Transforming Women Veterans’ Health Care: Susan Frayne’s Leadership in Advancing VA Initiatives

by dom-wp-admin | Sep 23, 2024 | 2024, Interventions

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Transforming Women Veterans’ Health Care: Susan Frayne’s Leadership in Advancing VA Initiatives

#Interventions

Susan Frayne, MD, a pioneer in women’s health at the VA, stands at the forefront of expanding research and clinical care to better serve the rapidly growing population of women veterans.

When Susan Frayne, MD, began her career in the early 1990s, Veterans Affairs (VA) medical services were almost entirely geared toward men.

“If a woman did show up in the clinic,” Frayne recalls, “it would take a half hour to locate a speculum to do a pelvic exam.”

Back then, VA clinicians saw very few women patients and were often rusty on how to care for them, says Frayne, who is now the director of the VA Health Systems Research Center for Innovation to Implementation (Ci2i) and a Stanford Medicine professor in the Division of Primary Care and Population Health.

As part of its mission, faculty in the Division of Primary Care and Population Health are committed to service at the VA. To that end, Frayne divides her time between VA activities and service at Stanford University.

Women have served in the U.S. military since the American Revolution, but it wasn’t until 1948 that Congress granted them entitlement to veterans benefits and not until 2015 that they were approved to serve in combat roles. Despite their long history of service, women have been an extreme numeric minority within the VA system, leading to historical gaps in addressing their healthcare needs.

Today women represent the fastest-growing population in the VA, comprising 10% of VA patients. This has heightened the need for a stronger evidence base to systematically enhance care at the bedside.

“Women veterans have been in the VA for a long time but used to receive less attention due to their small numbers. It is heartening to now be seeing how VA has been making it a priority to ensure that their healthcare needs receive the focus they deserve,” Frayne says.

Supported by the efforts of Frayne and her colleagues to advance the boundaries of women’s health research and care, the VA has implemented several key initiatives to advance clinical research and advocate for women veterans.

Prominent among these is the Women’s Health Research Network, which has accelerated the scope and impact of VA health research since Frayne and two colleagues at VA Greater Los Angeles and the University of California, Los Angeles – Elizabeth Yano, PhD, and Alison Hamilton, PhD – founded it in 2010. Its Women’s Health Practice-Based Research Network (WH-PBRN) component, which Frayne leads, connects 76 VA medical centers across the country – together representing over half of the women veterans served by the federal agency – and provides a national platform for multisite studies. While the number of women veterans at any one VA campus is still typically too low to supply enough study participants to yield meaningful conclusions, recruiting from multiple WH-PBRN member sites ensures better representation.

To date, over 100 multisite studies have been conducted through the WH-PBRN. These cover a wide range of high-priority areas such as mental health and suicide, pain and opioids, reproductive health, military sexual trauma, access to women’s health primary care providers, rural health care, and more. Responding to the aging of the women veterans population, the WH-PBRN has been supporting studies on conditions like heart disease and menopause.

The WH-PBRN also brings research to diverse patient populations and healthcare settings. “We’re able to reach populations that often tend to be underrepresented in research,” Frayne explains. “The WH-PBRN stretches all the way from Samoa to Puerto Rico and Alaska, and from big cities like New York, Houston, and San Francisco to facilities that serve largely rural populations like Fresno and Iowa City.”

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“We are working to ensure that women veterans are better represented in clinical research, which is crucial for developing effective treatments and interventions tailored to their unique needs.”

– Susan Frayne, MD

Findings from research conducted in a predominantly male patient population cannot reliably be used to guide the care of female veterans. As a spin-off of the Women’s Health Research Network, another initiative, the Women’s Enhanced Recruitment Process, is designed to improve the equitable representation of women in clinical trials. Led by Frayne and Karen Goldstein, MD, at VA Durham and Duke University, this program addresses the historical underrepresentation of women veterans in research to increase the inclusiveness of large VA trials.

“We are working to ensure that women veterans are better represented in clinical research, which is crucial for developing effective treatments and interventions tailored to their unique needs,” Frayne says.

To further support these efforts, the Women’s Health Evaluation Initiative (WHEI) leverages VA databases to inform national VA strategic planning and policy development. WHEI’s data-driven approach helps identify gaps in current research and care, guiding the development of targeted studies and interventions, and contributes to the VA as a learning healthcare system.

While Frayne cautions that more is still needed, she has seen steady improvement in VA services for women veterans since she started as a primary care doctor more than three decades ago. The implementation of women veteran program managers and women’s health medical directors at every VA facility has expanded access to specialized care. Dedicated women’s health clinics are now common.

The VA has also been focusing on culture change. For example, Women’s Health Research Network findings that identified harassment of women veterans led to national VA anti-harassment campaigns, and studies have shown subsequent improvements in women’s perceptions of the VA environment of care as safe and welcoming.

The Women’s Health Research Network’s body of work around culture change is just one example of its impact. As Frayne notes, “Our ability to quickly adapt and respond to emerging priority areas speaks to the robust infrastructure and partnerships we’ve built over the past 15 years.”

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Tracking a Mysterious Kidney Disease Across Time and Continents

by dom-wp-admin | Sep 23, 2024 | 2024, Partnerships

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Tracking a Mysterious Kidney Disease Across Time and Continents

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Stanford nephrologist Shuchi Anand, MD

The patient, age 30, arrives at the dialysis clinic at 4 a.m. He sits through four hours of dialysis that filters from his blood the waste and water his kidneys no longer can – leaving him exhausted. He rests for another hour, but rather than returning home to recover, he drives to the fields to harvest lettuce under the scorching sun.

Stories like this are common in Salinas Valley, the “Salad Bowl of the World,” and agricultural regions in Central California. They motivate researchers such as Stanford nephrologist Shuchi Anand, MD, to better understand a mysterious kidney disease impacting young farmworkers in hot agricultural areas around the globe.

Since 2018, Anand has been studying this illness in agricultural communities in Sri Lanka. Now, she and Marimar Contreras Nieves, MD, a Stanford nephrology fellow, are pushing the boundaries of what is known about the condition by investigating these two regions in parallel.

Unlike Sri Lanka, the predominantly Hispanic Central Valley and Central Coast of California are not yet confirmed hot spots and lack extensive analysis, largely due to a lack of data in a difficult-to-study population: migrant farmworkers.

To better understand what’s driving the high rates of end-stage kidney disease in Central California – a relatively unexplored yet critical frontier in kidney disease epidemiology – Anand and Contreras are interviewing patients in dialysis clinics in the five largest agricultural counties in the region, beginning in Salinas and Fresno. They’re developing innovative collaborations with local nephrologists, research students, and community groups to seek out possible causes and ultimately help prevent the devastating condition.

A Global but Underrecognized Problem

In the past two decades, younger adults without any of the usual risk factors have begun suffering irreversible kidney damage. In the U.S., kidney disease typically disproportionately affects poor communities in urban areas. However, this “chronic kidney disease of unknown origin,” or CKDu, is most common in hot, low-lying agricultural regions across the world. It primarily impacts young and middle-aged males whose livelihoods involve strenuous agricultural and manual labor.

The progressive disease is often not diagnosed until the patient has reached the final stage – at which point their kidneys are so damaged, they require costly, time-consuming dialysis or a kidney transplant for survival.

In recent years, analyses from the U.S. Renal Data System have revealed unusually high rates of end-stage kidney disease in Central California. While this region and Sri Lanka are separated by nearly 9,000 miles, they share similar geographic features and high temperatures.

A Sri Lankan man with kidney disease shows Dr. Anand and colleagues the household well as they investigate possible causes. A suspected risk factor for kidney disease of unknown origin is contaminated groundwater. Also pictured: Michele Barry, MD, Senior Associate Dean of Global Health and Director of the Stanford Center for Innovation in Global Health, and Mark Cullen, MD, a retired Senior Associate Dean of Research at the Stanford School of Medicine.

Devastating to Local Communities

From Sri Lanka to the Salinas Valley, the impacts of this mysterious kidney disease are devastating for the patient, their family, and their community.

“Life changes overnight when you give patients a diagnosis,” says Gopal Krishna, MD, a nephrologist with Central Coast Nephrology who grew up in a region of India that has become a hot spot for CKDu.

Krishna believes that up to 20% of his patients have been affected by the illness. He’s now partnering with Anand and Contreras by providing them access to interview patients on dialysis.

Anand, who also directs Stanford Medicine’s Center for Tubulointerstitial Kidney Disease, is motivated by the stories of those impacted. In Sri Lanka, she says, farmers have committed suicide to prevent their families from suffering the financial burden of treatment. In other cases, children left school early, or mothers left the home, to work.

“Progressive kidney disease in a working-age person impoverishes families and robs them of a loved one,” she says.

A Puzzle Spread Across Time

Despite the impact, few nephrologists, patients, and community members in Central California are aware of this condition, and an understanding of causes and solutions remains elusive.

Because the disease is difficult to detect in its early stages, researchers struggle to understand which exposures in a person’s life may have contributed to their illness. Compounding this, many impacted communities lack sufficient epidemiological data and research capacity to investigate the condition.

“It’s a puzzle that is very difficult to piece together – a puzzle not only with many pieces, but pieces spread across time,” says Anand.

Strenuous activity in extreme heat is one highly suspected risk factor – and a growing one in light of climate change, says Anand. Other possible contributors include drinking water contaminated by pesticides or naturally occurring elements, silica exposure from the burning of certain crops, and infection by viral diseases.

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“It’s a puzzle that is very difficult to piece together – a puzzle not only with many pieces, but pieces spread across time.”

– Shuchi Anand, MD

Two Hot Spots, Two Approaches

In Sri Lanka, Anand and community researchers have been following healthy people over time to identify risk factors and exposures in those who eventually fall ill. Anand is also helping communities build their local capacity for research, including blood testing, gathering environmental samples, and testing interventions, such as filtering drinking water for potential contaminants. This work has been supported by the Stanford Center for Innovation in Global Health through Global Health Seed Grants, an NIH/Fogarty Global Health Equity Scholarship, and mentorship from Michele Barry, MD, the center’s director.

A team of faculty at Stanford are collaborating to tackle the disease locally and in Sri Lanka, including Vivek Bhalla, MD, associate professor of nephrology; Kurella Tamura, MD, professor of nephrology; Neeraja Kambham, MD, professor of pathology; Andrew Fire, PhD, professor of pathology and genetics; and Maria Montez-Rath, PhD, senior research engineer.

Yet Central California requires a different approach, since those most impacted – farmworkers – move frequently, are hard to reach, may not trust the healthcare system, and usually aren’t aware of the illness. Anand and Contreras realized they needed to start with patients in the end stage of the disease and work backward to fully understand the relationship between a patient’s work, environmental exposure, residential history, and CKDu. The Stanford Woods Institute for the Environment has funded recent work in the Central Valley through an Environmental Venture Project grant.

“The base for this project is gathering information from patients and understanding their stories,” Contreras says. They’ve established strong relationships with local nephrologists serving patients in Central California, including Krishna, and begun interviewing dialysis patients. They’ve also collaborated with Clovis Community College, near Fresno, to identify young, bilingual research assistants from the community to interview patients.

Research Assistant Esteban Banda remembers the first time he entered a quiet Salinas dialysis clinic in the early morning, hesitant to disturb the sleeping patients’ rest and unsure whether they’d want to talk with him. Yet he was quickly surprised by how eager they were to discuss their lives and contribute information.

graphicoption_bidirectional learning_ unknown kidney disease (1)

Stanford researchers and their global colleagues are investigating a mysterious kidney disease impacting young farmworkers in hot agricultural areas around the globe. To better understand possible causes and risk factors, they’re exploring the similarities and differences between a known hot spot, Sri Lanka, and a possible new hot spot in Central California.

As a Clovis Community College and UC San Diego graduate who hopes to attend medical school, Banda says that this experience is motivating him to become a doctor capable of engendering trust in his patients.

‘Hope to Find Solutions’

While researchers hope to better understand the causes of CKDu, their ultimate goal is prevention across borders.

Meanwhile, researchers are collaborating with universities in Central California, as well as local farmworker rights organizations, to develop a project focused on protecting at-risk workers – particularly as rising temperatures put laborers at greater risk.

Krishna hopes the initiative can help catch or prevent the disease before it reaches its terrible end stage for many of his prospective patients.

“As we begin to recognize and appreciate that this entity exists,” he says, “I think there is a lot of hope to find solutions.”

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Harmony and Healing: How Stanford’s Department of Medicine Staff Find Resilience Through Music

by dom-wp-admin | Sep 23, 2024 | 2024, Communities

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Harmony and Healing: How Stanford’s Department of Medicine Staff Find Resilience Through Music

#Communities

From left: Staff members Winnie Ellerman, Elizabeth Chen, Loto Reed, and Brenda Padia find expression, connection, and healing through the act of making music.

“Making music is healing for the body, mind, spirit, and soul. Music is an invitation to step into a different space that can be healing, fun, wild, and peaceful,” says Elizabeth Chen, a research coordinator in the Division of Nephrology.

Chen is one of many staff members in the Department of Medicine who are also talented musicians. Several shared the different ways they’ve embraced music as a way to navigate challenging periods in their lives. For some, making music presents a much-needed path to the self and a way of practicing mindfulness. For others, it offers a chance to process and manage difficult emotions or to find meaningful connection with others.

DALL·E 2024-07-03 13.27.30 - A surreal scene featuring a grand piano leading up as a stairway into a new frontier. The piano keys form steps that ascend into a vast, mysterious la (1)

Music as a staircase to healing: Staff musicians find solace and strength in their craft, using their art to navigate adversity and explore new frontiers of personal growth. Courtesy of DALL-E.

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Music as a Path to Self-Expression and Presence

For Winnie Ellerman, administrative manager of nephrology and a dedicated piano teacher, making music is first and foremost a mode of self-expression.

“Even though a composer can write a piece of music with an intended emotion in mind, a musician has the power of interpreting and expressing that emotion or others,” Ellerman says. “When I learn a piece on the piano, the notes and fingering quickly become muscle memory, but the style and delivery changes almost every time I sit down to play the piece. It takes me a while to figure out my own version.”

For Fellowship Program Manager and vocalist Brenda Padia, singing classical arias represents a method of practicing mindfulness where the goal is to be fully present for the length of a song.

Brenda Padia performing “Batti, batti”

“If I mess up in a performance, I have to continue,” Padia says. “I have to accept what is in the moment so I can remain focused on the rest of my aria and then, afterward, reflect and learn from it. I’ve also noticed applying this approach to work-related or life challenges improves my mental well-being and reduces self-judgment.”

Music as a Way of Navigating Change and Processing Difficult Emotion

In addition to experiencing music as a means of self-expression and presence, staff in the department describe making music as a method for navigating periods of change.

For Loto Reed, administrative supervisor and program manager in Primary Care and Population Health, in the peak of the COVID-19 pandemic, playing the piano became an essential source of healing and refuge from the pressures of life and work. During this period, she kept a full-size digital piano in her office. When she felt the need to reset and recharge energetically and emotionally, she stepped away from her desk for a few minutes to play a song or a few chords.

Like Reed, Chen, a pianist and vocalist, recognizes the therapeutic potential of music to help musicians manage the difficult and common workplace emotions of stress and pressure. “Music is a stress reliever, stepping into a world away from obligations, and it brings so much joy and relief, peace, and gratitude,” she says.

For Chen, that joy is linked to the fact that making music is a choice she makes for herself on a daily basis. Her practice is what she makes of it, and it doesn’t depend on anyone else’s schedule or expectations.

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“As a Pacific Islander, music is woven deeply into our cultural traditions and identities. It is truly a healing art form and a creative way to bring communities together and share the richness of the cultures.”

– Loto Reed

Music as a Means of Connection

Many musicians in the department also expressed that music has the potential to heal the body, mind, soul, and spirit when it is made in the company or in the service of others.

Reed, for example, found relief from extreme social isolation during the pandemic in making and sharing music with others over social media. Though it was frightening to share recordings with others for consumption and critique, she experienced supportive outpourings of appreciation from listeners. The response served as a reminder that she was not alone, lifting her spirits and helping her get through a difficult period of her life.

Chen describes the critical role that making music played in forging lasting friendships (especially with other musicians): “The ability to make music has brought me so many close friendships. It brings together various people with musical gifts to serve a greater purpose.”

For Ellerman, making music has served the greater purpose of connecting her across time and space to past generations of family musicians. Sometime after her grandmother’s passing, Ellerman found among her things a book of sheet music that Ellerman’s great-grandmother (and namesake) Winnie used in the ’60s and ’70s to teach her mother and aunts.

Elizabeth Chen playing the piano

Winnie Ellerman playing the piano

It was the same book that Ellerman was using to teach one of her young students at the time, and at the top of the piece they had most recently worked on together was a date showing when her aunt had learned that same piece, 50 years earlier to the day.

“That moment was so surreal and grounding,” recalls Ellerman, “and it made me feel connected to a piece of my family history that I hadn’t really thought about before – I never met my great-grandmother Winnie.”

For Reed, the connective power of making music extends to the broader community. “As a Pacific Islander, music is woven deeply into our cultural traditions and identities,” she says. “It is truly a healing art form and a creative way to bring communities together and share the richness of the cultures.”

Reed’s family has made it a yearly tradition to host a “Music for the Soul” recital at their home, in honor of her father Nifai Tonga’s lifelong love of making music and his passing five years ago. The recital reunites Tonga’s grandchildren with other members of their small community, helping the family recover from grief and loss – and, in Reed’s words, “keeping music alive and well” in the hearts of all.

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That Was Me: Latin American Individuals and Identities in Medicine

by dom-wp-admin | Sep 23, 2024 | 2024, Communities

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That Was Me: Latin American Individuals and Identities in Medicine

#Communities

Maria Juarez-Reyes, PhD, MD; Dalia VanderZee, Department of Medicine staff; and Enrique Menendez, Department of Medicine staff

No two people are the same, especially in the Latin American community.

“I am different from others – we are all different in the Latin American community,” says Associate Director of Finance and Administration, Enrique Menendez.

Despite this, many still unfairly dismiss this widely diverse population of Americans. Menendez saw this when he first arrived in the United States from Guatemala more than 30 years ago. It took months for him to find employment, even though he already had a medical degree.

“Not even McDonald’s wanted to take a chance on me. It really was incredible,” Menendez remembers.

His first chance came from what might seem an unlikely place in such a prejudiced environment.

“I started working, actually, at Stanford, believe it or not,” Menendez laughs. “Even though I was rejected by everybody else, the only group, the only company that took a chance to hire me, was Stanford.”

Menendez’s expertise in medical research led him to administrative positions at UCSF and now back at Stanford. He capitalized on that first opportunity to create a career, proving again and again that he is a uniquely talented professional.

Being given that opportunity to succeed is crucial for members of the Latin American community who are often denied the chances their white counterparts get.

“When somebody comes to you, like I did with my chief, and says, ‘Hey, I’d really like to do this,’ say, ‘Go! Do it!’” Clinical Associate Professor of Primary Care and Population Health Maria Juarez-Reyes, PhD, MD, nods.

When Juarez-Reyes wanted to institute a new practice of behavioral health group medical visits in the Division of Primary Care and Population Health, Division Chief Sang-ick Chang, MD, gave her the go-ahead. She is grateful for that approval, but approval for such medically generative projects should be the norm for Latin American medical professionals, not contingent upon individual supervisors.

“I was bold enough to ask. He was generous enough to offer support. Offer that space more. People have ideas. Just encourage them,” Juarez-Reyes emphasizes.

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“Latino medical students and African American students are still struggling at Stanford. That should not be a culture here anymore. Start figuring out what we’re missing by talking to them. How can we make this culture better?”

– Maria Juarez-Reyes, PhD, MD

Far too often, medical institutions don’t offer that space and instead enable others to dismiss Latin American individuals with talent and experience.

“I’ve had physicians say, ‘What are you doing here? Why are you telling me what to do? You’re female. You’re from México,’ because I don’t introduce myself as a trained physician,” Dalia VanderZee affirms.

VanderZee practiced medicine in Mexico before moving to the United States and now works as an administrative division director at Stanford. Despite being in the Department of Medicine, she still is greeted with disbelief when she brings up her experience as a physician.

“What? You? From México?” people ask her, to which she replies, “Yes. Sure. Me.”

Latino/a/x community members don’t only face pressures to perform a certain identity from outside the community. Such pressure to be “correct” even comes from within the Latin American community, an extension of pressures to conform to ideas of what being “Latino/a/x” means. When VanderZee finished the paperwork to live in America, her lawyers told her that she would have more success getting jobs in the U.S. if she took her Dutch husband’s last name.

“So, I did. My dad was not very happy,” VanderZee says. “I also have been alienated from my community at times because I’m not the ‘typical migrant’ into California. Some people think you come here and work in the fields or you come here without papers. I’ve had the privilege of coming here differently. That doesn’t mean I’m going to lose my Mexican identity. There are a lot of people who don’t understand it, people who are going to resent it, and people who say, ‘You are one of us.’”

With such pressures on Latin Americans to perform, both within and outside the medical community, institutions need to reduce the disparities that they create. This gives Latino/a/x medical professionals the same space to excel as their peers.

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“Latino medical students and African American students are still struggling at Stanford. That should not be a culture here anymore,” Juarez-Reyes states sternly. “Start figuring out what we’re missing by talking to them. How can we make this culture better?”

Juarez-Reyes emphasizes that institutions can’t just focus on racial inequities among students and positions of lower authority. Stanford already focuses on medical inequities, making this the perfect place to continue positively redressing areas where we still fall short.

“Stanford is doing such a conscious effort to tackle health disparities and really looking at it from a policy standpoint and a research standpoint – which is wonderful. Can we recruit underrepresented minorities in medicine not just to be the ‘diversity chairman’?” Juarez-Reyes asks. “You want them to be the department chair, a division chief – don’t box us in.”

When institutions open doors for Latin Americans and other underrepresented minorities, they can broaden possibilities for health care and education in ways others do not imagine.

“I think the Department of Medicine is doing a concerted effort to reach out to the Latino/a/x community,” Menendez says. “They want to hear our experiences, to make sure we know about those individuals we otherwise wouldn’t know about. You don’t know what you don’t know about.”

Menendez links this back to his start at Stanford: No one knew him, but he just needed one opening to parlay that opportunity into a long career.

“I think it would be great if something like that could happen not only for people who come with a medical degree or a college background but for other individuals as well,” he says.

Regardless of the stories that each member of the Latin American community carries with them in the medical field and healthcare administration, everyone does so as an individual. An open door gives everyone a chance to show who they already are.

As VanderZee puts it, “Everything that happened after that was me.”

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New Digital Tools Advance DEI in Global Clinical Trial

by dom-wp-admin | Sep 20, 2024 | 2024, Methods

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New Digital Tools Advance DEI in Global Clinical Trial

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Julia Donahue (left) and Karma Lhamo are working to increase diversity, equity, and inclusion in global clinical trials.

Tackling racial bias in health care takes many forms. The Stanford Center for Clinical Research (SCCR) is doing its part from the research side by working to increase diversity, equity, and inclusion (DEI) throughout its programs – from observational research studies to clinical drug and device trials.

“Despite best efforts, certain demographic groups continue to be underrepresented in clinical research,” says Julia Donahue, senior project manager at SCCR. “We want to ensure we have full representation from all different backgrounds when testing the efficacy and safety of drugs, devices, and other interventions. Collecting the highest-quality data benefits patients – not just at Stanford but around the world.”

“We know from medical literature that participants from certain racial and ethnic minorities tend to be underrepresented in clinical trials, especially in cardiology,” explains Sneha S. Jain, MD, clinical assistant professor of cardiovascular medicine. “To mitigate this disparity, the FDA now requires minimum representation from certain groups in clinical trials. For example, Black participants should comprise at least 6 percent of our trial population in the U.S.”

“Additionally, we’re looking to enroll more women in clinical trials,” says Donahue. “A recent study found that just over 41 percent of people enrolled in clinical trials for investigational drugs for cardiovascular disease are women, despite representing 51 percent of the patient population. We know we can do better.”

Clinical Trial for A-fib Drug to Have DEI Focus

SCCR has an exciting opportunity to boost DEI participation in a global clinical trial sponsored by Janssen Research and Development, LLC, and Bristol Myers Squibb called LIBREXIA-AF. Stanford is one of hundreds of sites involved in testing the effectiveness of a new anticoagulation drug for patients with atrial fibrillation (A-fib or AF), and it’s been tapped to serve a leadership role in participant recruitment. Jain, a member of the executive team for the LIBREXIA-AF study, is one of many SCCR staff and Stanford faculty working on multiple clinical trials involving nearly 50,000 patients for this comprehensive drug development program.

Says Marco Perez, MD, associate professor of cardiovascular medicine, “We’re involved in much of the operations, the scientific development, clinical events adjudication, biostatistics, as well as DEI efforts, not only for atrial fibrillation but also for separate clinical trials related to stroke and acute coronary syndrome.”

A DEI focus is particularly important for the A-fib trial, explains Perez, because “underrepresented groups are less likely to be prescribed anticoagulation medication, and we want to find new outreach methods to help us identify people who would benefit from this drug.”

Introducing the Stanford Heartbeat Study

To achieve its DEI goals, the SCCR team engaged the Stanford Medicine Technology and Digital Solutions team to develop a set of digital tools that would allow Stanford to recruit more minority participants. Digital recruitment methods have proved successful with past clinical trials, allowing Stanford to cast a wider net in recruiting participants for the Apple Heart Study and Project Baseline.

Digital tools will enable Karma Lhamo (left) and Julia Donahue to recruit more women and minority patients to participate in clinical trials for atrial fibrillation.

“We want to ensure we have full representation from all different backgrounds when testing the efficacy and safety of drugs, devices, and other interventions. Collecting the highest-quality data benefits patients – not just at Stanford but around the world.”

– Julia Donahue

The first phase of SCCR’s digital recruitment efforts – the Stanford Heartbeat Study website – launched in winter 2024.

The website makes it easy for people to express interest in participating in clinical trials related to atrial fibrillation. Describes Karma Lhamo, SCCR senior project manager for the Stanford Heartbeat Study, “The website is a digital platform that facilitates various functions of the study such as participant identification, screening, enrollment consent, and data collection. Potential participants can review and provide informed consent for the Stanford Heartbeat Study, confirm they have atrial fibrillation, and are at least 18 years old. If they meet those criteria, they’re directed to provide baseline screening information specifically tailored for LIBREXIA-AF, including their gender and ethnicity.”

The SCCR team hopes the website will generate excitement about clinical trial participation. Says Jain, “When you participate in research, there is a chance you will be randomized into a cohort that provides state-of-the-art therapeutics. With the LIBREXIA-AF study, participants will either be taking a drug that is the standard of care for atrial fibrillation today or a new drug – where we already have rigorous safety data – that could potentially be the best new therapy that we have.” The LIBREXIA-AF Study is a global, Phase III, randomized, double-blind, parallel-group, event-driven clinical trial comparing milvexian (an investigational oral Factor XIa inhibitor) with apixaban (an FDA-approved oral anticoagulant) in participants with atrial fibrillation or atrial flutter.

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Digital Tools Will Revolutionize Clinical Trial Recruitment and Engagement

Recruitment efforts for clinical trials traditionally occur in clinical inpatient and outpatient settings, making the process labor-intensive and site-specific. The Stanford Heartbeat Study enables recruitment over a wider geographic area and with an increased range of outreach partners. Explains Jain, “We want to partner with groups that serve A-fib patients, and the Stanford Heartbeat Study is a resource to engage people in the research process and make recruitment and enrollment easier.” While Stanford is using the tool to identify candidates, those who join the clinical trial will participate at the research site closest to them.

The second phase of the Stanford Heartbeat Study is a mobile app scheduled for release in early 2025. The app is designed to be an engaging and educational tool for LIBREXIA-AF participants as well as for those unable to enroll in this A-fib clinical trial but who might be eligible for a future one. An added benefit for those who join the Stanford Heartbeat Study through the mobile app is the option to have data collected from their wearable device, such as a smartwatch.

“We want the app to help us build a community for people with atrial fibrillation,” says Perez, who is the principal investigator for the Stanford Heartbeat Study. “We hope it will serve as a hub that will allow people to track all of their A-fib-related information: their medication doses, procedures such as cardioversion and ablation, as well as data from their mobile devices.”

The app will enable Stanford to expand beyond hospital- and clinic-based recruitment by reaching out directly to potential clinical trial participants. “This is a completely different approach to outreach where we’ll be using new strategies like social media ads,” notes Perez. “So, for example, people who search for the term ‘atrial fibrillation’ on Google or who have a certain profile on Facebook will see an ad for our study.”

Participants will be able to upload their A-fib data from a wide variety of devices, including Apple, Android, Samsung, and Fitbit. Targeted messaging will be used to enlist those who are located near an enrolling site or whose data show they are now eligible for a clinical trial.

Ultimately, says Jain, “we’re hoping the Stanford Heartbeat Study is a pathway to help us build a diverse community of people who are excited to contribute to research and advance science by participating in clinical trials.”

More About LIBREXIA-AF

The LIBREXIA-AF study will compare a new blood thinner medication, milvexian, with one commonly prescribed today (apixaban, also known as Eliquis). Patients with atrial fibrillation, a common type of heart arrhythmia, may be prescribed this type of anticoagulation medication to reduce the risk of stroke and blood clots. The study will evaluate if milvexian is at least as effective as apixaban and if it is associated with less bleeding risk. To learn more about the LIBREXIA-AF clinical trial, check out The Stanford Heartbeat Study.

Stanford Uses Team Science Approach in LIBREXIA-AF Study

SCCR’s program is an example of Stanford’s team science approach to medicine, with participation from more than 20 Stanford faculty and staff in cardiology, neurology, primary care, emergency medicine, and data sciences, along with trial operational experts. Says Kenneth Mahaffey, MD, director of SCCR and principal investigator for the LIBREXIA-AF trial, “This program highlights the potential for impactful, rigorous science through collaborations between academia and industry and is a great opportunity for Stanford. The breadth and depth of our involvement is also going to provide great mentoring and training opportunities for our young faculty, trainees, and staff.”

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