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

NCT ID: NCT05956665

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2025-08-15

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.

Conditions

Polypharmacy; Dementia; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

ShedMEDS Intervention

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.

Group Type: EXPERIMENTAL

Shed-MEDS deprescribing intervention

Intervention Type: BEHAVIORAL

See single arm description

Interventions

Shed-MEDS deprescribing intervention

See single arm description

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abe's Garden Community

Nashville, Tennessee, United States

NHC At The Trace

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

#230560

Identifier Type: -

Identifier Source: org_study_id