PolypharmacyNCT05956665
Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living
A study testing Shed-MEDS deprescribing intervention in people with Polypharmacy and Dementia, run by Vanderbilt University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Dementia, Quality of Life
- What is being tested?
- Shed-MEDS deprescribing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Abe's Garden Community
Nashville, Tennessee, 37027
NHC At The Trace
Nashville, Tennessee, 37221
About this study
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.
Read the 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
- Being tested
- Shed-MEDS deprescribing intervention
- Keywords
- Deprescribing
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shed-MEDS deprescribing interventionBehavioural
See single arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Shed-MEDS deprescribing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start23 Jan 2024
- Primary completion27 Jun 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jennifer Kim, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956665
- Sponsor's protocol ID
- #230560
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2023
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data may be shared, per written request, upon study completion and all final analyses
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living
- ClinicalTrials.gov ID
- NCT05956665
- Acronym / sponsor ID
- #230560
- Conditions
- Polypharmacy, Dementia, Quality of Life
- Keywords
- Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| ShedMEDS Intervention | Experimental | Behavioral: Shed-MEDS deprescribing interventionShedMEDS 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shed-MEDS deprescribing interventionSee single arm description | Behavioural | ShedMEDS Intervention |
Primary outcome
Total Number of Medications That Have Been Deprescribed Since Enrollment
Time frame: 30 days
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.
Total Number of Medications That Have Been Deprescribed Since Enrollment
Time frame: 60 days
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.
Total Number of Medications That Have Been Deprescribed Since Enrollment
Time frame: 90 days
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.
Resident Quality of Life
Time frame: Enrollment
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).
Resident Quality of Life
Time frame: 90 days
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data may be shared, per written request, upon study completion and all final analyses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shed-MEDS deprescribing intervention in people with Polypharmacy and Dementia, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Medications That Have Been Deprescribed Since Enrollment (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.