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

NCT05689554 | Completed Results

• 2 other identifiers: SITE00000971CD002967
• Study Type: interventional
• Target: 2,367
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Accidental Fall

Outcome Measures

Primary Outcomes (1)

• Medically Treated Falls

  Falls for which medical attention is sought

  up to 26 months following intervention

Secondary Outcomes (1)

• Medication Discontinuation

  6 months following intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Educational intervention

Behavioral: STOP Falls Educational Intervention

Usual Care

NO INTERVENTION

Usual care

Interventions

STOP Falls Educational Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For opioid and sedative-hypnotic medications, eligible participants are aged 60 years or older, while for skeletal muscle relaxants, tricyclic antidepressants, and first-generation antihistamines, eligible participants are aged 65 years or older.
• Eligible participants must be long-term users of the target medication, defined as pharmacy dispensing of at least one of the target medication classes for at least 70 of the prior 90 days.
• Further, eligible participants must either be assigned to a primary care provider (PCP) or have had 1+ visits in the prior year with a PCP at one of the 18 Kaiser Permanente Washington clinics participating in the study.

You may not qualify if:

• diagnosis of dementia or a prescription for a medication used to treat dementia (i.e., a cholinesterase inhibitor or memantine);
• residence in a skilled nursing facility;
• metastatic cancer diagnosis in the prior 12 months;
• receiving hospice or palliative care;
• legally blind (unable to read print materials);
• indication the participant requires a translator (cannot read materials printed in English); g) enrolled in other KPWA opioid deprescribing research studies;
• h) enrolled in a KPWA pharmacy-driven initiative to reduce opioid doses; or i) diagnosed with opioid use disorder

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (3)

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

• Phelan EA, Williamson BD, Balderson BH, Cook AJ, Piccorelli AV, Fujii MM, Nakata KG, Graham VF, Theis MK, Turner JP, Tannenbaum C, Gray SL. Reducing Central Nervous System-Active Medications to Prevent Falls and Injuries Among Older Adults: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2424234. doi: 10.1001/jamanetworkopen.2024.24234.

  PMID: 39052289 DERIVED

• Balderson BH, Gray SL, Fujii MM, Nakata KG, Williamson BD, Cook AJ, Wellman R, Theis MK, Lewis CC, Key D, Phelan EA. 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. 2023 May 11;24(1):322. doi: 10.1186/s13063-023-07336-7.

  PMID: 37170329 DERIVED

Results Point of Contact

• Title: Dr. Elizabeth Phelan
• Organization: University of Washington

phelane@uw.edu

(206) 744-9112

Study Officials

• Elizabeth Phelan, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Gerontology & Geriatric Medicine

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 19, 2023
• Study Start: April 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)