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OpenTrials
Completed

NCT Number: NCT05777772

Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Health Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STOP Falls D Educational Intervention

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: STOP-FALLS-D

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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