Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia (STOP-FALLS-D)
Primary Purpose
Dementia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STOP Falls D Educational Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Dementia
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente Health Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational Intervention
Arm Description
Educational Intervention
Outcomes
Primary Outcome Measures
Medically treated falls
Percent of study sample with a fall-related healthcare visit
Secondary Outcome Measures
All-cause emergency department visit or hospitalization
Percent of study sample with an emergency department visit or hospitalization for any reason
Skilled nursing facility placement
Percent of study sample admitted to a skilled nursing facility
Full Information
NCT ID
NCT05777772
First Posted
February 3, 2023
Last Updated
June 29, 2023
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05777772
Brief Title
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
Acronym
STOP-FALLS-D
Official Title
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
Educational Intervention
Intervention Type
Behavioral
Intervention Name(s)
STOP Falls D Educational Intervention
Intervention Description
This is one-arm, health-system embedded pragmatic pilot trial
Primary Outcome Measure Information:
Title
Medically treated falls
Description
Percent of study sample with a fall-related healthcare visit
Time Frame
Through study completion, up to 6 months
Secondary Outcome Measure Information:
Title
All-cause emergency department visit or hospitalization
Description
Percent of study sample with an emergency department visit or hospitalization for any reason
Time Frame
Through study completion, up to 6 months
Title
Skilled nursing facility placement
Description
Percent of study sample admitted to a skilled nursing facility
Time Frame
Through study completion, up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Phelan, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
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