Large, multi-site, multi-intervention trial will test new patient-centered strategies
Each year, 1 out of 3 adults 65 and older will fall, sustaining injuries that can lead to a precipitous decline in health, loss of independence, even death. Seeking new ways to address the personal and public health burden of these falls, the University of Texas Medical Branch at Galveston is participating, along with nine other clinical health system sites across the country, in a clinical trial to test individually tailored interventions for preventing fall-related injuries.
The trial, sponsored by the National Institute on Aging and funded by the Patient-Centered Outcomes Research Institute, 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 June 1.
The study will integrate proven falls-reduction strategies into a cohesive intervention that can be adopted by many health care systems.
“The patient-centered outcomes approach exemplifies this project’s efforts to go beyond the norms to solve a very important health issue,” said Dr. Elena Volpi, the principal investigator for UTMB and interim director of UTMB’s Sealy Center on Aging. “The issue is complex and requires a thoughtful and complex array of solutions. This initiative shows great promise for truly improving the lives of those most at risk for falls.”
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.
“With this trial, we will be able to evaluate interventions on a comprehensive and very large scale,” said NIA director Dr. Richard J. Hodes. “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.”
The UTMB research team plans to enroll several hundred adults 75 and older, with one or more modifiable risk factors for falls. 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 the plans and monitor success.
Ten trial sites across the country were chosen to address geographic, rural/urban, academic/nonacademic, and racial/ethnic diversity, and to include a range of health care systems and models of care. The 14 NIA-funded Claude D. Pepper Older Americans Independence Centers, which include the nation’s premier research programs in complex geriatric syndromes, and of which UTMB is one with Volpi serving as director helped to develop the trial protocol and will participate in the study.
Along with UTMB, the other trial sites are Essentia Health, Duluth, Minn.; HealthCare Partners, Torrance, Calif.; Johns Hopkins Medicine, Baltimore, Md.; Mount Sinai Health System, New York; Partners HealthCare, Waltham, Mass.; Reliant Medical Group, Worcester, Mass.; University of Iowa Health Alliance, Iowa City, Iowa; University of Pittsburgh Medical Center, Pittsburgh, Pa.; University of Michigan, Ann Arbor, Mich.