Shed-MEDS Deprescribing for Dementia

No longer recruiting at 1 trial location

Overseen By Sandra Simmons, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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.

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?

Group I: ShedMEDS Intervention Experimental Treatment 1 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.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical Aspects of Physician Decision-Making for Deprescribing Among Older Adults With Dementia. Norton, JD., Zeng, C., Bayliss, EA., et al.[2023]

This study will evaluate the effectiveness of a clinician champion intervention over 24 months to reduce the use of potentially inappropriate medications (PIMs) in people living with dementia, aiming to improve medication safety.

The trial will also assess whether this intervention leads to fewer emergency department visits and hospitalizations due to falls, using Medicare claims data to track outcomes in two participating accountable care organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can clinician champions reduce potentially inappropriate medications in people living with dementia? Study protocol for a cluster randomized trial. Parchman, ML., Perloff, J., Ritter, G.[2022]

A scoping review identified 12 studies that evaluated various tools for deprescribing medications in people with severe dementia, highlighting the complexity of this task and its potential to improve patient safety and quality of life.

Despite the development of several deprescribing tools, only one study showed a clear clinical benefit from medication withdrawal, indicating a need for more evidence-based research to assess the effectiveness of these tools in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for deprescribing in severe dementia: A scoping review. Wang, C., Roberts, E., Smith, G., et al.[2023]

A systematic review of 26 studies found that the prevalence of potentially inappropriate prescribing in older people with dementia ranges from 14% to 74%, highlighting a significant risk for adverse events in this population.

The Beers criteria were the most commonly used tool for identifying inappropriate prescriptions, but many studies did not utilize the full criteria, suggesting a need for more standardized and comprehensive application of these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying potentially inappropriate prescribing in older people with dementia: a systematic review. Hukins, D., Macleod, U., Boland, JW.[2022]

Deprescribing, or reducing unnecessary medications, is a recognized priority for improving the health of older adults with dementia, but there is limited direct evidence on its safety and efficacy specifically for this group.

A review of nineteen studies showed that most focused on medication-related outcomes rather than patient-centered results, highlighting a need for more comprehensive research that includes the perspectives of patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of deprescribing in older adults with dementia: a narrative review. Sawan, MJ., Moga, DC., Ma, MJ., et al.[2021]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36745422/

A Shed-MEDS Randomized Clinical Trial - PubMed - NIH

Results of this trial showed that the Shed-MEDS patient-centered deprescribing intervention was safe and effective in reducing the total medication burden at ...

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jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2800886

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.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9989899/

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.

4.

uptodate.com

uptodate.com/contents/deprescribing/abstract/23,189

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, ...

5.

withpower.com

withpower.com/trial/shed-meds-deprescribing-for-dementia-5d8e9

Shed-MEDS Deprescribing 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 ...

6.

deprescribingresearch.org

deprescribingresearch.org/from-the-hospital-to-the-postacute-care-facility-how-well-is-shed-meds-working/

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, ...