Pharmacist-led Deprescribing for Alzheimer's Disease

No longer recruiting at 1 trial location
AG
Overseen ByAriel Green, MD, MPH, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins 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 determine if a pharmacist-led program can help people with dementia safely reduce their medication count. Participants will receive a brochure and have a telehealth chat with a pharmacist to discuss the pros and cons of their medications, tailored to their personal goals. The trial will compare those who receive the intervention immediately to those on a waitlist to see if more people stop at least one medication within three months. People with dementia who take five or more medications and have had a primary care visit in the past year might be suitable candidates. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative care strategies for dementia.

Will I have to stop taking my current medications?

The trial involves a process called deprescribing, which means you might stop taking some medications. A pharmacist will discuss your medications with you and your care partner to decide what's best for you.

What prior data suggests that this pharmacist-led deprescribing intervention is safe?

Research has shown that when pharmacists help reduce or stop certain medications for people with dementia, it is generally safe. In previous studies, patients tolerated these changes well. Pharmacists reviewed patients' medications to eliminate drugs that might be unnecessary or harmful, and this process did not cause any serious side effects.

One study examined the impact of pharmacist-led medication reviews on patients with dementia. It found that these patients experienced fewer drug-related issues without significant negative effects. The success of these reviews often depended on effective communication between pharmacists and doctors.

This approach does not involve adding new medications. Instead, it focuses on reducing or stopping some medications that might not be beneficial, resulting in a low risk of new side effects from the process itself.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a pharmacist-led deprescribing approach for Alzheimer's patients. Unlike the standard of care, which often involves managing symptoms with medications, this method focuses on reducing medication load by carefully evaluating the benefits and risks of each drug. This personalized approach can help align treatment with the patient's goals and preferences, potentially improving their quality of life. By involving pharmacists directly in the treatment process and leveraging telehealth, this trial could pave the way for more accessible and tailored care for those living with Alzheimer's.

What evidence suggests that this pharmacist-led deprescribing intervention is effective for Alzheimer's disease?

This trial will compare a pharmacist-led deprescribing intervention with a delayed intervention (wait list control) for people living with dementia (PLWD). Research has shown that when pharmacists assist people with dementia in reviewing their medications, management improves. In a small study, patients who collaborated with pharmacists were more likely to stop taking at least one unnecessary medication. This approach ensures that medications align with the patient's needs, reducing side effects and enhancing safety. Another review found that reducing unnecessary medications can improve health in older adults with dementia. These findings suggest that pharmacist involvement can greatly enhance medication management for people with dementia.12678

Who Is on the Research Team?

AG

Ariel Green, MD, MPH, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with dementia, taking five or more medications, and have visited their primary care clinic in the past year. A family member or companion over 21 who helps manage their meds must also participate. It's not for those in long-term care or hospice, nor for those unable to communicate by phone in English.

Inclusion Criteria

I have a family member or companion over 21 who helps me with my medications.
Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list
I am 65 years old or older.
See 2 more

Exclusion Criteria

Individuals residing in long-term care facilities or enrolled in hospice
I can hear well enough to talk on the phone in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a deprescribing educational brochure, a telehealth visit with a pharmacist, and pharmacist-PCP communication for deprescribing recommendations

3 months
1 telehealth visit

Follow-up

Participants are monitored for changes in medication use and shared decision-making outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pharmacist-led deprescribing intervention
Trial Overview The study tests a pharmacist-led intervention to reduce unnecessary medications among patients with dementia. It includes an educational brochure, a telehealth visit discussing medication benefits and harms, and tailored recommendations from the pharmacist to the patient's doctor.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Delayed intervention (wait list control)Active Control1 Intervention

Pharmacist-led deprescribing intervention is already approved in United States for the following indications:

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Approved in United States as Pharmacist-led deprescribing intervention for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Pharmacist-led deprescribing in primary care settings was found to be acceptable to both patients and healthcare professionals, indicating a positive reception for this approach.
The intervention successfully reduced the number of medications that were considered to pose more risk than benefit, highlighting its potential efficacy in improving patient care.
Implementation of pharmacist-led deprescribing in collaborative primary care settings.Trenaman, SC., Kennie-Kaulbach, N., d'Entremont-MacVicar, E., et al.[2022]
Deprescribing is a recognized strategy to reduce polypharmacy in older adults, which can help minimize risks of adverse outcomes like delirium and cognitive impairment, although evidence for its overall efficacy on health outcomes is still limited.
Challenges in implementing deprescribing interventions exist at multiple levels, including patient, healthcare professional, and healthcare system, highlighting the need for comprehensive management strategies and future multicenter studies to better understand its impact.
Deprescribing in the Older Patient: A Narrative Review of Challenges and Solutions.Wu, H., Kouladjian O'Donnell, L., Fujita, K., et al.[2021]
In a study involving 303 residents in aged care facilities, 77% of pharmacist-led deprescribing recommendations were accepted by general practitioners, indicating strong collaboration between pharmacists and doctors.
Of the accepted recommendations, 74% were successfully implemented within 12 months, demonstrating that structured, algorithm-based medication reviews can effectively reduce inappropriate polypharmacy in older adults.
Deprescribing for older people living in residential aged care facilities: Pharmacist recommendations, doctor acceptance and implementation.Quek, HW., Etherton-Beer, C., Page, A., et al.[2023]

Citations

Pharmacist-Led Telehealth Deprescribing for People ...A pilot study of a pharmacist-led intervention to optimize medications with patient-care partner priorities, ran May 2021–22 at two health systems.
Aligning Medications With What Matters Most ...The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with ...
Medicine Optimisation and Deprescribing Intervention ...This systematic review aimed to summarise the evidence on the outcomes of medicine optimisation and deprescribing interventions for older people with dementia ...
Study Details | NCT04938648 | Aligning Medications With ...The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce ...
Pharmacist‐led telehealth deprescribing for people living with ...Feasibility outcomes were enrollment, intervention completion, pharmacist time, and primary care provider (PCP) acceptance of recommendations.
Project DetailsThis project will develop and validate a risk prediction model that identifies older adults with ADRD at greatest need for medication review, will use a ...
Deprescribing for People with Dementia: A RoadmapInterventions have included medication reviews led by geriatricians, pharmacists, interdisciplinary teams, or computer algorithms that triggered ...
Effect of pharmacist-led medication reviews ... - BMC GeriatricsPatients with dementia (PwD) are often geriatric patients treated with multimedication increasing the risk of drug-related problems (DRP) ...
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