Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia

NCT ID: NCT05777772

Last Updated: 2024-05-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2023-12-15

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Educational Intervention

Educational Intervention

Group Type EXPERIMENTAL

STOP Falls D Educational Intervention

Intervention Type BEHAVIORAL

This is one-arm, health-system embedded pragmatic pilot trial

Interventions

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STOP Falls D Educational Intervention

This is one-arm, health-system embedded pragmatic pilot trial

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


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

Exclusion Criteria

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

Care Partner Sample
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Phelan

Professor: School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Phelan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Kaiser Permanente Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3U54AG063546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00015806

Identifier Type: -

Identifier Source: org_study_id

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