Deprescribing Program for Dementia and Diabetes

Overseen By Christine Slyne

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joslin Diabetes Center

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications (HRMs) among long term care facility (LTCF) residents with ADRD, 2) assess key implementation constructs (secondary outcomes) of the STRIDE program, including acceptability, appropriateness, and feasibility, and 3) validate the primary HRM use outcome measure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on reducing certain diabetes medications that have a high risk of causing low blood sugar. It's best to discuss with the trial team or your doctor.

Is the deprescribing program for dementia and diabetes safe for humans?

Research shows that older people with dementia are at risk of adverse events from inappropriate prescribing, and there are adverse drug events in older patients with dementia. However, specific safety data for the deprescribing program itself is not provided in the available research. ^{1 2 3 4 5}

How is the STRIDE treatment different from other treatments for dementia and diabetes?

The STRIDE treatment is unique because it focuses on deprescribing, which means reducing or stopping medications that may be unnecessary or harmful, especially for older adults with dementia who often take multiple medications. This approach aims to decrease the risk of adverse outcomes by minimizing the burden of unnecessary medication use. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment STRIDE for dementia and diabetes?

Research suggests that reducing unnecessary medications in people with dementia and diabetes can improve their quality of life and reduce hospital readmissions. Comprehensive medication reviews by pharmacists have been shown to help achieve these outcomes. ^{5 7 11 12 13}

Who Is on the Research Team?

Medha Munshi, MD

Principal Investigator

Joslin Diabetes Center

Are You a Good Fit for This Trial?

This trial is for clinical staff at long-term care facilities, including doctors, physician assistants, nurse practitioners, and clinical pharmacists. They must have participated in the STRIDE program aimed at educating on deprescribing diabetes medication for residents with Alzheimer's.

Inclusion Criteria

This criterion is not related to a clinical trial exclusion criteria. It appears to be related to the targeted providers for a specific program. If you need help with clinical trial exclusion criteria, please provide additional information.

Staff who took part in the STRIDE program (Providers doing stakeholder exit interviews).

Exclusion Criteria

Consistent with the pragmatic nature of the trial, there are no exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the STRIDE educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications among LTCF residents with ADRD

6 months

Follow-up

Participants are monitored for changes in HRM use and assessed for acceptability, appropriateness, and feasibility of the STRIDE program

6 months

What Are the Treatments Tested in This Trial?

Interventions

• STRIDE

Trial Overview The STRIDE educational program is being tested to see if it helps reduce the use of diabetes medications that carry a high risk of causing low blood sugar in elderly patients with dementia. The study will also evaluate how well the program is accepted and implemented by healthcare providers.

How Is the Trial Designed?

Group I: STRIDE Intervention Experimental Treatment 1 Intervention

Educational intervention for clinicians

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Theoria Medical

Collaborator

Trials

2

Recruited

320+

Published Research Related to This Trial

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]

In a study of 46,737 Medicare beneficiaries and 29,496 Danish participants, cholinesterase inhibitors like donepezil showed similar cardiovascular safety profiles, with no significant differences in the risk of myocardial infarction (MI) or heart failure compared to other medications.

Memantine was linked to a higher risk of fatal or nonfatal MI and cardiac death in the Danish cohort, as well as increased all-cause mortality in both cohorts, suggesting that patients prescribed memantine may have been sicker overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. Fosbøl, EL., Peterson, ED., Holm, E., et al.[2018]

In a study of 123 patients treated with donepezil for Alzheimer's dementia, 21% discontinued treatment due to adverse events (AEs), highlighting the need for careful monitoring during the initial months of therapy.

The most common AEs leading to discontinuation were nausea/vomiting, diarrhea, and loss of appetite, indicating that these side effects are significant considerations in the management of patients on donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. Carøe, TK., Moe, C.[2018]

A systematic review of 5 studies found that the prevalence of adverse drug events (ADEs) in older inpatients with dementia is alarmingly high at 81.5%, indicating a significant safety concern for this population.

The prevalence of adverse drug reactions (ADRs) varied between 12.7% and 24.0%, highlighting the need for better assessment methods and tailored tools to prevent these reactions in older patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. Sakiris, MA., Sawan, M., Hilmer, SN., et al.[2021]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Changes in Medication Use After Dementia Diagnosis in an Observational Cohort of Individuals with Diabetes Mellitus. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Associations of coprescribed medications for chronic comorbid conditions in very old adults with clinical dementia: a retrospective cohort study using insurance claims data. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Deintensification of Diabetes Medications among Veterans at the End of Life in VA Nursing Homes. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pharmacist participation in hospital ward teams and hospital readmission rates among people with dementia: a randomized controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Tools for deprescribing in severe dementia: A scoping review. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Identifying potentially inappropriate prescribing in older people with dementia: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. [2018]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Ethical Aspects of Physician Decision-Making for Deprescribing Among Older Adults With Dementia. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The value of deprescribing in older adults with dementia: a narrative review. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Attitudes toward deprescribing among older adults with dementia in the United States. [2023]