The eagerly awaited results for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Trial are now available in a new article in the New England Journal of Medicine, A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

For Immediate Release July 17, 2020

Large-Scale Fall Prevention Study Finds Smaller Than Expected Benefit
Randomized trial of more than 5,000 participants found 8% reduction in serious fall injuries

Falls are the leading cause of injury-related death among older Americans and lead to 3 million emergency department visits every year. About one out of every three adults age 65 years and older falls each year, and 20 to 30 percent of those who fall suffer moderate-to-severe injuries such as broken hips or head trauma. Investigators involved in the STRIDE (Strategies to Reduce Injuries and Develop Confidence in Elders) Study, including Elena Volpi, MD, PhD, University of Texas Medical Branch, Galveston Texas, evaluated the effectiveness of a nurse-delivered, fall-injury prevention strategy delivered through primary care. This week in the New England Journal of Medicine, the team reports an approximately 8 to 10 percent reduction in serious fall injuries — an intervention effect that was lower than expected.

“The STRIDE Study represents the largest randomized trial of fall injury prevention strategies that has been published,” said senior author Shalender Bhasin, MD, director of Research Programs in Men’s Health, Aging and Metabolism at Brigham and Women’s Hospital. “We found that the treatment effect of the intervention in real clinical practice was lower than we anticipated. Even with the study as large as it was, it just wasn’t large enough for the 8-10% percent treatment effect we saw to be statistically significant.”

The trial was conducted in 86 real-world clinical practices with substantial input from patients, caregivers, health care professionals and other stakeholders. Ten of these practices were at the University of Texas Medical Branch (UTMB) in collaboration with UT Health Houston. Dr. Elena Volpi, MD, PhD, director of the UTMB Sealy Center on Aging, was the principal investigator for the UTMB/UT Health Houston clinical site. The study evaluated the effectiveness of a multifactorial intervention that included risk assessment and individualized fall injury prevention plans administered by nurse Falls Care Managers. These interventions included measures to address strength, gait, and balance impairment; medications; drops in blood pressure when standing up; feet and footwear; vision; osteoporosis and vitamin D; and home safety.

The trial enrolled 5,451 people aged 70 and older who were at were at risk of fall injuries from 10 health systems in the U.S. In the trial's intervention arm, a nurse Falls Care Manager worked with the patients and their physicians to identify risk factors for falls and fall-related injuries and to create care plans to reduce these risk factors. Plans included referrals to community-based programs, as needed.

The study found that the multifactorial intervention did not significantly reduce the rate of serious fall injury, which was the primary outcome of the trial. The study did find a significant 10% reduction in self-reported injuries, a secondary outcome in the trial.

“The study reflects just how challenging it is to implement interventions to prevent fall injury in the real world,” said Bhasin. “Our Falls Care Managers were passionate about the care of their patients and creating individualized plans for them. But measures that may reduce risk in the setting of a clinical trial can be less effective in the real world, where daily challenges such as being unable to afford transportation or the cost of follow-up care may delay or prevent access for patients. To achieve a larger reduction in serious fall injuries, we need to think about how to improve the delivery and access to key interventions like exercise in our health systems."

“We would like to thank the 541 patients, their caregivers and healthcare providers who have participated in this important clinical trial at UTMB” said Dr. Volpi. “Many thanks also to our Local Patients and Stakeholders Council members, led by Dr. Rebecca Galloway, PT, PhD, and Alice Williams, MS, LBSW, who helped us adapt the clinical trial’s protocol and procedures to better meet our patients’ needs and successfully complete the study”.

This work was supported by the Patient-Centered Outcomes Research Institute and the National Institute on Aging of the National Institutes of Health (NIH) through a cooperative agreement (5U01AG048270) between the National Institute on Aging and UTMB. The project is part of the Falls Injuries Prevention Partnership between the National Institute on Aging and Patient-Centered Outcomes Research Institute. Research reported in this publication was also supported in part by the National Institute on Aging of the National Institutes of Health UTMB Claude D. Pepper Older Americans Independence Center under Award Number P30AG024832. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

The STRIDE trial was led by Shalender Bhasin, MD, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts; Thomas M. Gill, MD, Yale School of Medicine, New Haven, Connecticut; David B. Reuben, MD, David Geffen School of Medicine at the University of California, Los Angeles; and Peter Peduzzi, PhD, Yale School of Public Health, New Haven Connecticut. Dr. Elena Volpi, MD, PhD, was the Clinical Site Principal Investigator for UTMB. The STRIDE study team included more than 100 researchers, stakeholders, patients and their representatives at 10 clinical health system sites across the country.

For more general information about the STRIDE study, go to https://stride-study.org.

Paper cited: Bhasin, Shalender et al. “A Randomized Trial of a Multifactorial Fall Injury Prevention Strategy” New England Journal of Medicine DOI: 10.1056/NEJMoa2002183

Author Elena Volpi, MD, PhD is an internationally renowned expert in clinical and translational research on muscle aging and physical function in older adults. She is also a practicing geriatric endocrinologist. Dr. Volpi holds the Daisy Emery Allen Distinguished Chair in Geriatric Medicine and is Director of the Sealy Center on Aging and the UTMB Claude D. Pepper Older Americans Independence Center.

The Sealy Center on Aging is a leader in aging research and education since 1995. The Center focuses on improving the health and well-being of the elderly through interdisciplinary research, education, and community service by integrating the resources and activities relevant to aging at UTMB. The Center also implements our research findings in hospitals and clinics, improving the health of our seniors.