Clinical trial NCT05956665: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polypharmacy
Dementia
Quality of Life
Keywords: Deprescribing
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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 deprescribing
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Resident of 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

Primary outcomes:
measure: Total number of medications that have been deprescribed since enrollment
timeFrame: 30 days
measure: Total number of medications that have been deprescribed since enrollment
timeFrame: 60 days
measure: Total number of medications that have been deprescribed since enrollment
timeFrame: 90 days
measure: Resident's quality of life
timeFrame: Enrollment
measure: Resident's quality of life
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Abe's Garden Community
state: Tennessee
city: Nashville
country: United States
facility: NHC At The Trace
state: Tennessee
Study officials:
References: