A large, multisite clinical trial will test individually tailored fall-prevention interventions to find effective, evidence-based strategies to address the personal and public health burden of fall-related injuries, according to a news release.
Funding for the $30 million, five-year project will come from the National Institutes of Healths National Institute on Aging and the Patient-Centered Outcomes Research Institute.
Each year, one out of three adults age 65 and older falls. A third of those falls cause moderate to severe injuries that can lead to further declines in health and loss of independence, according to the release. Thousands of older adults die each year from such falls. The new trial will test an intervention centered on the concept of a falls care manager working with each participants primary care provider to develop the care plans and monitor success.
Marita Titler, RN, PhD, FAAN, associate dean of clinical scholarship and practice development at the U-M School of Nursing, and Maureen Fagan, DNP, FNP-BC, executive director of the Center for Patients and Families at Brigham and Womens Hospital in Boston, co-lead the patient/stakeholder engagement component of the study nationwide, which includes a National Patient and Stakeholder Council and local councils at each of 10 clinical health system sites. The councils include older patients, caregivers and other stakeholders who will provide ongoing feedback on the design and implementation of the study.
This is a large landmark study that addresses a very important health issue of older adults: preventing falls and injuries from falls, Titler said in a release. As a co-investigator on the study and lead investigator for patients, caregivers and other stakeholder engagement, I am looking forward to working with this very talented interdisciplinary team of investigators from across the U.S., assuring that the key stakeholders are integrated into the national and local investigative teams and decision-making about various aspects of the study. I will share expertise in fall prevention, implementation science, and engaging patients, communities and practices as partners in research.
The study will integrate proven falls reduction strategies into a cohesive intervention that can be adopted by many healthcare systems. Past studies have analyzed risk factors for falls and fall injuries, along with interventions to prevent them; however, the best evidence about how to reduce falls has not been broadly applied, according to the NIH.
Physicians at Harvard Medical School in Boston, Yale School of Medicine in New Haven, Conn., and the David Geffen School of Medicine at UCLA will lead the study.
The research team will include more than 100 researchers, stakeholders, patients and their representatives at the 10 sites. First-year funding of $7.6 million was awarded June 1. 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 healthcare and in the community can be involved, NIA Director Richard J. Hodes, MD, said in the release.
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 include proven fall risk reduction interventions that can be implemented by the research team, physicians and other healthcare providers, caregivers and community-based organizations. The participants PCP will have the chance to review and modify the plan before approving it.
The research team plans to enroll 6,000 adults ages 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 NIA and PCORI approve, enrollment for the full trial will start in year two and take place over 18 months. Participants will be followed for as long as three years.
The primary trial outcome is reduction in serious fall injuries, including nonspinal 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; and indicators of well-being, physical function, disability, anxiety and depression.
The 10 sites across the country were chosen specifically to address factors such as region, rural or urban location and racial and ethnic diversity.
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 Care, Iowa City (Midwest)
University of Pittsburgh Medical Center (Mid-Atlantic)
University of Texas Medical Branch at Galveston (Southwest)
University of Michigan, Ann Arbor (Midwest)