Aging Clinical Trial - Reducing CNS-Active Medications to Prevent Falls &

Status Active, not recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05689554
Study type	Interventional
Source	University of Washington
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 1, 2021
Completion date	September 29, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Completed	`NCT05293730` - Trial of the Impact of the Electronic Frailty Integrated With Social Needs	N/A
Recruiting	`NCT03932162` - Gene Expression Changes In Young and Geriatric Skin	Early Phase 1
Completed	`NCT04064528` - Effects of Age on Amino Acid Delivery to Tendon	N/A
Completed	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT06029920` - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment	N/A
Recruiting	`NCT05543980` - Leg Heat Therapy in Elderly Individuals	Phase 2
Recruiting	`NCT05566938` - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly	N/A
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Not yet recruiting	`NCT06071130` - Emotion, Aging, and Decision Making	N/A
Enrolling by invitation	`NCT04641663` - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)	N/A
Completed	`NCT04088006` - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity	N/A
Completed	`NCT03695081` - Patient Pathway Pharmacist - Optimal Drug-related Care	N/A
Recruiting	`NCT05424263` - Acetate and Age-associated Arterial Dysfunction	Phase 2
Completed	`NCT05601713` - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling	N/A
Completed	`NCT04551339` - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19	N/A
Recruiting	`NCT04997577` - Speech Perception and High Cognitive Demand	N/A
Completed	`NCT05922475` - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training	N/A
Completed	`NCT04015479` - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms