Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia (STOP-FALLS-D)

May 6, 2024 updated by: Elizabeth Phelan, University of Washington
STOP-FALLS-D is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (CNS) active medications and prevent adverse outcomes (falls and injuries) associated with their use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. The intervention consists of patient-facing educational brochures on CNS-active medications and decision support for the primary care provider. Ethnic/minority groups will be over-sampled to ensure a diverse study sample.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Kaiser Permanente Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Older Adult Sample

Inclusion Criteria:

  • Diagnosed dementia (dementia diagnosis code or prescription for dementia medication)
  • Receiving primary care at a Kaiser Permanente Washington integrated group practice outpatient clinic
  • Prescribed at least one CNS-active medication on a chronic (3 months or more) basis

Exclusion Criteria:

  • Skilled nursing facility resident
  • Current cancer diagnosis
  • On hospice or palliative care

Care Partner Sample

Inclusion Criteria:

  • Aged 18 years or older
  • Self-identify as a care partner for the older adult with dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Intervention
Behavioral: STOP Falls D Educational Intervention
This is one-arm, health-system embedded pragmatic pilot trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dementia With Medically Treated Falls
Time Frame: Through study completion, up to 6 months
Number of older adult participants with dementia with a fall-related healthcare visit
Through study completion, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations
Time Frame: Through study completion, up to 6 months
Number of older adult participants with dementia with an emergency department visit or hospitalization for any reason
Through study completion, up to 6 months
Number of Participants With Dementia With Skilled Nursing Facility Placement
Time Frame: Through study completion, up to 6 months
Number of older adult participants with dementia admitted to a skilled nursing facility
Through study completion, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Elizabeth Phelan, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00015806
  • 3U54AG063546 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on STOP Falls D Educational Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe