate markers such as ALT or GGT [gamma-glutamyltransferase] levels,” Naveed Sattar, PhD, FRCP, FRCPath, FRSE, FMedSci, commented in an interview.

“The Rotterdam study is merely cross-sectional and cannot answer the question of causality,” added Dr. Sattar, who is professor of metabolic medicine and Honorary Consultant in Cardiovascular & Medical Science at the University of Glasgow. “It may be people who have less NAFLD are more likely to be prescribed statins, perhaps because doctors are wary of prescribing statins to those with slightly deranged liver tests,” he qualified.

Moreover, said Dr. Sattar, “prior evidence shows statins are underused in people with heart disease but who have NAFLD, which represents a missed opportunity to prevent heart disease.

“If statins had positive effects for preventing conversion of NAFLD to NASH or lessening fibrosis, I believe we would have known that by now.”

As for use of statins in future treatments of fatty liver disease, Dr. Sattar said: “I would not pin my hopes on statins to improve liver health, but doctors need to remember statins are safe in people with NAFLD or NASH and they should not be withheld in those who have existing cardiovascular disease or at elevated risk.” 

The study received no commercial funding. Mr. Ayada and Dr. Sattar had no relevant conflicts of interest.
 

Following hospital discharge, patients are often in a vulnerable state due to new medical diagnoses, changes in medications, lack of understanding, and concerns for medical costs. In addition, the discharge process is complex and encompasses decisions regarding the postdischarge site of care, conveying patient instructions, and obtaining supplies and medications. There are several disciplines involved in the transitions of care process that are all essential for ensuring a successful transition and reducing the risk of hospital readmissions. Pharmacists play an integral role in the process.

When pharmacists are provided the opportunity to make therapeutic interventions, medication errors and hospital readmissions decrease and quality of life improves.¹ Studies have shown that many older patients return home from the hospital with a limited understanding of their discharge instructions and oftentimes are unable to recall their discharge diagnoses and treatment plan, leaving opportunities for error when patients transition from one level of care to another.^2,3 Additionally, high-quality transitional care is especially important for older adults with multiple comorbidities and complex therapeutic regimens as well as for their families and caregivers.⁴ To prevent hospital readmissions, pharmacists and other health care professionals (HCPs) should work diligently to prevent gaps in care as patients transition between settings. Common factors that lead to increased readmissions include premature discharge, inadequate follow-up, therapeutic errors, and medication-related problems. Furthermore, unintended hospital readmissions are common within the first 30 days following hospital discharge and lead to increased health care costs.² For these reasons, many health care institutions have developed comprehensive models to improve the discharge process, decrease hospital readmissions, and reduce incidence of adverse events in general medical patients and high-risk populations.⁵

A study evaluating 693 hospital discharges found that 27.6% of patients were recommended for outpatient workups; however only 9% were actually completed.⁶ Due to lack of communication regarding discharge summaries, primary care practitioners (PCPs) were unaware of the need for outpatient workups; thus, these patients were lost to follow-up, and appropriate care was not received. Future studies should focus on interventions to improve the quality and dissemination of discharge information to PCPs.⁶ Fosnight and colleagues assessed a new transitions process focusing on the role of pharmacists. They evaluated medication reconciliations performed and discussed medication adherence barriers, medication recommendations, and time spent performing the interventions.⁷ After patients received a pharmacy intervention, Fosnight and colleagues reported that readmission rates decreased from 21.0% to 15.3% and mean length of stay decreased from 5.3 to 4.4 days. They also observed greater improvements in patients who received the full pharmacy intervention vs those receiving only parts of the intervention. This study concluded that adding a comprehensive pharmacy intervention to transitions of care resulted in an average of nearly 10 medication recommendations per patient, improved length of stay, and reduced readmission rates. After a review of similar studies, we concluded that a comprehensive discharge model is imperative to improve patient outcomes, along with HCP monitoring of the process to ensure appropriate follow-up.⁸

At Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC) in Houston, Texas, 30-day readmissions data were reviewed for veterans 6 months before and 12 months after enrollment in the Home-Based Primary Care (HBPC) service. HBPC is an in-home health care service provided to home-bound veterans with complex health care needs or when routine clinic-based care is not feasible. HBPC programs may differ among various US Department of Veterans Affairs (VA) medical centers. Currently, there are 9 HBPC teams at MEDVAMC and nearly 540 veterans are enrolled in the program. HBPC teams typically consist of PCPs, pharmacists, nurses, psychologists, occupational/physical therapists, social workers, medical support assistants, and dietitians.

Readmissions data are reviewed quarterly by fiscal year (FY) (Table 1). In FY 2019 quarter (Q) 2, the readmission rate before HBPC enrollment was 31% and decreased to 20% after enrollment. In FY 2019 Q3, the readmission rate was 29% before enrollment and decreased to 16% afterward. In FY 2019 Q4, the readmission rate before HBPC enrollment was 28% and decreased to 19% afterward. Although the readmission rates appeared to be decreasing overall, improvements were needed to decrease these rates further and to ensure readmissions were not rising as there was a slight increase in Q4. After reviewing these data, the HBPC service implemented a streamlined hospital discharge process to lower readmission rates and improve patient outcomes.

Methods

We conducted a Plan-Do-Study-Act quality improvement project. The first step was to conduct a review of veterans enrolled in HBPC at MEDVAMC.⁹ Patients included were enrolled in HBPC at MEDVAMC from October 2019 to March 2020 (FY 2020 Q1 and Q2). The Computerized Patient Record System was used to access the patients’ electronic health records. Patient information collected included race, age, sex, admission diagnosis, date of discharge, HBPC pharmacist name, PCP notification on the discharge summary, and 30-day readmission rates. Unplanned return to the hospital within 30 days, which was counted as a readmission, was defined as any admission for acute clinical events that required urgent hospital management.¹⁰

Next, we identified specific pharmacist interventions, including medication reconciliation completed by an HBPC pharmacist postdischarge; mean time to contact patients postdischarge; correct medications and supplies on discharge; incorrect dose; incorrect medication frequency or route of administration; therapeutic duplications; discontinuation of medications; additional drug therapy recommendations; laboratory test recommendations; maintenance medications not restarted or omitted; new medication education; and medication or formulation changes.

Results

Medication reconciliation was completed postdischarge by an HBPC pharmacist in 118 of 175 study patients (67.4%). The mean age of patients was 76 years, about 95% were male (Table 2). There was a wide variety of admission diagnoses but sepsis, chronic obstructive pulmonary disease, and chronic kidney disease were most common. The PCP was notified on the discharge note for 68 (38.9%) patients. The mean time for HBPC pharmacists to contact patients postdischarge was about 3 days, which was much less than the 14 days allowed in the streamlined discharge process.

Pharmacists made the following interventions during medication reconciliation: New medication education was provided for 34 (19.4%) patients and was the largest intervention completed by HBPC pharmacists. Laboratory tests were recommended for 16 (9.1%) patients, medications were discontinued in 14 (8.0%) patients, and additional drug therapy recommendations were made for 7 (4.0%) patients. Medication or formulation changes were completed in 7 (4.0%) patients, incorrect doses were identified in 6 (3.4%) patients, 5 (2.9%) patients were not discharged with the correct medications or supplies, maintenance medications were not restarted in 3 (1.7%) patients, and there were no therapeutic duplications identified. In total, there were 92 (77.9%) patients with interventions compared with the 118 medication reconciliations completed (Table 3).

Process Improvement

As this was a new streamlined discharge process, it was important to assess the progress of the pharmacist role over time. We evaluated the number of medication reconciliations completed by quarter to determine whether more interventions were completed as the streamlined discharge process was being fully implemented. In FY 2020 Q1, medication reconciliation was completed by an HBPC pharmacist at a rate of 35%, and in FY 2020 Q2, at a rate of 65%.

In addition to assessing interventions completed by an HBPC pharmacist, we noted how many medication reconciliations were completed by an inpatient pharmacist as this may have impacted the results of this study. Of the 175 patients in this study, 49 (28%) received a medication reconciliation by an inpatient clinical pharmacy specialist before discharge. Last, when reviewing the readmissions data for the study period, it was evident that the streamlined discharge process was improving. In FY 2020 Q1, the readmissions rate prior to HBPC enrollment was 30% and decreased to 15% after and in FY 2020 Q2 was 31% before and decreased to 13% after HBPC enrollment. Before the study period in FY 2019 Q4, the readmissions rate after HBPC enrollment was 19%. Therefore, the readmissions rate decreased from 19% before the study period to 13% by the end of the study period.

Discussion

A comparison of the readmissions data from FYs 2019, 2020, and 2021 revealed that the newly implemented discharge process at MEDVAMC had been more effective. Our study suggests several opportunities for interventions to lower readmission rates. HBPC pharmacists completed a medication reconciliation for 118 of the 175 HBPC patients in this study. Of note this process did not exist before October 2019; overall, there has been a 67% increase in medication reconciliations completed by pharmacists.

There were 92 interventions made during the study period, which is about 78% of all medication reconciliations completed. Medication doses were changed based on patients’ renal function. Additional laboratory tests were recommended after discharge to ensure safety of therapy. Medications were discontinued if inappropriate or if patients were no longer on them to simplify their medication list and limit polypharmacy. New medication education was provided, including drug name, dose, route of administration, time of administration, frequency, indication, mechanism of action, adverse effect profile, monitoring parameters, and more. The HBPC pharmacists were able to make suitable interventions in a timely fashion as the average time to contact patients postdischarge was 3 days.

Areas for Improvement

The PCP was notified on the discharge note only in 68 (38.9%) patients. This could lead to gaps in care if other mechanisms are not in place to notify the PCP of the patient’s discharge. For this reason, it is imperative not only to implement a streamlined discharge process, but to review it and determine methods for continued improvement.⁹ The streamlined discharge process implemented by the HBPC team highlights when each team member should contact the patient postdischarge. However, it may be beneficial for each team member to have a list of vital information that should be communicated to the patient postdischarge and to other HCPs. For pharmacists, a standardized discharge note template may aid in the consistency of the medication reconciliation process postdischarge and may also increase interventions from pharmacists. For example, only some HBPC pharmacists inserted a new medication template in their discharge follow-up note. In addition, 23 (13.1%) patients were unreachable, and although a complete medication reconciliation was not feasible, a standardized note to review inpatient and outpatient medications along with the discharge plan may still serve as an asset for HCPs.

As the HBPC team continues to improve the discharge process, it is also important to highlight roles of the inpatient team who may assist with a smoother transition. For example, discharge summaries should be clear, complete, and concise, incorporating key elements from the hospital visit. Methods of communication on discharge should be efficient and understood by both inpatient and outpatient teams. Patients’ health literacy status should be considered when providing discharge instructions. Finally, patients should have a clear understanding of who is included in their primary care team should any questions arise. The potential interventions for HCPs highlighted in this study are critical for preventing adverse outcomes, improving patients’ quality of life, and decreasing hospital readmissions. However, implementing the streamlined discharge process was only step 1. Areas of improvement still exist to provide exceptional patient care.

Our goal is to increase pharmacist-led medication reconciliation after discharge to ≥ 80%. This will be assessed monthly after providing education to the HBPC team regarding the study results. The second goal is to maintain hospital readmission rates to ≤ 10%, which will be assessed with each quarterly review.

Strengths and Limitations

This study was one of the first to evaluate the impact of pharmacist intervention on improving patient outcomes in HBPC veterans. Additionally, only 1 investigator conducted the data collection, which decreased the opportunity for errors.

A notable limitation of this study is that the discharge processes may not be able to be duplicated in other HBPC settings due to variability in programs. Additionally, as this was a new discharge process, there were a few aspects that needed to be worked out in the beginning as it was established. Furthermore, this study did not clarify whether a medication reconciliation was conducted by a physician or nurse after discharge; therefore, this study cannot conclude that the medication interventions were solely attributed to pharmacists. Also this study did not assess readmissions for recurrent events only, which may have impacted the results in a different way from the current results that assessed readmission rates for any hospitalization. Other limitations include the retrospective study design at a single center.

Conclusions

This study outlines several opportunities for interventions to improve patient outcomes and aid in decreasing hospital readmission rates. Using the results from this study, education has been provided for the HBPC Service and its readmission committee. Additionally, the safety concerns identified have been addressed with inpatient and outpatient pharmacy leadership to improve the practices in both settings, prevent delays in patient care, and avoid future adverse outcomes. This project highlights the advantages of having pharmacists involved in transitions of care and demonstrates the benefit of HBPC pharmacists’ role in the streamlined discharge process. This project will be reviewed biannually to further improve the discharge process and quality of care for our veterans.

Following hospital discharge, patients are often in a vulnerable state due to new medical diagnoses, changes in medications, lack of understanding, and concerns for medical costs. In addition, the discharge process is complex and encompasses decisions regarding the postdischarge site of care, conveying patient instructions, and obtaining supplies and medications. There are several disciplines involved in the transitions of care process that are all essential for ensuring a successful transition and reducing the risk of hospital readmissions. Pharmacists play an integral role in the process.

When pharmacists are provided the opportunity to make therapeutic interventions, medication errors and hospital readmissions decrease and quality of life improves.¹ Studies have shown that many older patients return home from the hospital with a limited understanding of their discharge instructions and oftentimes are unable to recall their discharge diagnoses and treatment plan, leaving opportunities for error when patients transition from one level of care to another.^2,3 Additionally, high-quality transitional care is especially important for older adults with multiple comorbidities and complex therapeutic regimens as well as for their families and caregivers.⁴ To prevent hospital readmissions, pharmacists and other health care professionals (HCPs) should work diligently to prevent gaps in care as patients transition between settings. Common factors that lead to increased readmissions include premature discharge, inadequate follow-up, therapeutic errors, and medication-related problems. Furthermore, unintended hospital readmissions are common within the first 30 days following hospital discharge and lead to increased health care costs.² For these reasons, many health care institutions have developed comprehensive models to improve the discharge process, decrease hospital readmissions, and reduce incidence of adverse events in general medical patients and high-risk populations.⁵

A study evaluating 693 hospital discharges found that 27.6% of patients were recommended for outpatient workups; however only 9% were actually completed.⁶ Due to lack of communication regarding discharge summaries, primary care practitioners (PCPs) were unaware of the need for outpatient workups; thus, these patients were lost to follow-up, and appropriate care was not received. Future studies should focus on interventions to improve the quality and dissemination of discharge information to PCPs.⁶ Fosnight and colleagues assessed a new transitions process focusing on the role of pharmacists. They evaluated medication reconciliations performed and discussed medication adherence barriers, medication recommendations, and time spent performing the interventions.⁷ After patients received a pharmacy intervention, Fosnight and colleagues reported that readmission rates decreased from 21.0% to 15.3% and mean length of stay decreased from 5.3 to 4.4 days. They also observed greater improvements in patients who received the full pharmacy intervention vs those receiving only parts of the intervention. This study concluded that adding a comprehensive pharmacy intervention to transitions of care resulted in an average of nearly 10 medication recommendations per patient, improved length of stay, and reduced readmission rates. After a review of similar studies, we concluded that a comprehensive discharge model is imperative to improve patient outcomes, along with HCP monitoring of the process to ensure appropriate follow-up.⁸

At Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC) in Houston, Texas, 30-day readmissions data were reviewed for veterans 6 months before and 12 months after enrollment in the Home-Based Primary Care (HBPC) service. HBPC is an in-home health care service provided to home-bound veterans with complex health care needs or when routine clinic-based care is not feasible. HBPC programs may differ among various US Department of Veterans Affairs (VA) medical centers. Currently, there are 9 HBPC teams at MEDVAMC and nearly 540 veterans are enrolled in the program. HBPC teams typically consist of PCPs, pharmacists, nurses, psychologists, occupational/physical therapists, social workers, medical support assistants, and dietitians.

Readmissions data are reviewed quarterly by fiscal year (FY) (Table 1). In FY 2019 quarter (Q) 2, the readmission rate before HBPC enrollment was 31% and decreased to 20% after enrollment. In FY 2019 Q3, the readmission rate was 29% before enrollment and decreased to 16% afterward. In FY 2019 Q4, the readmission rate before HBPC enrollment was 28% and decreased to 19% afterward. Although the readmission rates appeared to be decreasing overall, improvements were needed to decrease these rates further and to ensure readmissions were not rising as there was a slight increase in Q4. After reviewing these data, the HBPC service implemented a streamlined hospital discharge process to lower readmission rates and improve patient outcomes.

Methods

We conducted a Plan-Do-Study-Act quality improvement project. The first step was to conduct a review of veterans enrolled in HBPC at MEDVAMC.⁹ Patients included were enrolled in HBPC at MEDVAMC from October 2019 to March 2020 (FY 2020 Q1 and Q2). The Computerized Patient Record System was used to access the patients’ electronic health records. Patient information collected included race, age, sex, admission diagnosis, date of discharge, HBPC pharmacist name, PCP notification on the discharge summary, and 30-day readmission rates. Unplanned return to the hospital within 30 days, which was counted as a readmission, was defined as any admission for acute clinical events that required urgent hospital management.¹⁰

Next, we identified specific pharmacist interventions, including medication reconciliation completed by an HBPC pharmacist postdischarge; mean time to contact patients postdischarge; correct medications and supplies on discharge; incorrect dose; incorrect medication frequency or route of administration; therapeutic duplications; discontinuation of medications; additional drug therapy recommendations; laboratory test recommendations; maintenance medications not restarted or omitted; new medication education; and medication or formulation changes.

Results

Medication reconciliation was completed postdischarge by an HBPC pharmacist in 118 of 175 study patients (67.4%). The mean age of patients was 76 years, about 95% were male (Table 2). There was a wide variety of admission diagnoses but sepsis, chronic obstructive pulmonary disease, and chronic kidney disease were most common. The PCP was notified on the discharge note for 68 (38.9%) patients. The mean time for HBPC pharmacists to contact patients postdischarge was about 3 days, which was much less than the 14 days allowed in the streamlined discharge process.

Pharmacists made the following interventions during medication reconciliation: New medication education was provided for 34 (19.4%) patients and was the largest intervention completed by HBPC pharmacists. Laboratory tests were recommended for 16 (9.1%) patients, medications were discontinued in 14 (8.0%) patients, and additional drug therapy recommendations were made for 7 (4.0%) patients. Medication or formulation changes were completed in 7 (4.0%) patients, incorrect doses were identified in 6 (3.4%) patients, 5 (2.9%) patients were not discharged with the correct medications or supplies, maintenance medications were not restarted in 3 (1.7%) patients, and there were no therapeutic duplications identified. In total, there were 92 (77.9%) patients with interventions compared with the 118 medication reconciliations completed (Table 3).

Process Improvement

As this was a new streamlined discharge process, it was important to assess the progress of the pharmacist role over time. We evaluated the number of medication reconciliations completed by quarter to determine whether more interventions were completed as the streamlined discharge process was being fully implemented. In FY 2020 Q1, medication reconciliation was completed by an HBPC pharmacist at a rate of 35%, and in FY 2020 Q2, at a rate of 65%.

In addition to assessing interventions completed by an HBPC pharmacist, we noted how many medication reconciliations were completed by an inpatient pharmacist as this may have impacted the results of this study. Of the 175 patients in this study, 49 (28%) received a medication reconciliation by an inpatient clinical pharmacy specialist before discharge. Last, when reviewing the readmissions data for the study period, it was evident that the streamlined discharge process was improving. In FY 2020 Q1, the readmissions rate prior to HBPC enrollment was 30% and decreased to 15% after and in FY 2020 Q2 was 31% before and decreased to 13% after HBPC enrollment. Before the study period in FY 2019 Q4, the readmissions rate after HBPC enrollment was 19%. Therefore, the readmissions rate decreased from 19% before the study period to 13% by the end of the study period.

Discussion

A comparison of the readmissions data from FYs 2019, 2020, and 2021 revealed that the newly implemented discharge process at MEDVAMC had been more effective. Our study suggests several opportunities for interventions to lower readmission rates. HBPC pharmacists completed a medication reconciliation for 118 of the 175 HBPC patients in this study. Of note this process did not exist before October 2019; overall, there has been a 67% increase in medication reconciliations completed by pharmacists.

There were 92 interventions made during the study period, which is about 78% of all medication reconciliations completed. Medication doses were changed based on patients’ renal function. Additional laboratory tests were recommended after discharge to ensure safety of therapy. Medications were discontinued if inappropriate or if patients were no longer on them to simplify their medication list and limit polypharmacy. New medication education was provided, including drug name, dose, route of administration, time of administration, frequency, indication, mechanism of action, adverse effect profile, monitoring parameters, and more. The HBPC pharmacists were able to make suitable interventions in a timely fashion as the average time to contact patients postdischarge was 3 days.

Areas for Improvement

The PCP was notified on the discharge note only in 68 (38.9%) patients. This could lead to gaps in care if other mechanisms are not in place to notify the PCP of the patient’s discharge. For this reason, it is imperative not only to implement a streamlined discharge process, but to review it and determine methods for continued improvement.⁹ The streamlined discharge process implemented by the HBPC team highlights when each team member should contact the patient postdischarge. However, it may be beneficial for each team member to have a list of vital information that should be communicated to the patient postdischarge and to other HCPs. For pharmacists, a standardized discharge note template may aid in the consistency of the medication reconciliation process postdischarge and may also increase interventions from pharmacists. For example, only some HBPC pharmacists inserted a new medication template in their discharge follow-up note. In addition, 23 (13.1%) patients were unreachable, and although a complete medication reconciliation was not feasible, a standardized note to review inpatient and outpatient medications along with the discharge plan may still serve as an asset for HCPs.

As the HBPC team continues to improve the discharge process, it is also important to highlight roles of the inpatient team who may assist with a smoother transition. For example, discharge summaries should be clear, complete, and concise, incorporating key elements from the hospital visit. Methods of communication on discharge should be efficient and understood by both inpatient and outpatient teams. Patients’ health literacy status should be considered when providing discharge instructions. Finally, patients should have a clear understanding of who is included in their primary care team should any questions arise. The potential interventions for HCPs highlighted in this study are critical for preventing adverse outcomes, improving patients’ quality of life, and decreasing hospital readmissions. However, implementing the streamlined discharge process was only step 1. Areas of improvement still exist to provide exceptional patient care.

Our goal is to increase pharmacist-led medication reconciliation after discharge to ≥ 80%. This will be assessed monthly after providing education to the HBPC team regarding the study results. The second goal is to maintain hospital readmission rates to ≤ 10%, which will be assessed with each quarterly review.

Strengths and Limitations

This study was one of the first to evaluate the impact of pharmacist intervention on improving patient outcomes in HBPC veterans. Additionally, only 1 investigator conducted the data collection, which decreased the opportunity for errors.

A notable limitation of this study is that the discharge processes may not be able to be duplicated in other HBPC settings due to variability in programs. Additionally, as this was a new discharge process, there were a few aspects that needed to be worked out in the beginning as it was established. Furthermore, this study did not clarify whether a medication reconciliation was conducted by a physician or nurse after discharge; therefore, this study cannot conclude that the medication interventions were solely attributed to pharmacists. Also this study did not assess readmissions for recurrent events only, which may have impacted the results in a different way from the current results that assessed readmission rates for any hospitalization. Other limitations include the retrospective study design at a single center.

Conclusions

This study outlines several opportunities for interventions to improve patient outcomes and aid in decreasing hospital readmission rates. Using the results from this study, education has been provided for the HBPC Service and its readmission committee. Additionally, the safety concerns identified have been addressed with inpatient and outpatient pharmacy leadership to improve the practices in both settings, prevent delays in patient care, and avoid future adverse outcomes. This project highlights the advantages of having pharmacists involved in transitions of care and demonstrates the benefit of HBPC pharmacists’ role in the streamlined discharge process. This project will be reviewed biannually to further improve the discharge process and quality of care for our veterans.

Following hospital discharge, patients are often in a vulnerable state due to new medical diagnoses, changes in medications, lack of understanding, and concerns for medical costs. In addition, the discharge process is complex and encompasses decisions regarding the postdischarge site of care, conveying patient instructions, and obtaining supplies and medications. There are several disciplines involved in the transitions of care process that are all essential for ensuring a successful transition and reducing the risk of hospital readmissions. Pharmacists play an integral role in the process.

When pharmacists are provided the opportunity to make therapeutic interventions, medication errors and hospital readmissions decrease and quality of life improves.¹ Studies have shown that many older patients return home from the hospital with a limited understanding of their discharge instructions and oftentimes are unable to recall their discharge diagnoses and treatment plan, leaving opportunities for error when patients transition from one level of care to another.^2,3 Additionally, high-quality transitional care is especially important for older adults with multiple comorbidities and complex therapeutic regimens as well as for their families and caregivers.⁴ To prevent hospital readmissions, pharmacists and other health care professionals (HCPs) should work diligently to prevent gaps in care as patients transition between settings. Common factors that lead to increased readmissions include premature discharge, inadequate follow-up, therapeutic errors, and medication-related problems. Furthermore, unintended hospital readmissions are common within the first 30 days following hospital discharge and lead to increased health care costs.² For these reasons, many health care institutions have developed comprehensive models to improve the discharge process, decrease hospital readmissions, and reduce incidence of adverse events in general medical patients and high-risk populations.⁵

A study evaluating 693 hospital discharges found that 27.6% of patients were recommended for outpatient workups; however only 9% were actually completed.⁶ Due to lack of communication regarding discharge summaries, primary care practitioners (PCPs) were unaware of the need for outpatient workups; thus, these patients were lost to follow-up, and appropriate care was not received. Future studies should focus on interventions to improve the quality and dissemination of discharge information to PCPs.⁶ Fosnight and colleagues assessed a new transitions process focusing on the role of pharmacists. They evaluated medication reconciliations performed and discussed medication adherence barriers, medication recommendations, and time spent performing the interventions.⁷ After patients received a pharmacy intervention, Fosnight and colleagues reported that readmission rates decreased from 21.0% to 15.3% and mean length of stay decreased from 5.3 to 4.4 days. They also observed greater improvements in patients who received the full pharmacy intervention vs those receiving only parts of the intervention. This study concluded that adding a comprehensive pharmacy intervention to transitions of care resulted in an average of nearly 10 medication recommendations per patient, improved length of stay, and reduced readmission rates. After a review of similar studies, we concluded that a comprehensive discharge model is imperative to improve patient outcomes, along with HCP monitoring of the process to ensure appropriate follow-up.⁸

At Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC) in Houston, Texas, 30-day readmissions data were reviewed for veterans 6 months before and 12 months after enrollment in the Home-Based Primary Care (HBPC) service. HBPC is an in-home health care service provided to home-bound veterans with complex health care needs or when routine clinic-based care is not feasible. HBPC programs may differ among various US Department of Veterans Affairs (VA) medical centers. Currently, there are 9 HBPC teams at MEDVAMC and nearly 540 veterans are enrolled in the program. HBPC teams typically consist of PCPs, pharmacists, nurses, psychologists, occupational/physical therapists, social workers, medical support assistants, and dietitians.

Readmissions data are reviewed quarterly by fiscal year (FY) (Table 1). In FY 2019 quarter (Q) 2, the readmission rate before HBPC enrollment was 31% and decreased to 20% after enrollment. In FY 2019 Q3, the readmission rate was 29% before enrollment and decreased to 16% afterward. In FY 2019 Q4, the readmission rate before HBPC enrollment was 28% and decreased to 19% afterward. Although the readmission rates appeared to be decreasing overall, improvements were needed to decrease these rates further and to ensure readmissions were not rising as there was a slight increase in Q4. After reviewing these data, the HBPC service implemented a streamlined hospital discharge process to lower readmission rates and improve patient outcomes.

Methods

We conducted a Plan-Do-Study-Act quality improvement project. The first step was to conduct a review of veterans enrolled in HBPC at MEDVAMC.⁹ Patients included were enrolled in HBPC at MEDVAMC from October 2019 to March 2020 (FY 2020 Q1 and Q2). The Computerized Patient Record System was used to access the patients’ electronic health records. Patient information collected included race, age, sex, admission diagnosis, date of discharge, HBPC pharmacist name, PCP notification on the discharge summary, and 30-day readmission rates. Unplanned return to the hospital within 30 days, which was counted as a readmission, was defined as any admission for acute clinical events that required urgent hospital management.¹⁰

Next, we identified specific pharmacist interventions, including medication reconciliation completed by an HBPC pharmacist postdischarge; mean time to contact patients postdischarge; correct medications and supplies on discharge; incorrect dose; incorrect medication frequency or route of administration; therapeutic duplications; discontinuation of medications; additional drug therapy recommendations; laboratory test recommendations; maintenance medications not restarted or omitted; new medication education; and medication or formulation changes.

Results

Medication reconciliation was completed postdischarge by an HBPC pharmacist in 118 of 175 study patients (67.4%). The mean age of patients was 76 years, about 95% were male (Table 2). There was a wide variety of admission diagnoses but sepsis, chronic obstructive pulmonary disease, and chronic kidney disease were most common. The PCP was notified on the discharge note for 68 (38.9%) patients. The mean time for HBPC pharmacists to contact patients postdischarge was about 3 days, which was much less than the 14 days allowed in the streamlined discharge process.

Pharmacists made the following interventions during medication reconciliation: New medication education was provided for 34 (19.4%) patients and was the largest intervention completed by HBPC pharmacists. Laboratory tests were recommended for 16 (9.1%) patients, medications were discontinued in 14 (8.0%) patients, and additional drug therapy recommendations were made for 7 (4.0%) patients. Medication or formulation changes were completed in 7 (4.0%) patients, incorrect doses were identified in 6 (3.4%) patients, 5 (2.9%) patients were not discharged with the correct medications or supplies, maintenance medications were not restarted in 3 (1.7%) patients, and there were no therapeutic duplications identified. In total, there were 92 (77.9%) patients with interventions compared with the 118 medication reconciliations completed (Table 3).

Process Improvement

As this was a new streamlined discharge process, it was important to assess the progress of the pharmacist role over time. We evaluated the number of medication reconciliations completed by quarter to determine whether more interventions were completed as the streamlined discharge process was being fully implemented. In FY 2020 Q1, medication reconciliation was completed by an HBPC pharmacist at a rate of 35%, and in FY 2020 Q2, at a rate of 65%.

In addition to assessing interventions completed by an HBPC pharmacist, we noted how many medication reconciliations were completed by an inpatient pharmacist as this may have impacted the results of this study. Of the 175 patients in this study, 49 (28%) received a medication reconciliation by an inpatient clinical pharmacy specialist before discharge. Last, when reviewing the readmissions data for the study period, it was evident that the streamlined discharge process was improving. In FY 2020 Q1, the readmissions rate prior to HBPC enrollment was 30% and decreased to 15% after and in FY 2020 Q2 was 31% before and decreased to 13% after HBPC enrollment. Before the study period in FY 2019 Q4, the readmissions rate after HBPC enrollment was 19%. Therefore, the readmissions rate decreased from 19% before the study period to 13% by the end of the study period.

Discussion

A comparison of the readmissions data from FYs 2019, 2020, and 2021 revealed that the newly implemented discharge process at MEDVAMC had been more effective. Our study suggests several opportunities for interventions to lower readmission rates. HBPC pharmacists completed a medication reconciliation for 118 of the 175 HBPC patients in this study. Of note this process did not exist before October 2019; overall, there has been a 67% increase in medication reconciliations completed by pharmacists.

There were 92 interventions made during the study period, which is about 78% of all medication reconciliations completed. Medication doses were changed based on patients’ renal function. Additional laboratory tests were recommended after discharge to ensure safety of therapy. Medications were discontinued if inappropriate or if patients were no longer on them to simplify their medication list and limit polypharmacy. New medication education was provided, including drug name, dose, route of administration, time of administration, frequency, indication, mechanism of action, adverse effect profile, monitoring parameters, and more. The HBPC pharmacists were able to make suitable interventions in a timely fashion as the average time to contact patients postdischarge was 3 days.

Areas for Improvement

The PCP was notified on the discharge note only in 68 (38.9%) patients. This could lead to gaps in care if other mechanisms are not in place to notify the PCP of the patient’s discharge. For this reason, it is imperative not only to implement a streamlined discharge process, but to review it and determine methods for continued improvement.⁹ The streamlined discharge process implemented by the HBPC team highlights when each team member should contact the patient postdischarge. However, it may be beneficial for each team member to have a list of vital information that should be communicated to the patient postdischarge and to other HCPs. For pharmacists, a standardized discharge note template may aid in the consistency of the medication reconciliation process postdischarge and may also increase interventions from pharmacists. For example, only some HBPC pharmacists inserted a new medication template in their discharge follow-up note. In addition, 23 (13.1%) patients were unreachable, and although a complete medication reconciliation was not feasible, a standardized note to review inpatient and outpatient medications along with the discharge plan may still serve as an asset for HCPs.

As the HBPC team continues to improve the discharge process, it is also important to highlight roles of the inpatient team who may assist with a smoother transition. For example, discharge summaries should be clear, complete, and concise, incorporating key elements from the hospital visit. Methods of communication on discharge should be efficient and understood by both inpatient and outpatient teams. Patients’ health literacy status should be considered when providing discharge instructions. Finally, patients should have a clear understanding of who is included in their primary care team should any questions arise. The potential interventions for HCPs highlighted in this study are critical for preventing adverse outcomes, improving patients’ quality of life, and decreasing hospital readmissions. However, implementing the streamlined discharge process was only step 1. Areas of improvement still exist to provide exceptional patient care.

Our goal is to increase pharmacist-led medication reconciliation after discharge to ≥ 80%. This will be assessed monthly after providing education to the HBPC team regarding the study results. The second goal is to maintain hospital readmission rates to ≤ 10%, which will be assessed with each quarterly review.

Strengths and Limitations

This study was one of the first to evaluate the impact of pharmacist intervention on improving patient outcomes in HBPC veterans. Additionally, only 1 investigator conducted the data collection, which decreased the opportunity for errors.

A notable limitation of this study is that the discharge processes may not be able to be duplicated in other HBPC settings due to variability in programs. Additionally, as this was a new discharge process, there were a few aspects that needed to be worked out in the beginning as it was established. Furthermore, this study did not clarify whether a medication reconciliation was conducted by a physician or nurse after discharge; therefore, this study cannot conclude that the medication interventions were solely attributed to pharmacists. Also this study did not assess readmissions for recurrent events only, which may have impacted the results in a different way from the current results that assessed readmission rates for any hospitalization. Other limitations include the retrospective study design at a single center.

Conclusions

This study outlines several opportunities for interventions to improve patient outcomes and aid in decreasing hospital readmission rates. Using the results from this study, education has been provided for the HBPC Service and its readmission committee. Additionally, the safety concerns identified have been addressed with inpatient and outpatient pharmacy leadership to improve the practices in both settings, prevent delays in patient care, and avoid future adverse outcomes. This project highlights the advantages of having pharmacists involved in transitions of care and demonstrates the benefit of HBPC pharmacists’ role in the streamlined discharge process. This project will be reviewed biannually to further improve the discharge process and quality of care for our veterans.

The Veterans Health Administration (VHA)—along with systems across the world—has spent the past 2 years continuously adapting to meet the emerging needs of persons infected with COVID-19. With the development of effective vaccines and global efforts to mitigate transmission, attention has now shifted to long COVID care as the need for further outpatient health care becomes increasingly apparent.^1,2

Background

Multiple terms describe the lingering, multisystem sequelae of COVID-19 that last longer than 4 weeks: long COVID, postacute COVID-19 syndrome, post-COVID condition, postacute sequalae of COVID-19, and COVID long hauler.^1,3 Common symptoms include fatigue, shortness of breath, cough, sleep disorders, brain fog or cognitive dysfunction, depression, anxiety, pain, and changes in taste or smell that impact a person’s functioning.^4,5 The multisystem nature of the postacute course of COVID-19 necessitates an interdisciplinary approach to devise comprehensive and individualized care plans.^6-9 Research is needed to better understand this postacute state (eg, prevalence, underlying effects, characteristics of those who experience long COVID) to establish and evaluate cost-effective treatment approaches.

Many patients who are experiencing symptoms beyond the acute course of COVID-19 have been referred to general outpatient clinics or home health, which may lack the capacity and knowledge of this novel disease to effectively manage complex long COVID cases.^2,3 To address this growing need, clinicians and leadership across a variety of disciplines and settings in the VHA created a community of practice (CoP) to create a mechanism for cross-facility communication, identify gaps in long COVID care and research, and cocreate knowledge on best practices for care delivery.

In this spirit, we are embracing a learning health system (LHS) approach that uses rapid-cycle methods to integrate data and real-world experience to iteratively evaluate and adapt models of long COVID care.¹⁰ Our clinically identified and data-driven objective is to provide high value health care to patients with long COVID sequalae by creating a framework to learn about this novel condition and develop innovative care models. This article provides an overview of our emerging LHS approach to the study of long COVID care that is fostering innovation and adaptability within the VHA. We describe 3 aspects of our engagement approach central to LHS: the ongoing development of a long COVID CoP dedicated to iteratively informing the bidirectional cycle of data from practice to research, results of a broad environmental scan of VHA long COVID care, and results of a survey administered to CoP members to inform ongoing needs of the community and identify early successful outcomes from participation.

Learning Health System Approach

The VHA is one of the largest integrated health care systems in the United States serving more than 9 million veterans.¹¹ Since 2017, the VHA has articulated a vision to become an LHS that informs and improves patient-centered care through practice-based and data-driven research (eAppendix).¹² During the early COVID-19 pandemic, an LHS approach in the VHA was critical to rapidly establishing a data infrastructure for disease surveillance, coordinating data-driven solutions, leveraging use of technology, collaborating across the globe to identify best practices, and implementing systematic responses (eg, policies, workforce adjustments).

Our long COVID CoP was developed as clinical observations and ongoing conversations with stakeholders (eg, veterans, health care practitioners [HCPs], leadership) identified a need to effectively identify and treat the growing number of veterans with long COVID. This clinical issue is compounded by the limited but emerging evidence on the clinical presentation of prolonged COVID-19 symptoms, treatment, and subsequent care pathways. The VHA’s efforts and lessons learned within the lens of an LHS are applicable to other systems confronting the complex identification and management of patients with persistent and encumbering long COVID symptoms. The VHA is building upon the LHS approach to proactively prepare for and address future clinical or public health challenges that require cross-system and sector collaborations, expediency, inclusivity, and patient/family centeredness.¹¹

Community of Practice

As of January 25, 2022, our workgroup consisted of 128 VHA employees representing 29 VHA medical centers. Members of the multidisciplinary workgroup have diverse backgrounds with HCPs from primary care (eg, physicians, nurse practitioners), rehabilitation (eg, physical therapists), specialty care (eg, pulmonologists, physiatrists), mental health (eg, psychologists), and complementary and integrated health/Whole Health services (eg, practitoners of services such as yoga, tai chi, mindfulness, acupuncture). Members also include clinical, operations, and research leadership at local, regional, and national VHA levels. Our first objective as a large, diverse group was to establish shared goals, which included: (1) determining efficient communication pathways; (2) identifying gaps in care or research; and (3) cocreating knowledge to provide solutions to identified gaps.

Communication Mechanisms

Our first goal was to create an efficient mechanism for cross-facility communication. The initial CoP was formed in April 2021 and the first virtual meeting focused on reaching a consensus regarding the best way to communicate and proceed. We agreed to convene weekly at a consistent time, created a standard agenda template, and elected a lead facilitator of meeting proceedings. In addition, a member of the CoP recorded and took extensive meeting notes, which were later distributed to the entire CoP to accommodate varying schedules and ability to attend live meetings. Approximately 20 to 30 participants attend the meetings in real-time.

To consolidate working documents, information, and resources in one location, we created a platform to communicate via a Microsoft Teams channel. All CoP members are given access to the folders and allowed to add to the growing library of resources. Resources include clinical assessment and note templates for electronic documentation of care, site-specific process maps, relevant literature on screening and interventions identified by practice members, and meeting notes along with the recordings. A chat feature alerts CoP members to questions posed by other members. Any resources or information shared on the chat discussion are curated by CoP leaders to disseminate to all members. Importantly, this platform allowed us to communicate efficiently within the VHA organization by creating a centralized space for documents and the ability to correspond with all or select members of the CoP. Additional VHA employees can easily be referred and request access.

To increase awareness of the CoP, expand reach, and diversify perspectives, every participant was encouraged to invite colleagues and stakeholders with interest or experience in long COVID care to join. While patients are not included in this CoP, we are working closely with the VHA user experience workgroup (many members overlap) that is gathering patient and caregiver perspectives on their COVID-19 experience and long COVID care. Concurrently, CoP members and leadership facilitate communication and set up formal collaborations with other non-VHA health care systems to create an intersystem network of collaboration for long COVID care. This approach further enhances the speed at which we can work together to share lessons learned and stay up-to-date on emerging evidence surrounding long COVID care.

Identifying Gaps in Care and Research

Our second goal was to identify gaps in care or knowledge to inform future research and quality improvement initiatives, while also creating a foundation to cocreate knowledge about safe, effective care management of the novel long COVID sequelae. To translate knowledge, we must first identify and understand the gaps between the current, best available evidence and current care practices or policies impacting that delivery.¹³ As such, the structured meeting agenda and facilitated meeting discussions focused on understanding current clinical decision making and the evidence base. We shared VHA evidence synthesis reports and living rapid reviews on complications following COVID-19 illness (ie, major organ damage and posthospitalization health care use) that provided an objective evidence base on common long COVID complications.^14,15

Since long COVID is a novel condition, we drew from literature in similar patient populations and translated that information in the context of our current knowledge of this unique syndrome. For example, we discussed the predominant and persistent symptom of fatigue post-COVID.⁵ In particular, the CoP discussed challenges in identifying and treating post-COVID fatigue, which is often a vague symptom with multiple or interacting etiologies that require a comprehensive, interdisciplinary approach. As such, we reviewed, adapted, and translated identification and treatment strategies from the literature on chronic fatigue syndrome to patients with post-COVID syndrome.^16,17 We continue to work collaboratively and engage the appropriate stakeholders to provide input on the gaps to prioritize targeting.

Cocreate Knowledge

Our third goal was to cocreate knowledge regarding the care of patients with long COVID. To accomplish this, our structured meetings and communication pathways invited members to share experiences on the who (delivers and receives care), what (type of care or HCPs), when (identification of post-COVID and access), and how (eg, telehealth) of care to patients post-COVID. As part of the workgroup, we identified and shared resources on standardized, facility-level practices to reduce variability across the VHA system. These resources included intake/assessment forms, care processes, and batteries of tests/measures used for screening and assessment. The knowledge obtained from outside the CoP and cocreated within is being used to inform data-driven tools to support and evaluate care for patients with long COVID. As such, members of the workgroup are in the formative stages of participating in quality improvement innovation pilots to test technologies and processes designed to improve and validate long COVID care pathways. These technologies include screening tools, clinical decision support tools, and population health management technologies. In addition, we are developing a formal collaboration with the VHA Office of Research and Development to create standardized intake forms across VHA long COVID clinics to facilitate both clinical monitoring and research.

Surveys

The US Department of Veterans Affairs Central Office collaborated with our workgroup to draft an initial set of survey questions designed to understand how each VHA facility defines, identifies, and provides care to veterans experiencing post-COVID sequalae. The 41-question survey was distributed through regional directors and chief medical officers at 139 VHA facilities in August 2021. One hundred nineteen responses (86%) were received. Sixteen facilities indicated they had established programs and 26 facilities were considering a program. Our CoP had representation from the 16 facilities with established programs indicating the deep and well-connected nature of our grassroots efforts to bring together stakeholders to learn as part of a CoP.

A separate, follow-up survey generated responses from 18 facilities and identified the need to capture evolving innovations and to develop smaller workstreams (eg, best practices, electronic documentation templates, pathway for referrals, veteran engagement, outcome measures). The survey not only exposed ongoing challenges to providing long COVID care, but importantly, outlined the ways in which CoP members were leveraging community knowledge and resources to inform innovations and processes of care changes at their specific sites. Fourteen of 18 facilities with long COVID programs in place explicitly identified the CoP as a resource they have found most beneficial when employing such innovations. Specific innovations reported included changes in care delivery, engagement in active outreach with veterans and local facility, and infrastructure development to sustain local long COVID clinics (Table).

Future Directions

Our CoP strives to contribute to an evidence base for long COVID care. At the system level, the CoP has the potential to impact access and continuity of care by identifying appropriate processes and ensuring that VHA patients receive outreach and an opportunity for post-COVID care. Comprehensive care requires input from HCP, clinical leadership, and operations levels. In this sense, our CoP provides an opportunity for diverse stakeholders to come together, discuss barriers to screening and delivering post-COVID care, and create an action plan to remove or lessen such barriers.¹⁸ Part of the process to remove barriers is to identify and support efficient resource allocation. Our CoP has worked to address issues in resource allocation (eg, space, personnel) for post-COVID care. For example, one facility is currently implementing interdisciplinary virtual post-COVID care. Another facility identified and restructured working assignments for psychologists who served in different capacities throughout the system to fill the need within the long COVID team.

At the HCP level, the CoP is currently developing workshops, media campaigns, written clinical resources, skills training, publications, and webinars/seminars with continuing medical education credits.¹⁹ The CoP may also provide learning and growth opportunities, such as clinical or VHA operational fellowships and research grants.

We are still in the formative stages of post-COVID care and future efforts will explore patient-centered outcomes. We are drawing on the Centers for Disease Control and Prevention’s guidance for evaluating patients with long COVID symptoms and examining the feasibility within VHA, as well as patient perspectives on post-COVID sequalae, to ensure we are selecting assessments that measure patient-centered constructs.¹⁸

Conclusions

A VHA-wide LHS approach is identifying issues related to the identification, delivery, and evaluation of long COVID care. This long COVID CoP has developed an infrastructure for communication, identified gaps in care, and cocreated knowledge related to best current practices for post-COVID care. This work is contributing to systemwide LHS efforts dedicated to creating a culture of quality care and innovation and is a process that is transferrable to other areas of care in the VHA, as well as other health care systems. The LHS approach continues to be highly relevant as we persist through the COVID-19 pandemic and reimagine a postpandemic world.

Acknowledgments

We thank all the members of the Veterans Health Administration long COVID Community of Practice who participate in the meetings and contribute to the sharing and spread of knowledge.

The Veterans Health Administration (VHA)—along with systems across the world—has spent the past 2 years continuously adapting to meet the emerging needs of persons infected with COVID-19. With the development of effective vaccines and global efforts to mitigate transmission, attention has now shifted to long COVID care as the need for further outpatient health care becomes increasingly apparent.^1,2

Background

Multiple terms describe the lingering, multisystem sequelae of COVID-19 that last longer than 4 weeks: long COVID, postacute COVID-19 syndrome, post-COVID condition, postacute sequalae of COVID-19, and COVID long hauler.^1,3 Common symptoms include fatigue, shortness of breath, cough, sleep disorders, brain fog or cognitive dysfunction, depression, anxiety, pain, and changes in taste or smell that impact a person’s functioning.^4,5 The multisystem nature of the postacute course of COVID-19 necessitates an interdisciplinary approach to devise comprehensive and individualized care plans.^6-9 Research is needed to better understand this postacute state (eg, prevalence, underlying effects, characteristics of those who experience long COVID) to establish and evaluate cost-effective treatment approaches.

Many patients who are experiencing symptoms beyond the acute course of COVID-19 have been referred to general outpatient clinics or home health, which may lack the capacity and knowledge of this novel disease to effectively manage complex long COVID cases.^2,3 To address this growing need, clinicians and leadership across a variety of disciplines and settings in the VHA created a community of practice (CoP) to create a mechanism for cross-facility communication, identify gaps in long COVID care and research, and cocreate knowledge on best practices for care delivery.

In this spirit, we are embracing a learning health system (LHS) approach that uses rapid-cycle methods to integrate data and real-world experience to iteratively evaluate and adapt models of long COVID care.¹⁰ Our clinically identified and data-driven objective is to provide high value health care to patients with long COVID sequalae by creating a framework to learn about this novel condition and develop innovative care models. This article provides an overview of our emerging LHS approach to the study of long COVID care that is fostering innovation and adaptability within the VHA. We describe 3 aspects of our engagement approach central to LHS: the ongoing development of a long COVID CoP dedicated to iteratively informing the bidirectional cycle of data from practice to research, results of a broad environmental scan of VHA long COVID care, and results of a survey administered to CoP members to inform ongoing needs of the community and identify early successful outcomes from participation.

Learning Health System Approach

The VHA is one of the largest integrated health care systems in the United States serving more than 9 million veterans.¹¹ Since 2017, the VHA has articulated a vision to become an LHS that informs and improves patient-centered care through practice-based and data-driven research (eAppendix).¹² During the early COVID-19 pandemic, an LHS approach in the VHA was critical to rapidly establishing a data infrastructure for disease surveillance, coordinating data-driven solutions, leveraging use of technology, collaborating across the globe to identify best practices, and implementing systematic responses (eg, policies, workforce adjustments).

Our long COVID CoP was developed as clinical observations and ongoing conversations with stakeholders (eg, veterans, health care practitioners [HCPs], leadership) identified a need to effectively identify and treat the growing number of veterans with long COVID. This clinical issue is compounded by the limited but emerging evidence on the clinical presentation of prolonged COVID-19 symptoms, treatment, and subsequent care pathways. The VHA’s efforts and lessons learned within the lens of an LHS are applicable to other systems confronting the complex identification and management of patients with persistent and encumbering long COVID symptoms. The VHA is building upon the LHS approach to proactively prepare for and address future clinical or public health challenges that require cross-system and sector collaborations, expediency, inclusivity, and patient/family centeredness.¹¹

Community of Practice

As of January 25, 2022, our workgroup consisted of 128 VHA employees representing 29 VHA medical centers. Members of the multidisciplinary workgroup have diverse backgrounds with HCPs from primary care (eg, physicians, nurse practitioners), rehabilitation (eg, physical therapists), specialty care (eg, pulmonologists, physiatrists), mental health (eg, psychologists), and complementary and integrated health/Whole Health services (eg, practitoners of services such as yoga, tai chi, mindfulness, acupuncture). Members also include clinical, operations, and research leadership at local, regional, and national VHA levels. Our first objective as a large, diverse group was to establish shared goals, which included: (1) determining efficient communication pathways; (2) identifying gaps in care or research; and (3) cocreating knowledge to provide solutions to identified gaps.

Communication Mechanisms

Our first goal was to create an efficient mechanism for cross-facility communication. The initial CoP was formed in April 2021 and the first virtual meeting focused on reaching a consensus regarding the best way to communicate and proceed. We agreed to convene weekly at a consistent time, created a standard agenda template, and elected a lead facilitator of meeting proceedings. In addition, a member of the CoP recorded and took extensive meeting notes, which were later distributed to the entire CoP to accommodate varying schedules and ability to attend live meetings. Approximately 20 to 30 participants attend the meetings in real-time.

To consolidate working documents, information, and resources in one location, we created a platform to communicate via a Microsoft Teams channel. All CoP members are given access to the folders and allowed to add to the growing library of resources. Resources include clinical assessment and note templates for electronic documentation of care, site-specific process maps, relevant literature on screening and interventions identified by practice members, and meeting notes along with the recordings. A chat feature alerts CoP members to questions posed by other members. Any resources or information shared on the chat discussion are curated by CoP leaders to disseminate to all members. Importantly, this platform allowed us to communicate efficiently within the VHA organization by creating a centralized space for documents and the ability to correspond with all or select members of the CoP. Additional VHA employees can easily be referred and request access.

To increase awareness of the CoP, expand reach, and diversify perspectives, every participant was encouraged to invite colleagues and stakeholders with interest or experience in long COVID care to join. While patients are not included in this CoP, we are working closely with the VHA user experience workgroup (many members overlap) that is gathering patient and caregiver perspectives on their COVID-19 experience and long COVID care. Concurrently, CoP members and leadership facilitate communication and set up formal collaborations with other non-VHA health care systems to create an intersystem network of collaboration for long COVID care. This approach further enhances the speed at which we can work together to share lessons learned and stay up-to-date on emerging evidence surrounding long COVID care.

Identifying Gaps in Care and Research

Our second goal was to identify gaps in care or knowledge to inform future research and quality improvement initiatives, while also creating a foundation to cocreate knowledge about safe, effective care management of the novel long COVID sequelae. To translate knowledge, we must first identify and understand the gaps between the current, best available evidence and current care practices or policies impacting that delivery.¹³ As such, the structured meeting agenda and facilitated meeting discussions focused on understanding current clinical decision making and the evidence base. We shared VHA evidence synthesis reports and living rapid reviews on complications following COVID-19 illness (ie, major organ damage and posthospitalization health care use) that provided an objective evidence base on common long COVID complications.^14,15

Since long COVID is a novel condition, we drew from literature in similar patient populations and translated that information in the context of our current knowledge of this unique syndrome. For example, we discussed the predominant and persistent symptom of fatigue post-COVID.⁵ In particular, the CoP discussed challenges in identifying and treating post-COVID fatigue, which is often a vague symptom with multiple or interacting etiologies that require a comprehensive, interdisciplinary approach. As such, we reviewed, adapted, and translated identification and treatment strategies from the literature on chronic fatigue syndrome to patients with post-COVID syndrome.^16,17 We continue to work collaboratively and engage the appropriate stakeholders to provide input on the gaps to prioritize targeting.

Cocreate Knowledge

Our third goal was to cocreate knowledge regarding the care of patients with long COVID. To accomplish this, our structured meetings and communication pathways invited members to share experiences on the who (delivers and receives care), what (type of care or HCPs), when (identification of post-COVID and access), and how (eg, telehealth) of care to patients post-COVID. As part of the workgroup, we identified and shared resources on standardized, facility-level practices to reduce variability across the VHA system. These resources included intake/assessment forms, care processes, and batteries of tests/measures used for screening and assessment. The knowledge obtained from outside the CoP and cocreated within is being used to inform data-driven tools to support and evaluate care for patients with long COVID. As such, members of the workgroup are in the formative stages of participating in quality improvement innovation pilots to test technologies and processes designed to improve and validate long COVID care pathways. These technologies include screening tools, clinical decision support tools, and population health management technologies. In addition, we are developing a formal collaboration with the VHA Office of Research and Development to create standardized intake forms across VHA long COVID clinics to facilitate both clinical monitoring and research.

Surveys

The US Department of Veterans Affairs Central Office collaborated with our workgroup to draft an initial set of survey questions designed to understand how each VHA facility defines, identifies, and provides care to veterans experiencing post-COVID sequalae. The 41-question survey was distributed through regional directors and chief medical officers at 139 VHA facilities in August 2021. One hundred nineteen responses (86%) were received. Sixteen facilities indicated they had established programs and 26 facilities were considering a program. Our CoP had representation from the 16 facilities with established programs indicating the deep and well-connected nature of our grassroots efforts to bring together stakeholders to learn as part of a CoP.

A separate, follow-up survey generated responses from 18 facilities and identified the need to capture evolving innovations and to develop smaller workstreams (eg, best practices, electronic documentation templates, pathway for referrals, veteran engagement, outcome measures). The survey not only exposed ongoing challenges to providing long COVID care, but importantly, outlined the ways in which CoP members were leveraging community knowledge and resources to inform innovations and processes of care changes at their specific sites. Fourteen of 18 facilities with long COVID programs in place explicitly identified the CoP as a resource they have found most beneficial when employing such innovations. Specific innovations reported included changes in care delivery, engagement in active outreach with veterans and local facility, and infrastructure development to sustain local long COVID clinics (Table).

Future Directions

Our CoP strives to contribute to an evidence base for long COVID care. At the system level, the CoP has the potential to impact access and continuity of care by identifying appropriate processes and ensuring that VHA patients receive outreach and an opportunity for post-COVID care. Comprehensive care requires input from HCP, clinical leadership, and operations levels. In this sense, our CoP provides an opportunity for diverse stakeholders to come together, discuss barriers to screening and delivering post-COVID care, and create an action plan to remove or lessen such barriers.¹⁸ Part of the process to remove barriers is to identify and support efficient resource allocation. Our CoP has worked to address issues in resource allocation (eg, space, personnel) for post-COVID care. For example, one facility is currently implementing interdisciplinary virtual post-COVID care. Another facility identified and restructured working assignments for psychologists who served in different capacities throughout the system to fill the need within the long COVID team.

At the HCP level, the CoP is currently developing workshops, media campaigns, written clinical resources, skills training, publications, and webinars/seminars with continuing medical education credits.¹⁹ The CoP may also provide learning and growth opportunities, such as clinical or VHA operational fellowships and research grants.

We are still in the formative stages of post-COVID care and future efforts will explore patient-centered outcomes. We are drawing on the Centers for Disease Control and Prevention’s guidance for evaluating patients with long COVID symptoms and examining the feasibility within VHA, as well as patient perspectives on post-COVID sequalae, to ensure we are selecting assessments that measure patient-centered constructs.¹⁸

Conclusions

A VHA-wide LHS approach is identifying issues related to the identification, delivery, and evaluation of long COVID care. This long COVID CoP has developed an infrastructure for communication, identified gaps in care, and cocreated knowledge related to best current practices for post-COVID care. This work is contributing to systemwide LHS efforts dedicated to creating a culture of quality care and innovation and is a process that is transferrable to other areas of care in the VHA, as well as other health care systems. The LHS approach continues to be highly relevant as we persist through the COVID-19 pandemic and reimagine a postpandemic world.

Acknowledgments

We thank all the members of the Veterans Health Administration long COVID Community of Practice who participate in the meetings and contribute to the sharing and spread of knowledge.

The Veterans Health Administration (VHA)—along with systems across the world—has spent the past 2 years continuously adapting to meet the emerging needs of persons infected with COVID-19. With the development of effective vaccines and global efforts to mitigate transmission, attention has now shifted to long COVID care as the need for further outpatient health care becomes increasingly apparent.^1,2

Background

Multiple terms describe the lingering, multisystem sequelae of COVID-19 that last longer than 4 weeks: long COVID, postacute COVID-19 syndrome, post-COVID condition, postacute sequalae of COVID-19, and COVID long hauler.^1,3 Common symptoms include fatigue, shortness of breath, cough, sleep disorders, brain fog or cognitive dysfunction, depression, anxiety, pain, and changes in taste or smell that impact a person’s functioning.^4,5 The multisystem nature of the postacute course of COVID-19 necessitates an interdisciplinary approach to devise comprehensive and individualized care plans.^6-9 Research is needed to better understand this postacute state (eg, prevalence, underlying effects, characteristics of those who experience long COVID) to establish and evaluate cost-effective treatment approaches.

Many patients who are experiencing symptoms beyond the acute course of COVID-19 have been referred to general outpatient clinics or home health, which may lack the capacity and knowledge of this novel disease to effectively manage complex long COVID cases.^2,3 To address this growing need, clinicians and leadership across a variety of disciplines and settings in the VHA created a community of practice (CoP) to create a mechanism for cross-facility communication, identify gaps in long COVID care and research, and cocreate knowledge on best practices for care delivery.

In this spirit, we are embracing a learning health system (LHS) approach that uses rapid-cycle methods to integrate data and real-world experience to iteratively evaluate and adapt models of long COVID care.¹⁰ Our clinically identified and data-driven objective is to provide high value health care to patients with long COVID sequalae by creating a framework to learn about this novel condition and develop innovative care models. This article provides an overview of our emerging LHS approach to the study of long COVID care that is fostering innovation and adaptability within the VHA. We describe 3 aspects of our engagement approach central to LHS: the ongoing development of a long COVID CoP dedicated to iteratively informing the bidirectional cycle of data from practice to research, results of a broad environmental scan of VHA long COVID care, and results of a survey administered to CoP members to inform ongoing needs of the community and identify early successful outcomes from participation.

Learning Health System Approach

The VHA is one of the largest integrated health care systems in the United States serving more than 9 million veterans.¹¹ Since 2017, the VHA has articulated a vision to become an LHS that informs and improves patient-centered care through practice-based and data-driven research (eAppendix).¹² During the early COVID-19 pandemic, an LHS approach in the VHA was critical to rapidly establishing a data infrastructure for disease surveillance, coordinating data-driven solutions, leveraging use of technology, collaborating across the globe to identify best practices, and implementing systematic responses (eg, policies, workforce adjustments).

Our long COVID CoP was developed as clinical observations and ongoing conversations with stakeholders (eg, veterans, health care practitioners [HCPs], leadership) identified a need to effectively identify and treat the growing number of veterans with long COVID. This clinical issue is compounded by the limited but emerging evidence on the clinical presentation of prolonged COVID-19 symptoms, treatment, and subsequent care pathways. The VHA’s efforts and lessons learned within the lens of an LHS are applicable to other systems confronting the complex identification and management of patients with persistent and encumbering long COVID symptoms. The VHA is building upon the LHS approach to proactively prepare for and address future clinical or public health challenges that require cross-system and sector collaborations, expediency, inclusivity, and patient/family centeredness.¹¹

Community of Practice

As of January 25, 2022, our workgroup consisted of 128 VHA employees representing 29 VHA medical centers. Members of the multidisciplinary workgroup have diverse backgrounds with HCPs from primary care (eg, physicians, nurse practitioners), rehabilitation (eg, physical therapists), specialty care (eg, pulmonologists, physiatrists), mental health (eg, psychologists), and complementary and integrated health/Whole Health services (eg, practitoners of services such as yoga, tai chi, mindfulness, acupuncture). Members also include clinical, operations, and research leadership at local, regional, and national VHA levels. Our first objective as a large, diverse group was to establish shared goals, which included: (1) determining efficient communication pathways; (2) identifying gaps in care or research; and (3) cocreating knowledge to provide solutions to identified gaps.

Communication Mechanisms

Our first goal was to create an efficient mechanism for cross-facility communication. The initial CoP was formed in April 2021 and the first virtual meeting focused on reaching a consensus regarding the best way to communicate and proceed. We agreed to convene weekly at a consistent time, created a standard agenda template, and elected a lead facilitator of meeting proceedings. In addition, a member of the CoP recorded and took extensive meeting notes, which were later distributed to the entire CoP to accommodate varying schedules and ability to attend live meetings. Approximately 20 to 30 participants attend the meetings in real-time.

To consolidate working documents, information, and resources in one location, we created a platform to communicate via a Microsoft Teams channel. All CoP members are given access to the folders and allowed to add to the growing library of resources. Resources include clinical assessment and note templates for electronic documentation of care, site-specific process maps, relevant literature on screening and interventions identified by practice members, and meeting notes along with the recordings. A chat feature alerts CoP members to questions posed by other members. Any resources or information shared on the chat discussion are curated by CoP leaders to disseminate to all members. Importantly, this platform allowed us to communicate efficiently within the VHA organization by creating a centralized space for documents and the ability to correspond with all or select members of the CoP. Additional VHA employees can easily be referred and request access.

To increase awareness of the CoP, expand reach, and diversify perspectives, every participant was encouraged to invite colleagues and stakeholders with interest or experience in long COVID care to join. While patients are not included in this CoP, we are working closely with the VHA user experience workgroup (many members overlap) that is gathering patient and caregiver perspectives on their COVID-19 experience and long COVID care. Concurrently, CoP members and leadership facilitate communication and set up formal collaborations with other non-VHA health care systems to create an intersystem network of collaboration for long COVID care. This approach further enhances the speed at which we can work together to share lessons learned and stay up-to-date on emerging evidence surrounding long COVID care.

Identifying Gaps in Care and Research

Our second goal was to identify gaps in care or knowledge to inform future research and quality improvement initiatives, while also creating a foundation to cocreate knowledge about safe, effective care management of the novel long COVID sequelae. To translate knowledge, we must first identify and understand the gaps between the current, best available evidence and current care practices or policies impacting that delivery.¹³ As such, the structured meeting agenda and facilitated meeting discussions focused on understanding current clinical decision making and the evidence base. We shared VHA evidence synthesis reports and living rapid reviews on complications following COVID-19 illness (ie, major organ damage and posthospitalization health care use) that provided an objective evidence base on common long COVID complications.^14,15

Since long COVID is a novel condition, we drew from literature in similar patient populations and translated that information in the context of our current knowledge of this unique syndrome. For example, we discussed the predominant and persistent symptom of fatigue post-COVID.⁵ In particular, the CoP discussed challenges in identifying and treating post-COVID fatigue, which is often a vague symptom with multiple or interacting etiologies that require a comprehensive, interdisciplinary approach. As such, we reviewed, adapted, and translated identification and treatment strategies from the literature on chronic fatigue syndrome to patients with post-COVID syndrome.^16,17 We continue to work collaboratively and engage the appropriate stakeholders to provide input on the gaps to prioritize targeting.

Cocreate Knowledge

Our third goal was to cocreate knowledge regarding the care of patients with long COVID. To accomplish this, our structured meetings and communication pathways invited members to share experiences on the who (delivers and receives care), what (type of care or HCPs), when (identification of post-COVID and access), and how (eg, telehealth) of care to patients post-COVID. As part of the workgroup, we identified and shared resources on standardized, facility-level practices to reduce variability across the VHA system. These resources included intake/assessment forms, care processes, and batteries of tests/measures used for screening and assessment. The knowledge obtained from outside the CoP and cocreated within is being used to inform data-driven tools to support and evaluate care for patients with long COVID. As such, members of the workgroup are in the formative stages of participating in quality improvement innovation pilots to test technologies and processes designed to improve and validate long COVID care pathways. These technologies include screening tools, clinical decision support tools, and population health management technologies. In addition, we are developing a formal collaboration with the VHA Office of Research and Development to create standardized intake forms across VHA long COVID clinics to facilitate both clinical monitoring and research.

Surveys

The US Department of Veterans Affairs Central Office collaborated with our workgroup to draft an initial set of survey questions designed to understand how each VHA facility defines, identifies, and provides care to veterans experiencing post-COVID sequalae. The 41-question survey was distributed through regional directors and chief medical officers at 139 VHA facilities in August 2021. One hundred nineteen responses (86%) were received. Sixteen facilities indicated they had established programs and 26 facilities were considering a program. Our CoP had representation from the 16 facilities with established programs indicating the deep and well-connected nature of our grassroots efforts to bring together stakeholders to learn as part of a CoP.

A separate, follow-up survey generated responses from 18 facilities and identified the need to capture evolving innovations and to develop smaller workstreams (eg, best practices, electronic documentation templates, pathway for referrals, veteran engagement, outcome measures). The survey not only exposed ongoing challenges to providing long COVID care, but importantly, outlined the ways in which CoP members were leveraging community knowledge and resources to inform innovations and processes of care changes at their specific sites. Fourteen of 18 facilities with long COVID programs in place explicitly identified the CoP as a resource they have found most beneficial when employing such innovations. Specific innovations reported included changes in care delivery, engagement in active outreach with veterans and local facility, and infrastructure development to sustain local long COVID clinics (Table).

Future Directions

Our CoP strives to contribute to an evidence base for long COVID care. At the system level, the CoP has the potential to impact access and continuity of care by identifying appropriate processes and ensuring that VHA patients receive outreach and an opportunity for post-COVID care. Comprehensive care requires input from HCP, clinical leadership, and operations levels. In this sense, our CoP provides an opportunity for diverse stakeholders to come together, discuss barriers to screening and delivering post-COVID care, and create an action plan to remove or lessen such barriers.¹⁸ Part of the process to remove barriers is to identify and support efficient resource allocation. Our CoP has worked to address issues in resource allocation (eg, space, personnel) for post-COVID care. For example, one facility is currently implementing interdisciplinary virtual post-COVID care. Another facility identified and restructured working assignments for psychologists who served in different capacities throughout the system to fill the need within the long COVID team.

At the HCP level, the CoP is currently developing workshops, media campaigns, written clinical resources, skills training, publications, and webinars/seminars with continuing medical education credits.¹⁹ The CoP may also provide learning and growth opportunities, such as clinical or VHA operational fellowships and research grants.

We are still in the formative stages of post-COVID care and future efforts will explore patient-centered outcomes. We are drawing on the Centers for Disease Control and Prevention’s guidance for evaluating patients with long COVID symptoms and examining the feasibility within VHA, as well as patient perspectives on post-COVID sequalae, to ensure we are selecting assessments that measure patient-centered constructs.¹⁸

Conclusions

A VHA-wide LHS approach is identifying issues related to the identification, delivery, and evaluation of long COVID care. This long COVID CoP has developed an infrastructure for communication, identified gaps in care, and cocreated knowledge related to best current practices for post-COVID care. This work is contributing to systemwide LHS efforts dedicated to creating a culture of quality care and innovation and is a process that is transferrable to other areas of care in the VHA, as well as other health care systems. The LHS approach continues to be highly relevant as we persist through the COVID-19 pandemic and reimagine a postpandemic world.

Acknowledgments

We thank all the members of the Veterans Health Administration long COVID Community of Practice who participate in the meetings and contribute to the sharing and spread of knowledge.

Tobacco smoking remains the leading cause of preventable disease and death in the United States, accounting for more than 480,000 deaths annually.¹ An estimated 50.6 million US adults (20.8%) identify as tobacco users, with even higher rates among veterans (29.2%).^2,3 Tobacco use is estimated to cost the US more than $300 billion annually in direct and indirect medical costs.⁴ According to a 2015 report, more than two-thirds of adult smokers reported a desire to quit, while only 7.5% reported successfully quitting in the past year.⁵ According to that same report, only 57.2% of smokers who had seen a health professional in the past year reported receiving advice to quit.⁵ This statistic is unfortunate, as interventions that combine behavioral and pharmacologic support can drastically increase tobacco cessation rates compared with self-help materials or no treatment.⁶

Currently, 7 first-line medications (5 nicotine, 2 nonnicotine) have been shown to increase long-term smoking abstinence rates. Varenicline was approved by the US Food and Drug Administration (FDA) in 2006 for use in adults as an aid to smoking cessation treatment. As a partial agonist of the α4β2 nicotinic acetylcholine receptor, varenicline’s mechanism of action is believed to involve reduction of nicotine’s rewarding capacity.⁷ Varenicline not only aids in complete tobacco cessation but also has been found to be effective for reducing cigarette consumption among smokers not yet willing or able to make a quit attempt.⁸ Furthermore, varenicline has demonstrated efficacy among users of smokeless tobacco in achieving continuous abstinence.⁹

Widespread adoption of varenicline into clinical practice was perhaps slowed by early concerns of psychiatric complications, prompting the FDA to issue a boxed warning for risk of serious neuropsychiatric events. This boxed warning was removed in 2016 in response to publication of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES). In this randomized controlled trial of more than 8000 participants, among whom 50.5% had a psychiatric disorder determined to be stable, varenicline significantly increased rates of continuous tobacco cessation compared with bupropion or the nicotine patch without an increased risk of neuropsychiatric events.¹⁰ This study underscored not only the safety of varenicline, but also its superiority over other first-line cessation products. The most recently published clinical practice guidelines recommend varenicline as a first-line agent for helping patients achieve long-term smoking cessation.^11,12

Pharmacists are uniquely positioned to provide tobacco cessation interventions given their medication expertise and accessibility to the public. Indeed, multiple studies have demonstrated the effectiveness of pharmacist-led interventions on tobacco cessation.^13-15 As of 2019, only 12 states had statutes or regulations addressing pharmacist prescribing of tobacco cessation aids without a collaborative practice agreement or local standing order.¹⁶ Until recently, most of these states limited pharmacists’ prescriptive authority to nicotine replacement therapy (NRT). New Mexico serves as the outlier, as pharmacists have been authorized to prescribe all FDA-approved tobacco cessation products since 2004. A 2014 New Mexico study consisting of > 1400 patients showed that pharmacist-provided tobacco cessation interventions, which included management of varenicline, resulted in quit rates similar to those seen with management by other health care professionals.¹⁷ Aside from this study, there is a paucity of data available to assess the impact of pharmacist management of varenicline, let alone provide a head-to-head comparison with management by other clinicians.

Within the US Department of Veterans Affairs (VA), the clinical pharmacy specialist (CPS) is credentialed as an advanced practitioner with authority to independently manage patient medication therapy for a variety of diseases specified under a scope of practice. Although CPSs have provided tobacco cessation services for years, expansion of their scope to include varenicline did not occur until June 26, 2019, at the Southern Arizona VA Health Care System (SAVAHCS). All VA prescribers must follow the same criteria for prescribing varenicline. Unless previously trialed on varenicline, patients must have failed an appropriate trial of first-line agents (NRT, bupropion, or combination therapy) or have a contraindication to use of these first-line therapies before varenicline can be considered. Exclusions to therapy would include history of serious hypersensitivity to varenicline; suicidal intent, plan, or attempt within the past 12 months; current substance use disorder other than nicotine (unless varenicline recommended or prescribed by mental health professional); or unstable mental health disorder.¹⁸

The purpose of this study was to evaluate the efficacy and safety of CPS management of varenicline compared with other clinicians. We hope that this study provides insight regarding how the expansion of CPS scope to include prescriptive authority for varenicline has affected patient outcomes.

Methods

This retrospective chart review was conducted using SAVAHCS electronic health records. This study was granted approval by the institutional review board and the research and development committee at SAVAHCS. Data were obtained through the Computerized Patient Record System from the information provided by the pharmacist informatics department and was recorded electronically on a secure Microsoft Excel spreadsheet.

To be eligible for this study, patients must have been aged ≥ 18 years with a varenicline prescription between July 1, 2019, and July 31, 2020. Patients were excluded if tobacco cessation was managed by community-based (non-VA) clincians or if there was a lack of documentation of tobacco use at baseline and after at least 12 weeks of varenicline therapy. Sample size was not designed to achieve statistical power. Potential patients were queried by a pharmacist specializing in clinical informatics. All patients meeting initial inclusion criteria were then screened individually to evaluate for exclusion criteria.

Data collected included baseline age, sex, race, type of tobacco use (cigarettes, smokeless, both), mean daily tobacco use, prespecified comorbidities (depression, anxiety, or other psychiatric condition), and previous cessation medications prescribed (NRT, bupropion, and previous trials of varenicline).

The primary outcomes were reduction in tobacco use calculated as change at 12 weeks from baseline (and 24 weeks if available), continuous abstinence at 12 weeks (and 24 weeks if available), adherence to varenicline therapy measured by proportion of days covered (days covered by refills during the measurement period divided by days between the first fill and the end of the measurement period), and time to first follow-up in days. For safety evaluation, charts were reviewed for documented adverse events (AEs) in the health record. These AEs were categorized as follows: gastrointestinal, mood disturbance, sleep disturbance, headache, seizures, allergy, or other.

Statistical analyses regarding veteran baseline characteristics were descriptive in nature. χ² test was used to analyze differences in complete cessation rates and AEs, whereas a Student t test was used to compare reductions of tobacco use, proportion of days covered (ie, adherence), and time to first follow-up. An α of .05 was used to determine significance.

Results

From the initial search, 255 charts met general inclusion criteria. After chart review, only 50 patients from the CPS group and 93 patients from the other clinician group met criteria to be included (Figure 1). The CPS group included pharmacists specializing in ambulatory care and outpatient mental health. The other clinician group was composed primarily of primary care practitioners, psychiatrists, and pulmonologists.

Overall, baseline characteristics were similar between the groups (Table 1). In the overall study population, the mean age was 57.5 years, 90% of patients were male, and 99% of patients were cigarette smokers. Baseline mean (SD) tobacco use was similar between the groups: 14.5 (10.8) vs 14.8 (8.6) cigarettes daily for the CPS and other clinician group, respectively.

Discussion

The results of this single center study suggest that management of varenicline by CPSs is associated with similar reductions in tobacco use and abstinence rates compared with management by other clinicians. These results provide evidence that CPS management of varenicline may be as safe and effective as management by other clinicians.

Adherence rates (reported as proportion of days covered when assessing varenicline refill data) were higher on average among patients managed by a CPS compared with patients managed by other clinicians. However, this outcome may not be as reflective of adherence as initially intended, given delays in follow-up (see limitations section). Time to first follow-up was drastically different between the groups, with much sooner follow-up by CPSs compared with other clinicians. Despite similar tobacco cessation rates between groups, more frequent follow-up by CPSs helps to assess patient barriers to cessation, adherence to therapy, and AEs with varenicline. A higher percentage of AEs were documented within the CPS group that could be attributed to disparities in documentation rather than true rates of AEs. While rates of AEs were initially intended to serve as the primary safety outcome, they may instead reflect pharmacists’ diligence in monitoring and documenting tolerability of medication therapy.

Limitations

Several limitations to this study should be noted. First, the data collected were only as detailed as the extent to which prescribers documented tobacco use, previous cessation trials, and AEs; thus, various data points are likely missing within this study that could impact the results presented. In line with lack of documentation, delays in follow-up (ie, annual primary care visits) sorely undermined proportion of days covered, making these data less indicative of true medication adherence. Furthermore, this study did not account for concurrent therapies, such as combination varenicline and nicotine gum/lozenges, or behavioral treatment strategies like cessation classes.

Another limitation was that some primary care practitioners prescribed varenicline but then referred these patients to a CPS for tobacco cessation follow-up. Per the study’s protocol, these patients were included within the other clinician group, which could have brought results closer to the null. Finally, the timing of this chart review (July 1, 2019, to July 31, 2020) intersects with the start of the COVID-19 pandemic, presenting a possible confounding factor if patients’ quit attempts were hindered by the stress and isolation of the pandemic.¹⁹ All pharmacist visits during the pandemic were conducted by telephone, which may have affected results.

Conclusions

In this study of veterans receiving varenicline, management by CPSs resulted in similar reductions of tobacco use and rates of complete abstinence compared with management by other clinicians. Pharmacist management was associated with greater adherence and shorter time to first follow-up compared with other clinicians. Additional research is needed to fully characterize the impact of pharmacist management of varenicline, justify expansion of clinical pharmacist scope of practice, and ultimately enhance patient outcomes regarding tobacco cessation.

It would be interesting to see more studies outside of the VA system to determine the impact of pharmacist management of varenicline for a more heterogenous patient population. At some point, a prospective controlled trial should be conducted to overcome the various confounding factors that limit the results of retrospective chart reviews

Acknowledgments

This article was prepared, and research was conducted with resources and the use of facilities at the Southern Arizona Veterans Affairs Health Care System in Tucson.

Tobacco smoking remains the leading cause of preventable disease and death in the United States, accounting for more than 480,000 deaths annually.¹ An estimated 50.6 million US adults (20.8%) identify as tobacco users, with even higher rates among veterans (29.2%).^2,3 Tobacco use is estimated to cost the US more than $300 billion annually in direct and indirect medical costs.⁴ According to a 2015 report, more than two-thirds of adult smokers reported a desire to quit, while only 7.5% reported successfully quitting in the past year.⁵ According to that same report, only 57.2% of smokers who had seen a health professional in the past year reported receiving advice to quit.⁵ This statistic is unfortunate, as interventions that combine behavioral and pharmacologic support can drastically increase tobacco cessation rates compared with self-help materials or no treatment.⁶

Currently, 7 first-line medications (5 nicotine, 2 nonnicotine) have been shown to increase long-term smoking abstinence rates. Varenicline was approved by the US Food and Drug Administration (FDA) in 2006 for use in adults as an aid to smoking cessation treatment. As a partial agonist of the α4β2 nicotinic acetylcholine receptor, varenicline’s mechanism of action is believed to involve reduction of nicotine’s rewarding capacity.⁷ Varenicline not only aids in complete tobacco cessation but also has been found to be effective for reducing cigarette consumption among smokers not yet willing or able to make a quit attempt.⁸ Furthermore, varenicline has demonstrated efficacy among users of smokeless tobacco in achieving continuous abstinence.⁹

Widespread adoption of varenicline into clinical practice was perhaps slowed by early concerns of psychiatric complications, prompting the FDA to issue a boxed warning for risk of serious neuropsychiatric events. This boxed warning was removed in 2016 in response to publication of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES). In this randomized controlled trial of more than 8000 participants, among whom 50.5% had a psychiatric disorder determined to be stable, varenicline significantly increased rates of continuous tobacco cessation compared with bupropion or the nicotine patch without an increased risk of neuropsychiatric events.¹⁰ This study underscored not only the safety of varenicline, but also its superiority over other first-line cessation products. The most recently published clinical practice guidelines recommend varenicline as a first-line agent for helping patients achieve long-term smoking cessation.^11,12

Pharmacists are uniquely positioned to provide tobacco cessation interventions given their medication expertise and accessibility to the public. Indeed, multiple studies have demonstrated the effectiveness of pharmacist-led interventions on tobacco cessation.^13-15 As of 2019, only 12 states had statutes or regulations addressing pharmacist prescribing of tobacco cessation aids without a collaborative practice agreement or local standing order.¹⁶ Until recently, most of these states limited pharmacists’ prescriptive authority to nicotine replacement therapy (NRT). New Mexico serves as the outlier, as pharmacists have been authorized to prescribe all FDA-approved tobacco cessation products since 2004. A 2014 New Mexico study consisting of > 1400 patients showed that pharmacist-provided tobacco cessation interventions, which included management of varenicline, resulted in quit rates similar to those seen with management by other health care professionals.¹⁷ Aside from this study, there is a paucity of data available to assess the impact of pharmacist management of varenicline, let alone provide a head-to-head comparison with management by other clinicians.

Within the US Department of Veterans Affairs (VA), the clinical pharmacy specialist (CPS) is credentialed as an advanced practitioner with authority to independently manage patient medication therapy for a variety of diseases specified under a scope of practice. Although CPSs have provided tobacco cessation services for years, expansion of their scope to include varenicline did not occur until June 26, 2019, at the Southern Arizona VA Health Care System (SAVAHCS). All VA prescribers must follow the same criteria for prescribing varenicline. Unless previously trialed on varenicline, patients must have failed an appropriate trial of first-line agents (NRT, bupropion, or combination therapy) or have a contraindication to use of these first-line therapies before varenicline can be considered. Exclusions to therapy would include history of serious hypersensitivity to varenicline; suicidal intent, plan, or attempt within the past 12 months; current substance use disorder other than nicotine (unless varenicline recommended or prescribed by mental health professional); or unstable mental health disorder.¹⁸

The purpose of this study was to evaluate the efficacy and safety of CPS management of varenicline compared with other clinicians. We hope that this study provides insight regarding how the expansion of CPS scope to include prescriptive authority for varenicline has affected patient outcomes.

Methods

This retrospective chart review was conducted using SAVAHCS electronic health records. This study was granted approval by the institutional review board and the research and development committee at SAVAHCS. Data were obtained through the Computerized Patient Record System from the information provided by the pharmacist informatics department and was recorded electronically on a secure Microsoft Excel spreadsheet.

To be eligible for this study, patients must have been aged ≥ 18 years with a varenicline prescription between July 1, 2019, and July 31, 2020. Patients were excluded if tobacco cessation was managed by community-based (non-VA) clincians or if there was a lack of documentation of tobacco use at baseline and after at least 12 weeks of varenicline therapy. Sample size was not designed to achieve statistical power. Potential patients were queried by a pharmacist specializing in clinical informatics. All patients meeting initial inclusion criteria were then screened individually to evaluate for exclusion criteria.

Data collected included baseline age, sex, race, type of tobacco use (cigarettes, smokeless, both), mean daily tobacco use, prespecified comorbidities (depression, anxiety, or other psychiatric condition), and previous cessation medications prescribed (NRT, bupropion, and previous trials of varenicline).

The primary outcomes were reduction in tobacco use calculated as change at 12 weeks from baseline (and 24 weeks if available), continuous abstinence at 12 weeks (and 24 weeks if available), adherence to varenicline therapy measured by proportion of days covered (days covered by refills during the measurement period divided by days between the first fill and the end of the measurement period), and time to first follow-up in days. For safety evaluation, charts were reviewed for documented adverse events (AEs) in the health record. These AEs were categorized as follows: gastrointestinal, mood disturbance, sleep disturbance, headache, seizures, allergy, or other.

Statistical analyses regarding veteran baseline characteristics were descriptive in nature. χ² test was used to analyze differences in complete cessation rates and AEs, whereas a Student t test was used to compare reductions of tobacco use, proportion of days covered (ie, adherence), and time to first follow-up. An α of .05 was used to determine significance.

Results

From the initial search, 255 charts met general inclusion criteria. After chart review, only 50 patients from the CPS group and 93 patients from the other clinician group met criteria to be included (Figure 1). The CPS group included pharmacists specializing in ambulatory care and outpatient mental health. The other clinician group was composed primarily of primary care practitioners, psychiatrists, and pulmonologists.

Overall, baseline characteristics were similar between the groups (Table 1). In the overall study population, the mean age was 57.5 years, 90% of patients were male, and 99% of patients were cigarette smokers. Baseline mean (SD) tobacco use was similar between the groups: 14.5 (10.8) vs 14.8 (8.6) cigarettes daily for the CPS and other clinician group, respectively.

Discussion

The results of this single center study suggest that management of varenicline by CPSs is associated with similar reductions in tobacco use and abstinence rates compared with management by other clinicians. These results provide evidence that CPS management of varenicline may be as safe and effective as management by other clinicians.

Adherence rates (reported as proportion of days covered when assessing varenicline refill data) were higher on average among patients managed by a CPS compared with patients managed by other clinicians. However, this outcome may not be as reflective of adherence as initially intended, given delays in follow-up (see limitations section). Time to first follow-up was drastically different between the groups, with much sooner follow-up by CPSs compared with other clinicians. Despite similar tobacco cessation rates between groups, more frequent follow-up by CPSs helps to assess patient barriers to cessation, adherence to therapy, and AEs with varenicline. A higher percentage of AEs were documented within the CPS group that could be attributed to disparities in documentation rather than true rates of AEs. While rates of AEs were initially intended to serve as the primary safety outcome, they may instead reflect pharmacists’ diligence in monitoring and documenting tolerability of medication therapy.

Limitations

Several limitations to this study should be noted. First, the data collected were only as detailed as the extent to which prescribers documented tobacco use, previous cessation trials, and AEs; thus, various data points are likely missing within this study that could impact the results presented. In line with lack of documentation, delays in follow-up (ie, annual primary care visits) sorely undermined proportion of days covered, making these data less indicative of true medication adherence. Furthermore, this study did not account for concurrent therapies, such as combination varenicline and nicotine gum/lozenges, or behavioral treatment strategies like cessation classes.

Another limitation was that some primary care practitioners prescribed varenicline but then referred these patients to a CPS for tobacco cessation follow-up. Per the study’s protocol, these patients were included within the other clinician group, which could have brought results closer to the null. Finally, the timing of this chart review (July 1, 2019, to July 31, 2020) intersects with the start of the COVID-19 pandemic, presenting a possible confounding factor if patients’ quit attempts were hindered by the stress and isolation of the pandemic.¹⁹ All pharmacist visits during the pandemic were conducted by telephone, which may have affected results.

Conclusions

In this study of veterans receiving varenicline, management by CPSs resulted in similar reductions of tobacco use and rates of complete abstinence compared with management by other clinicians. Pharmacist management was associated with greater adherence and shorter time to first follow-up compared with other clinicians. Additional research is needed to fully characterize the impact of pharmacist management of varenicline, justify expansion of clinical pharmacist scope of practice, and ultimately enhance patient outcomes regarding tobacco cessation.

It would be interesting to see more studies outside of the VA system to determine the impact of pharmacist management of varenicline for a more heterogenous patient population. At some point, a prospective controlled trial should be conducted to overcome the various confounding factors that limit the results of retrospective chart reviews

Acknowledgments

This article was prepared, and research was conducted with resources and the use of facilities at the Southern Arizona Veterans Affairs Health Care System in Tucson.

Tobacco smoking remains the leading cause of preventable disease and death in the United States, accounting for more than 480,000 deaths annually.¹ An estimated 50.6 million US adults (20.8%) identify as tobacco users, with even higher rates among veterans (29.2%).^2,3 Tobacco use is estimated to cost the US more than $300 billion annually in direct and indirect medical costs.⁴ According to a 2015 report, more than two-thirds of adult smokers reported a desire to quit, while only 7.5% reported successfully quitting in the past year.⁵ According to that same report, only 57.2% of smokers who had seen a health professional in the past year reported receiving advice to quit.⁵ This statistic is unfortunate, as interventions that combine behavioral and pharmacologic support can drastically increase tobacco cessation rates compared with self-help materials or no treatment.⁶

Currently, 7 first-line medications (5 nicotine, 2 nonnicotine) have been shown to increase long-term smoking abstinence rates. Varenicline was approved by the US Food and Drug Administration (FDA) in 2006 for use in adults as an aid to smoking cessation treatment. As a partial agonist of the α4β2 nicotinic acetylcholine receptor, varenicline’s mechanism of action is believed to involve reduction of nicotine’s rewarding capacity.⁷ Varenicline not only aids in complete tobacco cessation but also has been found to be effective for reducing cigarette consumption among smokers not yet willing or able to make a quit attempt.⁸ Furthermore, varenicline has demonstrated efficacy among users of smokeless tobacco in achieving continuous abstinence.⁹

Widespread adoption of varenicline into clinical practice was perhaps slowed by early concerns of psychiatric complications, prompting the FDA to issue a boxed warning for risk of serious neuropsychiatric events. This boxed warning was removed in 2016 in response to publication of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES). In this randomized controlled trial of more than 8000 participants, among whom 50.5% had a psychiatric disorder determined to be stable, varenicline significantly increased rates of continuous tobacco cessation compared with bupropion or the nicotine patch without an increased risk of neuropsychiatric events.¹⁰ This study underscored not only the safety of varenicline, but also its superiority over other first-line cessation products. The most recently published clinical practice guidelines recommend varenicline as a first-line agent for helping patients achieve long-term smoking cessation.^11,12

Pharmacists are uniquely positioned to provide tobacco cessation interventions given their medication expertise and accessibility to the public. Indeed, multiple studies have demonstrated the effectiveness of pharmacist-led interventions on tobacco cessation.^13-15 As of 2019, only 12 states had statutes or regulations addressing pharmacist prescribing of tobacco cessation aids without a collaborative practice agreement or local standing order.¹⁶ Until recently, most of these states limited pharmacists’ prescriptive authority to nicotine replacement therapy (NRT). New Mexico serves as the outlier, as pharmacists have been authorized to prescribe all FDA-approved tobacco cessation products since 2004. A 2014 New Mexico study consisting of > 1400 patients showed that pharmacist-provided tobacco cessation interventions, which included management of varenicline, resulted in quit rates similar to those seen with management by other health care professionals.¹⁷ Aside from this study, there is a paucity of data available to assess the impact of pharmacist management of varenicline, let alone provide a head-to-head comparison with management by other clinicians.

Within the US Department of Veterans Affairs (VA), the clinical pharmacy specialist (CPS) is credentialed as an advanced practitioner with authority to independently manage patient medication therapy for a variety of diseases specified under a scope of practice. Although CPSs have provided tobacco cessation services for years, expansion of their scope to include varenicline did not occur until June 26, 2019, at the Southern Arizona VA Health Care System (SAVAHCS). All VA prescribers must follow the same criteria for prescribing varenicline. Unless previously trialed on varenicline, patients must have failed an appropriate trial of first-line agents (NRT, bupropion, or combination therapy) or have a contraindication to use of these first-line therapies before varenicline can be considered. Exclusions to therapy would include history of serious hypersensitivity to varenicline; suicidal intent, plan, or attempt within the past 12 months; current substance use disorder other than nicotine (unless varenicline recommended or prescribed by mental health professional); or unstable mental health disorder.¹⁸

The purpose of this study was to evaluate the efficacy and safety of CPS management of varenicline compared with other clinicians. We hope that this study provides insight regarding how the expansion of CPS scope to include prescriptive authority for varenicline has affected patient outcomes.

Methods

This retrospective chart review was conducted using SAVAHCS electronic health records. This study was granted approval by the institutional review board and the research and development committee at SAVAHCS. Data were obtained through the Computerized Patient Record System from the information provided by the pharmacist informatics department and was recorded electronically on a secure Microsoft Excel spreadsheet.

To be eligible for this study, patients must have been aged ≥ 18 years with a varenicline prescription between July 1, 2019, and July 31, 2020. Patients were excluded if tobacco cessation was managed by community-based (non-VA) clincians or if there was a lack of documentation of tobacco use at baseline and after at least 12 weeks of varenicline therapy. Sample size was not designed to achieve statistical power. Potential patients were queried by a pharmacist specializing in clinical informatics. All patients meeting initial inclusion criteria were then screened individually to evaluate for exclusion criteria.

Data collected included baseline age, sex, race, type of tobacco use (cigarettes, smokeless, both), mean daily tobacco use, prespecified comorbidities (depression, anxiety, or other psychiatric condition), and previous cessation medications prescribed (NRT, bupropion, and previous trials of varenicline).

The primary outcomes were reduction in tobacco use calculated as change at 12 weeks from baseline (and 24 weeks if available), continuous abstinence at 12 weeks (and 24 weeks if available), adherence to varenicline therapy measured by proportion of days covered (days covered by refills during the measurement period divided by days between the first fill and the end of the measurement period), and time to first follow-up in days. For safety evaluation, charts were reviewed for documented adverse events (AEs) in the health record. These AEs were categorized as follows: gastrointestinal, mood disturbance, sleep disturbance, headache, seizures, allergy, or other.

Statistical analyses regarding veteran baseline characteristics were descriptive in nature. χ² test was used to analyze differences in complete cessation rates and AEs, whereas a Student t test was used to compare reductions of tobacco use, proportion of days covered (ie, adherence), and time to first follow-up. An α of .05 was used to determine significance.

Results

From the initial search, 255 charts met general inclusion criteria. After chart review, only 50 patients from the CPS group and 93 patients from the other clinician group met criteria to be included (Figure 1). The CPS group included pharmacists specializing in ambulatory care and outpatient mental health. The other clinician group was composed primarily of primary care practitioners, psychiatrists, and pulmonologists.

Overall, baseline characteristics were similar between the groups (Table 1). In the overall study population, the mean age was 57.5 years, 90% of patients were male, and 99% of patients were cigarette smokers. Baseline mean (SD) tobacco use was similar between the groups: 14.5 (10.8) vs 14.8 (8.6) cigarettes daily for the CPS and other clinician group, respectively.

Discussion

The results of this single center study suggest that management of varenicline by CPSs is associated with similar reductions in tobacco use and abstinence rates compared with management by other clinicians. These results provide evidence that CPS management of varenicline may be as safe and effective as management by other clinicians.

Adherence rates (reported as proportion of days covered when assessing varenicline refill data) were higher on average among patients managed by a CPS compared with patients managed by other clinicians. However, this outcome may not be as reflective of adherence as initially intended, given delays in follow-up (see limitations section). Time to first follow-up was drastically different between the groups, with much sooner follow-up by CPSs compared with other clinicians. Despite similar tobacco cessation rates between groups, more frequent follow-up by CPSs helps to assess patient barriers to cessation, adherence to therapy, and AEs with varenicline. A higher percentage of AEs were documented within the CPS group that could be attributed to disparities in documentation rather than true rates of AEs. While rates of AEs were initially intended to serve as the primary safety outcome, they may instead reflect pharmacists’ diligence in monitoring and documenting tolerability of medication therapy.

Limitations

Several limitations to this study should be noted. First, the data collected were only as detailed as the extent to which prescribers documented tobacco use, previous cessation trials, and AEs; thus, various data points are likely missing within this study that could impact the results presented. In line with lack of documentation, delays in follow-up (ie, annual primary care visits) sorely undermined proportion of days covered, making these data less indicative of true medication adherence. Furthermore, this study did not account for concurrent therapies, such as combination varenicline and nicotine gum/lozenges, or behavioral treatment strategies like cessation classes.

Another limitation was that some primary care practitioners prescribed varenicline but then referred these patients to a CPS for tobacco cessation follow-up. Per the study’s protocol, these patients were included within the other clinician group, which could have brought results closer to the null. Finally, the timing of this chart review (July 1, 2019, to July 31, 2020) intersects with the start of the COVID-19 pandemic, presenting a possible confounding factor if patients’ quit attempts were hindered by the stress and isolation of the pandemic.¹⁹ All pharmacist visits during the pandemic were conducted by telephone, which may have affected results.

Conclusions

In this study of veterans receiving varenicline, management by CPSs resulted in similar reductions of tobacco use and rates of complete abstinence compared with management by other clinicians. Pharmacist management was associated with greater adherence and shorter time to first follow-up compared with other clinicians. Additional research is needed to fully characterize the impact of pharmacist management of varenicline, justify expansion of clinical pharmacist scope of practice, and ultimately enhance patient outcomes regarding tobacco cessation.

It would be interesting to see more studies outside of the VA system to determine the impact of pharmacist management of varenicline for a more heterogenous patient population. At some point, a prospective controlled trial should be conducted to overcome the various confounding factors that limit the results of retrospective chart reviews

Acknowledgments

This article was prepared, and research was conducted with resources and the use of facilities at the Southern Arizona Veterans Affairs Health Care System in Tucson.