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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956665
• Other study ID #: #230560
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University
• Contact: Jennifer Kim, DNP
• Phone: 6159360739
• Email: jennifer.kim[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Polypharmacy
• Quality of Life

Intervention

Behavioral:
• Shed-MEDS deprescribing intervention
See single arm description

Locations

Country	Name	City	State
United States	Abe's Garden Community	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of medications that have been deprescribed since enrollment	Deprescribed is defined as medication termination or dose reduction	30 days
Primary	Total number of medications that have been deprescribed since enrollment	Deprescribed is defined as medication termination or dose reduction	60 days
Primary	Total number of medications that have been deprescribed since enrollment	Deprescribed is defined as medication termination or dose reduction	90 days
Primary	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
Primary	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