Each year, one in three adults aged 65 or older falls, and a third of these falls result in moderate to severe injuries that can lead to further declines in health and a loss of independence. Thousands of older adults also die every year from such falls.
To find effective, evidence-based strategies to address the personal and public health burden of these falls, the National Institutes of Health and the Patient-Centered Outcomes Research Institute (PCORI) have joined together to support a clinical trial to test individually tailored interventions to prevent fall-related injuries. The award, made by the NIH's National Institute on Aging and funded by PCORI as part of the two organizations' Falls Injuries Prevention Partnership, is expected to total $30 million over the five-year project.
The trial will be led by Dr. David Reuben of the David Geffen School of Medicine at UCLA; Dr. Shalender Bhasin of Brigham and Women’s Hospital, Harvard Medical School; and Dr. Thomas Gill of Yale School of Medicine. The team will include more than 100 researchers, stakeholders and patients and their representatives at 10 clinical health system sites across the country. First-year funding of $7.6 million was awarded on June 1.
“For too long, we have known what care processes are needed to reduce the risk of injuries due to falls. However, we haven’t been able to get these care processes done in practice,” said Reuben, chief of the UCLA Division of Geriatrics. “This study will develop and test a new approach to ensure that patients at risk of falling are participants in determining what falls-prevention care is right for them and ensuring that they get that care.”
The study’s approach differs from others in that it will integrate proven fall-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,” said Dr. Francis S. Collins, director of the NIH. “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.”
Previous studies have analyzed risk factors for falls and injuries from falls, along with interventions to prevent them. But the best evidence about how to reduce falls has not been broadly applied, and attempts to change physicians' behavior concerning 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 Dr. Richard Hodes, director of the National Institute on Aging (NIA). “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 will 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 focuses on the concept of a falls care manager working with each participant’s primary care provider to develop the plans and monitor success.
The research team plans to enroll 6,000 adults aged 75 and older living in the community who have 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 the NIA and PCORI to proceed with the study, enrollment for the full trial will start in the second year and take place over 18 months. The participants will be followed for up to three years.
This main goal of the clinical trial is to determine the effectiveness of the evidence-based, multi-factorial, patient-centered intervention in reducing the risk of serious fall injuries among non-institutionalized older people. Secondary goals, based on input from patients and stakeholders, include reducing injurious falls and all falls, regardless of injury, and improving indicators of well-being, including fall efficacy, physical function and reduction of physical function and disability, anxiety and depressive symptoms.
“PCORI’s goal is to develop evidence and provide that information to help patients, their health care providers and health care policymakers make better-informed decisions,” said Dr. Joe Selby, executive director of PCORI. “With active input from patients and other stakeholders from the very beginning of this study, we think we can have a major impact, changing practice to make a real difference in the lives of older people.”
Patients and other stakeholders will partner with the investigators in national and local councils throughout the study development process and will continue to be engaged during the trial at national and site levels. These contributors have advised the research team on several important study features. For example, one recommendation focused on the need for someone to follow up on referrals to determine whether and how participants follow through on them. Another honed in on occupational therapy as a component of interventions for improving quality of life for patients with sensory impairments such as low vision. Community organizations also helped inform the design of the community-based exercise program and the use of referral forms.
Ten trial sites across the country were chosen to address geographic, rural vs. urban, academic vs. nonacademic, and racial and ethnic diversity issues, 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, helped to develop the trial protocol and will participate in the study. Some centers will be involved as trial sites, while others will be involved in data analysis and dissemination of the study findings.
“We have an interdisciplinary 'dream team' of investigators, clinicians and stakeholders from the participating Pepper Centers and trial sites,” said principal investigator 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.”
The trial sites and regions they serve are Essentia Health in Duluth, Minnesota (Midwest); HealthCare Partners in Torrance, California (Southern California); Johns Hopkins Medicine in Baltimore (mid-Atlantic); Mount Sinai Health System in New York City (Northeast); Partners HealthCare in Waltham, Massachusetts (Northeast); Reliant Medical Group in Worcester, Massachusetts (Northeast); the University of Iowa Health Alliance in Iowa City (Midwest); the University of Pittsburgh Medical Center (Mid-Atlantic); the University of Texas Medical Branch, Galveston Health (Southwest); and the University of Michigan, Ann Arbor (Midwest).
Data management and analysis will be coordinated by Yale University's School of Public Health.
The NIH award for a Randomized Trial of a Multifactorial Fall Injury Prevention Strategy was supported by PCORI through a research partnership with the NIH.
PCORI is an independent, non-profit research funder authorized by Congress to help people make informed health care decisions and improve health care delivery and outcomes. For more information, visit www.pcori.org.
Learn more about the National Institutes of Health and the UCLA Division of Geriatrics.
The challenge is accepting submissions through May 1, 2019