Federal Practitioner

This transcript has been edited for clarity. 

Aspirin. Once upon a time, everybody over age 50 years was supposed to take a baby aspirin. Now we make it a point to tell people to stop. What is going on?  

Our recommendations vis-à-vis aspirin have evolved at a dizzying pace. The young’uns watching us right now don’t know what things were like in the 1980s. The Reagan era was a wild, heady time where nuclear war was imminent and we didn’t prescribe aspirin to patients. 

That only started in 1988, which was a banner year in human history. Not because a number of doves were incinerated by the lighting of the Olympic torch at the Seoul Olympics — look it up if you don’t know what I’m talking about — but because 1988 saw the publication of the ISIS-2 trial, which first showed a mortality benefit to prescribing aspirin post–myocardial infarction (MI).

Giving patients aspirin during or after a heart attack is not controversial. It’s one of the few things in this business that isn’t, but that’s secondary prevention — treating somebody after they develop a disease. Primary prevention, treating them before they have their incident event, is a very different ballgame. Here, things are messy. 

For one thing, the doses used have been very inconsistent. We should point out that the reason for 81 mg of aspirin is very arbitrary and is rooted in the old apothecary system of weights and measurements. A standard dose of aspirin was 5 grains, where 20 grains made 1 scruple, 3 scruples made 1 dram, 8 drams made 1 oz, and 12 oz made 1 lb - because screw you, metric system. Therefore, 5 grains was 325 mg of aspirin, and 1 quarter of the standard dose became 81 mg if you rounded out the decimal. 

People have tried all kinds of dosing structures with aspirin prophylaxis. The Physicians’ Health Study used a full-dose aspirin, 325 mg every 2 days, while the Hypertension Optimal Treatment (HOT) trial tested 75 mg daily and the Women’s Health Study tested 100 mg, but every other day. 

Ironically, almost no one has studied 81 mg every day, which is weird if you think about it. The bigger problem here is not the variability of doses used, but the discrepancy when you look at older vs newer studies.

Older studies, like the Physicians’ Health Study, did show a benefit, at least in the subgroup of patients over age 50 years, which is probably where the “everybody over 50 should be taking an aspirin” idea comes from, at least as near as I can tell. 

More recent studies, like the Women’s Health Study, ASPREE, or ASPIRE, didn’t show a benefit. I know what you’re thinking: Newer stuff is always better. That’s why you should never trust anybody over age 40 years. The context of primary prevention studies has changed. In the ‘80s and ‘90s, people smoked more and we didn’t have the same medications that we have today. We talked about all this in the beta-blocker video to explain why beta-blockers don’t seem to have a benefit post MI.

We have a similar issue here. The magnitude of the benefit with aspirin primary prevention has decreased because we’re all just healthier overall. So, yay! Progress! Here’s where the numbers matter. No one is saying that aspirin doesn’t help. It does. 

If we look at the 2019 meta-analysis published in JAMA, there is a cardiovascular benefit. The numbers bear that out. I know you’re all here for the math, so here we go. Aspirin reduced the composite cardiovascular endpoint from 65.2 to 60.2 events per 10,000 patient-years; or to put it more meaningfully in absolute risk reduction terms, because that’s my jam, an absolute risk reduction of 0.41%, which means a number needed to treat of 241, which is okay-ish. It’s not super-great, but it may be justifiable for something that costs next to nothing. 

The tradeoff is bleeding. Major bleeding increased from 16.4 to 23.1 bleeds per 10,000 patient-years, or an absolute risk increase of 0.47%, which is a number needed to harm of 210. That’s the problem. Aspirin does prevent heart disease. The benefit is small, for sure, but the real problem is that it’s outweighed by the risk of bleeding, so you’re not really coming out ahead. 

The real tragedy here is that the public is locked into this idea of everyone over age 50 years should be taking an aspirin. Even today, even though guidelines have recommended against aspirin for primary prevention for some time, data from the National Health Interview Survey sample found that nearly one in three older adults take aspirin for primary prevention when they shouldn’t be. That’s a large number of people. That’s millions of Americans — and Canadians, but nobody cares about us. It’s fine. 

That’s the point. We’re not debunking aspirin. It does work. The benefits are just really small in a primary prevention population and offset by the admittedly also really small risks of bleeding. It’s a tradeoff that doesn’t really work in your favor.

But that’s aspirin for cardiovascular disease. When it comes to cancer or DVT prophylaxis, that’s another really interesting story. We might have to save that for another time. Do I know how to tease a sequel or what?

Labos, a cardiologist at Kirkland Medical Center, Montreal, Quebec, Canada, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Aspirin. Once upon a time, everybody over age 50 years was supposed to take a baby aspirin. Now we make it a point to tell people to stop. What is going on?  

Our recommendations vis-à-vis aspirin have evolved at a dizzying pace. The young’uns watching us right now don’t know what things were like in the 1980s. The Reagan era was a wild, heady time where nuclear war was imminent and we didn’t prescribe aspirin to patients. 

That only started in 1988, which was a banner year in human history. Not because a number of doves were incinerated by the lighting of the Olympic torch at the Seoul Olympics — look it up if you don’t know what I’m talking about — but because 1988 saw the publication of the ISIS-2 trial, which first showed a mortality benefit to prescribing aspirin post–myocardial infarction (MI).

Giving patients aspirin during or after a heart attack is not controversial. It’s one of the few things in this business that isn’t, but that’s secondary prevention — treating somebody after they develop a disease. Primary prevention, treating them before they have their incident event, is a very different ballgame. Here, things are messy. 

For one thing, the doses used have been very inconsistent. We should point out that the reason for 81 mg of aspirin is very arbitrary and is rooted in the old apothecary system of weights and measurements. A standard dose of aspirin was 5 grains, where 20 grains made 1 scruple, 3 scruples made 1 dram, 8 drams made 1 oz, and 12 oz made 1 lb - because screw you, metric system. Therefore, 5 grains was 325 mg of aspirin, and 1 quarter of the standard dose became 81 mg if you rounded out the decimal. 

People have tried all kinds of dosing structures with aspirin prophylaxis. The Physicians’ Health Study used a full-dose aspirin, 325 mg every 2 days, while the Hypertension Optimal Treatment (HOT) trial tested 75 mg daily and the Women’s Health Study tested 100 mg, but every other day. 

Ironically, almost no one has studied 81 mg every day, which is weird if you think about it. The bigger problem here is not the variability of doses used, but the discrepancy when you look at older vs newer studies.

Older studies, like the Physicians’ Health Study, did show a benefit, at least in the subgroup of patients over age 50 years, which is probably where the “everybody over 50 should be taking an aspirin” idea comes from, at least as near as I can tell. 

More recent studies, like the Women’s Health Study, ASPREE, or ASPIRE, didn’t show a benefit. I know what you’re thinking: Newer stuff is always better. That’s why you should never trust anybody over age 40 years. The context of primary prevention studies has changed. In the ‘80s and ‘90s, people smoked more and we didn’t have the same medications that we have today. We talked about all this in the beta-blocker video to explain why beta-blockers don’t seem to have a benefit post MI.

We have a similar issue here. The magnitude of the benefit with aspirin primary prevention has decreased because we’re all just healthier overall. So, yay! Progress! Here’s where the numbers matter. No one is saying that aspirin doesn’t help. It does. 

If we look at the 2019 meta-analysis published in JAMA, there is a cardiovascular benefit. The numbers bear that out. I know you’re all here for the math, so here we go. Aspirin reduced the composite cardiovascular endpoint from 65.2 to 60.2 events per 10,000 patient-years; or to put it more meaningfully in absolute risk reduction terms, because that’s my jam, an absolute risk reduction of 0.41%, which means a number needed to treat of 241, which is okay-ish. It’s not super-great, but it may be justifiable for something that costs next to nothing. 

The tradeoff is bleeding. Major bleeding increased from 16.4 to 23.1 bleeds per 10,000 patient-years, or an absolute risk increase of 0.47%, which is a number needed to harm of 210. That’s the problem. Aspirin does prevent heart disease. The benefit is small, for sure, but the real problem is that it’s outweighed by the risk of bleeding, so you’re not really coming out ahead. 

The real tragedy here is that the public is locked into this idea of everyone over age 50 years should be taking an aspirin. Even today, even though guidelines have recommended against aspirin for primary prevention for some time, data from the National Health Interview Survey sample found that nearly one in three older adults take aspirin for primary prevention when they shouldn’t be. That’s a large number of people. That’s millions of Americans — and Canadians, but nobody cares about us. It’s fine. 

That’s the point. We’re not debunking aspirin. It does work. The benefits are just really small in a primary prevention population and offset by the admittedly also really small risks of bleeding. It’s a tradeoff that doesn’t really work in your favor.

But that’s aspirin for cardiovascular disease. When it comes to cancer or DVT prophylaxis, that’s another really interesting story. We might have to save that for another time. Do I know how to tease a sequel or what?

Labos, a cardiologist at Kirkland Medical Center, Montreal, Quebec, Canada, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Aspirin. Once upon a time, everybody over age 50 years was supposed to take a baby aspirin. Now we make it a point to tell people to stop. What is going on?  

Our recommendations vis-à-vis aspirin have evolved at a dizzying pace. The young’uns watching us right now don’t know what things were like in the 1980s. The Reagan era was a wild, heady time where nuclear war was imminent and we didn’t prescribe aspirin to patients. 

That only started in 1988, which was a banner year in human history. Not because a number of doves were incinerated by the lighting of the Olympic torch at the Seoul Olympics — look it up if you don’t know what I’m talking about — but because 1988 saw the publication of the ISIS-2 trial, which first showed a mortality benefit to prescribing aspirin post–myocardial infarction (MI).

Giving patients aspirin during or after a heart attack is not controversial. It’s one of the few things in this business that isn’t, but that’s secondary prevention — treating somebody after they develop a disease. Primary prevention, treating them before they have their incident event, is a very different ballgame. Here, things are messy. 

For one thing, the doses used have been very inconsistent. We should point out that the reason for 81 mg of aspirin is very arbitrary and is rooted in the old apothecary system of weights and measurements. A standard dose of aspirin was 5 grains, where 20 grains made 1 scruple, 3 scruples made 1 dram, 8 drams made 1 oz, and 12 oz made 1 lb - because screw you, metric system. Therefore, 5 grains was 325 mg of aspirin, and 1 quarter of the standard dose became 81 mg if you rounded out the decimal. 

People have tried all kinds of dosing structures with aspirin prophylaxis. The Physicians’ Health Study used a full-dose aspirin, 325 mg every 2 days, while the Hypertension Optimal Treatment (HOT) trial tested 75 mg daily and the Women’s Health Study tested 100 mg, but every other day. 

Ironically, almost no one has studied 81 mg every day, which is weird if you think about it. The bigger problem here is not the variability of doses used, but the discrepancy when you look at older vs newer studies.

Older studies, like the Physicians’ Health Study, did show a benefit, at least in the subgroup of patients over age 50 years, which is probably where the “everybody over 50 should be taking an aspirin” idea comes from, at least as near as I can tell. 

More recent studies, like the Women’s Health Study, ASPREE, or ASPIRE, didn’t show a benefit. I know what you’re thinking: Newer stuff is always better. That’s why you should never trust anybody over age 40 years. The context of primary prevention studies has changed. In the ‘80s and ‘90s, people smoked more and we didn’t have the same medications that we have today. We talked about all this in the beta-blocker video to explain why beta-blockers don’t seem to have a benefit post MI.

We have a similar issue here. The magnitude of the benefit with aspirin primary prevention has decreased because we’re all just healthier overall. So, yay! Progress! Here’s where the numbers matter. No one is saying that aspirin doesn’t help. It does. 

If we look at the 2019 meta-analysis published in JAMA, there is a cardiovascular benefit. The numbers bear that out. I know you’re all here for the math, so here we go. Aspirin reduced the composite cardiovascular endpoint from 65.2 to 60.2 events per 10,000 patient-years; or to put it more meaningfully in absolute risk reduction terms, because that’s my jam, an absolute risk reduction of 0.41%, which means a number needed to treat of 241, which is okay-ish. It’s not super-great, but it may be justifiable for something that costs next to nothing. 

The tradeoff is bleeding. Major bleeding increased from 16.4 to 23.1 bleeds per 10,000 patient-years, or an absolute risk increase of 0.47%, which is a number needed to harm of 210. That’s the problem. Aspirin does prevent heart disease. The benefit is small, for sure, but the real problem is that it’s outweighed by the risk of bleeding, so you’re not really coming out ahead. 

The real tragedy here is that the public is locked into this idea of everyone over age 50 years should be taking an aspirin. Even today, even though guidelines have recommended against aspirin for primary prevention for some time, data from the National Health Interview Survey sample found that nearly one in three older adults take aspirin for primary prevention when they shouldn’t be. That’s a large number of people. That’s millions of Americans — and Canadians, but nobody cares about us. It’s fine. 

That’s the point. We’re not debunking aspirin. It does work. The benefits are just really small in a primary prevention population and offset by the admittedly also really small risks of bleeding. It’s a tradeoff that doesn’t really work in your favor.

But that’s aspirin for cardiovascular disease. When it comes to cancer or DVT prophylaxis, that’s another really interesting story. We might have to save that for another time. Do I know how to tease a sequel or what?

Labos, a cardiologist at Kirkland Medical Center, Montreal, Quebec, Canada, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Vaccination against human papilloma virus (HPV), a group of more than 200 viruses infecting at least 50% of sexually active people over their lifetimes, has proved more than 90% effective for preventing several diseases caused by high-risk HPV types. 

Gardasil 4: 2006 

It started in 2006 with the approval of Human Papillomavirus Quadrivalent, types 6, 11, 16, and 18 (Gardasil 4). Merck’s vaccine began to lower rates of cervical cancer, a major global killer of women.

“It’s fair to say the vaccine has been an American and a global public health success story in reducing rates of cervical cancer,” Paula M. Cuccaro, PhD, assistant professor of health promotion and behavioral sciences at University of Texas School of Public Health, Houston, said in an interview.

How does a common virus trigger such a lethal gynecologic malignancy? “It knocks out two important cancer suppressor genes in cells,” explained Christina Annunziata,MD, PhD, a medical oncologist and senior vice president of extramural discovery science for the American Cancer Society. HPV oncoproteins are encoded by the E6 and E7 genes. As in other DNA tumor viruses, the E6 and E7 proteins functionally inactivate the tumor suppressor proteins p53 and pRB, respectively.
 

US Prevalence

Despite screening and vaccination, cervical cancer is still very much around. This year, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, and approximately 4360 women will die of it, according to the American Cancer Society. Even before the advent of Gardasil 4, incidence rates had already decreased by more than half from the mid-1970s to the mid-2000s, thanks largely to Pap smear screening programs for treatable premalignant lesions. “The US rate had dropped to about 20 per 100,000 women even before Gardasil 4,” said Annunziata. “After the introduction of the first vaccine, it decreased to 7 per 100,000, a decrease of about 30%, but it remains plateaued now at about the same level.”

Although the past decade has seen rates generally stabilize, there have been some changes in different age groups. In women ages 30-44, rates increased 1.7% each year from 2012 to 2019, while rates declined 11% each year for women ages 20-24— probably reflecting the impact of the first wave of prevention from Gardasil 4.

In one 2021 population-based study of US cancer registry data from 1999 to 2017, rates of both cervical squamous cell carcinoma and adenocarcinoma dropped. The largest declines occurred in females 15-20 years old, the age group most likely to be vaccinated against HPV but not typically screened, suggesting a vaccine-related effect.
 

Gardasil 9: 2014

With the 2014 approval of the vaccine’s second iteration, Gardasil 9, which replaced Gardasil 4 and targeted 9 HPV strains, immunization has taken broader aim. The strains covered by Gardasil 9 protect against oropharyngeal and other head and neck cancers — as well as penile, anal, vulvar, and vaginal malignancies and premalignancies, and genital warts in both sexes ages 9-45. 

It may be years, however, before the impact of the newer polyvalent formulation is felt. “While the first vaccine has been successful against the prevalent strains of HPV linked to cervical cancer, it’s a little early to call it for the newer vaccine since oropharyngeal cancers tend to develop later in older men,” Cuccaro said. “But the types of HPV linked to mouth and throat cancers and covered by the newer vaccines are much less prevalent in those who are vaccinated. The strains not covered in the vaccine you see are equally present in the vaccinated and non-vaccinated.”

Angela L. Myers, MD, MPH, division director of infectious diseases and medical director of the Center for Wellbeing at Children’s Mercy in Kansas City, Missouri, added, “Unlike for cervical cancer, there are no screening programs for oropharyngeal lesions, so you have to wait to see rates until actual cancer develops.”

A 2023 review reported that HPV vaccination reduced levels of oropharyngeal HPV positivity in men, strengthening the case for pangender immunization. 

And in a recent phase 3 doubled-blind trial, GARDASIL 9 reduced the incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo. 
 

Increasing Uptake

The current public health aim is to have 80% of young people in the targeted age group vaccinated with two doses. Today, uptake among those 9-26 years old stands at about 78% of girls and 75% of boys for the first dose, said Annunziata. “But it’s only about 61% for the two doses in the current series, and we want to improve that.” 

Some parents may still harbor fears that immunizing teens and tweens — both the American Academy of Pediatrics and the American Cancer Society recommend immunization at age 9 — will open the door to precocious sexual activity. 

“But overall, uptake in tweens and young teens has increased because the messaging has changed,” said Myers, with the rationale now focusing on cancer prevention not sexual-infection prophylaxis. “This is similar to the hepatitis B vaccine, which used to be given to young adults and is now given to newborns to prevent cancer.” 

Cuccaro added that a proactive presentation by healthcare professionals has a significant effect on vaccine uptake and increases the odds of vaccination ninefold. “Providers should take a presumptive approach and avoid just offering the vaccine as an option. It should be included with regular childhood vaccinations,” she said. “And the advantage of starting early at age 9 is that you can spread the doses out across other regular childhood vaccinations, whereas if you start at age 11, you need to add the HPV vaccine to three other vaccines that are given at that time.” 

After age 15, three doses are necessary. “Providers should stress to parents that it’s most effective when given before young people become sexually active and exposed to HPV,” Cuccaro said. And Myers stressed that despite the vaccine’s effectiveness, routine screening for cervical premalignancies is still important. 

Despite increasing coverage, vaccination rates have some distance to go before the public health target of at least 80% uptake of the series in the targeted age group, Cuccaro cautioned.

On the global stage, barriers to immunization remain, but the World Health Organization has endorsed a campaign to eradicate cervical cancer through HPV vaccination. It has predicted that the 21st century may be the last to experience HPV-associated cancers, currently responsible for more than 300,000 annual deaths worldwide.
 

A Brief History of HPV Vaccines

• 1951. Cervical cancer patient Henrietta Lacks’ rapidly dividing cervical cells are collected by George Otto Gey at Johns Hopkins Hospital. They create the first immortal cell line (HeLa) used to study cancers and vaccines worldwide.
• 1976. Harald zur Hausen suggests that genital wart-associated HPV, not herpes simplex, is the probable cause of cervical cancer.
• 1983. HPV is confirmed as a cause of cancer.
• 1991. The first HPV vaccine is developed.
• 2002. Proof of principle and protective efficacy for the monovalent HPV 16 are shown.
• 2006. Merck’s Gardasil 4 (HPV 4) is FDA approved in girls ages 9-26 for protection against strains 6, 11, 16, and 18 — the cause of more than 70% of cervical cancer cases.
• 2009. Approval of Gardasil 4 is expanded to boys ages 9-26 for the prevention of genital warts.
• 2009. The FDA approves GlaxoSmithKline’s Cervarix (HPV 16 and 18) for girls and young women. The vaccine was withdrawn from the US market in 2016 following the success of Gardasil 9 but is used abroad for HPV cancer prevention.
• 2014. The 9-valent recombinant vaccine Gardasil 9 is FDA approved for protection against several low-risk, wart-causing HPV strains as well as the high-risk cancer strains targeted by HPV 4.
• 2018. The FDA expands approval to include females and males 27-45 years old.
• 2020. The FDA extends approval of Gardasil 9 to include prevention not only of cervical cancer but also, vaginal, vulvar, anal, oropharyngeal, and other head and neck cancers.

Annunziata, Cuccaro, and Myers had no competing interests to declare.
 

A version of this article appeared on Medscape.com.

Vaccination against human papilloma virus (HPV), a group of more than 200 viruses infecting at least 50% of sexually active people over their lifetimes, has proved more than 90% effective for preventing several diseases caused by high-risk HPV types. 

Gardasil 4: 2006 

It started in 2006 with the approval of Human Papillomavirus Quadrivalent, types 6, 11, 16, and 18 (Gardasil 4). Merck’s vaccine began to lower rates of cervical cancer, a major global killer of women.

“It’s fair to say the vaccine has been an American and a global public health success story in reducing rates of cervical cancer,” Paula M. Cuccaro, PhD, assistant professor of health promotion and behavioral sciences at University of Texas School of Public Health, Houston, said in an interview.

How does a common virus trigger such a lethal gynecologic malignancy? “It knocks out two important cancer suppressor genes in cells,” explained Christina Annunziata,MD, PhD, a medical oncologist and senior vice president of extramural discovery science for the American Cancer Society. HPV oncoproteins are encoded by the E6 and E7 genes. As in other DNA tumor viruses, the E6 and E7 proteins functionally inactivate the tumor suppressor proteins p53 and pRB, respectively.
 

US Prevalence

Despite screening and vaccination, cervical cancer is still very much around. This year, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, and approximately 4360 women will die of it, according to the American Cancer Society. Even before the advent of Gardasil 4, incidence rates had already decreased by more than half from the mid-1970s to the mid-2000s, thanks largely to Pap smear screening programs for treatable premalignant lesions. “The US rate had dropped to about 20 per 100,000 women even before Gardasil 4,” said Annunziata. “After the introduction of the first vaccine, it decreased to 7 per 100,000, a decrease of about 30%, but it remains plateaued now at about the same level.”

Although the past decade has seen rates generally stabilize, there have been some changes in different age groups. In women ages 30-44, rates increased 1.7% each year from 2012 to 2019, while rates declined 11% each year for women ages 20-24— probably reflecting the impact of the first wave of prevention from Gardasil 4.

In one 2021 population-based study of US cancer registry data from 1999 to 2017, rates of both cervical squamous cell carcinoma and adenocarcinoma dropped. The largest declines occurred in females 15-20 years old, the age group most likely to be vaccinated against HPV but not typically screened, suggesting a vaccine-related effect.
 

Gardasil 9: 2014

With the 2014 approval of the vaccine’s second iteration, Gardasil 9, which replaced Gardasil 4 and targeted 9 HPV strains, immunization has taken broader aim. The strains covered by Gardasil 9 protect against oropharyngeal and other head and neck cancers — as well as penile, anal, vulvar, and vaginal malignancies and premalignancies, and genital warts in both sexes ages 9-45. 

It may be years, however, before the impact of the newer polyvalent formulation is felt. “While the first vaccine has been successful against the prevalent strains of HPV linked to cervical cancer, it’s a little early to call it for the newer vaccine since oropharyngeal cancers tend to develop later in older men,” Cuccaro said. “But the types of HPV linked to mouth and throat cancers and covered by the newer vaccines are much less prevalent in those who are vaccinated. The strains not covered in the vaccine you see are equally present in the vaccinated and non-vaccinated.”

Angela L. Myers, MD, MPH, division director of infectious diseases and medical director of the Center for Wellbeing at Children’s Mercy in Kansas City, Missouri, added, “Unlike for cervical cancer, there are no screening programs for oropharyngeal lesions, so you have to wait to see rates until actual cancer develops.”

A 2023 review reported that HPV vaccination reduced levels of oropharyngeal HPV positivity in men, strengthening the case for pangender immunization. 

And in a recent phase 3 doubled-blind trial, GARDASIL 9 reduced the incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo. 
 

Increasing Uptake

The current public health aim is to have 80% of young people in the targeted age group vaccinated with two doses. Today, uptake among those 9-26 years old stands at about 78% of girls and 75% of boys for the first dose, said Annunziata. “But it’s only about 61% for the two doses in the current series, and we want to improve that.” 

Some parents may still harbor fears that immunizing teens and tweens — both the American Academy of Pediatrics and the American Cancer Society recommend immunization at age 9 — will open the door to precocious sexual activity. 

“But overall, uptake in tweens and young teens has increased because the messaging has changed,” said Myers, with the rationale now focusing on cancer prevention not sexual-infection prophylaxis. “This is similar to the hepatitis B vaccine, which used to be given to young adults and is now given to newborns to prevent cancer.” 

Cuccaro added that a proactive presentation by healthcare professionals has a significant effect on vaccine uptake and increases the odds of vaccination ninefold. “Providers should take a presumptive approach and avoid just offering the vaccine as an option. It should be included with regular childhood vaccinations,” she said. “And the advantage of starting early at age 9 is that you can spread the doses out across other regular childhood vaccinations, whereas if you start at age 11, you need to add the HPV vaccine to three other vaccines that are given at that time.” 

After age 15, three doses are necessary. “Providers should stress to parents that it’s most effective when given before young people become sexually active and exposed to HPV,” Cuccaro said. And Myers stressed that despite the vaccine’s effectiveness, routine screening for cervical premalignancies is still important. 

Despite increasing coverage, vaccination rates have some distance to go before the public health target of at least 80% uptake of the series in the targeted age group, Cuccaro cautioned.

On the global stage, barriers to immunization remain, but the World Health Organization has endorsed a campaign to eradicate cervical cancer through HPV vaccination. It has predicted that the 21st century may be the last to experience HPV-associated cancers, currently responsible for more than 300,000 annual deaths worldwide.
 

A Brief History of HPV Vaccines

• 1951. Cervical cancer patient Henrietta Lacks’ rapidly dividing cervical cells are collected by George Otto Gey at Johns Hopkins Hospital. They create the first immortal cell line (HeLa) used to study cancers and vaccines worldwide.
• 1976. Harald zur Hausen suggests that genital wart-associated HPV, not herpes simplex, is the probable cause of cervical cancer.
• 1983. HPV is confirmed as a cause of cancer.
• 1991. The first HPV vaccine is developed.
• 2002. Proof of principle and protective efficacy for the monovalent HPV 16 are shown.
• 2006. Merck’s Gardasil 4 (HPV 4) is FDA approved in girls ages 9-26 for protection against strains 6, 11, 16, and 18 — the cause of more than 70% of cervical cancer cases.
• 2009. Approval of Gardasil 4 is expanded to boys ages 9-26 for the prevention of genital warts.
• 2009. The FDA approves GlaxoSmithKline’s Cervarix (HPV 16 and 18) for girls and young women. The vaccine was withdrawn from the US market in 2016 following the success of Gardasil 9 but is used abroad for HPV cancer prevention.
• 2014. The 9-valent recombinant vaccine Gardasil 9 is FDA approved for protection against several low-risk, wart-causing HPV strains as well as the high-risk cancer strains targeted by HPV 4.
• 2018. The FDA expands approval to include females and males 27-45 years old.
• 2020. The FDA extends approval of Gardasil 9 to include prevention not only of cervical cancer but also, vaginal, vulvar, anal, oropharyngeal, and other head and neck cancers.

Annunziata, Cuccaro, and Myers had no competing interests to declare.
 

A version of this article appeared on Medscape.com.

Vaccination against human papilloma virus (HPV), a group of more than 200 viruses infecting at least 50% of sexually active people over their lifetimes, has proved more than 90% effective for preventing several diseases caused by high-risk HPV types. 

Gardasil 4: 2006 

It started in 2006 with the approval of Human Papillomavirus Quadrivalent, types 6, 11, 16, and 18 (Gardasil 4). Merck’s vaccine began to lower rates of cervical cancer, a major global killer of women.

“It’s fair to say the vaccine has been an American and a global public health success story in reducing rates of cervical cancer,” Paula M. Cuccaro, PhD, assistant professor of health promotion and behavioral sciences at University of Texas School of Public Health, Houston, said in an interview.

How does a common virus trigger such a lethal gynecologic malignancy? “It knocks out two important cancer suppressor genes in cells,” explained Christina Annunziata,MD, PhD, a medical oncologist and senior vice president of extramural discovery science for the American Cancer Society. HPV oncoproteins are encoded by the E6 and E7 genes. As in other DNA tumor viruses, the E6 and E7 proteins functionally inactivate the tumor suppressor proteins p53 and pRB, respectively.
 

US Prevalence

Despite screening and vaccination, cervical cancer is still very much around. This year, 13,820 new cases of invasive cervical cancer will be diagnosed in the United States, and approximately 4360 women will die of it, according to the American Cancer Society. Even before the advent of Gardasil 4, incidence rates had already decreased by more than half from the mid-1970s to the mid-2000s, thanks largely to Pap smear screening programs for treatable premalignant lesions. “The US rate had dropped to about 20 per 100,000 women even before Gardasil 4,” said Annunziata. “After the introduction of the first vaccine, it decreased to 7 per 100,000, a decrease of about 30%, but it remains plateaued now at about the same level.”

Although the past decade has seen rates generally stabilize, there have been some changes in different age groups. In women ages 30-44, rates increased 1.7% each year from 2012 to 2019, while rates declined 11% each year for women ages 20-24— probably reflecting the impact of the first wave of prevention from Gardasil 4.

In one 2021 population-based study of US cancer registry data from 1999 to 2017, rates of both cervical squamous cell carcinoma and adenocarcinoma dropped. The largest declines occurred in females 15-20 years old, the age group most likely to be vaccinated against HPV but not typically screened, suggesting a vaccine-related effect.
 

Gardasil 9: 2014

With the 2014 approval of the vaccine’s second iteration, Gardasil 9, which replaced Gardasil 4 and targeted 9 HPV strains, immunization has taken broader aim. The strains covered by Gardasil 9 protect against oropharyngeal and other head and neck cancers — as well as penile, anal, vulvar, and vaginal malignancies and premalignancies, and genital warts in both sexes ages 9-45. 

It may be years, however, before the impact of the newer polyvalent formulation is felt. “While the first vaccine has been successful against the prevalent strains of HPV linked to cervical cancer, it’s a little early to call it for the newer vaccine since oropharyngeal cancers tend to develop later in older men,” Cuccaro said. “But the types of HPV linked to mouth and throat cancers and covered by the newer vaccines are much less prevalent in those who are vaccinated. The strains not covered in the vaccine you see are equally present in the vaccinated and non-vaccinated.”

Angela L. Myers, MD, MPH, division director of infectious diseases and medical director of the Center for Wellbeing at Children’s Mercy in Kansas City, Missouri, added, “Unlike for cervical cancer, there are no screening programs for oropharyngeal lesions, so you have to wait to see rates until actual cancer develops.”

A 2023 review reported that HPV vaccination reduced levels of oropharyngeal HPV positivity in men, strengthening the case for pangender immunization. 

And in a recent phase 3 doubled-blind trial, GARDASIL 9 reduced the incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo. 
 

Increasing Uptake

The current public health aim is to have 80% of young people in the targeted age group vaccinated with two doses. Today, uptake among those 9-26 years old stands at about 78% of girls and 75% of boys for the first dose, said Annunziata. “But it’s only about 61% for the two doses in the current series, and we want to improve that.” 

Some parents may still harbor fears that immunizing teens and tweens — both the American Academy of Pediatrics and the American Cancer Society recommend immunization at age 9 — will open the door to precocious sexual activity. 

“But overall, uptake in tweens and young teens has increased because the messaging has changed,” said Myers, with the rationale now focusing on cancer prevention not sexual-infection prophylaxis. “This is similar to the hepatitis B vaccine, which used to be given to young adults and is now given to newborns to prevent cancer.” 

Cuccaro added that a proactive presentation by healthcare professionals has a significant effect on vaccine uptake and increases the odds of vaccination ninefold. “Providers should take a presumptive approach and avoid just offering the vaccine as an option. It should be included with regular childhood vaccinations,” she said. “And the advantage of starting early at age 9 is that you can spread the doses out across other regular childhood vaccinations, whereas if you start at age 11, you need to add the HPV vaccine to three other vaccines that are given at that time.” 

After age 15, three doses are necessary. “Providers should stress to parents that it’s most effective when given before young people become sexually active and exposed to HPV,” Cuccaro said. And Myers stressed that despite the vaccine’s effectiveness, routine screening for cervical premalignancies is still important. 

Despite increasing coverage, vaccination rates have some distance to go before the public health target of at least 80% uptake of the series in the targeted age group, Cuccaro cautioned.

On the global stage, barriers to immunization remain, but the World Health Organization has endorsed a campaign to eradicate cervical cancer through HPV vaccination. It has predicted that the 21st century may be the last to experience HPV-associated cancers, currently responsible for more than 300,000 annual deaths worldwide.
 

A Brief History of HPV Vaccines

• 1951. Cervical cancer patient Henrietta Lacks’ rapidly dividing cervical cells are collected by George Otto Gey at Johns Hopkins Hospital. They create the first immortal cell line (HeLa) used to study cancers and vaccines worldwide.
• 1976. Harald zur Hausen suggests that genital wart-associated HPV, not herpes simplex, is the probable cause of cervical cancer.
• 1983. HPV is confirmed as a cause of cancer.
• 1991. The first HPV vaccine is developed.
• 2002. Proof of principle and protective efficacy for the monovalent HPV 16 are shown.
• 2006. Merck’s Gardasil 4 (HPV 4) is FDA approved in girls ages 9-26 for protection against strains 6, 11, 16, and 18 — the cause of more than 70% of cervical cancer cases.
• 2009. Approval of Gardasil 4 is expanded to boys ages 9-26 for the prevention of genital warts.
• 2009. The FDA approves GlaxoSmithKline’s Cervarix (HPV 16 and 18) for girls and young women. The vaccine was withdrawn from the US market in 2016 following the success of Gardasil 9 but is used abroad for HPV cancer prevention.
• 2014. The 9-valent recombinant vaccine Gardasil 9 is FDA approved for protection against several low-risk, wart-causing HPV strains as well as the high-risk cancer strains targeted by HPV 4.
• 2018. The FDA expands approval to include females and males 27-45 years old.
• 2020. The FDA extends approval of Gardasil 9 to include prevention not only of cervical cancer but also, vaginal, vulvar, anal, oropharyngeal, and other head and neck cancers.

Annunziata, Cuccaro, and Myers had no competing interests to declare.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Virtual yoga classes significantly reduced chronic low back pain intensity and improved back-related function in health system employees. Improvements were sustained at 24 weeks, with reduced pain medication use and better sleep quality.

METHODOLOGY:

• A single-blinded, 24-week, 2-arm, randomized clinical trial was conducted from May 3, 2022, through May 23, 2023, comparing live-streamed yoga classes with a wait-list control among adults with chronic low back pain.
• A total of 140 participants aged 18-64 years with chronic low back pain were recruited from the Cleveland Clinic Employee Health Plan.
• Inclusion criteria included a mean low back pain intensity score of at least 4 on an 11-point numerical rating scale and daily back pain interference about half or more of the days.
• The intervention consisted of 12 consecutive weekly, 60-minute, virtual, live-streamed hatha yoga group classes.

Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire at 12 weeks.

TAKEAWAY:

• Participants in the virtual yoga group showed greater reductions in mean pain intensity at 12 weeks (mean change, –1.5 points; P < .001) and 24 weeks (mean change, –2.3 points; P < .001) compared to the wait-list control group.
• Back-related function improved significantly in the virtual yoga group at 12 weeks (mean change, –2.8 points; P < .001) and 24 weeks (mean change, –4.6 points; P < .001), compared with the control group.
• Virtual yoga participants reported 21.2 percentage points less use of any analgesic medication during the past week at 24 weeks, compared with the control group.
• Sleep quality improved more in the virtual yoga group at 12 weeks (mean change, 0.4 points; P = .008) and 24 weeks (mean change, 0.4 points; P = .005), compared with the control group.

IN PRACTICE:

“Given the demonstrated noninferiority of yoga to physical therapy, structured virtual yoga programs and physical therapy are reasonable choices for patients with [chronic low back pain] depending on accessibility, cost, and patient preference. These findings support the call by the National Academy of Medicine for increased evidenced-based pain treatments that can be disseminated via technology-based platforms,” wrote the authors of the study.

SOURCE:

The study was led by Hallie Tankha, PhD, Cleveland Clinic in Ohio. It was published online on November 1, 2024, in JAMA Network Open.

LIMITATIONS: 

The study had a low adherence rate, with only 36.6% of participants attending at least 50% of the yoga classes. There was also a higher rate of missing data in the yoga group compared to the control group. The study did not include a longer-term follow-up assessment beyond 24 weeks.

DISCLOSURES:

This study was supported by grants from Cleveland Clinic Healthcare Delivery and Implementation Science Center. One coauthor disclosed receiving personal fees from the Blue Cross Blue Shield Association. Eric Roseen, DC, PhD, reported receiving grants from the National Institutes of Health National Center for Complementary and Integrative Health. One coauthor disclosed receiving personal fees from UpToDate and grants from NCCIH related to yoga and tai chi for treatment of pain. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Virtual yoga classes significantly reduced chronic low back pain intensity and improved back-related function in health system employees. Improvements were sustained at 24 weeks, with reduced pain medication use and better sleep quality.

METHODOLOGY:

• A single-blinded, 24-week, 2-arm, randomized clinical trial was conducted from May 3, 2022, through May 23, 2023, comparing live-streamed yoga classes with a wait-list control among adults with chronic low back pain.
• A total of 140 participants aged 18-64 years with chronic low back pain were recruited from the Cleveland Clinic Employee Health Plan.
• Inclusion criteria included a mean low back pain intensity score of at least 4 on an 11-point numerical rating scale and daily back pain interference about half or more of the days.
• The intervention consisted of 12 consecutive weekly, 60-minute, virtual, live-streamed hatha yoga group classes.

Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire at 12 weeks.

TAKEAWAY:

• Participants in the virtual yoga group showed greater reductions in mean pain intensity at 12 weeks (mean change, –1.5 points; P < .001) and 24 weeks (mean change, –2.3 points; P < .001) compared to the wait-list control group.
• Back-related function improved significantly in the virtual yoga group at 12 weeks (mean change, –2.8 points; P < .001) and 24 weeks (mean change, –4.6 points; P < .001), compared with the control group.
• Virtual yoga participants reported 21.2 percentage points less use of any analgesic medication during the past week at 24 weeks, compared with the control group.
• Sleep quality improved more in the virtual yoga group at 12 weeks (mean change, 0.4 points; P = .008) and 24 weeks (mean change, 0.4 points; P = .005), compared with the control group.

IN PRACTICE:

“Given the demonstrated noninferiority of yoga to physical therapy, structured virtual yoga programs and physical therapy are reasonable choices for patients with [chronic low back pain] depending on accessibility, cost, and patient preference. These findings support the call by the National Academy of Medicine for increased evidenced-based pain treatments that can be disseminated via technology-based platforms,” wrote the authors of the study.

SOURCE:

The study was led by Hallie Tankha, PhD, Cleveland Clinic in Ohio. It was published online on November 1, 2024, in JAMA Network Open.

LIMITATIONS: 

The study had a low adherence rate, with only 36.6% of participants attending at least 50% of the yoga classes. There was also a higher rate of missing data in the yoga group compared to the control group. The study did not include a longer-term follow-up assessment beyond 24 weeks.

DISCLOSURES:

This study was supported by grants from Cleveland Clinic Healthcare Delivery and Implementation Science Center. One coauthor disclosed receiving personal fees from the Blue Cross Blue Shield Association. Eric Roseen, DC, PhD, reported receiving grants from the National Institutes of Health National Center for Complementary and Integrative Health. One coauthor disclosed receiving personal fees from UpToDate and grants from NCCIH related to yoga and tai chi for treatment of pain. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Virtual yoga classes significantly reduced chronic low back pain intensity and improved back-related function in health system employees. Improvements were sustained at 24 weeks, with reduced pain medication use and better sleep quality.

METHODOLOGY:

• A single-blinded, 24-week, 2-arm, randomized clinical trial was conducted from May 3, 2022, through May 23, 2023, comparing live-streamed yoga classes with a wait-list control among adults with chronic low back pain.
• A total of 140 participants aged 18-64 years with chronic low back pain were recruited from the Cleveland Clinic Employee Health Plan.
• Inclusion criteria included a mean low back pain intensity score of at least 4 on an 11-point numerical rating scale and daily back pain interference about half or more of the days.
• The intervention consisted of 12 consecutive weekly, 60-minute, virtual, live-streamed hatha yoga group classes.

Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire at 12 weeks.

TAKEAWAY:

• Participants in the virtual yoga group showed greater reductions in mean pain intensity at 12 weeks (mean change, –1.5 points; P < .001) and 24 weeks (mean change, –2.3 points; P < .001) compared to the wait-list control group.
• Back-related function improved significantly in the virtual yoga group at 12 weeks (mean change, –2.8 points; P < .001) and 24 weeks (mean change, –4.6 points; P < .001), compared with the control group.
• Virtual yoga participants reported 21.2 percentage points less use of any analgesic medication during the past week at 24 weeks, compared with the control group.
• Sleep quality improved more in the virtual yoga group at 12 weeks (mean change, 0.4 points; P = .008) and 24 weeks (mean change, 0.4 points; P = .005), compared with the control group.

IN PRACTICE:

“Given the demonstrated noninferiority of yoga to physical therapy, structured virtual yoga programs and physical therapy are reasonable choices for patients with [chronic low back pain] depending on accessibility, cost, and patient preference. These findings support the call by the National Academy of Medicine for increased evidenced-based pain treatments that can be disseminated via technology-based platforms,” wrote the authors of the study.

SOURCE:

The study was led by Hallie Tankha, PhD, Cleveland Clinic in Ohio. It was published online on November 1, 2024, in JAMA Network Open.

LIMITATIONS: 

The study had a low adherence rate, with only 36.6% of participants attending at least 50% of the yoga classes. There was also a higher rate of missing data in the yoga group compared to the control group. The study did not include a longer-term follow-up assessment beyond 24 weeks.

DISCLOSURES:

This study was supported by grants from Cleveland Clinic Healthcare Delivery and Implementation Science Center. One coauthor disclosed receiving personal fees from the Blue Cross Blue Shield Association. Eric Roseen, DC, PhD, reported receiving grants from the National Institutes of Health National Center for Complementary and Integrative Health. One coauthor disclosed receiving personal fees from UpToDate and grants from NCCIH related to yoga and tai chi for treatment of pain. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The US Department of Veterans Affairs (VA) is awarding $15.9 million in grants to fund adaptive sports, recreational activities, and equine therapy for > 15,000 veterans and service members living with disabilities.

Marine Corps veteran Jataya Taylor — who competed in wheelchair fencing at the 2024 Paralympics — experienced mental health symptoms until she began participating in adaptive sports through an organization supported by the VA Adaptive Sports Grant Program.

“Getting involved in adaptive sports was a saving grace for me,” Taylor said. “Participating in these programs got me on the bike to start with, then got me climbing, and eventually it became an important part of my mental health to participate. I found my people. I found my new network of friends.”

Adaptive sports, which are customized to fit the needs of veterans with disabilities, include paralympic sports, archery, cycling, skiing, hunting, rock climbing, and sky diving. Mike Gooler, another Marine Corps veteran, praised the Adaptive Sports Center’s facilities in Crested Butte, Colorado, calling it “nothing short of amazing.”

“[S]ki therapy has been instrumental in helping me navigate through my experiences and injuries,” Gooler said. “Skiing provides me with sense of freedom and empowerment … and having my family by my side, witnessing my progress and sharing the joy of skiing, was truly special.”

The grant program is facilitated and managed by the National Veterans Sports Programs and Special Events Office and will provide grants to 91 national, regional, and community-based programs for fiscal year 2024 across all 50 states, the District of Columbia, Guam, and Puerto Rico.

“These grants give veterans life-changing opportunities,” Secretary of VA Denis McDonough said. “We know adaptive sports and recreational activities can be transformational for veterans living with disabilities, improving their overall physical and mental health, and also giving them important community with fellow heroes who served.”

Information about the awardees and details of the program are available at www.va.gov/adaptivesports and on Facebook at Sports4Vets.

The US Department of Veterans Affairs (VA) is awarding $15.9 million in grants to fund adaptive sports, recreational activities, and equine therapy for > 15,000 veterans and service members living with disabilities.

Marine Corps veteran Jataya Taylor — who competed in wheelchair fencing at the 2024 Paralympics — experienced mental health symptoms until she began participating in adaptive sports through an organization supported by the VA Adaptive Sports Grant Program.

“Getting involved in adaptive sports was a saving grace for me,” Taylor said. “Participating in these programs got me on the bike to start with, then got me climbing, and eventually it became an important part of my mental health to participate. I found my people. I found my new network of friends.”

Adaptive sports, which are customized to fit the needs of veterans with disabilities, include paralympic sports, archery, cycling, skiing, hunting, rock climbing, and sky diving. Mike Gooler, another Marine Corps veteran, praised the Adaptive Sports Center’s facilities in Crested Butte, Colorado, calling it “nothing short of amazing.”

“[S]ki therapy has been instrumental in helping me navigate through my experiences and injuries,” Gooler said. “Skiing provides me with sense of freedom and empowerment … and having my family by my side, witnessing my progress and sharing the joy of skiing, was truly special.”

The grant program is facilitated and managed by the National Veterans Sports Programs and Special Events Office and will provide grants to 91 national, regional, and community-based programs for fiscal year 2024 across all 50 states, the District of Columbia, Guam, and Puerto Rico.

“These grants give veterans life-changing opportunities,” Secretary of VA Denis McDonough said. “We know adaptive sports and recreational activities can be transformational for veterans living with disabilities, improving their overall physical and mental health, and also giving them important community with fellow heroes who served.”

Information about the awardees and details of the program are available at www.va.gov/adaptivesports and on Facebook at Sports4Vets.

The US Department of Veterans Affairs (VA) is awarding $15.9 million in grants to fund adaptive sports, recreational activities, and equine therapy for > 15,000 veterans and service members living with disabilities.

Marine Corps veteran Jataya Taylor — who competed in wheelchair fencing at the 2024 Paralympics — experienced mental health symptoms until she began participating in adaptive sports through an organization supported by the VA Adaptive Sports Grant Program.

“Getting involved in adaptive sports was a saving grace for me,” Taylor said. “Participating in these programs got me on the bike to start with, then got me climbing, and eventually it became an important part of my mental health to participate. I found my people. I found my new network of friends.”

Adaptive sports, which are customized to fit the needs of veterans with disabilities, include paralympic sports, archery, cycling, skiing, hunting, rock climbing, and sky diving. Mike Gooler, another Marine Corps veteran, praised the Adaptive Sports Center’s facilities in Crested Butte, Colorado, calling it “nothing short of amazing.”

“[S]ki therapy has been instrumental in helping me navigate through my experiences and injuries,” Gooler said. “Skiing provides me with sense of freedom and empowerment … and having my family by my side, witnessing my progress and sharing the joy of skiing, was truly special.”

The grant program is facilitated and managed by the National Veterans Sports Programs and Special Events Office and will provide grants to 91 national, regional, and community-based programs for fiscal year 2024 across all 50 states, the District of Columbia, Guam, and Puerto Rico.

“These grants give veterans life-changing opportunities,” Secretary of VA Denis McDonough said. “We know adaptive sports and recreational activities can be transformational for veterans living with disabilities, improving their overall physical and mental health, and also giving them important community with fellow heroes who served.”

Information about the awardees and details of the program are available at www.va.gov/adaptivesports and on Facebook at Sports4Vets.

Nearly two thirds of patients with rheumatic conditions switched to medical cannabis from medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, with the substitution being associated with greater self-reported improvement in symptoms than nonsubstitution.

METHODOLOGY:

• Researchers conducted a secondary analysis of a cross-sectional survey to investigate the prevalence of switching to medical cannabis from traditional medications in patients with rheumatic conditions from the United States and Canada.
• The survey included questions on current and past medical cannabis use, sociodemographic characteristics, medication taken and substituted, substance use, and patient-reported outcomes.
• Of the 1727 patients who completed the survey, 763 patients (mean age, 59 years; 84.1% women) reported current use of cannabis and were included in this analysis.
• Participants were asked if they had substituted any medications with medical cannabis and were sub-grouped accordingly.
• They also reported any changes in symptoms after initiating cannabis, the current and anticipated duration of medical cannabis use, methods of ingestion, cannabinoid content, and frequency of use.

TAKEAWAY:

• Overall, 62.5% reported substituting medical cannabis for certain medications, including NSAIDs (54.7%), opioids (48.6%), sleep aids (29.6%), muscle relaxants (25.2%), benzodiazepines (15.5%), and gabapentinoids (10.5%).
• The most common reasons given for substituting medical cannabis were fewer side effects (39%), better symptom control (27%), and fewer adverse effects (12%).
• Participants who substituted medical cannabis reported significant improvements in symptoms such as pain, sleep, joint stiffness, muscle spasms, and inflammation, and in overall health, compared with those who did not substitute it for medications.
• The substitution group was more likely to use inhalation methods (smoking and vaporizing) than the nonsubstitution group; they also used medical cannabis more frequently and preferred products containing delta-9-tetrahydrocannabinol.

IN PRACTICE:

“The changing legal status of cannabis has allowed a greater openness with more people willing to try cannabis for symptom relief. These encouraging results of medication reduction and favorable effect of [medical cannabis] require confirmation with more rigorous methods. At this time, survey information may be seen as a signal for effect, rather than sound evidence that could be applicable to those with musculoskeletal complaints in general,” the authors wrote. 

SOURCE:

The study was led by Kevin F. Boehnke, PhD, University of Michigan Medical School, Ann Arbor, and was published online in ACR Open Rheumatology.

LIMITATIONS: 

The cross-sectional nature of the study limited the determination of causality between medical cannabis use and symptom improvement. Moreover, the anonymous and self-reported nature of the survey at a single timepoint may have introduced recall bias. The sample predominantly consisted of older, White females, which may have limited the generalizability of the findings to other demographic groups.

DISCLOSURES:

Some authors received grant support from the National Institute on Drug Abuse and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some others received payments, honoraria, grant funding, consulting fees, and travel support, and reported other ties with pharmaceutical companies and other institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Nearly two thirds of patients with rheumatic conditions switched to medical cannabis from medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, with the substitution being associated with greater self-reported improvement in symptoms than nonsubstitution.

METHODOLOGY:

• Researchers conducted a secondary analysis of a cross-sectional survey to investigate the prevalence of switching to medical cannabis from traditional medications in patients with rheumatic conditions from the United States and Canada.
• The survey included questions on current and past medical cannabis use, sociodemographic characteristics, medication taken and substituted, substance use, and patient-reported outcomes.
• Of the 1727 patients who completed the survey, 763 patients (mean age, 59 years; 84.1% women) reported current use of cannabis and were included in this analysis.
• Participants were asked if they had substituted any medications with medical cannabis and were sub-grouped accordingly.
• They also reported any changes in symptoms after initiating cannabis, the current and anticipated duration of medical cannabis use, methods of ingestion, cannabinoid content, and frequency of use.

TAKEAWAY:

• Overall, 62.5% reported substituting medical cannabis for certain medications, including NSAIDs (54.7%), opioids (48.6%), sleep aids (29.6%), muscle relaxants (25.2%), benzodiazepines (15.5%), and gabapentinoids (10.5%).
• The most common reasons given for substituting medical cannabis were fewer side effects (39%), better symptom control (27%), and fewer adverse effects (12%).
• Participants who substituted medical cannabis reported significant improvements in symptoms such as pain, sleep, joint stiffness, muscle spasms, and inflammation, and in overall health, compared with those who did not substitute it for medications.
• The substitution group was more likely to use inhalation methods (smoking and vaporizing) than the nonsubstitution group; they also used medical cannabis more frequently and preferred products containing delta-9-tetrahydrocannabinol.

IN PRACTICE:

“The changing legal status of cannabis has allowed a greater openness with more people willing to try cannabis for symptom relief. These encouraging results of medication reduction and favorable effect of [medical cannabis] require confirmation with more rigorous methods. At this time, survey information may be seen as a signal for effect, rather than sound evidence that could be applicable to those with musculoskeletal complaints in general,” the authors wrote. 

SOURCE:

The study was led by Kevin F. Boehnke, PhD, University of Michigan Medical School, Ann Arbor, and was published online in ACR Open Rheumatology.

LIMITATIONS: 

The cross-sectional nature of the study limited the determination of causality between medical cannabis use and symptom improvement. Moreover, the anonymous and self-reported nature of the survey at a single timepoint may have introduced recall bias. The sample predominantly consisted of older, White females, which may have limited the generalizability of the findings to other demographic groups.

DISCLOSURES:

Some authors received grant support from the National Institute on Drug Abuse and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some others received payments, honoraria, grant funding, consulting fees, and travel support, and reported other ties with pharmaceutical companies and other institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Nearly two thirds of patients with rheumatic conditions switched to medical cannabis from medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids, with the substitution being associated with greater self-reported improvement in symptoms than nonsubstitution.

METHODOLOGY:

• Researchers conducted a secondary analysis of a cross-sectional survey to investigate the prevalence of switching to medical cannabis from traditional medications in patients with rheumatic conditions from the United States and Canada.
• The survey included questions on current and past medical cannabis use, sociodemographic characteristics, medication taken and substituted, substance use, and patient-reported outcomes.
• Of the 1727 patients who completed the survey, 763 patients (mean age, 59 years; 84.1% women) reported current use of cannabis and were included in this analysis.
• Participants were asked if they had substituted any medications with medical cannabis and were sub-grouped accordingly.
• They also reported any changes in symptoms after initiating cannabis, the current and anticipated duration of medical cannabis use, methods of ingestion, cannabinoid content, and frequency of use.

TAKEAWAY:

• Overall, 62.5% reported substituting medical cannabis for certain medications, including NSAIDs (54.7%), opioids (48.6%), sleep aids (29.6%), muscle relaxants (25.2%), benzodiazepines (15.5%), and gabapentinoids (10.5%).
• The most common reasons given for substituting medical cannabis were fewer side effects (39%), better symptom control (27%), and fewer adverse effects (12%).
• Participants who substituted medical cannabis reported significant improvements in symptoms such as pain, sleep, joint stiffness, muscle spasms, and inflammation, and in overall health, compared with those who did not substitute it for medications.
• The substitution group was more likely to use inhalation methods (smoking and vaporizing) than the nonsubstitution group; they also used medical cannabis more frequently and preferred products containing delta-9-tetrahydrocannabinol.

IN PRACTICE:

“The changing legal status of cannabis has allowed a greater openness with more people willing to try cannabis for symptom relief. These encouraging results of medication reduction and favorable effect of [medical cannabis] require confirmation with more rigorous methods. At this time, survey information may be seen as a signal for effect, rather than sound evidence that could be applicable to those with musculoskeletal complaints in general,” the authors wrote. 

SOURCE:

The study was led by Kevin F. Boehnke, PhD, University of Michigan Medical School, Ann Arbor, and was published online in ACR Open Rheumatology.

LIMITATIONS: 

The cross-sectional nature of the study limited the determination of causality between medical cannabis use and symptom improvement. Moreover, the anonymous and self-reported nature of the survey at a single timepoint may have introduced recall bias. The sample predominantly consisted of older, White females, which may have limited the generalizability of the findings to other demographic groups.

DISCLOSURES:

Some authors received grant support from the National Institute on Drug Abuse and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some others received payments, honoraria, grant funding, consulting fees, and travel support, and reported other ties with pharmaceutical companies and other institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

As large-scale natural disasters become more common, health care coalitions and the engagement of health systems with local, state, and federal public health departments have effectively bolstered communities’ resilience via collective sharing and distribution of resources.¹ These resources may include supplies and the dissemination of emergency information, education, and training.² The COVID-19 pandemic demonstrated that larger health care systems including hospital networks and nursing homes are better connected to health care coalition resources than smaller, independent systems, such as community home health agencies.³ This leaves some organizations on their own to meet requirements that maintain continuity of care and support their patients and staff throughout a natural disaster.

Home health care workers play important roles in the care of older adults.⁴ Older adults experience high levels of disability and comorbidities that put them at risk during emergencies; they often require support from paid, family, and neighborhood caregivers to live independently.⁵ More than 9.3 million US adults receive paid care from 2.6 million home health care workers (eg, home health aides and personal care assistants).⁶ Many of these individuals are hired through small independent home health agencies (HHAs), while others may work directly for an individual. When neighborhood resources and family caregiving are disrupted during emergencies, the critical services these workers administer become even more essential to ensuring continued access to medical care and social services.

The importance of these services was underscored by the Centers for Medicare and Medicaid Services 2017 inclusion of HHAs in federal emergency preparedness guidelines.^7,8 The fractured and decentralized nature of the home health care industry means many HHAs struggle to maintain continuous care during emergencies and protect their staff. HHAs, and health care workers in the home, are often isolated, under-resourced, and disconnected from broader emergency planning efforts. Additionally, home care jobs are largely part-time, unstable, and low paying, making the workers themselves vulnerable during emergencies.^3,9-13

This is a significant issue for the Veterans Health Administration (VHA), which annually purchases 10.5 million home health care worker visits for 150,000 veterans from community-based HHAs to enable those individuals to live independently. Figure 1 illustrates the existing structure of directly provided and contracted VHA services for community-dwelling veterans, highlighting the circle of care around the veteran.^8,9 Home health care workers anchored health care teams during the COVID-19 pandemic, observing and reporting on patients’ well-being to family caregivers, primary care practitioners, and HHAs. They also provided critical emotional support and companionship to patients isolated from family and friends.⁹ These workers also exposed themselves and their families to considerable risk and often lacked the protection afforded by personal protective equipment (PPE) in accordance with infection prevention guidance.^3,12

Through a combination of its national and local health care networks, the VHA has a robust and well-positioned emergency infrastructure to supportcommunity-dwelling older adults during disasters.¹⁴ This network is supported by the VHA Office of Emergency Management, which shares resources and guidance with local emergency managers at each facility as well as individual programs such as the VHA Home Based Primary Care (HBPC) program, which provides 38,000 seriously ill veterans with home medical visits.¹⁵ Working closely with their local and national hospital networks and emergency managers, individual VHA HBPC programs were able to maintain the safety of staff and continuity of care for patients enrolled in HBPC by rapidly administering COVID-19 vaccines to patients, caregivers, and staff, and providing emergency assistance during the 2017 hurricane season.^16,17 These efforts were successful because HBPC practitioners and their patients, had access to a level of emergency-related information, resources, and technology that are often out of reach for individual community-based health care practitioners (HCPs). The US Department of Veterans Affairs (VA) also supports local communities through its Fourth Mission, which provides emergency resources to non-VHA health care facilities (ie, hospitals and nursing homes) during national emergencies and natural disasters.¹⁷ Although there has been an expansion in the definition of shared resources, such as extending behavioral health support to local communities, the VHA has not historically provided these resources to HHAs.¹⁴

This study examines opportunities to leverage VHA emergency management resources to support contracted HHAs and inform other large health system emergency planning efforts. The findings from the exploratory phase are described in this article. We interviewed VHA emergency managers, HBPC and VA staff who coordinate home health care worker services, as well as administrators at contracted HHAs within a Veterans Integrated Services Network (VISN). These findings will inform the second (single-site pilot study) and third (feasibility study) phases. Our intent was to (1) better understand the relationships between VA medical centers (VAMCs) and their contracted HHAs; (2) identify existing VHA emergency protocols to support community-dwelling older adults; and (3) determine opportunities to build on existing infrastructure and relationships to better support contracted HHAs and their staff in emergencies.

Methods

The 18 VISNs act as regional systems of care that are loosely connected to better meet local health needs and maximize access to care. This study was conducted at 6 of 9 VAMCs within VISN 2, the New York/New Jersey VHA Health Care Network.¹⁸ VAMCs that serve urban, rural, and mixed urban/rural catchment areas were included.

Each VAMC has an emergency management program led by an emergency manager, an HBPC program led by a program director and medical director, and a community care or purchased care office that has a liaison who manages contracted home health care worker services. The studyfocused on HBPC programs because they are most likely to interact with veterans’ home health care workers in the home and care for community-dwelling veterans during emergencies. Each VHA also contracts with a series of local HHAs that generally have a dedicated staff member who interfaces with the VHA liaison. Our goal was to interview ≥ 1 emergency manager, ≥ 1 HBPC team member, ≥ 1 community care staff person, and ≥ 1 contracted home health agency administrator at each site to gain multiple perspectives from the range of HCPs serving veterans in the community.

Recruitment and Data Collection

The 6 sites were selected in consultation with VISN 2 leadership for their strong HBPC and emergency management programs. To recruit respondents, we contacted VISN and VAMC leads and used our professional networks to identify a sample of multidisciplinary individuals who represent both community care and HBPC programs who were contacted via email.

Since each VAMC is organized differently, we utilized a snowball sampling approach to identify the appropriate contacts.¹⁹ At the completion of each interview, we asked the participant to suggest additional contacts and introduce us to any remaining stakeholders (eg, the emergency manager) at that site or colleagues at other VISN facilities. Because roles vary among VAMCs, we contacted the person who most closely resembled the identified role and asked them to direct us to a more appropriate contact, if necessary. We asked community care managers to identify 1 to 2 agencies serving the highest volume of patients who are veterans at their site and requested interviews with those liaisons. This resulted in the recruitment of key stakeholders from 4 teams across the 6 sites (Table).

A semistructured interview guide was jointly developed based on constructs of interest, including relationships within VAMCs and between VAMCs and HHAs; existing emergency protocols and experience during disasters; and suggestions and opportunities for supporting agencies during emergencies and potential barriers. Two researchers (TWL and EF) who were trained in qualitative methods jointly conducted interviews using the interview guide, with 1 researcher leading and another taking notes and asking clarifying questions.

Interviews were conducted virtually via Microsoft Teams with respondents at their work locations between September 2022 and January 2023. Interviews were audio recorded and transcribed and 2 authors (TWL and ESO) reviewed transcripts for accuracy. Interviews averaged 47 minutes in length (range, 20-59).

The study was reviewed and determined to be exempt by institutional review boards at the James J. Peters VAMC and Greater Los Angeles VAMC. We asked participants for verbal consent to participate and preserved their confidentiality.

Analysis

Data were analyzed via an inductive approach, which involves drawing salient themes rather than imposing preconceived theories.²⁰ Three researchers (TWL, EF, and ES) listened to and discussed 2 staff interviews and tagged text with specific codes (eg, communication between the VHA and HHA, internal communication, and barriers to case fulfillment) so the team could selectively return to the interview text for deeper analysis, allowing for the development of a final codebook. The project team synthesized the findings to identify higher-level themes, drawing comparisons across and within the respondent groups, including within and between health care systems. Throughout the analysis, we maintained analytic memos, documented discussions, and engaged in analyst triangulation to ensure trustworthiness.^21,22 To ensure the analysis accurately reflected the participants’ understanding, we held 2 virtual member-checking sessions with participants to share preliminary findings and conclusions and solicit feedback. Analysis was conducted using ATLAS.ti version 20.

Results

VHA-based participants described internal emergency management systems that are deployed during a disaster to support patients and staff. Agency participants described their own internal emergency management protocols. Respondents discussed how and when the 2 intersected, as well as opportunities for future mutual support. The analysis identified several themes: (1) relationships between VAMC teams; (2) relationships between VHA and HHAs; (3) VHA and agencies responses during emergencies; (4) receptivity and opportunities for extending VHA resources into the community; and (5) barriers and facilitators to deeper engagement.

Relationships Within VHA (n = 17)

Staff at all VHA sites described close relationships between the internal emergency management and HBPC teams. HBPC teams identified patients who were most at risk during emergencies to triage those with the highest medical needs (eg, patients dependent on home infusion, oxygen, or electronic medical devices) and worked alongside emergency managers to develop plans to continue care during an emergency. HBPC representatives were part of their facilities’ local emergency response committees. Due to this close collaboration, VHA emergency managers were familiar with the needs of homebound veterans and caregivers. “I invite our [HBPC] program manager to attend [committee] meetings and … they’re part of the EOC [emergency operations center]," an emergency manager said. “We work together and I’m constantly in contact with that individual, especially during natural disasters and so forth, to ensure that everybody’s prepared in the community.”

On the other hand, community caremanagers—who described frequent interactions with HBPC teams, largely around coordinating and managing non-VHA home care services—were less likely to have direct relationships with their facility emergency managers. For example, when asked if they had a relationship with their emergency manager, a community care manager admitted, “I [only] know who he is.” They also did not report having structured protocols for veteran outreach during emergencies, “because all those veterans who are receiving [home health care worker] services also belong to a primary care team,” and considered the outreach to be the responsibility of the primary care team and HHA.

Relationships Between the VHA and HHAs (n = 17)

Communication between VAMCs and contracted agencies primarily went through community care managers, who described established long-term relationships with agency administrators. Communication was commonly restricted to operational activities, such as processing referrals and occasional troubleshooting. According to a community care manager most communication is “why haven’t you signed my orders?” There was a general sense from participants that communication was promptly answered, problems were addressed, and professional collegiality existed between the agencies as patients were referred and placed for services. One community care manager reported meeting with agencies regularly, noting, “I talk to them pretty much daily.”

If problems arose, community care managers described themselves as “the liaison” between agencies and VHA HCPs who ordered the referrals. This is particularly the case if the agency needed help finding a VHA clinician or addressing differences in care delivery protocols.

Responding During Emergencies (n = 19)

During emergencies, VHA and agency staff described following their own organization’s protocols and communicating with each other only on a case-by-case basis rather than through formal or systematic channels and had little knowledge of their counterpart’s emergency protocols. Beyond patient care, there was no evidence of information sharing between VHA and agency staff. Regarding sharing information with their local community, an HBPC Program Director said, “it’s almost like the VHA had become siloed” and operated on its own without engaging with community health systems or emergency managers.

Beyond the guidance provided by state departments of public health, HHAs described collaborating with other agencies in their network and relying on their informal professional network to manage the volume of information and updates they followed during emergencies like the COVID-19 pandemic. One agency administrator did not frequently communicate with VHA partners during the pandemic but explained that the local public health department helped work through challenges. However, “we realized pretty quickly they were overloaded and there was only so much they could do.” The agency administrator turned to a “sister agency” and local hospitals, noting, “Wherever you have connections in the field or in the industry, you know you’re going to reach out to people for guidance on policies and… protocol.”

Opportunities for Extending VHA Resources to the Community (n = 16)

All VHA emergency managers were receptive to extending support to community-based HCPS and, in some cases, felt strongly that they were an essential part of veterans’ care networks. Emergency managers offered examples for how they supportedcommunity-based HCPs, such as helping those in the VAMC medical foster home program develop and evaluate emergency plans. Many said they had not explicitly considered HHAs before (Appendix).

Emergency managers also described how supporting community-based HCPs could be considered within the scope of the VHA role and mission, specifically the Fourth Mission. “I think that we should be making our best effort to make sure that we’re also providing that same level [of protection] to the people taking care of the veteran [as our VHA staff],” an emergency manager said. “It’s our responsibility to provide the best for the staff that are going into those homes to take care of that patient.”

In many cases, emergency managers had already developed practical tools that could be easily shared outside the VHA, including weather alerts, trainings, emergency plan templates, and lists of community resources and shelters (Figure 2). A number of these examples built on existing communication channels. One emergency manager said that the extension of resources could be an opportunity to decrease the perceived isolation of home health care workers through regular training for agencies that are providing health care aides, so that they know that “some bigger folks are keeping an eye on it.”

On the agency side, participants noted that some HHAs could benefit more from support than others. While some agencies are well staffed and have good protocols and keep up to date, “There are smaller agencies, agencies that are starting up that may not have the resources to just disseminate all the information. Those are the agencies [that] could well benefit from the VHA,” an HBPC medical director explained. Agency administrators suggested several areas where they would welcome support, including a deeper understanding of available community resources and access to PPE for staff. Regarding informational resources, an administrator said, “Anytime we can get information, it’s good to have it come to you and not always have to go out searching for it.”

Barriers and Facilitators to Partnering With Community Agencies (n = 16)

A primary barrier regarding resource sharing was potential misalignment between each organization’s policies. HHAs followed state and federal public health guidelines, which sometimes differed from VHA policies. Given that agencies care for both VHA and non-VHA clients, questions also arose around how agencies would prioritize information from the VHA, if they were already receiving information from other sources. When asked about information sharing, both VHA staff and agencies agreed staff time to support any additional activities should be weighed against the value of the information gained.

Six participants also shared that education around emergency preparedness could be an opportunity to bridge gaps between VAMCs and their surrounding communities. One local Chief of Community Care noted, “Any opportunity to just give information is going to make it a lot better for the veteran patient … to have something that’s a little more robust.”

Two emergency managers noted the need to be sensitive in the way they engaged with partners, respecting and building on the work that agencies were already doing in this area to ensure VHA was seen as a trusted partner and resource rather than trying to impose new policies or rules on community-based HCPs. “I know that like all leadership in various organizations, there’s a little bit of bristling going on when other people try and tell them what to do,” an HBPC medical director said. “However, if it is established that as a sort of greater level like a state level or a federal level, that VHA can be a resource. I think that as long as that’s recognized by their own professional organizations within each state, then I think that that would be a tremendous advantage to many agencies.”

In terms of sharing physical resources, emergency managers raised concerns around potential liability, although they also acknowledged this issue was important enough to think about potential workarounds. As one emergency manager said, “I want to know that my PPE is not compromised in any way shape or form and that I am in charge of that PPE, so to rely upon going to a home and hoping that [the PPE] wasn’t compromised … would kind of make me a little uneasy.” This emergency manager suggested possible solutions, such as creating a sealed PPE package to give directly to an aide.

Discussion

As the prevalence of climate-related disasters increases, the need to ensure the safety and independence of older adults during emergencies grows more urgent. Health systems must think beyond the direct services they provide and consider the community resources upon which their patients rely. While relationships did not formally exist between VHA emergency managers and community home health HCPs in the sample analyzed in this article, there is precedent and interest in supporting contracted home health agencies caring for veterans in the community. Although not historically part of the VA Fourth Mission, creating a pipeline of support for contracted HHAs by leveraging existing relationships and resources can potentially strengthen its mission to protect older veterans in emergencies, help them age safely in place, and provide a model for health systems to collaborate with community-based HCPs around emergency planning and response (Figure 3).²³

Existing research on the value of health care coalitions highlights the need for established and growing partnerships with a focus on ensuring they are value-added, which echoes concerns we heard in interviews.²⁴ Investment in community partnerships not only includes sharing supplies but also relying on bidirectional support that can be a trusted form of timely information.^1,25 The findings in this study exhibit strong communication practices within the VHA during periods of nonemergency and underscore the untapped value of the pre-existing relationship between VAMCs and their contracted HHAs as an area of potential growth for health care coalitions.

Sharing resources in a way that does not put new demands on partners contributes to the sustainability and value-added nature of coalitions. Examples include establishing new low-investment practices (ie, information sharing) that support capacity and compliance with existing requirements rather than create new responsibilities for either member of the coalition. The relationship between the VHA emergency managers and the VHA HBPC program can act as a guide. The emergency managers interviewed for this study are currently engaged with HBPC programs and therefore understand the needs of homebound older adults and their caregivers. Extending the information already available to the HBPC teams via existing channels strengthens workforce practices and increased security for the shared patient, even without direct relationships between emergency managers and agencies. It is important to understand the limitations of these practices, including concerns around conflicting federal and state mandates, legal concerns around the liability of sharing physical resources (such as PPE), and awareness that the objective is not for the VHA to increase burdens (eg, increasing compliance requirements) but rather to serve as a resource for a mutual population in a shared community.

Offering training and practical resources to HHA home health care workers can help them meet disaster preparedness requirements. This is particularly important considering the growing home care workforce shortages, a topic mentioned by all HBPC and community care participants interviewed for this study.^26,27 Home health care workers report feeling underprepared and isolated while on the job in normal conditions, a sentiment exacerbated by the COVID-19 pandemic.^3,10 Supporting these individuals may help them feel more prepared and connected to their work, improving stability and quality of care.

While these issues are priorities within the VHA, there is growing recognition at the state and federal level of the importance of including older adults and their HCPs in disaster preparedness and response.^5,28 The US Department of Health and Human Services, for example, includes older adults and organizations that serve them on its National Advisory Committee on Seniors and Disasters. The Senate version of the 2023 reauthorization of the Pandemic and All-Hazards Preparedness and Response Act included specific provisions to support community-dwelling older adults and people with disabilities, incorporating funding for community organizations to support continuity of services and avoid institutionalization in an emergency.²⁹ Other proposed legislation includes the Real Emergency Access for Aging and Disability Inclusion for Disasters Act, which would ensure the needs of older adults and people with disabilities are explicitly included in all phases of emergency planning and response.³⁰

The VHA expansion of the its VEText program to include disaster response is an effort to more efficiently extend outreach to older and vulnerable patients who are veterans.³¹ Given these growing efforts, the VHA and other health systems have an opportunity to expand internal emergency preparedness efforts to ensure the health and safety of individuals living in the community.

Limitations

VISN 2 has been a target of terrorism and other disasters. In addition to the sites being initially recruited for their strong emergency management protocols, this context may have biased respondents who are favorable to extending their resources into the community. At the time of recruitment, contracted HHAs were still experiencing staff shortages due to the COVID-19 pandemic, which limited the ability of agency staff to participate in interviews. Additionally, while the comprehensive exploration of VISN 2 facilities allows for confidence of the organizational structures described, the qualitative research design and small study sample, the study findings cannot be immediately generalized to all VISNs.

Conclusions

Many older veterans increasingly rely on home health care workers to age safely. The VHA, as a large national health care system and leader in emergency preparedness, could play an important role in supporting home health care workers and ameliorating their sense of isolation during emergencies and natural disasters. Leveraging existing resources and relationships may be a low-cost, low-effort opportunity to build higher-level interventions that support the needs of patients. Future research and work in this field, including the authors’ ongoing work, will expand agency participation and engage agency staff in conceptualizing pilot projects to ensure they are viable and feasible for the field.

As large-scale natural disasters become more common, health care coalitions and the engagement of health systems with local, state, and federal public health departments have effectively bolstered communities’ resilience via collective sharing and distribution of resources.¹ These resources may include supplies and the dissemination of emergency information, education, and training.² The COVID-19 pandemic demonstrated that larger health care systems including hospital networks and nursing homes are better connected to health care coalition resources than smaller, independent systems, such as community home health agencies.³ This leaves some organizations on their own to meet requirements that maintain continuity of care and support their patients and staff throughout a natural disaster.

Home health care workers play important roles in the care of older adults.⁴ Older adults experience high levels of disability and comorbidities that put them at risk during emergencies; they often require support from paid, family, and neighborhood caregivers to live independently.⁵ More than 9.3 million US adults receive paid care from 2.6 million home health care workers (eg, home health aides and personal care assistants).⁶ Many of these individuals are hired through small independent home health agencies (HHAs), while others may work directly for an individual. When neighborhood resources and family caregiving are disrupted during emergencies, the critical services these workers administer become even more essential to ensuring continued access to medical care and social services.

The importance of these services was underscored by the Centers for Medicare and Medicaid Services 2017 inclusion of HHAs in federal emergency preparedness guidelines.^7,8 The fractured and decentralized nature of the home health care industry means many HHAs struggle to maintain continuous care during emergencies and protect their staff. HHAs, and health care workers in the home, are often isolated, under-resourced, and disconnected from broader emergency planning efforts. Additionally, home care jobs are largely part-time, unstable, and low paying, making the workers themselves vulnerable during emergencies.^3,9-13

This is a significant issue for the Veterans Health Administration (VHA), which annually purchases 10.5 million home health care worker visits for 150,000 veterans from community-based HHAs to enable those individuals to live independently. Figure 1 illustrates the existing structure of directly provided and contracted VHA services for community-dwelling veterans, highlighting the circle of care around the veteran.^8,9 Home health care workers anchored health care teams during the COVID-19 pandemic, observing and reporting on patients’ well-being to family caregivers, primary care practitioners, and HHAs. They also provided critical emotional support and companionship to patients isolated from family and friends.⁹ These workers also exposed themselves and their families to considerable risk and often lacked the protection afforded by personal protective equipment (PPE) in accordance with infection prevention guidance.^3,12

Through a combination of its national and local health care networks, the VHA has a robust and well-positioned emergency infrastructure to supportcommunity-dwelling older adults during disasters.¹⁴ This network is supported by the VHA Office of Emergency Management, which shares resources and guidance with local emergency managers at each facility as well as individual programs such as the VHA Home Based Primary Care (HBPC) program, which provides 38,000 seriously ill veterans with home medical visits.¹⁵ Working closely with their local and national hospital networks and emergency managers, individual VHA HBPC programs were able to maintain the safety of staff and continuity of care for patients enrolled in HBPC by rapidly administering COVID-19 vaccines to patients, caregivers, and staff, and providing emergency assistance during the 2017 hurricane season.^16,17 These efforts were successful because HBPC practitioners and their patients, had access to a level of emergency-related information, resources, and technology that are often out of reach for individual community-based health care practitioners (HCPs). The US Department of Veterans Affairs (VA) also supports local communities through its Fourth Mission, which provides emergency resources to non-VHA health care facilities (ie, hospitals and nursing homes) during national emergencies and natural disasters.¹⁷ Although there has been an expansion in the definition of shared resources, such as extending behavioral health support to local communities, the VHA has not historically provided these resources to HHAs.¹⁴

This study examines opportunities to leverage VHA emergency management resources to support contracted HHAs and inform other large health system emergency planning efforts. The findings from the exploratory phase are described in this article. We interviewed VHA emergency managers, HBPC and VA staff who coordinate home health care worker services, as well as administrators at contracted HHAs within a Veterans Integrated Services Network (VISN). These findings will inform the second (single-site pilot study) and third (feasibility study) phases. Our intent was to (1) better understand the relationships between VA medical centers (VAMCs) and their contracted HHAs; (2) identify existing VHA emergency protocols to support community-dwelling older adults; and (3) determine opportunities to build on existing infrastructure and relationships to better support contracted HHAs and their staff in emergencies.

Methods

The 18 VISNs act as regional systems of care that are loosely connected to better meet local health needs and maximize access to care. This study was conducted at 6 of 9 VAMCs within VISN 2, the New York/New Jersey VHA Health Care Network.¹⁸ VAMCs that serve urban, rural, and mixed urban/rural catchment areas were included.

Each VAMC has an emergency management program led by an emergency manager, an HBPC program led by a program director and medical director, and a community care or purchased care office that has a liaison who manages contracted home health care worker services. The studyfocused on HBPC programs because they are most likely to interact with veterans’ home health care workers in the home and care for community-dwelling veterans during emergencies. Each VHA also contracts with a series of local HHAs that generally have a dedicated staff member who interfaces with the VHA liaison. Our goal was to interview ≥ 1 emergency manager, ≥ 1 HBPC team member, ≥ 1 community care staff person, and ≥ 1 contracted home health agency administrator at each site to gain multiple perspectives from the range of HCPs serving veterans in the community.

Recruitment and Data Collection

The 6 sites were selected in consultation with VISN 2 leadership for their strong HBPC and emergency management programs. To recruit respondents, we contacted VISN and VAMC leads and used our professional networks to identify a sample of multidisciplinary individuals who represent both community care and HBPC programs who were contacted via email.

Since each VAMC is organized differently, we utilized a snowball sampling approach to identify the appropriate contacts.¹⁹ At the completion of each interview, we asked the participant to suggest additional contacts and introduce us to any remaining stakeholders (eg, the emergency manager) at that site or colleagues at other VISN facilities. Because roles vary among VAMCs, we contacted the person who most closely resembled the identified role and asked them to direct us to a more appropriate contact, if necessary. We asked community care managers to identify 1 to 2 agencies serving the highest volume of patients who are veterans at their site and requested interviews with those liaisons. This resulted in the recruitment of key stakeholders from 4 teams across the 6 sites (Table).

A semistructured interview guide was jointly developed based on constructs of interest, including relationships within VAMCs and between VAMCs and HHAs; existing emergency protocols and experience during disasters; and suggestions and opportunities for supporting agencies during emergencies and potential barriers. Two researchers (TWL and EF) who were trained in qualitative methods jointly conducted interviews using the interview guide, with 1 researcher leading and another taking notes and asking clarifying questions.

Interviews were conducted virtually via Microsoft Teams with respondents at their work locations between September 2022 and January 2023. Interviews were audio recorded and transcribed and 2 authors (TWL and ESO) reviewed transcripts for accuracy. Interviews averaged 47 minutes in length (range, 20-59).

The study was reviewed and determined to be exempt by institutional review boards at the James J. Peters VAMC and Greater Los Angeles VAMC. We asked participants for verbal consent to participate and preserved their confidentiality.

Analysis

Data were analyzed via an inductive approach, which involves drawing salient themes rather than imposing preconceived theories.²⁰ Three researchers (TWL, EF, and ES) listened to and discussed 2 staff interviews and tagged text with specific codes (eg, communication between the VHA and HHA, internal communication, and barriers to case fulfillment) so the team could selectively return to the interview text for deeper analysis, allowing for the development of a final codebook. The project team synthesized the findings to identify higher-level themes, drawing comparisons across and within the respondent groups, including within and between health care systems. Throughout the analysis, we maintained analytic memos, documented discussions, and engaged in analyst triangulation to ensure trustworthiness.^21,22 To ensure the analysis accurately reflected the participants’ understanding, we held 2 virtual member-checking sessions with participants to share preliminary findings and conclusions and solicit feedback. Analysis was conducted using ATLAS.ti version 20.

Results

VHA-based participants described internal emergency management systems that are deployed during a disaster to support patients and staff. Agency participants described their own internal emergency management protocols. Respondents discussed how and when the 2 intersected, as well as opportunities for future mutual support. The analysis identified several themes: (1) relationships between VAMC teams; (2) relationships between VHA and HHAs; (3) VHA and agencies responses during emergencies; (4) receptivity and opportunities for extending VHA resources into the community; and (5) barriers and facilitators to deeper engagement.

Relationships Within VHA (n = 17)

Staff at all VHA sites described close relationships between the internal emergency management and HBPC teams. HBPC teams identified patients who were most at risk during emergencies to triage those with the highest medical needs (eg, patients dependent on home infusion, oxygen, or electronic medical devices) and worked alongside emergency managers to develop plans to continue care during an emergency. HBPC representatives were part of their facilities’ local emergency response committees. Due to this close collaboration, VHA emergency managers were familiar with the needs of homebound veterans and caregivers. “I invite our [HBPC] program manager to attend [committee] meetings and … they’re part of the EOC [emergency operations center]," an emergency manager said. “We work together and I’m constantly in contact with that individual, especially during natural disasters and so forth, to ensure that everybody’s prepared in the community.”

On the other hand, community caremanagers—who described frequent interactions with HBPC teams, largely around coordinating and managing non-VHA home care services—were less likely to have direct relationships with their facility emergency managers. For example, when asked if they had a relationship with their emergency manager, a community care manager admitted, “I [only] know who he is.” They also did not report having structured protocols for veteran outreach during emergencies, “because all those veterans who are receiving [home health care worker] services also belong to a primary care team,” and considered the outreach to be the responsibility of the primary care team and HHA.

Relationships Between the VHA and HHAs (n = 17)

Communication between VAMCs and contracted agencies primarily went through community care managers, who described established long-term relationships with agency administrators. Communication was commonly restricted to operational activities, such as processing referrals and occasional troubleshooting. According to a community care manager most communication is “why haven’t you signed my orders?” There was a general sense from participants that communication was promptly answered, problems were addressed, and professional collegiality existed between the agencies as patients were referred and placed for services. One community care manager reported meeting with agencies regularly, noting, “I talk to them pretty much daily.”

If problems arose, community care managers described themselves as “the liaison” between agencies and VHA HCPs who ordered the referrals. This is particularly the case if the agency needed help finding a VHA clinician or addressing differences in care delivery protocols.

Responding During Emergencies (n = 19)

During emergencies, VHA and agency staff described following their own organization’s protocols and communicating with each other only on a case-by-case basis rather than through formal or systematic channels and had little knowledge of their counterpart’s emergency protocols. Beyond patient care, there was no evidence of information sharing between VHA and agency staff. Regarding sharing information with their local community, an HBPC Program Director said, “it’s almost like the VHA had become siloed” and operated on its own without engaging with community health systems or emergency managers.

Beyond the guidance provided by state departments of public health, HHAs described collaborating with other agencies in their network and relying on their informal professional network to manage the volume of information and updates they followed during emergencies like the COVID-19 pandemic. One agency administrator did not frequently communicate with VHA partners during the pandemic but explained that the local public health department helped work through challenges. However, “we realized pretty quickly they were overloaded and there was only so much they could do.” The agency administrator turned to a “sister agency” and local hospitals, noting, “Wherever you have connections in the field or in the industry, you know you’re going to reach out to people for guidance on policies and… protocol.”

Opportunities for Extending VHA Resources to the Community (n = 16)

All VHA emergency managers were receptive to extending support to community-based HCPS and, in some cases, felt strongly that they were an essential part of veterans’ care networks. Emergency managers offered examples for how they supportedcommunity-based HCPs, such as helping those in the VAMC medical foster home program develop and evaluate emergency plans. Many said they had not explicitly considered HHAs before (Appendix).

Emergency managers also described how supporting community-based HCPs could be considered within the scope of the VHA role and mission, specifically the Fourth Mission. “I think that we should be making our best effort to make sure that we’re also providing that same level [of protection] to the people taking care of the veteran [as our VHA staff],” an emergency manager said. “It’s our responsibility to provide the best for the staff that are going into those homes to take care of that patient.”

In many cases, emergency managers had already developed practical tools that could be easily shared outside the VHA, including weather alerts, trainings, emergency plan templates, and lists of community resources and shelters (Figure 2). A number of these examples built on existing communication channels. One emergency manager said that the extension of resources could be an opportunity to decrease the perceived isolation of home health care workers through regular training for agencies that are providing health care aides, so that they know that “some bigger folks are keeping an eye on it.”

On the agency side, participants noted that some HHAs could benefit more from support than others. While some agencies are well staffed and have good protocols and keep up to date, “There are smaller agencies, agencies that are starting up that may not have the resources to just disseminate all the information. Those are the agencies [that] could well benefit from the VHA,” an HBPC medical director explained. Agency administrators suggested several areas where they would welcome support, including a deeper understanding of available community resources and access to PPE for staff. Regarding informational resources, an administrator said, “Anytime we can get information, it’s good to have it come to you and not always have to go out searching for it.”

Barriers and Facilitators to Partnering With Community Agencies (n = 16)

A primary barrier regarding resource sharing was potential misalignment between each organization’s policies. HHAs followed state and federal public health guidelines, which sometimes differed from VHA policies. Given that agencies care for both VHA and non-VHA clients, questions also arose around how agencies would prioritize information from the VHA, if they were already receiving information from other sources. When asked about information sharing, both VHA staff and agencies agreed staff time to support any additional activities should be weighed against the value of the information gained.

Six participants also shared that education around emergency preparedness could be an opportunity to bridge gaps between VAMCs and their surrounding communities. One local Chief of Community Care noted, “Any opportunity to just give information is going to make it a lot better for the veteran patient … to have something that’s a little more robust.”

Two emergency managers noted the need to be sensitive in the way they engaged with partners, respecting and building on the work that agencies were already doing in this area to ensure VHA was seen as a trusted partner and resource rather than trying to impose new policies or rules on community-based HCPs. “I know that like all leadership in various organizations, there’s a little bit of bristling going on when other people try and tell them what to do,” an HBPC medical director said. “However, if it is established that as a sort of greater level like a state level or a federal level, that VHA can be a resource. I think that as long as that’s recognized by their own professional organizations within each state, then I think that that would be a tremendous advantage to many agencies.”

In terms of sharing physical resources, emergency managers raised concerns around potential liability, although they also acknowledged this issue was important enough to think about potential workarounds. As one emergency manager said, “I want to know that my PPE is not compromised in any way shape or form and that I am in charge of that PPE, so to rely upon going to a home and hoping that [the PPE] wasn’t compromised … would kind of make me a little uneasy.” This emergency manager suggested possible solutions, such as creating a sealed PPE package to give directly to an aide.

Discussion

As the prevalence of climate-related disasters increases, the need to ensure the safety and independence of older adults during emergencies grows more urgent. Health systems must think beyond the direct services they provide and consider the community resources upon which their patients rely. While relationships did not formally exist between VHA emergency managers and community home health HCPs in the sample analyzed in this article, there is precedent and interest in supporting contracted home health agencies caring for veterans in the community. Although not historically part of the VA Fourth Mission, creating a pipeline of support for contracted HHAs by leveraging existing relationships and resources can potentially strengthen its mission to protect older veterans in emergencies, help them age safely in place, and provide a model for health systems to collaborate with community-based HCPs around emergency planning and response (Figure 3).²³

Existing research on the value of health care coalitions highlights the need for established and growing partnerships with a focus on ensuring they are value-added, which echoes concerns we heard in interviews.²⁴ Investment in community partnerships not only includes sharing supplies but also relying on bidirectional support that can be a trusted form of timely information.^1,25 The findings in this study exhibit strong communication practices within the VHA during periods of nonemergency and underscore the untapped value of the pre-existing relationship between VAMCs and their contracted HHAs as an area of potential growth for health care coalitions.

Sharing resources in a way that does not put new demands on partners contributes to the sustainability and value-added nature of coalitions. Examples include establishing new low-investment practices (ie, information sharing) that support capacity and compliance with existing requirements rather than create new responsibilities for either member of the coalition. The relationship between the VHA emergency managers and the VHA HBPC program can act as a guide. The emergency managers interviewed for this study are currently engaged with HBPC programs and therefore understand the needs of homebound older adults and their caregivers. Extending the information already available to the HBPC teams via existing channels strengthens workforce practices and increased security for the shared patient, even without direct relationships between emergency managers and agencies. It is important to understand the limitations of these practices, including concerns around conflicting federal and state mandates, legal concerns around the liability of sharing physical resources (such as PPE), and awareness that the objective is not for the VHA to increase burdens (eg, increasing compliance requirements) but rather to serve as a resource for a mutual population in a shared community.

Offering training and practical resources to HHA home health care workers can help them meet disaster preparedness requirements. This is particularly important considering the growing home care workforce shortages, a topic mentioned by all HBPC and community care participants interviewed for this study.^26,27 Home health care workers report feeling underprepared and isolated while on the job in normal conditions, a sentiment exacerbated by the COVID-19 pandemic.^3,10 Supporting these individuals may help them feel more prepared and connected to their work, improving stability and quality of care.

While these issues are priorities within the VHA, there is growing recognition at the state and federal level of the importance of including older adults and their HCPs in disaster preparedness and response.^5,28 The US Department of Health and Human Services, for example, includes older adults and organizations that serve them on its National Advisory Committee on Seniors and Disasters. The Senate version of the 2023 reauthorization of the Pandemic and All-Hazards Preparedness and Response Act included specific provisions to support community-dwelling older adults and people with disabilities, incorporating funding for community organizations to support continuity of services and avoid institutionalization in an emergency.²⁹ Other proposed legislation includes the Real Emergency Access for Aging and Disability Inclusion for Disasters Act, which would ensure the needs of older adults and people with disabilities are explicitly included in all phases of emergency planning and response.³⁰

The VHA expansion of the its VEText program to include disaster response is an effort to more efficiently extend outreach to older and vulnerable patients who are veterans.³¹ Given these growing efforts, the VHA and other health systems have an opportunity to expand internal emergency preparedness efforts to ensure the health and safety of individuals living in the community.

Limitations

VISN 2 has been a target of terrorism and other disasters. In addition to the sites being initially recruited for their strong emergency management protocols, this context may have biased respondents who are favorable to extending their resources into the community. At the time of recruitment, contracted HHAs were still experiencing staff shortages due to the COVID-19 pandemic, which limited the ability of agency staff to participate in interviews. Additionally, while the comprehensive exploration of VISN 2 facilities allows for confidence of the organizational structures described, the qualitative research design and small study sample, the study findings cannot be immediately generalized to all VISNs.

Conclusions

Many older veterans increasingly rely on home health care workers to age safely. The VHA, as a large national health care system and leader in emergency preparedness, could play an important role in supporting home health care workers and ameliorating their sense of isolation during emergencies and natural disasters. Leveraging existing resources and relationships may be a low-cost, low-effort opportunity to build higher-level interventions that support the needs of patients. Future research and work in this field, including the authors’ ongoing work, will expand agency participation and engage agency staff in conceptualizing pilot projects to ensure they are viable and feasible for the field.

As large-scale natural disasters become more common, health care coalitions and the engagement of health systems with local, state, and federal public health departments have effectively bolstered communities’ resilience via collective sharing and distribution of resources.¹ These resources may include supplies and the dissemination of emergency information, education, and training.² The COVID-19 pandemic demonstrated that larger health care systems including hospital networks and nursing homes are better connected to health care coalition resources than smaller, independent systems, such as community home health agencies.³ This leaves some organizations on their own to meet requirements that maintain continuity of care and support their patients and staff throughout a natural disaster.

Home health care workers play important roles in the care of older adults.⁴ Older adults experience high levels of disability and comorbidities that put them at risk during emergencies; they often require support from paid, family, and neighborhood caregivers to live independently.⁵ More than 9.3 million US adults receive paid care from 2.6 million home health care workers (eg, home health aides and personal care assistants).⁶ Many of these individuals are hired through small independent home health agencies (HHAs), while others may work directly for an individual. When neighborhood resources and family caregiving are disrupted during emergencies, the critical services these workers administer become even more essential to ensuring continued access to medical care and social services.

The importance of these services was underscored by the Centers for Medicare and Medicaid Services 2017 inclusion of HHAs in federal emergency preparedness guidelines.^7,8 The fractured and decentralized nature of the home health care industry means many HHAs struggle to maintain continuous care during emergencies and protect their staff. HHAs, and health care workers in the home, are often isolated, under-resourced, and disconnected from broader emergency planning efforts. Additionally, home care jobs are largely part-time, unstable, and low paying, making the workers themselves vulnerable during emergencies.^3,9-13

This is a significant issue for the Veterans Health Administration (VHA), which annually purchases 10.5 million home health care worker visits for 150,000 veterans from community-based HHAs to enable those individuals to live independently. Figure 1 illustrates the existing structure of directly provided and contracted VHA services for community-dwelling veterans, highlighting the circle of care around the veteran.^8,9 Home health care workers anchored health care teams during the COVID-19 pandemic, observing and reporting on patients’ well-being to family caregivers, primary care practitioners, and HHAs. They also provided critical emotional support and companionship to patients isolated from family and friends.⁹ These workers also exposed themselves and their families to considerable risk and often lacked the protection afforded by personal protective equipment (PPE) in accordance with infection prevention guidance.^3,12

Through a combination of its national and local health care networks, the VHA has a robust and well-positioned emergency infrastructure to supportcommunity-dwelling older adults during disasters.¹⁴ This network is supported by the VHA Office of Emergency Management, which shares resources and guidance with local emergency managers at each facility as well as individual programs such as the VHA Home Based Primary Care (HBPC) program, which provides 38,000 seriously ill veterans with home medical visits.¹⁵ Working closely with their local and national hospital networks and emergency managers, individual VHA HBPC programs were able to maintain the safety of staff and continuity of care for patients enrolled in HBPC by rapidly administering COVID-19 vaccines to patients, caregivers, and staff, and providing emergency assistance during the 2017 hurricane season.^16,17 These efforts were successful because HBPC practitioners and their patients, had access to a level of emergency-related information, resources, and technology that are often out of reach for individual community-based health care practitioners (HCPs). The US Department of Veterans Affairs (VA) also supports local communities through its Fourth Mission, which provides emergency resources to non-VHA health care facilities (ie, hospitals and nursing homes) during national emergencies and natural disasters.¹⁷ Although there has been an expansion in the definition of shared resources, such as extending behavioral health support to local communities, the VHA has not historically provided these resources to HHAs.¹⁴

This study examines opportunities to leverage VHA emergency management resources to support contracted HHAs and inform other large health system emergency planning efforts. The findings from the exploratory phase are described in this article. We interviewed VHA emergency managers, HBPC and VA staff who coordinate home health care worker services, as well as administrators at contracted HHAs within a Veterans Integrated Services Network (VISN). These findings will inform the second (single-site pilot study) and third (feasibility study) phases. Our intent was to (1) better understand the relationships between VA medical centers (VAMCs) and their contracted HHAs; (2) identify existing VHA emergency protocols to support community-dwelling older adults; and (3) determine opportunities to build on existing infrastructure and relationships to better support contracted HHAs and their staff in emergencies.

Methods

The 18 VISNs act as regional systems of care that are loosely connected to better meet local health needs and maximize access to care. This study was conducted at 6 of 9 VAMCs within VISN 2, the New York/New Jersey VHA Health Care Network.¹⁸ VAMCs that serve urban, rural, and mixed urban/rural catchment areas were included.

Each VAMC has an emergency management program led by an emergency manager, an HBPC program led by a program director and medical director, and a community care or purchased care office that has a liaison who manages contracted home health care worker services. The studyfocused on HBPC programs because they are most likely to interact with veterans’ home health care workers in the home and care for community-dwelling veterans during emergencies. Each VHA also contracts with a series of local HHAs that generally have a dedicated staff member who interfaces with the VHA liaison. Our goal was to interview ≥ 1 emergency manager, ≥ 1 HBPC team member, ≥ 1 community care staff person, and ≥ 1 contracted home health agency administrator at each site to gain multiple perspectives from the range of HCPs serving veterans in the community.

Recruitment and Data Collection

The 6 sites were selected in consultation with VISN 2 leadership for their strong HBPC and emergency management programs. To recruit respondents, we contacted VISN and VAMC leads and used our professional networks to identify a sample of multidisciplinary individuals who represent both community care and HBPC programs who were contacted via email.

Since each VAMC is organized differently, we utilized a snowball sampling approach to identify the appropriate contacts.¹⁹ At the completion of each interview, we asked the participant to suggest additional contacts and introduce us to any remaining stakeholders (eg, the emergency manager) at that site or colleagues at other VISN facilities. Because roles vary among VAMCs, we contacted the person who most closely resembled the identified role and asked them to direct us to a more appropriate contact, if necessary. We asked community care managers to identify 1 to 2 agencies serving the highest volume of patients who are veterans at their site and requested interviews with those liaisons. This resulted in the recruitment of key stakeholders from 4 teams across the 6 sites (Table).

A semistructured interview guide was jointly developed based on constructs of interest, including relationships within VAMCs and between VAMCs and HHAs; existing emergency protocols and experience during disasters; and suggestions and opportunities for supporting agencies during emergencies and potential barriers. Two researchers (TWL and EF) who were trained in qualitative methods jointly conducted interviews using the interview guide, with 1 researcher leading and another taking notes and asking clarifying questions.

Interviews were conducted virtually via Microsoft Teams with respondents at their work locations between September 2022 and January 2023. Interviews were audio recorded and transcribed and 2 authors (TWL and ESO) reviewed transcripts for accuracy. Interviews averaged 47 minutes in length (range, 20-59).

The study was reviewed and determined to be exempt by institutional review boards at the James J. Peters VAMC and Greater Los Angeles VAMC. We asked participants for verbal consent to participate and preserved their confidentiality.

Analysis

Data were analyzed via an inductive approach, which involves drawing salient themes rather than imposing preconceived theories.²⁰ Three researchers (TWL, EF, and ES) listened to and discussed 2 staff interviews and tagged text with specific codes (eg, communication between the VHA and HHA, internal communication, and barriers to case fulfillment) so the team could selectively return to the interview text for deeper analysis, allowing for the development of a final codebook. The project team synthesized the findings to identify higher-level themes, drawing comparisons across and within the respondent groups, including within and between health care systems. Throughout the analysis, we maintained analytic memos, documented discussions, and engaged in analyst triangulation to ensure trustworthiness.^21,22 To ensure the analysis accurately reflected the participants’ understanding, we held 2 virtual member-checking sessions with participants to share preliminary findings and conclusions and solicit feedback. Analysis was conducted using ATLAS.ti version 20.

Results

VHA-based participants described internal emergency management systems that are deployed during a disaster to support patients and staff. Agency participants described their own internal emergency management protocols. Respondents discussed how and when the 2 intersected, as well as opportunities for future mutual support. The analysis identified several themes: (1) relationships between VAMC teams; (2) relationships between VHA and HHAs; (3) VHA and agencies responses during emergencies; (4) receptivity and opportunities for extending VHA resources into the community; and (5) barriers and facilitators to deeper engagement.

Relationships Within VHA (n = 17)

Staff at all VHA sites described close relationships between the internal emergency management and HBPC teams. HBPC teams identified patients who were most at risk during emergencies to triage those with the highest medical needs (eg, patients dependent on home infusion, oxygen, or electronic medical devices) and worked alongside emergency managers to develop plans to continue care during an emergency. HBPC representatives were part of their facilities’ local emergency response committees. Due to this close collaboration, VHA emergency managers were familiar with the needs of homebound veterans and caregivers. “I invite our [HBPC] program manager to attend [committee] meetings and … they’re part of the EOC [emergency operations center]," an emergency manager said. “We work together and I’m constantly in contact with that individual, especially during natural disasters and so forth, to ensure that everybody’s prepared in the community.”

On the other hand, community caremanagers—who described frequent interactions with HBPC teams, largely around coordinating and managing non-VHA home care services—were less likely to have direct relationships with their facility emergency managers. For example, when asked if they had a relationship with their emergency manager, a community care manager admitted, “I [only] know who he is.” They also did not report having structured protocols for veteran outreach during emergencies, “because all those veterans who are receiving [home health care worker] services also belong to a primary care team,” and considered the outreach to be the responsibility of the primary care team and HHA.

Relationships Between the VHA and HHAs (n = 17)

Communication between VAMCs and contracted agencies primarily went through community care managers, who described established long-term relationships with agency administrators. Communication was commonly restricted to operational activities, such as processing referrals and occasional troubleshooting. According to a community care manager most communication is “why haven’t you signed my orders?” There was a general sense from participants that communication was promptly answered, problems were addressed, and professional collegiality existed between the agencies as patients were referred and placed for services. One community care manager reported meeting with agencies regularly, noting, “I talk to them pretty much daily.”

If problems arose, community care managers described themselves as “the liaison” between agencies and VHA HCPs who ordered the referrals. This is particularly the case if the agency needed help finding a VHA clinician or addressing differences in care delivery protocols.

Responding During Emergencies (n = 19)

During emergencies, VHA and agency staff described following their own organization’s protocols and communicating with each other only on a case-by-case basis rather than through formal or systematic channels and had little knowledge of their counterpart’s emergency protocols. Beyond patient care, there was no evidence of information sharing between VHA and agency staff. Regarding sharing information with their local community, an HBPC Program Director said, “it’s almost like the VHA had become siloed” and operated on its own without engaging with community health systems or emergency managers.

Beyond the guidance provided by state departments of public health, HHAs described collaborating with other agencies in their network and relying on their informal professional network to manage the volume of information and updates they followed during emergencies like the COVID-19 pandemic. One agency administrator did not frequently communicate with VHA partners during the pandemic but explained that the local public health department helped work through challenges. However, “we realized pretty quickly they were overloaded and there was only so much they could do.” The agency administrator turned to a “sister agency” and local hospitals, noting, “Wherever you have connections in the field or in the industry, you know you’re going to reach out to people for guidance on policies and… protocol.”

Opportunities for Extending VHA Resources to the Community (n = 16)

All VHA emergency managers were receptive to extending support to community-based HCPS and, in some cases, felt strongly that they were an essential part of veterans’ care networks. Emergency managers offered examples for how they supportedcommunity-based HCPs, such as helping those in the VAMC medical foster home program develop and evaluate emergency plans. Many said they had not explicitly considered HHAs before (Appendix).

Emergency managers also described how supporting community-based HCPs could be considered within the scope of the VHA role and mission, specifically the Fourth Mission. “I think that we should be making our best effort to make sure that we’re also providing that same level [of protection] to the people taking care of the veteran [as our VHA staff],” an emergency manager said. “It’s our responsibility to provide the best for the staff that are going into those homes to take care of that patient.”

In many cases, emergency managers had already developed practical tools that could be easily shared outside the VHA, including weather alerts, trainings, emergency plan templates, and lists of community resources and shelters (Figure 2). A number of these examples built on existing communication channels. One emergency manager said that the extension of resources could be an opportunity to decrease the perceived isolation of home health care workers through regular training for agencies that are providing health care aides, so that they know that “some bigger folks are keeping an eye on it.”

On the agency side, participants noted that some HHAs could benefit more from support than others. While some agencies are well staffed and have good protocols and keep up to date, “There are smaller agencies, agencies that are starting up that may not have the resources to just disseminate all the information. Those are the agencies [that] could well benefit from the VHA,” an HBPC medical director explained. Agency administrators suggested several areas where they would welcome support, including a deeper understanding of available community resources and access to PPE for staff. Regarding informational resources, an administrator said, “Anytime we can get information, it’s good to have it come to you and not always have to go out searching for it.”

Barriers and Facilitators to Partnering With Community Agencies (n = 16)

A primary barrier regarding resource sharing was potential misalignment between each organization’s policies. HHAs followed state and federal public health guidelines, which sometimes differed from VHA policies. Given that agencies care for both VHA and non-VHA clients, questions also arose around how agencies would prioritize information from the VHA, if they were already receiving information from other sources. When asked about information sharing, both VHA staff and agencies agreed staff time to support any additional activities should be weighed against the value of the information gained.

Six participants also shared that education around emergency preparedness could be an opportunity to bridge gaps between VAMCs and their surrounding communities. One local Chief of Community Care noted, “Any opportunity to just give information is going to make it a lot better for the veteran patient … to have something that’s a little more robust.”

Two emergency managers noted the need to be sensitive in the way they engaged with partners, respecting and building on the work that agencies were already doing in this area to ensure VHA was seen as a trusted partner and resource rather than trying to impose new policies or rules on community-based HCPs. “I know that like all leadership in various organizations, there’s a little bit of bristling going on when other people try and tell them what to do,” an HBPC medical director said. “However, if it is established that as a sort of greater level like a state level or a federal level, that VHA can be a resource. I think that as long as that’s recognized by their own professional organizations within each state, then I think that that would be a tremendous advantage to many agencies.”

In terms of sharing physical resources, emergency managers raised concerns around potential liability, although they also acknowledged this issue was important enough to think about potential workarounds. As one emergency manager said, “I want to know that my PPE is not compromised in any way shape or form and that I am in charge of that PPE, so to rely upon going to a home and hoping that [the PPE] wasn’t compromised … would kind of make me a little uneasy.” This emergency manager suggested possible solutions, such as creating a sealed PPE package to give directly to an aide.

Discussion

As the prevalence of climate-related disasters increases, the need to ensure the safety and independence of older adults during emergencies grows more urgent. Health systems must think beyond the direct services they provide and consider the community resources upon which their patients rely. While relationships did not formally exist between VHA emergency managers and community home health HCPs in the sample analyzed in this article, there is precedent and interest in supporting contracted home health agencies caring for veterans in the community. Although not historically part of the VA Fourth Mission, creating a pipeline of support for contracted HHAs by leveraging existing relationships and resources can potentially strengthen its mission to protect older veterans in emergencies, help them age safely in place, and provide a model for health systems to collaborate with community-based HCPs around emergency planning and response (Figure 3).²³

Existing research on the value of health care coalitions highlights the need for established and growing partnerships with a focus on ensuring they are value-added, which echoes concerns we heard in interviews.²⁴ Investment in community partnerships not only includes sharing supplies but also relying on bidirectional support that can be a trusted form of timely information.^1,25 The findings in this study exhibit strong communication practices within the VHA during periods of nonemergency and underscore the untapped value of the pre-existing relationship between VAMCs and their contracted HHAs as an area of potential growth for health care coalitions.

Sharing resources in a way that does not put new demands on partners contributes to the sustainability and value-added nature of coalitions. Examples include establishing new low-investment practices (ie, information sharing) that support capacity and compliance with existing requirements rather than create new responsibilities for either member of the coalition. The relationship between the VHA emergency managers and the VHA HBPC program can act as a guide. The emergency managers interviewed for this study are currently engaged with HBPC programs and therefore understand the needs of homebound older adults and their caregivers. Extending the information already available to the HBPC teams via existing channels strengthens workforce practices and increased security for the shared patient, even without direct relationships between emergency managers and agencies. It is important to understand the limitations of these practices, including concerns around conflicting federal and state mandates, legal concerns around the liability of sharing physical resources (such as PPE), and awareness that the objective is not for the VHA to increase burdens (eg, increasing compliance requirements) but rather to serve as a resource for a mutual population in a shared community.

Offering training and practical resources to HHA home health care workers can help them meet disaster preparedness requirements. This is particularly important considering the growing home care workforce shortages, a topic mentioned by all HBPC and community care participants interviewed for this study.^26,27 Home health care workers report feeling underprepared and isolated while on the job in normal conditions, a sentiment exacerbated by the COVID-19 pandemic.^3,10 Supporting these individuals may help them feel more prepared and connected to their work, improving stability and quality of care.

While these issues are priorities within the VHA, there is growing recognition at the state and federal level of the importance of including older adults and their HCPs in disaster preparedness and response.^5,28 The US Department of Health and Human Services, for example, includes older adults and organizations that serve them on its National Advisory Committee on Seniors and Disasters. The Senate version of the 2023 reauthorization of the Pandemic and All-Hazards Preparedness and Response Act included specific provisions to support community-dwelling older adults and people with disabilities, incorporating funding for community organizations to support continuity of services and avoid institutionalization in an emergency.²⁹ Other proposed legislation includes the Real Emergency Access for Aging and Disability Inclusion for Disasters Act, which would ensure the needs of older adults and people with disabilities are explicitly included in all phases of emergency planning and response.³⁰

The VHA expansion of the its VEText program to include disaster response is an effort to more efficiently extend outreach to older and vulnerable patients who are veterans.³¹ Given these growing efforts, the VHA and other health systems have an opportunity to expand internal emergency preparedness efforts to ensure the health and safety of individuals living in the community.

Limitations

VISN 2 has been a target of terrorism and other disasters. In addition to the sites being initially recruited for their strong emergency management protocols, this context may have biased respondents who are favorable to extending their resources into the community. At the time of recruitment, contracted HHAs were still experiencing staff shortages due to the COVID-19 pandemic, which limited the ability of agency staff to participate in interviews. Additionally, while the comprehensive exploration of VISN 2 facilities allows for confidence of the organizational structures described, the qualitative research design and small study sample, the study findings cannot be immediately generalized to all VISNs.

Conclusions

Many older veterans increasingly rely on home health care workers to age safely. The VHA, as a large national health care system and leader in emergency preparedness, could play an important role in supporting home health care workers and ameliorating their sense of isolation during emergencies and natural disasters. Leveraging existing resources and relationships may be a low-cost, low-effort opportunity to build higher-level interventions that support the needs of patients. Future research and work in this field, including the authors’ ongoing work, will expand agency participation and engage agency staff in conceptualizing pilot projects to ensure they are viable and feasible for the field.

Actively Recruiting

→Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes

More than 25% of the patients admitted in the general wards have a history of diabetes mellitus. Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In veterans, the prevalence is disproportionally higher. It is estimated that 40% to 50% of hospitalized veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System, with which glucose values can be wirelessly transmitted from the patient’s bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.

ID: NCT03508934

Sponsor; Investigator: VA Office of Research and Development; Ilias Spanakis, MD

Locations: Baltimore VA Medical Center, Maryland

→Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation (GEM)

The population of older veterans with nontraumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for veterans with nontraumatic lower limb amputation. Additionally, this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for veterans with nontraumatic amputation through gait training programs based in motor learning principles, resulting in improved.

ID: NCT003995238

Sponsor; Investigator: VA Office of Research and Development; Cory L. Christiansen, PhD

Locations: Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

→Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial (ACTIVet-2)

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators haveshown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a hybrid type 2 effectiveness implementation trial using a cluster randomized stepped wedgedesign at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

ID: NCT05169359

Sponsor; Investigator: VA Office of Research and Development; Howard S. Gordon, MD

Location: 8 locations, including Jesse Brown VA Medical Center, Chicago; Edward Hines Jr. VA Hopsital, Hines, Illinois

→The Diabetes Staging System in Patient Aligned Care Teams

The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System in patient aligned care teams and its ability to increase sodium-glucosecotransporter-2 inhibitor and glucagon-like-1 peptide use in veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease. A novel type 2 diabetes staging system patterned after Tumor Node Metastasis cancer staging that uses the number of macrovascular and microvascular complications and most recent hemoglobin A_1c and glomerular filtration rate to determine Diabetes Staging System stage which reflects disease severity.

ID: NCT06142006

Sponsor; Collaborator: Durham VA Medical Center; Moahad Dar, MD

Location: Greenville VA Health Care Center, North Carolina

→Enhancing Mental and Physical Health of Women Veterans (EMPOWER)

Women veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women veterans’ needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation effectiveness trial testing 2 strategies designed to support implementation and sustainment of evidence-based practices for women veterans in at least 20 VA facilities from 4 regions.

ID: NCT05050266

Sponsor; Investigator: VA Office of Research and Development; Alison B. Hamilton, PhD, MPH

Location: VA Greater Los Angeles Healthcare System

→Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)

The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in patients with diabetes. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.

ID: NCT03012529

Sponsor; Investigator: VA Office of Research and Development; Paul A. Monach, MD, PhD

Location: 30 VA locations, including South Texas Health Care System, San Antonio; Cincinnati VA Medical Center, Ohio; VA Northern California Health Care System, Mather; Washington DC VA Medical Center; William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin

→Effectiveness of Remote Foot Temperature Monitoring (STOP)

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poorbecause the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a “smart” mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

ID: NCT05728411

Sponsor; Investigator: VA Office of Research and Development; Rachel M. Thomas

Location: Edward Hines Jr. VA Hospital, Hines, Illinois; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; VA Puget Sound Health Care System, Seattle, Washington

→Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit who received continuous glucose monitoring vs point of care glucose monitoring. The study will examine relevant outcomes for patients in the intensive care unit with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).

ID: NCT05442853

Sponsor; Investigator: Malcom Randall VA Medical Center; Andrew J. Franck, PharmD

Location: Malcolm Randall VA Medical Center, Gainesville, Florida

→Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA _1c , fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m ² ; and do not fulfill any exclusion criteria.

ID: NCT04838392

Sponsor; Investigator: VA Office of Research and Development; Gregory G. Schwartz, PhD, MD

Locations: 40 locations

Actively Recruiting

→Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes

More than 25% of the patients admitted in the general wards have a history of diabetes mellitus. Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In veterans, the prevalence is disproportionally higher. It is estimated that 40% to 50% of hospitalized veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System, with which glucose values can be wirelessly transmitted from the patient’s bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.

ID: NCT03508934

Sponsor; Investigator: VA Office of Research and Development; Ilias Spanakis, MD

Locations: Baltimore VA Medical Center, Maryland

→Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation (GEM)

The population of older veterans with nontraumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for veterans with nontraumatic lower limb amputation. Additionally, this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for veterans with nontraumatic amputation through gait training programs based in motor learning principles, resulting in improved.

ID: NCT003995238

Sponsor; Investigator: VA Office of Research and Development; Cory L. Christiansen, PhD

Locations: Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

→Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial (ACTIVet-2)

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators haveshown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a hybrid type 2 effectiveness implementation trial using a cluster randomized stepped wedgedesign at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

ID: NCT05169359

Sponsor; Investigator: VA Office of Research and Development; Howard S. Gordon, MD

Location: 8 locations, including Jesse Brown VA Medical Center, Chicago; Edward Hines Jr. VA Hopsital, Hines, Illinois

→The Diabetes Staging System in Patient Aligned Care Teams

The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System in patient aligned care teams and its ability to increase sodium-glucosecotransporter-2 inhibitor and glucagon-like-1 peptide use in veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease. A novel type 2 diabetes staging system patterned after Tumor Node Metastasis cancer staging that uses the number of macrovascular and microvascular complications and most recent hemoglobin A_1c and glomerular filtration rate to determine Diabetes Staging System stage which reflects disease severity.

ID: NCT06142006

Sponsor; Collaborator: Durham VA Medical Center; Moahad Dar, MD

Location: Greenville VA Health Care Center, North Carolina

→Enhancing Mental and Physical Health of Women Veterans (EMPOWER)

Women veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women veterans’ needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation effectiveness trial testing 2 strategies designed to support implementation and sustainment of evidence-based practices for women veterans in at least 20 VA facilities from 4 regions.

ID: NCT05050266

Sponsor; Investigator: VA Office of Research and Development; Alison B. Hamilton, PhD, MPH

Location: VA Greater Los Angeles Healthcare System

→Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)

The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in patients with diabetes. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.

ID: NCT03012529

Sponsor; Investigator: VA Office of Research and Development; Paul A. Monach, MD, PhD

Location: 30 VA locations, including South Texas Health Care System, San Antonio; Cincinnati VA Medical Center, Ohio; VA Northern California Health Care System, Mather; Washington DC VA Medical Center; William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin

→Effectiveness of Remote Foot Temperature Monitoring (STOP)

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poorbecause the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a “smart” mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

ID: NCT05728411

Sponsor; Investigator: VA Office of Research and Development; Rachel M. Thomas

Location: Edward Hines Jr. VA Hospital, Hines, Illinois; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; VA Puget Sound Health Care System, Seattle, Washington

→Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit who received continuous glucose monitoring vs point of care glucose monitoring. The study will examine relevant outcomes for patients in the intensive care unit with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).

ID: NCT05442853

Sponsor; Investigator: Malcom Randall VA Medical Center; Andrew J. Franck, PharmD

Location: Malcolm Randall VA Medical Center, Gainesville, Florida

→Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA _1c , fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m ² ; and do not fulfill any exclusion criteria.

ID: NCT04838392

Sponsor; Investigator: VA Office of Research and Development; Gregory G. Schwartz, PhD, MD

Locations: 40 locations

Actively Recruiting

→Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes

More than 25% of the patients admitted in the general wards have a history of diabetes mellitus. Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In veterans, the prevalence is disproportionally higher. It is estimated that 40% to 50% of hospitalized veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System, with which glucose values can be wirelessly transmitted from the patient’s bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.

ID: NCT03508934

Sponsor; Investigator: VA Office of Research and Development; Ilias Spanakis, MD

Locations: Baltimore VA Medical Center, Maryland

→Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation (GEM)

The population of older veterans with nontraumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for veterans with nontraumatic lower limb amputation. Additionally, this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for veterans with nontraumatic amputation through gait training programs based in motor learning principles, resulting in improved.

ID: NCT003995238

Sponsor; Investigator: VA Office of Research and Development; Cory L. Christiansen, PhD

Locations: Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

→Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial (ACTIVet-2)

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators haveshown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a hybrid type 2 effectiveness implementation trial using a cluster randomized stepped wedgedesign at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

ID: NCT05169359

Sponsor; Investigator: VA Office of Research and Development; Howard S. Gordon, MD

Location: 8 locations, including Jesse Brown VA Medical Center, Chicago; Edward Hines Jr. VA Hopsital, Hines, Illinois

→The Diabetes Staging System in Patient Aligned Care Teams

The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System in patient aligned care teams and its ability to increase sodium-glucosecotransporter-2 inhibitor and glucagon-like-1 peptide use in veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease. A novel type 2 diabetes staging system patterned after Tumor Node Metastasis cancer staging that uses the number of macrovascular and microvascular complications and most recent hemoglobin A_1c and glomerular filtration rate to determine Diabetes Staging System stage which reflects disease severity.

ID: NCT06142006

Sponsor; Collaborator: Durham VA Medical Center; Moahad Dar, MD

Location: Greenville VA Health Care Center, North Carolina

→Enhancing Mental and Physical Health of Women Veterans (EMPOWER)

Women veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women veterans’ needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation effectiveness trial testing 2 strategies designed to support implementation and sustainment of evidence-based practices for women veterans in at least 20 VA facilities from 4 regions.

ID: NCT05050266

Sponsor; Investigator: VA Office of Research and Development; Alison B. Hamilton, PhD, MPH

Location: VA Greater Los Angeles Healthcare System

→Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)

The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in patients with diabetes. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.

ID: NCT03012529

Sponsor; Investigator: VA Office of Research and Development; Paul A. Monach, MD, PhD

Location: 30 VA locations, including South Texas Health Care System, San Antonio; Cincinnati VA Medical Center, Ohio; VA Northern California Health Care System, Mather; Washington DC VA Medical Center; William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin

→Effectiveness of Remote Foot Temperature Monitoring (STOP)

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poorbecause the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a “smart” mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

ID: NCT05728411

Sponsor; Investigator: VA Office of Research and Development; Rachel M. Thomas

Location: Edward Hines Jr. VA Hospital, Hines, Illinois; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; VA Puget Sound Health Care System, Seattle, Washington

→Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit who received continuous glucose monitoring vs point of care glucose monitoring. The study will examine relevant outcomes for patients in the intensive care unit with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).

ID: NCT05442853

Sponsor; Investigator: Malcom Randall VA Medical Center; Andrew J. Franck, PharmD

Location: Malcolm Randall VA Medical Center, Gainesville, Florida

→Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA _1c , fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m ² ; and do not fulfill any exclusion criteria.

ID: NCT04838392

Sponsor; Investigator: VA Office of Research and Development; Gregory G. Schwartz, PhD, MD

Locations: 40 locations

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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