NCT05689554

Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,367 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The overall objective of STOP-FALLS is to test whether a patient-centered deprescribing intervention that focuses on CNS-active medications reduces medically treated falls among older adults. The aims are: AIM 1: Adapt and pilot-test an evidence-based medication reduction intervention for use in an integrated health care system. AIM 2: Implement and evaluate the adapted intervention using a cluster-randomized controlled trial design. Aim 3: Assess barriers and facilitators to intervention implementation.

Detailed description

Background: Central 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. This is 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. Sample size calculations ensured 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. The study team will also examine medication signetur fields for attempts to decrease medications. The study team will report factors affecting implementation of the intervention.

Conditions

• Aging
• Accidental Fall

Interventions

Type	Name	Description
BEHAVIORAL	STOP Falls Educational Intervention	This is a pragmatic, cluster-randomized, parallel-group, controlled clinical trial. The unit of randomization is the clinic, to avoid the risk of contamination if healthcare providers within a clinic were randomized (i.e., reducing the potential for intervention providers to communicate with control providers about the intervention and share materials). Eighteen clinics were identified for the trial, of which 9 were randomized to the intervention and 9 to usual care.

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-01-19
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

1 site across 1 country: United States