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

About this trial
This is an interventional health services research trial for Polypharmacy focused on measuring Deprescribing
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
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
NCT ID
NCT05956665
First Posted
July 11, 2023
Last Updated
July 18, 2023
Sponsor
Vanderbilt University
Collaborators
National Institute on Aging (NIA)
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
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