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

Sponsor

Vanderbilt University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05956665

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polypharmacy Dementia Quality of Life	Behavioral: Shed-MEDS deprescribing intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 deprescribingAll 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)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Outcome Measures

Primary Outcome Measures

Total number of medications that have been deprescribed since enrollment [30 days]
Deprescribed is defined as medication termination or dose reduction
Total number of medications that have been deprescribed since enrollment [60 days]
Deprescribed is defined as medication termination or dose reduction
Total number of medications that have been deprescribed since enrollment [90 days]
Deprescribed is defined as medication termination or dose reduction
Resident's quality of life [Enrollment]
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 [90 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Vanderbilt University
National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Kim, Professor, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT05956665

Other Study ID Numbers:

9360739

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Kim, Professor, Vanderbilt University

Deprescribing

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Jul 21, 2023