search
Back to results

Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living

Primary Purpose

Polypharmacy, Dementia, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shed-MEDS deprescribing intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Polypharmacy focused on measuring Deprescribing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Resident of Abe's Garden assisted living facility Speaks English (due to interview-based assessments) Diagnosis of dementia Taking a total of 5 medications or at least one potentially inappropriate medication (defined by the Beers criteria, STOPP criteria, and the Rationalization of home medication by an Adjusted STOPP in older Patients [RASP]) Able self-consent or has a proxy (surrogate) Exclusion Criteria: - None

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Total number of medications that have been deprescribed since enrollment
    Deprescribed is defined as medication termination or dose reduction
    Total number of medications that have been deprescribed since enrollment
    Deprescribed is defined as medication termination or dose reduction
    Total number of medications that have been deprescribed since enrollment
    Deprescribed is defined as medication termination or dose reduction
    Resident's quality of life
    Quality of life as measured by scores on the DEMQOL-Proxy scale. The DEMQOL-Proxy is a 31-item questionnaire. All answers are reported on a four-point Likert scale (a lot/quite a bit/a little/not at all) and scored items are summed to produce a total score. Total scores range from 31-124 points. Higher scores indicate a better health-related quality of life.
    Resident's quality of life
    Quality of life as measured by scores on the DEMQOL-Proxy scale The DEMQOL-Proxy is a 31-item questionnaire. All answers are reported on a four-point Likert scale (a lot/quite a bit/a little/not at all) and scored items are summed to produce a total score. Total scores range from 31-124 points. Higher scores indicate a better health-related quality of life.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 18, 2023
    Sponsor
    Vanderbilt University
    Collaborators
    National Institute on Aging (NIA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05956665
    Brief Title
    Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living
    Official Title
    Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University
    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This single-arm pilot study will evaluate the effects of an intervention to reduce exposure to unnecessary or potentially harmful medications among residents with dementia living in an assisted living facility. The goal of the intervention is to safely deprescribe medications (defined by dose reductions and stopped medications), based on a combination of clinical criteria and resident/surrogate preferences. The investigators will evaluate the effects of the intervention on the total number of medications deprescribed from enrollment at 30, 60, and 90 days along with resident/surrogate reports of quality of life at enrollment and 90 days.
    Detailed Description
    This single-arm pilot trial will evaluate an evidence-based, patient-centered deprescribing intervention with assisted living facility (ALF) residents age 65+ who have a diagnosis of dementia. This deprescribing intervention was demonstrated to be safe and effective in reducing medication burden during the Shed-MEDS randomized clinical trial that enrolled hospitalized older adults discharging to post-acute care facilities. The intervention includes a comprehensive review of a participant's medications by the study's clinician and deprescribing recommendations using evidence-based guidelines. Deprescribing recommendations will be shared with residents/surrogate decision makers (i.e., respective family member/s) to determine their willingness to stop or reduce the dose of the targeted medications. If the resident/surrogate-decision maker agrees, deprescribing recommendations will then be communicated with the routine ALF medical providers for consideration and final deprescribing decisions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polypharmacy, Dementia, Quality of Life
    Keywords
    Deprescribing

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All participants will receive a clinical review of their prescribed medications by a research clinician, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the research clinician. The facility's medical providers will also be part of the deprescribing decision process and will initiate any agreed upon deprescribing
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Shed-MEDS deprescribing intervention
    Intervention Description
    See single arm description
    Primary Outcome Measure Information:
    Title
    Total number of medications that have been deprescribed since enrollment
    Description
    Deprescribed is defined as medication termination or dose reduction
    Time Frame
    30 days
    Title
    Total number of medications that have been deprescribed since enrollment
    Description
    Deprescribed is defined as medication termination or dose reduction
    Time Frame
    60 days
    Title
    Total number of medications that have been deprescribed since enrollment
    Description
    Deprescribed is defined as medication termination or dose reduction
    Time Frame
    90 days
    Title
    Resident's quality of life
    Description
    Quality of life as measured by scores on the DEMQOL-Proxy scale. The DEMQOL-Proxy is a 31-item questionnaire. All answers are reported on a four-point Likert scale (a lot/quite a bit/a little/not at all) and scored items are summed to produce a total score. Total scores range from 31-124 points. Higher scores indicate a better health-related quality of life.
    Time Frame
    Enrollment
    Title
    Resident's quality of life
    Description
    Quality of life as measured by scores on the DEMQOL-Proxy scale The DEMQOL-Proxy is a 31-item questionnaire. All answers are reported on a four-point Likert scale (a lot/quite a bit/a little/not at all) and scored items are summed to produce a total score. Total scores range from 31-124 points. Higher scores indicate a better health-related quality of life.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Resident of Abe's Garden assisted living facility Speaks English (due to interview-based assessments) Diagnosis of dementia Taking a total of 5 medications or at least one potentially inappropriate medication (defined by the Beers criteria, STOPP criteria, and the Rationalization of home medication by an Adjusted STOPP in older Patients [RASP]) Able self-consent or has a proxy (surrogate) Exclusion Criteria: - None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Kim, DNP
    Phone
    6159360739
    Email
    jennifer.kim@vanderbilt.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra Simmons, PhD
    Phone
    615-343-6729
    Email
    sandra.simmons@vumc.org

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified data may be shared, per written request, upon study completion and all final analyses

    Learn more about this trial

    Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living

    We'll reach out to this number within 24 hrs