Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults
NCT ID: NCT05689554
Last Updated: 2024-12-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
2367 participants
INTERVENTIONAL
2021-04-01
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Educational intervention
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.
Usual Care
Usual care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
2. residence in a skilled nursing facility;
3. metastatic cancer diagnosis in the prior 12 months;
4. receiving hospice or palliative care;
5. legally blind (unable to read print materials);
6. 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
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elizabeth Phelan
Professor, Division of Gerontology & Geriatric Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Phelan, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CD002967
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SITE00000971
Identifier Type: -
Identifier Source: org_study_id