NCT05689554: STOP-FALLS

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

Completed NA Results posted Last updated 9 December 2024

What this trial tests

NA trial testing STOP Falls Educational Intervention in Aging in 2,367 participants. Completed in 30 September 2023.

Timeline

1 April 2021

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	2,367
Start date	1 April 2021
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across United States

Drugs / interventions tested

• STOP Falls Educational Intervention

Conditions studied

• Aging — all drugs for Aging →
• Accidental Fall — all drugs for Accidental Fall →

Sponsor

University of Washington

Who can join

60 and older, any sex, with Aging or Accidental Fall. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medically Treated Falls Primary · up to 26 months following intervention

Falls for which medical attention is sought

Group	Value	95% CI
Intervention	328
Usual Care	349

Medication Discontinuation Secondary · 6 months following intervention

Target medication has not been prescribed for 90 days 6 months post intervention

Opioids

Group	Value	95% CI
Intervention	32
Usual Care	40

Benzodiazepines

Group	Value	95% CI
Intervention	55
Usual Care	49

Tricyclic Antidepressants

Group	Value	95% CI
Intervention	34
Usual Care	23

Muscle Relaxants

Group	Value	95% CI
Intervention	34
Usual Care	40

Antihistamines (rx)

Group	Value	95% CI
Intervention	5
Usual Care	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Events were collected 6 months after study enrollement. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 10/1106 (1%)

Deaths: 86/1106

Usual Care

Serious: 4/1261 (0%)

Deaths: 72/1261

Serious adverse events (1 terms)

Reaction	System	Intervention	Usual Care
Serious adverse drug withdrawal events involving opioids or sedative-hypnotics	General disorders	—	—

Most-reported serious reactions: Serious adverse drug withdrawal events involving opioids or sedative-hypnotics.

Data from ClinicalTrials.gov NCT05689554 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reducing Central Nervous System-Active Medications to Prevent Falls and Injuries Among Older Adults: A Cluster Randomized Clinical Trial.
   Phelan EA, Williamson BD, Balderson BH, Cook AJ, et al · · 2024 · cited 10× · PMID 39052289 · DOI 10.1001/jamanetworkopen.2024.24234
2. 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.
   Balderson BH, Gray SL, Fujii MM, Nakata KG, et al · · 2023 · cited 4× · PMID 37170329 · DOI 10.1186/s13063-023-07336-7
3. 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
   Balderson BH, Gray SL, Fujii MM, Nakata KG, et al · · 2023 · DOI 10.21203/rs.3.rs-2497340/v1