To find effective, evidence-based strategies to address the personal and public health burden of falls in older adults, the National Institutes of Health (NIH) and the Patient-Centered Outcomes Research Institute (PCORI) have joined to support a clinical trial to test individually tailored interventions to prevent fall-related injuries. The award, made by the National Institute on Aging (NIA) of the NIH and funded by PCORI as part of the Falls Injuries Prevention Partnership of the two organizations, is expected to total some $30 million over the five year project. First-year funding of $7.6 million was awarded last June.
The trial is led by Shalender Bhasin, MD, a researcher in the Division of Endocrinology, Diabetes and Hypertension at Brigham and Women's Hospital; Thomas Gill, MD, of Yale School of Medicine; and David Reuben, MD, of the David Geffen School of Medicine at the University of California. The team includes more than 100 researchers, stakeholders, patients and their representatives at 10 clinical health system sites across the country.
The study’s approach differs from others in that it will integrate proven falls reduction strategies into a cohesive intervention that can be adopted by many health care systems.
Previous studies have analyzed risk factors for falls and falls injuries, along with interventions to prevent them. But the best evidence about how to reduce falls has not been broadly applied. Attempts to change physician behavior about falls through conventional medical education channels and other methods have not been very effective. Patients and other stakeholders generally have not been partners in the research process and, as a result, not fully engaged.
NIA Director Richard J. Hodes, MD, said, “This study will focus on people at increased risk for injuries from falls, the specific care plans that should be implemented, including interventions tailored to individual patients, and how physicians and others in health care and in the community can be involved.”
Each person in the trial will be assessed for his or her risk of falling, and receive either the current standard of care – primarily information about preventing falls – or the experimental study intervention in which individualized care plans will be developed and administered. The plans will be presented to the participant’s primary care physician 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. The intervention centers on the concept of a falls care manager working with each participant’s primary care provider to develop and monitor the plans.
The research team plans to enroll 6,000 adults in the U.S. age 75 and older, living in the community, with one or more modifiable risk factors for falls. The first year of the study is a pilot phase, during which many aspects of the intervention will be tested with small numbers of people across 10 clinical sites. If the go-ahead is given by NIA and PCORI to proceed with the study after that, enrollment for the full trial will start in year two and take place over 18 months. The 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.
“We have an interdisciplinary dream team of investigators, clinicians, and stakeholders from the participating trial sites,” said principal investigator Dr. 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.”
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