A team led by research scientists from Indiana University School of Medicine and the Regenstrief Institute has received funding expected to total $15.5 million from the National Institute on Aging of the National Institutes of Health to establish a national network structure to involve more nursing home residents in clinical trials.
Although clinical trials are critical to the development and testing of medical therapies and treatments, including medications and models of care, individuals living in nursing homes are rarely included in clinical trials.
The new five-year award will fund the development of NEXT STEPs (Nursing Home EXplanatory Clinical Trials: Supporting Transformation by Enhancing Partnerships), an innovative national network for nursing home clinical trials. Researchers-clinicians from the IU School of Medicine and Regenstrief will lead the multi-institutional initiative to remove barriers to nursing home resident participation in clinical trials, creating a more inclusive approach to advancing medical science and improve human health.
Kathleen T. Unroe, MD, MHA, MS, of the IU School of Medicine and Regenstrief, is the principal investigator of NEXT STEPs, which includes research sites in nine states.
There is an urgent need to expand the infrastructure and capacity of researchers to conduct high-quality clinical trials to test diagnostic and therapeutic advances and care delivery in nursing homes. Our network will work with industry leaders and nursing home resident advocates to identify key priorities and strategies to advance nursing home research.”
Dr. Kathleen T. Unroe, MD, MHA, MS, of the IU School of Medicine and Regenstrief
The NEXT STEPs network will enable researchers from various disciplines to increase the number and quality of clinical trials conducted in nursing homes, including trials that focus on prevention, medical therapies, and behavioral and health care interventions.
NEXT STEPs will also create strong links between researchers, industry and other critical collaborators, driving evidence-based innovations on key priorities to optimize care for residents and the quality of life for those who live and support family members and friends, as well as for those who work in nursing homes.
Approximately 1.4 million people receive care in nursing homes in the US, the majority of whom have cognitive impairment or have been diagnosed with Alzheimer’s. Previous research by Dr. Unroe and colleagues successfully addressed barriers to inclusion of this vulnerable population in studies, including developing partnerships and identifying priorities; aligning recruitment and engagement strategies to ensure diverse representation of residents, families and staff; designing interventions with attention to common workflows in nursing homes and pathways for dissemination to real-world clinical practice.
NEXT STEPs will create an organizational structure, processes and procedures to develop a sustainable, diverse network of nursing home partners and researchers conducting successful explanatory studies to support high-quality care for people with multiple chronic conditions and serious illnesses. This infrastructure will be built through three cores that support three objectives. The cores are:
- recruitment and retention
- methods, measures and data
- training and projects
Goal 1: Provide integrated support to researchers in conducting equitable, explanatory studies in nursing homes.
Goal 2: Develop a sustainable, collaborative community of committed nursing home researchers and partners.
Goal 3: Build research capacity for high-quality, high-impact clinical trials in nursing homes.
The Nursing Home Explanatory Trials Network: Supporting Transformation by Enhancing Partnerships (U24AG087939) was awarded to Indiana University through the Alzheimer’s Disease Initiative and includes funding for consortium activities with:
- Regenstrif Institute, Inc.
- Brown University
- University of Maryland, Baltimore
- University of Utah
- Hebrew Rehabilitation Center
- The Regents of the University of California, Los Angeles (UCLA)
- University of Colorado Denver in the amount
- Institute for Healthcare Improvement
- Rhode Island Hospital
- University of North Carolina at Chapel Hill
- Duke University
- New York University
Besides Dr. Unroe, the researchers include co-investigators Wanzhu Tu, PhD, Regenstrief Institute and IU; Jennifer Carnahan, MD, MPH, MA, Regenstrief Institute and IU School of Medicine; Nicole Fowler, PhD, MHSA, Regenstrief Institute and IU School of Medicine. Susan Hickman, PhD, Regenstrief Institute, IU School of Medicine and IU School of Nursing leads the methods, measurements and data core. Shaun Grannis, MD, MS, Regenstrief Institute and IU School of Medicine serves in an advisory role.
Kathleen T. Unroe, MD, MHA, MS
In addition to her role as a research scientist at the Regenstrief Institute’s Indiana University Center for Aging Research, Kathleen Unroe, MD, MHA, is a professor of medicine at the Indiana University School of Medicine and a practicing geriatrician at a nursing home in Indianapolis.