Clinical trial NCT05689554: Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults
Official title: Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Accidental Fall
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 2367
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. diagnosis of dementia or a prescription for a medication used to treat dementia (i.e., a cholinesterase inhibitor or memantine);
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

Primary outcomes:
measure: Medically Treated Falls
timeFrame: up to 26 months following intervention
Secondary outcomes:
measure: Medication Discontinuation
timeFrame: 6 months following intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: University of Washington
name: Elizabeth Phelan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: