A health-system-embedded deprescribing intervention targeting patients and providers to prevent falls in older adults (STOP-FALLS trial): study protocol for a pragmatic cluster-randomized controlled trial

Trials

Study Protocol

Brian D. Williamson¹  Kanichi G. Nakata²  Benjamin H. Balderson²  Mary Kay Theis²  Cara C. Lewis²  Monica M. Fujii²  Robert Wellman²  Dustin Key²  Andrea J. Cook³  Shelly L. Gray⁴  Elizabeth A. Phelan⁴ 

[1] Kaiser Permanente Washington Health Research Institute, Fred Hutchinson Cancer Center, Seattle, USA;Kaiser Permanente Washington Health Research Institute, Seattle, USA;Kaiser Permanente Washington Health Research Institute, University of Washington, Seattle, USA;University of Washington, Seattle, USA;

关键词: Falls;    Deprescribing;    Opioids;    Sedative-hypnotics;    Muscle relaxers;    Antidepressant;    Antihistamines;   

DOI  :  10.1186/s13063-023-07336-7

 received in 2023-03-15, accepted in 2023-04-29,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundCentral nervous system (CNS) active medications have been consistently linked to falls in older people. However, few randomized trials have evaluated whether CNS-active medication reduction reduces falls and fall-related injuries. The objective of the Reducing CNS-active Medications to Prevent Falls and Injuries in Older Adults (STOP-FALLS) trial is to test the effectiveness of a health-system-embedded deprescribing intervention focused on CNS-active medications on the incidence of medically treated falls among community-dwelling older adults.MethodsWe will conduct a pragmatic, cluster-randomized, parallel-group, controlled clinical trial within Kaiser Permanente Washington to test the effectiveness of a 12-month deprescribing intervention consisting of (1) an educational brochure and self-care handouts mailed to older adults prescribed one or more CNS-active medications (aged 60 + : opioids, benzodiazepines and Z-drugs; aged 65 + : skeletal muscle relaxants, tricyclic antidepressants, and antihistamines) and (2) decision support for their primary health care providers. Outcomes are examined over 18–26 months post-intervention. The primary outcome is first incident (post-baseline) medically treated fall as determined from health plan data. Our sample size calculations ensure at least 80% power to detect a 20% reduction in the rate of medically treated falls for participants receiving care within the intervention (n = 9) versus usual care clinics (n = 9) assuming 18 months of follow-up. Secondary outcomes include medication discontinuation or dose reduction of any target medications. Safety outcomes include serious adverse drug withdrawal events, unintentional overdose, and death. We will also examine medication signetur fields for attempts to decrease medications. We will report factors affecting implementation of the intervention.DiscussionThe STOP-FALLS trial will provide new information about whether a health-system-embedded deprescribing intervention that targets older participants and their primary care providers reduces medically treated falls and CNS-active medication use. Insights into factors affecting implementation will inform future research and healthcare organizations that may be interested in replicating the intervention.Trial registrationClinicalTrial.gov NCT05689554. Registered on 18 January 2023, retrospectively registered.

【 授权许可】

CC BY   
© The Author(s) 2023

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