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

Aging Clinical Trial

— STOP-FALLS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05689554
• Other study ID #: SITE00000971
• Secondary ID: CD002967
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: January 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Our 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.

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.

We will conduct 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. Our 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. We will also examine medication signetur fields for attempts to decrease medications. We will report factors affecting implementation of the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2497
• Est. completion date: September 29, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Fall
• Aging

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medically Treated Fall	Falls for which medical attention is sought	up to 26 months following intervention
Secondary	Medication Dose Reduction	Dose of target medication is lower in the 90 days after intervention compared to the 90 days prior	6 months following intervention
Secondary	Medication Discontinuation	Target medication has not been prescribed for 90 days post intervention	6 months following intervention
Secondary	Medication Sustained Discontinuation	Target medication has not been prescribed for 180 days post intervention	6 months following intervention