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

NCT05956665 | Completed Results DMC

• 1 other identifier: #230560
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Polypharmacy; Dementia; Quality of Life

Keywords

Deprescribing

Outcome Measures

Primary Outcomes (5)

• Total Number of Medications That Have Been Deprescribed Since Enrollment

  The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.

  30 days

• Total Number of Medications That Have Been Deprescribed Since Enrollment

  The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.

  60 days

• Total Number of Medications That Have Been Deprescribed Since Enrollment

  The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.

  90 days

• Resident Quality of Life

  The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better).

  Enrollment

• Resident Quality of Life

  The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better).

  90 days

Study Arms (1)

ShedMEDS Intervention

EXPERIMENTAL

ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference. All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing.

Behavioral: Shed-MEDS deprescribing intervention

Interventions

Shed-MEDS deprescribing intervention BEHAVIORAL

See single arm description

ShedMEDS Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- None

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Abe's Garden Community

Nashville, Tennessee, 37027, United States

Location

NHC At The Trace

Nashville, Tennessee, 37221, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Jennifer Kim, DNP, GNP-BC
• Organization: Vanderbilt University School of Nursing

jennifer.kim@vanderbilt.edu

615-936-0739

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 21, 2023
• Study Start: January 23, 2024
• Primary Completion: June 27, 2025
• Study Completion: August 15, 2025
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)