PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care.
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2025-09
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Abstract
Background
Patients who receive post-acute care in a skilled nursing facility (SNF) following a fracture are at high risk for subsequent fall-related injuries. Optimizing medication management may mitigate this risk. This manuscript describes the protocol for a cluster crossover randomized controlled trial titled, PReventing Injury in Skilled Nursing Facilities through optimizing Medications (PRISM), designed to compare the effectiveness of three care models on the rates of injurious falls and other patient-centered outcomes.Methods
We will enroll 42 SNFs that are sharing electronic health record data with the Long-Term Care Data Cooperative (LTCDC). Matched control facilities will be identified at a ratio of 3:1 based on rural/urban location, profit status, and annual number of post-acute care admissions. Over 6-month periods, in random order, the participating SNFs will sequentially implement three evidence-based care models in a random order: a Deprescribing model, a Bone Health model, and a combined model (referred to as an Injury Prevention model). Patients with recent fractures admitted to participating SNFs for post-acute care during the intervention period will be eligible (target n = 3780). A remote nurse fracture consultant will review medical records, engage in shared decision-making, develop and coordinate a medication optimization plan with SNF and primary care providers, and follow up with the patient and primary care provider upon discharge. The primary outcome is incident injurious falls, measured using Medicare claims data (mean 2-year follow-up). Secondary outcomes include process measures (e.g., adherence with recommendations) and patient-reported outcomes ascertained by telephone survey at 90 days (e.g., medication burden, anxiety, depression, pain, sleep). Safety outcomes will be compared between the three models using Medicare claims data to identify events.Discussion
This cluster crossover trial aims to compare patient outcomes between each of the three care models and against matched control facilities. Results will inform patients, payors, health systems, and SNF chains of the most effective model to improve outcomes for older adults receiving post-acute care following a fracture.Trial registration
NCT06304428. Registered on February 25, 2025.Type
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Berry, Sarah D, Mark Toles, Thomas G Travison, Eleanor S McConnell, Andrew R Zullo, Milta O Little, Lisa Gwyther, Cara McDermott, et al. (2025). PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care. Trials, 26(1). p. 367. 10.1186/s13063-025-09122-z Retrieved from https://hdl.handle.net/10161/34644.
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Scholars@Duke
Eleanor Schildwachter McConnell
Dr. McConnell's program of research focuses on factors that influence functional decline in very frail older adults. She has been funded by the National Institute of Nursing Research and the Department of Veterans Affairs to conduct a series of studies designed to identify modifiable risk factors for worsening self-care disability in long-stay nursing home residents with chronic cognitive impairment. She has also developed and tested a variety of interventions to modify risk factors for worsening disability. Her research builds upon existing knowledge of the bio-physical determinants of disability as conceptualized in the Nagi Disablement Model. Dr. McConnell's academic interests include frailty in the aged, the role of the environment in promoting function, and the conduct and testing of nursing interventions to prevent decline in those with chronic illness.
Milta O Little
Dr. Milta Oyola Little has extensive experience in caring and advocating for older adults across care settings, including the entire post-acute and long-term care continuum, inpatient geriatric consultation, outpatient primary care/consultation, home care, and hospice. She currently serves as medical director for The Forest at Duke Continuing Care Retirement Community and for the North Carolina Longevity Health Plan institutional Special Needs Plan (a Medicare Managed Care insurance). Dr. Little has completed four elected board terms for AMDA: The Society for Post-Acute and Long-Term Care Medicine and is the current President-Elect of The Society. Her primary scholarly interests are interprofessional education, deprescribing initiatives, and implementation of Dementia-Friendly and Age-Friendly Health System programs across settings of care. Dr. Little is currently working on the implementation of Cognitive Stimulation Therapy and development of clinical programs to address the longitudinal needs of PLWD and their caregivers in the Duke Health system.
Lisa Pepper Gwyther
Lisa Gwyther, MSW, LCSW, is an Associate Professor in the Department of Psychiatry and Behavioral Sciences and Co-Director for the Social Work Professional Unit. Ms. Gwyther (along with Co-Director William Meyer, MSW, LCSW) provide mentorship to the department’s social workers and communicates the needs of the department’s social workers to senior leadership.
Ms. Gwyther is approaching her fourth decade of service dedicated to help the increasing number of individuals and families living with Alzheimer's and related diseases. The focus of her work has been in the community as a representative of the Duke Center for Aging, the Bryan Alzheimer's Disease Research Center and the Duke Family support program. She has had continuous annual contracts from the NC DHHS Division of Aging since 1984, reaching families, health and social service professionals in communities throughout North Carolina. She is the founder and Director of the Duke Center for Aging’s Alzheimer’s Family Support Program, which was named “Agency of the Year” by the NC Chapter of the National Association of Social Workers in 1999.
Ms. Gwyther received her graduate training in social work at Case Western Reserve University in Cleveland, OH. She has published over 144 articles, book chapters, and books on Alzheimer’s care and family caregiving research. She served on the U.S. federal advisory panel on Alzheimer’s disease for nine years. Ms. Gwyther was recognized in the 20th anniversary issue of Contemporary Long-Term Care as one of the 20 people who made a difference in U.S. long-term care during those twenty years. She was named a distinguished social work practitioner by the National Academies of Practice.
Ms. Gwyther is the co-author of The Alzheimer’s Action Plan: A Family Guide (2009), winner of two prestigious consumer health awards.
Most recently she was a member of The National Academies Committees on Cognitive Aging for the 2015 report: Cognitive Aging: Progress in Understanding and Opportunities for Action, and she co-chaired the NC Alzheimer's Disease and Related Disorders Task Force of the NC Institute of Medicine and NC DHHS which issued a report and recommendations to the NC Legislature in April 2016.
Current research interests: Alzheimer's disease nursing home and assisted living care, community translation of evidence-based dementia caregiver interventions, early stage Alzheimer's programming, non-pharmacological approaches to dementia-related behavioral symptoms.
Cara L. McDermott
Dr. Cara McDermott is an Assistant Professor in Medicine, Division of Geriatrics, at Duke University School of Medicine. She has a K23 award from NIH's National Heart, Lung and Blood Institute on deprescribing fall-risk increasing drugs among multimorbid adults with chronic obstructive pulmonary disease. Her research focuses on identifying gaps in healthcare delivery and using implementation science to adapt and assess evidence-based interventions. Dr. McDermott works to optimize medication use, improve symptom management, and reduce unwanted healthcare use among older adults with multiple chronic conditions, with a particular interest in improving outcomes for patients with cancer, COPD, or dementia and their caregivers. She is particularly interested in improving shared decision making in this population and medication deprescribing for adults with serious illness. In recent projects, she investigated ways to improve end-of-life care from the perspective of bereaved caregivers and care delivery gaps leading to unwanted healthcare utilization at end of life for patients with multimorbidity. She completed a T32 postdoctoral fellowship with the Cambia Palliative Care Center of Excellence at the University of Washington and a K12 with the University of Washington’s Implementation Sciences Training Program.
Richard H. Lee
Michael Paul Cary
Dr. Cary is an Associate Professor and Elizabeth C. Clipp Term Chair of Nursing in the Duke University School of Nursing. Dually trained as a health services researcher and applied data scientist, Dr. Cary uses AI and machine learning to study health disparities related to aging and develop strategies to advance health equity and improve healthcare delivery to older adults in diverse populations. His research has been supported by the National Library of Medicine, National Institute of Nursing Research, and the Duke Clinical and Translational Science Institute. He has published more than 50 manuscripts, book chapters, and editorials and has mentored numerous students and faculty members. In 2022, he was inducted as a Fellow of the American Academy of Nursing for his significant contributions to improve health and healthcare.
Most recently, he was selected by Duke Health to be the inaugural AI Health Equity Scholar. In this health system leadership position, he leads an interdisciplinary team in identifying clinical algorithms that perpetuate racial and ethnic health and health care disparities and implementing system-wide standards for mitigating their harmful discriminatory effects on patients. These meaningful contributions are vital to addressing health disparities and promoting equitable health outcomes for all patients at Duke and beyond.
Dr. Cary received a bachelor’s degree in health services administration from James Madison University. He also earned a bachelors, masters, and doctoral degree in nursing from the University of Virginia.
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