As the U.S. population ages nationwide, seniors have been vastly underrepresented in clinical trials.
This is particularly true for people living in the nation’s 15,000-plus nursing homes. Fortunately, due to a recent grant from the National Institutes of Health, that could soon change.
The National Institutes of Health’s (NIH) National Institute on Aging (NIA) has granted a $15.5 million award toward the team at Indiana University School of Medicine and the Regenstrief Institute. The grant, spread out over a five-year period, will be put toward the team’s creation of a national network structure that seeks to include more nursing home residents in clinical trials.
The team is currently developing the program from the grant, titled NEXT STEPs (Nursing Home Explanatory Clinical Trials: Supporting Transformation by Enhancing Partnerships). As part of this program, researchers and clinicians will work together with nursing home industry partners to enhance more inclusive practices in the nursing home space, allowing for advanced medical science and improved health practices for older Americans.
Dr. Kathleen T. Unroe, professor of medicine at the IU School of Medicine and a research scientist at Regenstrief Institute, is leading the team in this effort, which includes research partners in at least nine states.
Unroe has worked in advance care planning and palliative care, dating back to experience at the Duke University Medical Center as a Geriatric Fellow and as a fellow for the Office of Disability, Aging, and Long Term Care Policy at the U.S. Department of Health and Human Services. In the years since, she honed in on the importance of these areas for the country’s rapidly aging population.
“The whole purpose of this is to have more evidence-based therapies, programs and tools to support people living in nursing homes, their families, and the staff that care for them,” she said.
As she relayed, the NEXT STEPs program will focus on three core principles in its structure:
- Staff recruitment and retention
- Methods, measures and data
- Training and pilot projects
“Woven into each of these core principles is the critical importance of health equity,” Unroe said. “We want to test interventions in nursing homes that are high functioning, but also those that struggle with chronic issues such as high turnover. Interventions need to work in all types of nursing homes to address long-term scalability. If our goal is to assist diverse resident and staff populations, we need to build those resources up front when we are designing studies.”
According to July 2022 research from the U.S. Centers for Medicare and Medicaid Services, approximately 1.2 million people reside in more than 15,000 certified nursing homes. Yet, this population has been underserved in representation in clinical trials, advanced care planning and palliative care.
While researchers have carried out a long and seasoned process to launch the NEXT STEPs project, the real work begins now, Unroe said. The team is still working on launching a website for its partners, and will be sharing more with prospective grantees about the available one-year pilot grant program for nursing home researchers nationwide to receive funding, mentorship and support from NEXT STEPs.
The NEXT STEPs program will be coordinated among the following partners, with Dr. Unroe as the project leader:
- Regenstrief Institute
- Brown University
- University of Maryland, Baltimore
- University of Utah
- Hebrew Rehabilitation Center
- The Regents of University of California, Los Angeles (UCLA)
- University of Colorado at Denver
- Institute for Healthcare Improvement
- Rhode Island Hospital
- University of North Carolina at Chapel Hill
- Duke University
- New York University
Additionally, the team will be establishing an education effort to assist researchers in designing clinical trials that make more sense for nursing home residents and help to enhance care for these participants.
“This infrastructure allows us to join forces and work together, to think through all of the different aspects of care and what the common challenges are, and how we can navigate them,” Unroe said. “How do we create resources and tools that really work in regard to collaboration?”
