Shed-MEDS Deprescribing for Dementia

No longer recruiting at 1 trial location
JK
SS
Overseen BySandra Simmons, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the use of unnecessary or potentially harmful medications in people with dementia living in assisted living facilities. The focus is on safely lowering doses or stopping certain medications, based on expert advice and patient or representative preferences. Researchers will monitor how many medications are reduced and whether quality of life improves over 90 days. Individuals with dementia who live in an assisted living facility and take five or more medications, or at least one potentially unsuitable medication, are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance medication management and quality of life for people with dementia.

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 prior data suggests that this deprescribing intervention is safe for residents with dementia?

Research has shown that the Shed-MEDS deprescribing method is safe. In several studies, this approach helped people reduce their medication count without harm. These studies found that patients could safely stop or lower their medication doses. Importantly, no major negative effects were reported, making it a well-tolerated option for reducing unnecessary medications.12345

Why are researchers excited about this trial?

Researchers are excited about the Shed-MEDS Deprescribing Intervention because it offers a personalized approach to managing medications for individuals with dementia. Unlike traditional treatments that often focus on adding medications, this intervention emphasizes safely reducing or stopping medicines based on clinical criteria and patient preferences. This method could potentially minimize medication-related side effects and improve overall quality of life for patients, making it a promising alternative to the usual medication-heavy approach in dementia care.

What evidence suggests that the Shed-MEDS Deprescribing Intervention is effective for dementia?

Research has shown that the Shed-MEDS Deprescribing Intervention, which participants in this trial will receive, helps reduce unnecessary medications in older adults. One study found that this approach safely lowered the number of medications without harming patients. For people with dementia, reducing medications can improve quality of life by minimizing the risk of side effects from unnecessary drugs. The intervention involves reviewing a patient's medications and suggesting which ones can be reduced or stopped, based on medical advice and patient preferences. This method has shown promise in enhancing well-being by focusing on essential medications.12346

Are You a Good Fit for This Trial?

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)
Resident of Abe's Garden assisted living facility
I have been diagnosed with dementia.
See 1 more

Exclusion Criteria

N/A

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Shed-MEDS Deprescribing Intervention
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ShedMEDS InterventionExperimental Treatment1 Intervention

Shed-MEDS Deprescribing Intervention is already approved in United States for the following indications:

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Approved in United States as Shed-MEDS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials
714
Recruited
6,143,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

A study of 422 people with dementia revealed that 87% were willing to stop one or more of their medications, indicating a strong openness to deprescribing, which could enhance their quality of life.
Among those taking six or more medications, 29% believed they were on unnecessary medications, and 92% expressed willingness to deprescribe, suggesting that higher medication burden correlates with a desire to reduce medication use.
Attitudes toward deprescribing among older adults with dementia in the United States.Growdon, ME., Espejo, E., Jing, B., et al.[2023]
The study outlines a comprehensive five-step process for developing an intervention aimed at reducing the use of antidepressants among nursing home residents with dementia, emphasizing collaboration among GPs, nursing staff, and families.
Key themes identified during the development included the need for professional training, effective communication, and active involvement of patients and relatives, which informed the creation of a case-based training course and a structured consultation tool.
Tailoring a complex intervention to reduce antidepressants in institutionalized older persons with dementia.Hølmkjær, P., Vermehren, C., Holm, A., et al.[2023]
A national survey of 890 primary care physicians revealed that the two main barriers to deprescribing medications for older adults with moderate dementia are the perception of symptomatic benefit reported by patients or families, and the fact that the medication was prescribed by another physician.
Understanding these ethical concerns can help improve clinician education on medication management and deprescribing practices for older adults, ensuring safer and more effective treatment strategies.
Ethical Aspects of Physician Decision-Making for Deprescribing Among Older Adults With Dementia.Norton, JD., Zeng, C., Bayliss, EA., et al.[2023]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36745422/
A Shed-MEDS Randomized Clinical Trial - PubMed - NIHResults of this trial showed that the Shed-MEDS patient-centered deprescribing intervention was safe and effective in reducing the total medication burden at ...
Deprescribing Medications Among Older Adults From End ...This randomized clinical trial examines the safety and efficacy of reducing or stopping medications among inpatients 50 years or older.
Deprescribing Medications Among Older Adults From End ...This randomized clinical trial examines the safety and efficacy of reducing or stopping medications among inpatients 50 years or older.
Medline ® Abstracts for References 23189 of 'Deprescribing'DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial of the Shed-MEDS (Best Possible Medication History, Evaluate, Deprescribing Recommendations, ...
Shed-MEDS Deprescribing for DementiaThe Shed-MEDS Deprescribing Intervention is unique because it focuses on reducing or stopping unnecessary medications in people with dementia, which can help ...
From the hospital to the postacute care facility: How well is ...Vasilevskis conducted a randomized clinical trial of the Shed-MEDS (Best Possible Medication History, Evaluate, Deprescribing Recommendations, ...
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