Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods.
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Bhasin Shalender, Gill Thomas M, Reuben David B, Latham Nancy K, Gurwitz Jerry H, Dykes Patricia, McMahon Siobhan, Storer Thomas W, Duncan Pamela W, Ganz David A, Basaria Shehzad, Miller Michael E, Travison Thomas G, Greene Erich J, Dziura James, Esserman Denise, Allore Heather, Carnie Martha B, Fagan Maureen, Hanson Catherine, Baker Dorothy, Greenspan Susan L, Alexander Neil, Ko Fred, Siu Albert L, Volpi Elena, Wu Albert W, Rich Jeremy, Waring Stephen C, Wallace Robert, Casteel Carri, Magaziner Jay, Charpentier Peter, Lu Charles, Araujo Katy, Rajeevan Haseena, Margolis Scott, Eder Richard, McGloin Joanne M, Skokos Eleni, Wiggins Jocelyn, Garber Lawrence, Clauser Steven B, Correa-De-Araujo Rosaly, Peduzzi Peter
Аннотация
METHODS: Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control.
RESULTS: Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing.
CONCLUSIONS: The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.