Shed-MEDS Deprescribing for Dementia
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University
Disqualifiers: None
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial aims to reduce or stop unnecessary or potentially harmful medications for participants with dementia. This means you might need to stop or reduce some of your current medications, based on clinical guidelines and your preferences.
What data supports the effectiveness of the Shed-MEDS Deprescribing Intervention treatment for dementia?
Research shows that deprescribing (reducing or stopping medications that may not be needed) in people with dementia can be safe and may improve their quality of life by reducing harmful side effects. Studies also suggest that interventions to reduce unnecessary medications, like antidepressants, in dementia patients are feasible and can be beneficial.
12345Is the Shed-MEDS Deprescribing Intervention safe for people with dementia?
There is limited direct evidence on the safety of deprescribing specifically for older adults with dementia, but it is generally aimed at reducing unnecessary or risky medications, which could potentially lower the risk of adverse events.
12367How is the Shed-MEDS Deprescribing Intervention different from other treatments for dementia?
The Shed-MEDS Deprescribing Intervention is unique because it focuses on reducing or stopping unnecessary medications in people with dementia, which can help avoid harmful side effects and improve quality of life. Unlike other treatments that may add medications, this approach carefully evaluates and recommends stopping certain drugs to manage dementia more safely.
12346Eligibility Criteria
This trial is for English-speaking residents with dementia at Abe's Garden assisted living facility, who are on five or more medications or taking medication that may not be suitable (as defined by specific criteria). They must be able to consent themselves or have someone who can consent for them.Inclusion Criteria
Able self-consent or has a proxy (surrogate)
I have been diagnosed with dementia.
Resident of Abe's Garden assisted living facility
+2 more
Exclusion Criteria
N/A
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants undergo a deprescribing intervention to reduce unnecessary or potentially harmful medications
90 days
Regular consultations with clinicians and surrogate decision makers
Follow-up
Participants are monitored for safety and effectiveness after the intervention
4 weeks
Participant Groups
The study is testing a deprescribing intervention aimed at safely reducing unnecessary or potentially harmful medications among those with dementia. The effects will be measured by the number of reduced doses and stopped medications over 30, 60, and 90 days, as well as quality of life reports.
Shed-MEDS Deprescribing Intervention is already approved in United States for the following indications:
🇺🇸 Approved in United States as Shed-MEDS for:
- Polypharmacy reduction in older adults transitioning from hospital to post-acute care facilities
- Deprescribing for dementia care in assisted living facilities
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NHC At The TraceNashville, TN
Abe's Garden CommunityNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Tools for deprescribing in severe dementia: A scoping review. [2023]Identification of inappropriate medications in people living with severe dementia is a complex task which has the potential to reduce avoidable adverse events and increase quality of life. This scoping review (i) identifies published tools intended to aid deprescribing in people living with severe dementia and (ii) describes evaluations of their usefulness in clinical practice.
Attitudes toward deprescribing among older adults with dementia in the United States. [2023]People with dementia (PWD) take medications that may be unnecessary or harmful. This problem can be addressed through deprescribing, but it is unclear if PWD would be willing to engage in deprescribing with their providers. Our goal was to investigate attitudes toward deprescribing among PWD.
Ethical Aspects of Physician Decision-Making for Deprescribing Among Older Adults With Dementia. [2023]Physicians endorse deprescribing of risky or unnecessary medications for older adults (aged ≥65 years) with dementia, but there is a lack of information on what influences decisions to deprescribe in this population.
Tailoring a complex intervention to reduce antidepressants in institutionalized older persons with dementia. [2023]First-line treatment for behavioral and psychiatric symptoms of dementia is non-pharmacological. Still, psychotropic medication is widely used, despite its limited effect and harmful side-effects. More than half of all nursing home residents with dementia receive antidepressants, even though deprescribing is safe and feasible. Interventions to promote deprescribing of antidepressants in nursing homes are few and complex. To optimize the deprescribing process through an intervention, transparency for the development of the intervention is needed. We aim to describe the steps in the development and tailoring of an intervention targeting GPs, nursing home staff, and relatives to enhance collaboration on reducing the use of antidepressants in institutionalized older persons with dementia in Denmark.
Can clinician champions reduce potentially inappropriate medications in people living with dementia? Study protocol for a cluster randomized trial. [2022]For people living with dementia (PLWD) the overuse of potentially inappropriate medications (PIMs) remains a persistent problem. De-prescribing trials in the elderly have mixed results. Clinician champions may be uniquely suited to lead efforts to address this challenge. Here we describe the study protocol for a 24-month embedded pragmatic cluster-randomized clinical trial within two accountable care organizations (ACOs) of such a clinician champion intervention. The specific aims are to (1) assess the effectiveness of a clinician champion on de-implementing PIMs in PLWD, (2) determine if the intervention is associated with a reduction in emergency department (ED) visits and hospitalizations attributed to a fall, and (3) examine five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity.
The value of deprescribing in older adults with dementia: a narrative review. [2021]Introduction:Mitigating the burden of unnecessary polypharmacy or multiple medication use in people living with dementia has been recognized as a key priority internationally. One approach to reducing inappropriate polypharmacy is through medication withdrawal or deprescribing.Area covered:Non-systematic searches of key databases including PubMed, Embase, and Google Scholar were conducted from inception to 28 February 2021 for articles that assessed the safety and/or efficacy of deprescribing in older adults living with dementia. Personal reference libraries were also utilized. Information on current clinical trials was found in clinicaltrial.gov.Expert Opinion: There is limited direct evidence to inform deprescribing in older adults with dementia specifically. This review identified nineteen studies that have assessed the impact of deprescribing interventions to reduce inappropriate polypharmacy or direct deprescribing of specific medications. However, the current evidence is limited in scope as most studies focused on medication-related outcomes (e.g. discontinuation of high-risk medications) rather than patient-centered outcomes in individuals living with dementia. Furthermore, most studies focused on addressing inappropriate polypharmacy in older adults with dementia living in long-term care facilities, and interventions did not involve the person and their carer. Further evidence on the impact of deprescribing in this population across clinical settings is needed.
Identifying potentially inappropriate prescribing in older people with dementia: a systematic review. [2022]Older people with dementia are at risk of adverse events associated with potentially inappropriate prescribing.