Fargo-Moorhead Muscle Health with Amanda Simmers of Inspire Fitness and Nutrition & Tessa Simmers, RD, Nutrition Coach

Amanda Simmers, Nutrition Coach, Owner of Inspire Fitness and Nutrition; Tessa Simmers, RD, Nutrition Coach

Fargo-Moorhead Muscle Health with Amanda Simmers of Inspire Fitness and Nutrition & Tessa Simmers, RD, Nutrition Coach
Amanda Simmers (photo by Sadie Swift) (left) & Tessa Simmers (photo courtesy of Tessa Simmers) (right)

Sister-in-law duo, Amanda and Tessa, share a passion for nutrition and exercise. Amanda graduated from NDSU with an education degree. After working as a preschool director for 14 years, she went back to school for personal training and nutrition coaching. She started the company almost 10 years ago, and Tessa joined her as a nutrition coach in January 2023. Tessa graduated from NDSU with a degree in food & nutrition and is currently a Registered Dietitian living in Fargo

Why is it important?
“Muscles are essential! They play a critical role in our bodies by keeping us alive and allowing us to interact with our world. Muscles are important for movement, stability, posture and many other functions. Strong, healthy muscles are critical for our overall health and wellness.”

3 Things You Should Know

1. Building muscle requires sufficient and consistent nutrition.

“It is very important that you fuel your body adequately with enough calories that include [the right amount of] protein, carbs and fat. Protein is the key nutrient to help recover and build those muscles. Carbs are your number one fuel source that will give you lasting energy during your workouts and fats help support hormone levels. Trendy diets can be appealing because they promise quick results, but they are restrictive in caloric intake and do more harm than good on your metabolism and they could cause you to lose lean muscle mass because of inadequate energy (food). How much one should eat depends on each person individually and depends on their goals, daily energy output and dieting history. In my Ditch the Diet program, we help each client individually figure out exactly how much they should be eating each day. It is not a one-size-fits-all plan and takes some deeper digging to get more accurate numbers.”

2. There is a smarter way to build lean muscle without having to spend hours a day lifting weights.

“We understand that most people have jobs, families, school and many other responsibilities and time can be hard to come by some days. Doing more so always better in this situation. As a matter of fact, rest days are a very important part of building lean muscle. You can see significant improvement in your lean muscle mass just by doing a strength training program for 20-30 minute sessions, 2-4x/week. These strength training programs can be done at a gym or at home. No matter where you train, it is best to push yourself mentally and physically with a shorter program than trying to pile on many exercises with a longer program.”

3. It is normal to lose strength as we age but it doesn’t mean we can’t continue trying to preserve and even grow muscle.

“Research shows that keeping your muscles strong as you age can lower your risk of falls, fractures and disability. Loss of strength may also limit mobility and prevent you from living independently. Strong, healthy muscles help you live an active life and work to support your skeletal system. When muscle mass decreases, fat mass increases which could put you at a higher risk of cardiovascular disease, high blood pressure and diabetes.”

Try Local!

  • “Power Plate Meals of Fargo inspires change by making healthy eating accessible for everyone, one meal at a time. I purchase a lot of my lunches from Power Plate Meals because I know each meal is made with high-quality ingredients and flavor. Plus each meal has a great deal of protein in them to help reach your daily protein goals.”
  • “Dynasty Performance Training and Owner/Trainer Cole Jirik can help you develop and execute a personalized, effective strength training program in a top-of-the-line facility.”

Dynasty performance Training owner Cole Jirk has developed the gym’s training principles through his own thoughts, his experience playing for NDSU football where he worked with one of the top strength and conditioning coaches in the country, Jim Kramer, and from his time training at ETS Performance in Minneapolis, MN!


  • “Swanson Health Products Retail Store offers the best selection of vitamins and supplements plus an excellent variety of organic and natural products.”
  • “Kota Botanics is a premium CBD wellness brand and marketplace in Fargo, ND and Shakopee, MN that focuses on providing the highest quality and the most effective CBD and other wellness products to improve their customers’ well-being such as inflammation, pain, stress and sleep. Kota Botanics owner, Vivian, has a wealth of knowledge and will help you find the best product to suit your needs.”

Who To Follow:

Make sure to follow Amanda & Tessa online for more tips and to try out the program!

Website: a m a n d a s i m m e r s . c o m
Facebook: / a m a n d a . l . s i m m e r s
Facebook: /tessasimmers.nutrition
Instagram: /amandasimmers
Instagram: /tessasimmers_nutrition

How to ensure social determinants of health actually improve health care

Presented 80 p.c of a person’s health is affected by non-healthcare variables, it is no surprise that the two overall health treatment companies and well being strategies are on the lookout for means to superior deal with the broader established of social and economic disorders that influence wellbeing. Emblematic of the ongoing shift from quantity to value, an escalating quantity of Medicaid-managed care contracts are requiring health plans to measure and handle the social determinants of overall health (SDoH), with the final objective of lowering well being disparities and escalating overall health and fitness. Although relocating in the suitable way, the means for wellbeing options to employ evidence-centered interventions to increase health and fitness fairness is significantly hampered by a absence of provider Z code utilization. If you can not measure it, you can’t handle it.

In 2016, diagnosis codes Z55-Z65 were launched to the healthcare coding system to permit vendors to report the presence of non-scientific factors that are recognised to affect well being results (this sort of as employment, housing, foodstuff insecurity, etcetera.). When properly documented, these Z codes are an powerful way for vendors and wellness strategies to coordinate care and to establish qualified group-centered interventions. Even so, uptake has been sluggish thanks to administrative load, a lack of benchmarks, a lack of service provider consciousness, as effectively as vendors remaining unwell-geared up to handle these wants.

Learning from Z code utilization

In Oct 2021, Centers for Medicare and Medicaid Companies (CMS) launched a report, which shown that Z codes are mostly unreported in Medicare rate-for-support promises. By 2019, homelessness was the most regularly used Z code, on the other hand Z codes have been only documented on .11 {bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of all promises.

We analyzed details by way of 2022 and observed that the use of Z codes throughout commercially insured, Medicare Edge and Medicaid populations carries on to stall. On a yearly basis, the proportion of individuals with a Z code ranges from .13 percent in 2017 to .15 per cent in 2019 and 2020. In major metropolitan parts, the proportion of sufferers with a Z code is as low as .03 p.c in Atlanta, Georgia to .17 percent in San Francisco, California.

Even with the present state of very low adoption, federal and state policy efforts go on to double down on the importance of improving upon documentation and measurement of social things, ranging from the Medicaid and CHIP Payment and Access Commission’s (MACPAC) most current recommendations to Congress, to Centers for Illness Management and Prevention’s (CDC) release of extra Z codes, which go into effect April 1, 2023. The exacerbation of well being inequities on full screen for the duration of the COVID-19 pandemic without doubt supports the rationale driving these coverage initiatives and the ongoing concentrate on enhanced measurement. Even so, policymakers keep on to overlook a significant place: Facilitating access does not guarantee adoption.

As we have witnessed numerous situations before (which include with COVID-19 telehealth growth), procedures that just make a thing obtainable, unbiased of how precious that company or item is, do not always translate to significant use or adoption. If utilization of Z Codes from 2017 to 2022 is only a tenth of a percent, what is to say that introducing more codes will increase adoption of current codes, let by yourself new codes? If the priority is to maximize measurement, and hence, provide additional qualified social care, then should not plan attempts be targeted on overcoming present barriers to use?

Driving Z code adoption

Very well-intentioned policies like The American Rescue Approach Act of 2021 involved efforts to deal with food and housing insecurity, these types of as developing a standard method to measuring and accumulating results linked to overall health equity. Having said that, equally federal and state procedures similar to this situation proceed to overlook the concentrate on — while delivering a course of action in which to obtain the intended consequence, they do not alter the system that sales opportunities to the wished-for behavior, which is greater documentation. Illustrating this disconnect, researchers have identified that even among the minority of providers that doc social needs via clinical notes, an even more compact share of all those providers are translating these notes into Z codes.

Many levers need to be pulled to meaningfully spur Z code adoption on a national stage. The aforementioned CMS report from 2021 acknowledges the absence of money incentives and providers’ perceived skill to handle SDOH-linked problems as remaining persistent limitations to greater adoption of Z coding in clinical practices.

Ultimately, screening for health and fitness-relevant social complications is essentially diverse from screening for healthcare issues, which raises the query: What policies are becoming carried out to present instruction for both equally the screening and “treatment” of SDoH? The option needs recognition of the truth that major care suppliers are at the “front lines” of wellness care and are progressively screening and dealing with patients for a lot more specialised disorders, like despair. In a well being financial state wherever supplier provide is currently substantially constrained, policymakers should consider the evolving (and at any time-expanding) responsibilities of companies and what that usually means for their capacity to get on added social screening tasks.

Policymakers will require to calibrate their investment in growing provider capability (which include social personnel) to fulfill the requires of populace-based mostly screening and documentation. Ultimately, as the health treatment industry has found with the adoption of other novel CMS steps, incentivizing the use of Z codes as a aspect of price-based mostly care arrangements may be the finest way to integrate them into a portion of day-to-day apply.

In the meantime, if the goal is to connect patients promptly and competently to social treatment methods, policymakers and payers can concentrate on non-personal steps to predict unique requires. Although not ideal, econometrics have demonstrated that Z codes are associated with a large Area Deprivation Index, and there is plenty of Zip Code-unique overall health treatment utilization, demographic and behavioral information now offered to use. If analyzed appropriately, the want for Z codes could develop into significantly less salient.

To make significant and lasting transform in well being equity, and, in turn, health outcomes, by improved coordination and connectivity in between social and professional medical care, CMS really should not simply make new prognosis codes, but thoughtfully incentivize the behaviors needed to make adoption.

Allison Oakes, Ph.D., is the director of exploration at health care analytics corporation Trilliant Wellness.

Sanjula Jain, Ph.D., is the senior vice president of market method and main exploration officer at Trilliant Health.

Copyright 2023 Nexstar Media Inc. All legal rights reserved. This content might not be published, broadcast, rewritten, or redistributed.

End of Covid Emergency Will Usher in Changes Across the US Health System

The Biden administration’s choice to end the covid-19 general public health unexpected emergency in May well will institute sweeping modifications throughout the wellness treatment procedure that go much past quite a few persons having to pay back a lot more for covid exams.

In response to the pandemic, the federal government in 2020 suspended lots of of its guidelines on how care is shipped. That reworked fundamentally each and every corner of American health and fitness care — from hospitals and nursing residences to public wellness and treatment method for folks recovering from dependancy.

Now, as the authorities prepares to reverse some of these techniques, here’s a glimpse at approaches individuals will be affected:

Instruction Guidelines for Nursing House Staff members Get Stricter

The end of the emergency means nursing households will have to meet better requirements for instruction personnel.

Advocates for nursing property people are eager to see the aged, more durable instruction necessities reinstated, but the field claims that shift could worsen staffing shortages plaguing facilities nationwide.

In the early days of the pandemic, to aid nursing households operate less than the virus’s onslaught, the federal govt relaxed training needs. The Facilities for Medicare & Medicaid Solutions instituted a nationwide plan stating nursing households needn’t stick to regulations necessitating nurse aides to go through at minimum 75 hours of condition-accepted education. Commonly, a nursing household couldn’t make use of aides for a lot more than four months except if they met those people requirements.

Past yr, CMS determined the comfortable coaching rules would no extended implement nationwide, but states and facilities could ask for authorization to be held to the reduce requirements. As of March, 17 states experienced such exemptions, in accordance to CMS — Ga, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, and Washington — as did 356 person nursing residences in Arizona, California, Delaware, Florida, Illinois, Iowa, Kansas, Kentucky, Michigan, Nebraska, New Hampshire, North Carolina, Ohio, Oregon, Virginia, Wisconsin, and Washington, D.C.

Nurse aides generally provide the most direct and labor-intense care for inhabitants, which includes bathing and other cleanliness-linked jobs, feeding, monitoring very important indications, and trying to keep rooms clear. Research has demonstrated that nursing properties with staffing instability manage a lessen high quality of care.

Advocates for nursing dwelling residents are happy the education exceptions will close but panic that the high-quality of treatment could nevertheless deteriorate. That’s for the reason that CMS has signaled that, soon after the looser criteria expire, some of the hrs that nurse aides logged through the pandemic could rely towards their 75 several hours of demanded instruction. On-the-work working experience, however, is not always a seem substitute for the instruction employees skipped, advocates argue.

Satisfactory training of aides is critical so “they know what they’re carrying out before they supply care, for their own superior as nicely as for the inhabitants,” explained Toby Edelman, a senior coverage legal professional for the Center for Medicare Advocacy.

The American Well being Care Affiliation, the largest nursing household lobbying group, launched a December survey finding that approximately 4 in 5 services ended up dealing with average to significant ranges of employees shortages.

Therapy Threatened for Individuals Recovering From Addiction

A looming rollback of broader entry to buprenorphine, an crucial medicine for persons in restoration from opioid addiction, is alarming people and medical practitioners.

Through the general public wellbeing emergency, the Drug Enforcement Administration stated vendors could prescribe specific managed substances just about or around the cellphone without first conducting an in-man or woman medical evaluation. One of individuals medication, buprenorphine, is an opioid that can avert debilitating withdrawal indicators for persons trying to get better from habit to other opioids. Investigate has shown utilizing it a lot more than halves the threat of overdose.

Amid a nationwide epidemic of opioid dependancy, if the expanded policy for buprenorphine ends, “thousands of folks are going to die,” explained Ryan Hampton, an activist who is in recovery.

The DEA in late February proposed restrictions that would partly roll again the prescribing of managed substances by way of telemedicine. A clinician could use telemedicine to purchase an first 30-day provide of medicines this kind of as buprenorphine, Ambien, Valium, and Xanax, but individuals would require an in-human being evaluation to get a refill.

For another team of medicines, such as Adderall, Ritalin, and oxycodone, the DEA proposal would institute tighter controls. Clients looking for individuals prescription drugs would have to have to see a medical professional in person for an preliminary prescription.

David Herzberg, a historian of medication at the University at Buffalo, mentioned the DEA’s strategy reflects a fundamental problem in creating drug policy: assembly the desires of individuals who count on a drug that can be abused without the need of creating that drug far too easily readily available to other individuals.

The DEA, he additional, is “clearly critically wrestling with this issue.”

Hospitals Return to Typical, Fairly

During the pandemic, CMS has tried out to limit troubles that could arise if there weren’t plenty of well being care employees to handle sufferers — especially prior to there ended up covid vaccines when staff ended up at better chance of obtaining sick.

For case in point, CMS permitted hospitals to make broader use of nurse practitioners and health practitioner assistants when caring for Medicare sufferers. And new medical professionals not however credentialed to operate at a certain medical center — for case in point, for the reason that governing bodies lacked time to perform their assessments — could even so practice there.

Other changes all through the community well being crisis were intended to shore up clinic capability. Critical obtain hospitals, little hospitals located in rural spots, did not have to comply with federal regulations for Medicare stating they have been minimal to 25 inpatient beds and patients’ stays could not exceed 96 hours, on normal.

The moment the unexpected emergency ends, those exceptions will disappear.

Hospitals are striving to persuade federal officials to preserve numerous covid-period guidelines over and above the emergency or get the job done with Congress to adjust the legislation.

Surveillance of Infectious Health conditions Splinters

The way point out and local community health and fitness departments keep an eye on the distribute of disorder will adjust after the crisis finishes, for the reason that the Department of Wellbeing and Human Providers won’t be able to need labs to report covid screening facts.

With out a uniform, federal prerequisite, how states and counties observe the unfold of the coronavirus will vary. In addition, even though hospitals will still supply covid info to the federal government, they may do so less commonly.

Public well being departments are however obtaining their arms around the scope of the improvements, mentioned Janet Hamilton, government director of the Council of Condition and Territorial Epidemiologists.

In some strategies, the close of the unexpected emergency provides public health officers an possibility to rethink covid surveillance. In comparison with the pandemic’s early times, when at-home checks ended up unavailable and men and women relied closely on labs to figure out irrespective of whether they ended up infected, testing facts from labs now reveals considerably less about how the virus is spreading.

General public health officers never assume “getting all test outcomes from all lab exams is potentially the appropriate system any longer,” Hamilton reported. Flu surveillance offers a possible option model: For influenza, community health and fitness departments find exam success from a sampling of labs.

“We’re nonetheless striving to get the job done out what is the very best, steady approach. And I never think we have that nonetheless,” Hamilton explained.

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End of COVID public health emergency will bring changes to U.S. hospitals, nursing homes, addiction treatment and more

The Biden administration’s decision to end the COVID-19 public health emergency in May will institute sweeping changes across the health care system that go far beyond many people having to pay more for COVID tests.

In response to the pandemic, the federal government in 2020 suspended many of its rules on how care is delivered. That transformed essentially every corner of American health care — from hospitals and nursing homes to public health and treatment for people recovering from addiction.

Now, as the government prepares to reverse some of those steps, here’s a glimpse at ways patients will be affected:

Training rules for nursing home staff get stricter

The end of the emergency means nursing homes will have to meet higher standards for training workers.

Advocates for nursing home residents are eager to see the old, tougher training requirements reinstated, but the industry says that move could worsen staffing shortages plaguing facilities nationwide.

In the early days of the pandemic, to help nursing homes function under the virus’s onslaught, the federal government relaxed training requirements. The Centers for Medicare & Medicaid Services instituted a national policy saying nursing homes needn’t follow regulations requiring nurse aides to undergo at least 75 hours of state-approved training. Normally, a nursing home couldn’t employ aides for more than four months unless they met those requirements.

Last year, CMS decided the relaxed training rules would no longer apply nationwide, but states and facilities could ask for permission to be held to the lower standards. As of March, 17 states had such exemptions, according to CMS — Georgia, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, and Washington — as did 356 individual nursing homes in Arizona, California, Delaware, Florida, Illinois, Iowa, Kansas, Kentucky, Michigan, Nebraska, New Hampshire, North Carolina, Ohio, Oregon, Virginia, Wisconsin, and Washington, D.C.

Nurse aides often provide the most direct and labor-intensive care for residents, including bathing and other hygiene-related tasks, feeding, monitoring vital signs, and keeping rooms clean. Research has shown that nursing homes with staffing instability maintain a lower quality of care.

Advocates for nursing home residents are pleased the training exceptions will end but fear that the quality of care could nevertheless deteriorate. That’s because CMS has signaled that, after the looser standards expire, some of the hours that nurse aides logged during the pandemic could count toward their 75 hours of required training. On-the-job experience, however, is not necessarily a sound substitute for the training workers missed, advocates argue.

Adequate training of aides is crucial so “they know what they’re doing before they provide care, for their own good as well as for the residents,” said Toby Edelman, a senior policy attorney for the Center for Medicare Advocacy.

The American Health Care Association, the largest nursing home lobbying group, released a December survey finding that roughly 4 in 5 facilities were dealing with moderate to high levels of staff shortages.

Treatment threatened for people recovering from addiction

A looming rollback of broader access to buprenorphine, an important medication for people in recovery from opioid addiction, is alarming patients and doctors.

During the public health emergency, the Drug Enforcement Administration said providers could prescribe certain controlled substances virtually or over the phone without first conducting an in-person medical evaluation. One of those drugs, buprenorphine, is an opioid that can prevent debilitating withdrawal symptoms for people trying to recover from addiction to other opioids. Research has shown using it more than halves the risk of overdose.

Amid a national epidemic of opioid addiction, if the expanded policy for buprenorphine ends, “thousands of people are going to die,” said Ryan Hampton, an activist who is in recovery.

The DEA in late February proposed regulations that would partly roll back the prescribing of controlled substances through telemedicine. A clinician could use telemedicine to order an initial 30-day supply of medications such as buprenorphine, Ambien, Valium, and Xanax, but patients would need an in-person evaluation to get a refill.

For another group of drugs, including Adderall, Ritalin, and oxycodone, the DEA proposal would institute tighter controls. Patients seeking those medications would need to see a doctor in person for an initial prescription.

David Herzberg, a historian of drugs at the University at Buffalo, said the DEA’s approach reflects a fundamental challenge in developing drug policy: meeting the needs of people who rely on a drug that can be abused without making that drug too readily available to others.

The DEA, he added, is “clearly seriously wrestling with this problem.”

Hospitals return to normal, somewhat

During the pandemic, CMS has tried to limit problems that could arise if there weren’t enough health care workers to treat patients — especially before there were COVID vaccines when workers were at greater risk of getting sick.

For example, CMS allowed hospitals to make broader use of nurse practitioners and physician assistants when caring for Medicare patients. And new physicians not yet credentialed to work at a particular hospital — for example, because governing bodies lacked time to conduct their reviews — could nonetheless practice there.

Other changes during the public health emergency were meant to shore up hospital capacity. Critical access hospitals, small hospitals located in rural areas, didn’t have to comply with federal rules for Medicare stating they were limited to 25 inpatient beds and patients’ stays could not exceed 96 hours, on average.

Once the emergency ends, those exceptions will disappear.

Hospitals are trying to persuade federal officials to maintain multiple COVID-era policies beyond the emergency or work with Congress to change the law.

Surveillance of infectious diseases splinters

The way state and local public health departments monitor the spread of disease will change after the emergency ends, because the Department of Health and Human Services won’t be able to require labs to report COVID testing data.

Without a uniform, federal requirement, how states and counties track the spread of the coronavirus will vary. In addition, though hospitals will still provide COVID data to the federal government, they may do so less frequently. 

Public health departments are still getting their arms around the scope of the changes, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

In some ways, the end of the emergency provides public health officials an opportunity to rethink COVID surveillance. Compared with the pandemic’s early days, when at-home tests were unavailable and people relied heavily on labs to determine whether they were infected, testing data from labs now reveals less about how the virus is spreading.

Public health officials don’t think “getting all test results from all lab tests is potentially the right strategy anymore,” Hamilton said. Flu surveillance provides a potential alternative model: For influenza, public health departments seek test results from a sampling of labs.

“We’re still trying to work out what’s the best, consistent strategy. And I don’t think we have that yet,” Hamilton said.


KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Social frailty comes with health risks for older adults



CNN
 — 

Consider three hypothetical women in their mid-70s, all living alone in identical economic circumstances with the same array of ailments: diabetes, arthritis and high blood pressure.

Ms. Green stays home most of the time and sometimes goes a week without seeing people. But she’s in frequent touch by phone with friends and relatives, and she takes a virtual class with a discussion group from a nearby college.

Ms. Smith also stays home but rarely talks to anyone. She has lost contact with friends, stopped going to church and spends most of her time watching TV.

Ms. Johnson has a wide circle of friends and a busy schedule. She walks with neighbors regularly, volunteers at a local school twice a week, goes to church and is in close touch with her children, who don’t live nearby.

Three sets of social circumstances, three levels of risk should the women experience a fall, bout of pneumonia or serious deterioration in health.

Of the women, Ms. Johnson would be most likely to get a ride to the doctor or a visit in the hospital, experts suggest. Several people may check on Ms. Green and arrange assistance while she recovers.

But Ms. Smith would be unlikely to get much help and more likely than the others to fare poorly if her health became challenged. She’s what some experts would call “socially vulnerable” or “socially frail.”

Social frailty is a corollary to physical frailty, a set of vulnerabilities (including weakness, exhaustion, unintentional weight loss, slowness and low physical activity) shown to increase the risk of falls, disability, hospitalization, poor surgical outcomes, admission to a nursing home and earlier death in older adults.

Essentially, people who are physically frail have less physiological strength and a reduced biological ability to bounce back from illness or injury.

Those who are socially frail similarly have fewer resources to draw upon but for different reasons — they don’t have close relationships, can’t rely on others for help, aren’t active in community groups or religious organizations, or live in neighborhoods that feel unsafe, among other circumstances. Also, social frailty can entail feeling a lack of control over one’s life or being devalued by others.

Many of these factors have been linked to poor health outcomes in later life, along with so-called social determinants of health — low socioeconomic status, poor nutrition, insecure housing and inaccessible transportation.

Social frailty assumes that each factor contributes to an older person’s vulnerability and that they interact with and build upon each other.

“It’s a more complete picture of older adults’ circumstances than any one factor alone,” said Dr. Melissa Andrew, a professor of geriatric medicine at Dalhousie University in Halifax, Nova Scotia, who published one of the first social vulnerability indices for older adults in 2008.

This way of thinking about older adults’ social lives, and how they influence health outcomes, is getting new attention from experts in the United States and elsewhere. In February, researchers at Massachusetts General Hospital and the University of California, San Francisco published a 10-item “social frailty index” in the Proceedings of the National Academy of Sciences journal.

Using data from 8,250 adults 65 and older who participated in the national Health and Retirement Study from 2010 to 2016, the researchers found that the index helped predict an increased risk of death during the period studied in a significant number of older adults, complementing medical tools used for this purpose.

“Our goal is to help clinicians identify older patients who are socially frail and to prompt problem-solving designed to help them cope with various challenges,” said Dr. Sachin Shah, a coauthor of the paper and a researcher at Massachusetts General Hospital.

“It adds dimensions of what a clinician should know about their patients beyond current screening instruments, which are focused on physical health,” said Dr. Linda Fried, a frailty researcher and dean of the Mailman School of Public Health at Columbia University.

Beyond the corridors of medicine, Fried said, “we need society to build solutions” to issues raised in the index — the ability of older adults to work, volunteer and engage with other people; the safety and accessibility of neighborhoods in which they live; ageism and discrimination against older adults; and more.

Meanwhile, a team of Chinese researchers recently published a comprehensive review of social frailty in adults age 60 and older, based on results from dozens of studies with about 83,900 participants in Japan, China, Korea and Europe. They determined that 24{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of these older adults, assessed both in hospitals and in the community, were socially frail — a higher portion than those deemed physically frail (12{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}) or cognitively frail (9{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}) in separate studies. Most vulnerable were people 75 and older.

What are the implications for health care? “If someone is socially vulnerable, perhaps they’ll need more help at home while they’re recovering from surgery. Or maybe they’ll need someone outside their family circle to be an advocate for them in the hospital,” said Dr. Kenneth Covinsky, a geriatrician at UC San Francisco and coauthor of the recent Proceedings of the National Academy of Sciences article.

“I can see a social frailty index being useful in identifying older adults who need extra assistance and directing them to community resources,” said Jennifer Ailshire, an associate professor of gerontology and sociology at the University of Southern California Leonard Davis School of Gerontology.

Older people who are socially vulnerable may need more assistance with health care.

Unlike other physicians, geriatricians regularly screen older adults for extra needs, albeit without using a well-vetted or consistent set of measures. “I’ll ask, ‘Who do you depend on most and how do you depend on them? Do they bring you food? Drive you places? Come by and check on you? Give you their time and attention?’ ” said Dr. William Dale, the Arthur M. Coppola family chair in supportive care medicine at City of Hope, a comprehensive cancer center in Duarte, California.

Depending on the patients’ answers, Dale will refer them to a social worker or help modify their plan of care. But he cautioned that primary care physicians and specialists don’t routinely take the time to do this.

Oak Street Health, a Chicago-based chain of 169 primary care centers for older adults in 21 states and recently purchased by CVS Health, is trying to change that in its clinics, said Dr. Ali Khan, the company’s chief medical officer of value-based care strategy.

At least three times a year, medical assistants, social workers or clinicians ask patients about loneliness and social isolation, barriers to transportation, food insecurity, financial strain, housing quality and safety, access to broadband services and utility services.

The organization combines these findings with patient-specific medical information in a “global risk assessment” that separates older people into four tiers of risk, from very high to very low. In turn, this informs the kinds of services provided to patients, the frequency of service delivery and individual wellness plans, which include social as well as medical priorities.

The central issue, Khan said, is “what is this patient’s ability to continue down a path of resilience in the face of a very complicated health care system?” and what Oak Street Health can do to enhance that.

What’s left out of an approach such as this, however, is something crucial to older adults: whether their relationships with other people are positive or negative. That isn’t typically measured, but it’s essential in considering whether their social needs are being met, said Linda Waite, the George Herbert Mead distinguished service professor of sociology at the University of Chicago and director of the National Social Life, Health, and Aging Project.

For older adults who want to think about their own social vulnerability, consider this five-item index, developed by researchers in Japan.

1. Do you go out less frequently compared with last year?

2. Do you sometimes visit your friends?

3. Do you feel you are helpful to friends or family?

4. Do you live alone?

5. Do you talk to someone every day?

Think about your answers. If you find your responses unsatisfactory, it might be time to reconsider your social circumstances and make a change.

Bay Pines VA Research Program | VA Bay Pines Health Care

Study Area Psoriasis Title/BP Study Number A Multicenter, Open Registry of Patients with Psoriasis who are Candidates for Systemic Therapy Including Biologics “PSOLAR” Study #1573980 Synopsis Observational Study collecting information related to the treatment of psoriasis and evaluates patient and disease characteristics, patient-reported assessments and clinical and quality of life outcomes. Clinical Trials: NCT00508547 Study Team Local PI: Daniel Hogan, MD Lori Sisler lorine.sisler@va.gov 727-385-0223 Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Status Enrolling Study Area Genetics Title/BP Study Number Million Veteran Program “MVP” Study #1612959 Synopsis A national research program to learn how genes, lifestyle, and military exposures affect health and illness. All Veterans can participate in this one-time blood collection project. Study Team Local PI: Allison Williams, RN, Ph.D., ND Gary Smith gary.smith@va.gov 727-398-6661, ext.17284 Lori Sisler lorine.sisler@va.gov 727-385-0223 Status Enrolling Study Area Opioid Abuse Title/BP Study Number Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans “VA BRAVE” CSP 2014 Study #1612560 Synopsis Treat Veterans with Opioid Use Disorder (OUD) to understand whether Buprenorphine a medication to treat OUD, given in a monthly injection form works similarly to or better than buprenorphine oral form. Participation in the study will last 1 year. Clinical Trials: NCT04375033 Study Team Local PI: Maha Lahoud-Bladykas, MD Chris Vallanat christopher.vallanat@va.gov 727-398-6661, ext. 15992 Mariah Alexis mariah.alexis@va.gov 727-398-6661, ext. 10152 Status Enrolling Study Area Opioid Abuse Title/BP Study Number A Randomized, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in Treatment-Seeking Adult Participants with Opioid Use Disorder and High-risk Opioid Use ”INDIVIOR” Study #1651131 Synopsis The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks. Clinical Trials: NCT04995029 Study Team Local PI: Maha Lahoud-Bladykas, MD Mariah Alexis mariah.alexis@va.gov 727-398-6661, ext. 10152 Chayla Lee Chayla.lee@va.gov 727-398-6661, ext. 10111 Status To be launched Study Area Lung Cancer Title/BP Study Number Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial “VALOR” CSP 2005 Study #1573963 Synopsis Veterans diagnosed with stage I non-small cell lung cancer who are healthy enough to have surgery, agree to be randomized to either surgery (standard of care treatment) or an alternative non-surgical treatment – Stereotactic Radiotherapy (SBRT). Clinical Trials: NCT02984761 Study Team Local PIs: Edward Hong, MD Ryan Burri, MD Marlena Kern, RN marlene.kern@va.gov (VA cell) 727-219-7174 Status Enrolling Study Area PTSD/Mental Health Title/BP Study Number Veteran Health Behavior Study (Wave 2) Study #1573969 Synopsis Observational trial recruiting Veterans who were deployed to Iraq or Afghanistan to learn more about the bidirectional relationships between sleep quality, PTSD symptoms and Alcohol Use Disorder symptoms. Clinical Trials: NCT04552782 Study Team Local PI: Jessica Keith, PhD Anna Rosenblatt Anna.Rosenblatt2@va.gov 727-398-6661, ext.14728 or 727-317-7361 Camille Compton Lori.Compton@va.gov 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Infectious Disease Title/BP Study Number Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V Study #1624732 Synopsis Phase III clinical trial to evaluate the safety and efficacy of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years. Clinical Trials: NCT04899336 Study Team Local PI: Kaley Tash, MD Anna Rosenblatt Anna.Rosenblatt2@va.gov 727-398-6661, ext.17051 or 727-317-7361 Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext.15900 Status Enrolling Study Area PTSD/Insomnia Title/BP Study Number CSP #2016 National Adaptive Trial for PTSD related Insomnia (NAP) Study #1612520 Synopsis A clinical trial to compare the efficacy of trazodone hydrochloride, eszopiclone, and gabapentin to placebo, as adjunctive therapies in the treatment of insomnia symptoms among Veterans with military related PTSD. Study Team Local PI: Ateiat Philips, MD Stella Inting-Toothman 727-398-6661, ext. 17184 727-776-8687 Stella.inting-toothman@va.gov Status Enrolling Study Area Psoriatic Arthritis Title/BP Study Number Solstice- Guselkumab therapy in patients with active Psoraitic Arthritis (PsA) Study #1634796 Synopsis For Veterans with active psoriatic arthritis who have failed a prior anti-TNF (Humira, Enbrel, etc.) The primary objective is to evaluate the efficacy of guselkumab. Study Team Local PI: Priyanka Murali, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Camille Compton Camille.compton@va.gov 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Psoriatic Arthritis Title/BP Study Number Star- Guselkumab therapy in patients with Psoraitic Arthritis (PsA) who have never been treated with a biologic before Study #1634798 Synopsis For bionaive Veterans who have never been treated with a biologic participants with psoriatic arthritis axial disease. The goal is to evaluate the efficacy of guselkumab by assessing reduction in axial symptoms. Study Team Local PI: Priyanka Murali, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Camille Compton Camille.compton@va.gov 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Psoriatic Arthritis Title/BP Study Number Affinity- Combination therapy with guselkumab and golimumab in patients with Psoriatic Arthritis (PsA) Study #1634801 Synopsis For Veterans with active psoriatic arthritis, who have failed prior treatment of anti-TNF (Humira, Enbrel, etc.) and are interested in a dual therapy of guselkumab AND golimumab. Study Team Local PI: Priyanka Murali, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Camille Compton Camille.compton@va.gov 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Cardiology Title/BP Study Number Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE) Trial Study #1612747 Synopsis PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study that will evaluate if taking a statin could help older adults live independently for longer by preventing dementia, disability, or heart disease. PREVENTABLE will randomly assign Atorvastatin 40 mg daily or matching placebo once daily to 20,000 community-dwelling adults ≥75 years of age without clinically evident cardiovascular disease, significant disability, or dementia, and follow them for up to 5 years. Clinical Trials: NCT04262206 Study Team Local PI: Dennis Hall Chayla Lee Chayla.lee@va.gov 727-398-6661, ext. 10111 Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Status Enrolling Study Area Infectious Disease Title/BP Study Number CSP #2001 Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID) Study #1613455 Synopsis VA Cooperative Study #2001 is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for Diabetic Foot Osteomyelitis. The primary endpoint is amputation-free survival. Clinical Trials: NCT03012529 Study Team Local PI: Melissa Abercrombie, MD Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Status Enrolling Study Area Infectious Disease Title/BP Study Number CSP #596 Optimal Treatment for Recurrent Clostridium difficile Infection (OpTION) Study #1613094 Synopsis The primary objective of this study is to determine whether 1) standard fidaxomicin treatment and 2) standard vancomycin treatment followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment alone for sustained clinical response at day 59 for all treatments, for participants with either their first or second recurrence of C. difficile infection. Clinical Trials: NCT02667418 Study Team Local PI: Kaley Tash, MD Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Status Enrolling Study Area Cardiology Title/BP Study Number CSP2002 VA-IMPACT Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes Study #TBD Synopsis VA Cooperative Studies Program #2002 will determine whether treatment with metformin, compared with placebo, reduces the risk of major adverse cardiovascular events (MACE) in patients with pre-diabetes and established atherosclerotic cardiovascular disease (ASCVD). Study Team Local PI: Manjunath Harlapur, MD Stella Inting-Toothman (727) 398-6661, ext. 17184 (727) 776-8687 Stella.inting-toothman@va.gov Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Status To be launched Study Area Lung Cancer Title/BP Study Number LungLife AI Inc. Study #1651410 Synopsis The objective of this study is to use blood draws to validate a device developed by LungLife AI Inc in detecting circulating tumor cells for patients presenting with pulmonary nodules. The test aims to aid in the detection of early-stage lung cancer. Clinical Trials: NCT05171491 Study Team Local PI: Stephen Clum, MD Camille Compton Lori.compton@va.gov 727-398-6661, ext. 10151 Mariah Alexis Mariah.alexis@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.wheelock@va.gov 727-398-6661, ext. 17842 Status Enrolling Study Area Prostate Cancer Title/BP Study Number Identification of Targetable Prostate Cancer Alterations Through Tumor DNA Screening Study #1573965 Synopsis This is an observational, non-interventional study of screening veterans receiving care within Bay Pines VA Healthcare System who carry the diagnosis of advanced prostate cancer, metastatic or recurrent, for the presence of DNA mutations in tumor or germline DNA which could provide access to therapies with potential to significantly prolong survival. Study Team Local PI: Ryan Burri, MD Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Status Enrolling Study Area Prostate Cancer Title/BP Study Number VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of Standard Systemic Therapy with or without PET-directed Local Therapy for Oligorecurrent Prostate Cancer Study #1616760 Synopsis This is an interventional study for patients with oligorecurrent prostate cancer to determine whether adding metastasis-directed therapy to standard systemic therapy improves disease outcomes further. This study also determines if certain mutations present in tumor DNA can predict if Veterans will benefit from PET-directed local therapy. Study Team Local PI: Ryan Burri, MD Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Status Enrolling Study Area Lung Cancer Title/BP Study Number A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Study #1600510 Synopsis This is a study assessing the efficacy and safety of durvalumab versus placebo with standard of care Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) Non-Small Cell Lung Cancer. Study Team Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Status Enrolling Study Area Bladder Cancer Title/BP Study Number A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC). Study #1573968 Synopsis This is a trial for muscle-invasive bladder cancer to compare intact event-free survival in participants from Arm A (pembrolizumab + chemoradiotherapy) and Arm B (placebo + chemoradiotherapy). Study Team Local PI: Andrew Leone, MD Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Status Enrolling Study Area Lung Cancer Title/BP Study Number A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation Study #1679339 Synopsis This is a study assessing the efficacy and safety of MRTX849 alone and in combination with Pembrolizumab as a first-line treatment in patients with Advanced Non-Small Cell Lung Cancer with a KRAS G12C mutation. Patients will be randomized to different arms depending on their Tumor Progression Score (TPS). Study Team Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Status Enrolling Study Area Bladder Cancer Title/BP Study Number An observational study of efficacy and utility of Cxbladder tests in the identification of low vs high risk patients and the detection of urothelial carcinoma in patients presenting with hematuria Study #1683093 Synopsis This is an observational study recruiting patients presenting with blood in the urine, who are undergoing investigation for the presence of Urothelial Carcinoma. This study is designed to compare the Cxbladder tests versus standard of care procedures. Study Team Local PI: Andrew Leone, MD Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Status To be launched Study Area Head and Neck Cancer Title/BP Study Number Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Clinical Trials: NCT05050162. Study #1682403 Synopsis This study for patients with locoregionally advanced squamous cell carcinoma of the head and neck is to determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity to radiation with high-dose cisplatin every 3 weeks. Study Team Local PI: Ryan Burri, MD Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Status Enrolling Study Area Prostate Cancer Title/BP Study Number A Single-arm, Open-label, Phase II Study of Checkpoint Inhibitors in Men with Progressive Metastatic Castrate Prostate Cancer (mCRPC) Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP). Study #1612473 Synopsis The purpose of this study is to determine the response rate to the anti-PD1 antibody, pembrolizumab in Veterans with mCRPC characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12. Study Team Local PI: Ryan Burri, MD Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Status Enrolling Study Area Prostate Cancer Title/BP Study Number An open-label, multicenter phase II study to compare the efficacy of carboplatin as first-line followed by second-line olaparib versus olaparib as first-line followed by second-line carboplatin in the treatment of patients with castration resistant prostate cancer containing homologous recombination deficiency (COBRA). Study #1612483 Synopsis To determine progression free survival (PFS) to initial therapy (PFS-1L) with carboplatin vs. olaparib in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) containing inactivation of the homologous DNA repair pathway, including BRCA1, BRCA2, PALB2, BARD1, BRIP1, CHEK1, FANCL, RAD51B, RAD51C, and RAD54L. Study Team Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Status Enrolling Study Area Prostate Cancer Title/BP Study Number VA Multi-Omics Analysis Platform for Prostate Cancer and Sequencing (VA MAPP-SEQ) Biorepository Study #1713735 Synopsis Biorepository for men with the potential to be diagnosed with prostate cancer or having a diagnosis of prostate cancer scheduled to undergo surgical/non-surgical procedure on the prostate gland or metastatic tissue. The purpose of this study is to create a centralized biorepository for future research for Veterans with prostate cancer. Study Team Local PI: Andrew Leone, MD Hayley Maither Hayley.maither@va.gov 727-398-6661, ext. 15925 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Status Enrolling Study Area Pulmonary/COPD Title/BP Study Number A Phase III, Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety to Two Dose Regimens of MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA). Study #1672631 Synopsis For Veterans 40 years and older with a diagnosis of COPD who have a history of exacerbations within the past year. The goal is to evaluate the efficacy and safety of MEDI3506 300 mg every 8 weeks and 300 mg every 4 weeks dose regimens. The study is to be conducted. Study Team Local PI: Ravi Patel, MD Sarah Crim Sarah.Crim@va.gov 727-398-6661, ext. 17975 Lori Camille Compton Lori.Compton@va.gov 727-398-6661, ext. 10151 Chayla Lee Chayla.Lee@va.gov 727-398-6661, ext. 10111 Status Enrolling Study Area Cardiology Title/BP Study Number A Multi-Center Study Evaluating Participants who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation. Study #1605396 Synopsis The purpose of this study is to look at the differences of healing and complications in patients who have had previous heart device procedures done. The study will compare the results of the previous procedure (a type of envelope used or no envelope used). Clinical Trials: NCT04645173 Study Team Local PI: Afolabi Sangosanya, MD Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Lori Camille Compton Lori.Compton@va.gov 727-398-6661, ext. 10151 Chayla Lee Chayla.Lee@va.gov 727-398-6661, ext. 10111 Status Enrolling