Shalender Bhasin, MD, director, Boston Claude D. Pepper Older Americans Independence Center at BWH, will lead a major study funded by the National Institutes of Health (NIH) and the Patient-Centered Outcomes Research Institute (PCORI) to research effective, evidence-based strategies addressing the personal and public health burden of falls in older adults. Part of the NIH-PCORI Falls Injuries Prevention Partnership, funding for the study is expected to total some $30 million over five years. First-year funding of $7.6 million was awarded on June 1, 2014.
Along with Bhasin, co-principal investigators from Yale School of Medicine and the David Geffen School of Medicine at the University of California, Los Angeles will lead a team of more than 100 researchers, stakeholders, patients and their representatives at 10 clinical health system sites across the United States.
“We have an interdisciplinary dream team of investigators, clinicians and stakeholders,” said Bhasin. “With this team, we can put all the different pieces of the falls prevention puzzle together. The trial will focus on clinical practice redesign, while also using interventions tailored to individuals. The goal is to recognize and overcome challenges in implementing fall-injury prevention strategies in diverse health systems.”
About the Study
The study’s approach will integrate proven falls reduction strategies into a cohesive intervention that can be adopted by many health care systems. Trial participants will be assessed for their individual risk of falling, and receive either current standard of care, such as information about preventing falls, or the experimental study intervention in which individualized care plans will be developed and administered.
The participant’s primary care physician will receive the plans for review, modification and approval and will include proven fall risk reduction interventions that can be implemented by the research team, physicians and other health care providers, caregivers and community-based organizations.
Six-thousand adults, age 75 and older, living in the community, with one or more modifiable risk factors for falls are expected to be enrolled in the study. The first-year pilot phase will involve testing of various aspects of the intervention with small numbers of people across 10 clinical sites. After evaluation by the National Institute on Aging at NIH and PCORI, enrollment for the full trial will start in year two and take place over 18 months. Study participants will be followed for up to three years.
The primary trial outcome is reduction in serious fall injuries, including non-spinal fractures, joint dislocation, head injuries, lacerations, internal injuries and hypothermia. Secondary outcomes include reduction in all falls that cause injuries; all falls regardless of injury; indicators of well-being, physical function and disability; and anxiety and depression.
Patients and other stakeholders will partner with researchers in national and local councils throughout the study development process and will be engaged during the trial at national and site levels.
With BWH as one of the clinical health system sites, Patricia C. Dykes PhD, RN, FAAN, FACMI, program director, BWH Center for Patient Safety Research and Practice and BWH Center for Nursing Excellence, will serve as site principal investigator for Partners HealthCare. She will lead a team to reach out to primary care practices within BWH, Brigham and Women’s Faulkner Hospital and Massachusetts General Hospital to recruit study participants.