Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia

Dementia Clinical Trial

— STOP-FALLS-D  

Official title:

Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05777772
• Other study ID #: STUDY00015806
• Secondary ID: 3U54AG063546
• Status: Completed
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 15, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dementia With Medically Treated Falls	Number of older adult participants with dementia with a fall-related healthcare visit	Through study completion, up to 6 months
Secondary	Number of Participants With Dementia With All-cause Emergency Department Visits or Hospitalizations	Number of older adult participants with dementia with an emergency department visit or hospitalization for any reason	Through study completion, up to 6 months
Secondary	Number of Participants With Dementia With Skilled Nursing Facility Placement	Number of older adult participants with dementia admitted to a skilled nursing facility	Through study completion, up to 6 months