The National Institutes of Health (NIH) and the Patient-Centered Outcomes Research Institute (PCORI) have partnered in an effort to support a clinical trial designed to test individually tailored interventions to prevent fall-related injuries.
The award, according to an NIH news release, was 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. The award is expected to total $30 million during the 5-year project.
The release reports that Shalender Bhasin, MD, Brigham and Women’s Hospital, Harvard Medical School, Thomas Gill, MD, Yale School of Medicine, New Haven, Connecticut, and David Reuben, MD, David Geffen School of Medicine at the University of California, Los Angeles, will lead the trial. The team will encompass more than 100 researchers, stakeholders, patients, and their representatives at 10 clinical health system sites nationwide. First year funding of $7.6 million was awarded June 1.
The study’s approach will center on integrating falls reduction strategies into a cohesive intervention that can be adopted by many health care systems.
‘This collaboration with PCORI exemplifies our efforts to go beyond the norms to solve the nation’s health issues,” explains Francis S. Collins, MD, PhD, NIH director. “The problems we face are complex and therefore require thoughtful and complex solutions. I am hopeful this initiative will greatly improve the lives of those most at risk for falls.”
In the release, Richard J. Hodes, MD, NIA director, echoes Collins’ sentiments and adds that the 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.”
During the trial, the release reports that each person will be assessed for 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 each study participant’s primary care physician for review, modification, and approval.
The plans will also include 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 hinges on the concept of a falls care manager working with each participant’s primary care provider to develop the plans and monitor success.
The release states that the research team plans to enroll 6,000 adults aged 75 years and older living in the community with one or more modifiable risk factors for falls. The first year of the study will serve as a pilot phase, involving the testing of many aspects of the intervention among small numbers of individuals across 10 clinical sites. Once approval has been given by the NIA and PCORI to proceed, study enrollment for the full trial will start in year two and take place during a span of 18 months. The participants will then be followed up for up to 3 years.
The primary trial outcome centers on reduction in serious fall injuries, including nonspinal fractures, joint dislocation, head injuries, lacerations, internal injuries, and hypothermia. The release notes that secondary outcomes include reduction in falls that cause injuries, all falls regardless of injury, indicators of well-being, physical function and disability, and anxiety and depression.
The 10 trial sites and the regions they serve include Essentia Health, Duluth, Minnesota (Midwest); HealthCare Partners, Torrance, Calif, (Southern California); Johns Hopkins Medicine, Baltimore (Mid-Atlantic); Mount Sinai Health System, New York City (Northeast); Partners HealthCare, Waltham, Mass, (Northeast); Reliant Medical Group, Worcester, Mass, (Northeast); University of Iowa Health Alliance, Iowa City (Midwest); University of Pittsburgh Medical Center (Mid-Atlantic); University of Texas Medical Branch, Galveston Health (Southwest); and University of Michigan, Ann Arbor (Midwest).