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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polypharmacy, Dementia, Quality of Life

Intervention / Treatment
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* Behavioral: Shed-MEDS deprescribing intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Shed-MEDS deprescribing intervention|See single arm description|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of medications that have been deprescribed since enrollment | Deprescribed is defined as medication termination or dose reduction | 30 days | 
| Total number of medications that have been deprescribed since enrollment | Deprescribed is defined as medication termination or dose reduction | 60 days | 
| Total number of medications that have been deprescribed since enrollment | Deprescribed is defined as medication termination or dose reduction | 90 days | 
| 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. | Enrollment | 
| 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. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deprescribing