Clincosm LogoSign in Get a demo

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

Sponsor
University of Washington (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05777772
Collaborator
National Institute on Aging (NIA) (NIH)
207
Enrollment
1
Location
1
Arm
18.6
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: STOP Falls D Educational Intervention
 N/A

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 level of randomization is the clinic. A sample of 120 eligible participants and their primary care providers will receive the intervention, which 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 Design

Study Type:
Interventional
Anticipated Enrollment :
207 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Educational Intervention

Educational Intervention

Behavioral: STOP Falls D Educational Intervention
This is one-arm, health-system embedded pragmatic pilot trial

Outcome Measures

Primary Outcome Measures

  1. Medically treated falls [Through study completion, up to 6 months]

    Percent of study sample with a fall-related healthcare visit

Secondary Outcome Measures

  1. All-cause emergency department visit or hospitalization [Through study completion, up to 6 months]

    Percent of study sample with an emergency department visit or hospitalization for any reason

  2. Skilled nursing facility placement [Through study completion, up to 6 months]

    Percent of study sample admitted to a skilled nursing facility

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Health Research Institute Seattle Washington United States 98101

Sponsors and Collaborators

  • University of Washington
  • National Institute on Aging (NIA)

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Elizabeth Phelan, Professor: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT05777772
Other Study ID Numbers:
  • STUDY00015806
  • 3U54AG063546
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dementia

Study Results

No Results Posted as of Mar 21, 2023