BACKGROUND Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.)
Bibliographical noteFunding Information:
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 Brigham and Women’s Hospital. The project is part of the Falls Injuries Prevention Partnership between the National Institute on Aging and Patient-Centered Outcomes Research Institute. This research is partially supported by the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women’s Hospital (P30AG013679) and Harvard Catalyst, the Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH Award UL1TR001102) and financial contributions from Harvard University and its affiliated academic health care centers. Support was also provided by the Claude D. Pepper Older Americans Independence Centers at the University of California, Los Angeles (P30AG028748), Yale University (P30AG021342), Mount Sinai Medical Center (P30AG2874106), the University of Texas Medical Branch (P30AG024832), the University of Michigan (P30AG024824), the University of Pittsburgh (P30AG024827), Wake Forest University School of Medicine (P30AG021332), and the Older Americans Independence Center National Coordinating Center (U24AG059624). Mount Sinai Medical Center also received grant support from the New York Academy of Medicine. Additional support at Yale University was provided by the Clinical and Translational Science Awards program of the National Center for Advancing Translational Sciences of the NIH (UL1TR000142) and by the National Institute on Aging to Dr. Gill (Academic Leadership Award K07AG043587). Dr. McMahon was supported by grants (KL2TR000113 and UL1TR000114) from the University of Minnesota Clinical and Translational Science Institute, which is funded by the National Center for Advancing Translational Sciences of the NIH. The University of Michigan also received support from Michigan Medicine, its academic health care system. The University of Pittsburgh also received support from the University of Pittsburgh Medical Center, its academic health care system.
Copyright © 2020 Massachusetts Medical Society.
PubMed: MeSH publication types
- Journal Article
- Multicenter Study
- Pragmatic Clinical Trial
- Randomized Controlled Trial
- Research Support, N.I.H., Extramural
- Research Support, Non-U.S. Gov't