Pharmacist-led Deprescribing for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Ariel Green, MD, MPH, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Long-term care, Hospice, Hearing impairment, others

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: 1

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 dementia (PLWD) and the person's care partners. The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP. The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months.

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.

Is pharmacist-led deprescribing generally safe for humans?

Pharmacist-led deprescribing has been shown to be generally safe, with studies reporting no significant adverse effects related to the withdrawal of medications. However, more research is needed to fully understand its impact on patient-centered outcomes like quality of life and cognitive function. ^{1 2 3 4 5}

How is the pharmacist-led deprescribing intervention unique for Alzheimer's disease?

This treatment is unique because it involves pharmacists actively reviewing and reducing unnecessary medications, which can help manage polypharmacy (use of multiple medications) and improve cognitive function in Alzheimer's patients. Unlike standard treatments that focus on adding medications, this approach optimizes existing medication use to enhance overall health and quality of life. ^{6 7 8 9 10}

What data supports the effectiveness of the pharmacist-led deprescribing treatment for Alzheimer's Disease?

Research shows that pharmacist-led deprescribing interventions can improve medication-related outcomes, such as reducing the number of medications and potentially inappropriate medications, in older adults. However, there is limited evidence of its impact on other health outcomes like quality of life or cognitive function. ^{1 5 10 11 12}

Who Is on the Research Team?

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.

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?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention consists of the following: 1. Mailing a deprescribing educational brochure to PLWD and care partners; 2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; 3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.

Group II: Delayed intervention (wait list control) Active Control 1 Intervention

The intervention consists of the following: 1. Mailing a deprescribing educational brochure to PLWD and care partners; 2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; 3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.

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

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

• Dementia care
• Polypharmacy management

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 interventions significantly improved medication-related outcomes in older individuals, with beneficial effects observed in 22 out of 32 outcomes related to medication use, such as reducing the number of medications and discontinuing potentially inappropriate ones.

Despite the positive impact on medication management, most studies (18 out of 25) found no significant effects on broader health outcomes like healthcare use, mortality, or quality of life, indicating a need for more robust studies to assess these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Pharmacist-Initiated Deprescribing Interventions in Older People: A Narrative Review of Randomized Controlled Trials. Nguyen, M., Beier, MT., Louden, DN., et al.[2023]

Deprescribing is a systematic process that involves withdrawing or reducing medications under professional supervision, aimed at improving patient quality of life and aligning treatment with their health goals.

The review highlights key factors for successful deprescribing, including identifying high-risk patients and specific medications that warrant a therapy review, while also addressing the barriers and enablers faced by patients and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deprescribing: an essential part of rational pharmacotherapy]. Engi, Z., Matuz, M., Soós, G., et al.[2023]

The Shed-MEDS deprescribing intervention significantly reduced the total number of medications taken by older adults transitioning to postacute care, with a 14% reduction at PAC facility discharge and a 15% reduction at 90-day follow-up, indicating its efficacy in managing polypharmacy.

The intervention was safe, as it did not increase the rate of adverse drug events compared to usual care, while also decreasing exposure to potentially inappropriate medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. Vasilevskis, EE., Shah, AS., Hollingsworth, EK., et al.[2023]

In a study involving 129 patients aged 65 and older with polypharmacy, 45% were identified as candidates for deprescribing, highlighting the potential for reducing unnecessary medications in this population.

The pharmacist-led model successfully deprescribed 50% of the identified medications during the hospital stay, indicating that this approach can effectively enhance patient safety by prioritizing the balance of medication benefits and harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pharmacist-led physician-supported inpatient deprescribing model in older patients admitted to an acute general medical unit. Potter, EL., Lew, TE., Sooriyakumaran, M., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deprescribing in the Older Patient: A Narrative Review of Challenges and Solutions. Wu, H., Kouladjian O'Donnell, L., Fujita, K., et al.[2021]

The OPTIMIZE trial showed that educating patients, caregivers, and clinicians about deprescribing can lead to a reduction in the number of chronic and potentially inappropriate medications in older adults with cognitive impairment, with positive feedback from all stakeholder groups involved.

Key barriers to effective deprescribing included short consultation times for healthcare providers, while factors like patient engagement and the importance of timing and repetition in delivering the intervention were crucial for its success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial. Sheehan, OC., Gleason, KS., Bayliss, EA., et al.[2023]

The DE-PHARM project, a clinical pharmacist-driven initiative aimed at reducing potentially inappropriate medications (PIMs) in nursing home residents, demonstrated feasibility in a pilot study involving 47 residents over a 6-month period.

Despite the pharmacist making 39 recommendations for deprescribing, only 26% were accepted by the primary care teams, highlighting challenges in interprofessional collaboration and the need for careful consideration of medication management at the end of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DE-PHARM Project: A Pharmacist-Driven Deprescribing Initiative in a Nursing Facility. Pruskowski, J., Handler, SM.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of pharmacist-led deprescribing in collaborative primary care settings. Trenaman, SC., Kennie-Kaulbach, N., d'Entremont-MacVicar, E., et al.[2022]

Pharmacists play a crucial role in managing medications for patients with Alzheimer's disease and related disorders, focusing on reducing polypharmacy and the anticholinergic burden, which can help improve cognitive function and medication adherence.

Interventions by pharmacists include medication reviews, therapeutic education for patients and caregivers, and personalized follow-ups, but more studies are needed to assess the overall impact of pharmaceutical care on both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmaceutical care for patients and their caregivers in Alzheimer's disease and related disorders: a review and new perspectives]. Novais, T., Mouchoux, C.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Deprescribing, or the process of reducing or stopping medications, faces significant barriers such as lack of knowledge and skills among prescribers, indicating that systemic changes are necessary for it to be effectively implemented.

Pharmacists, especially those specializing in senior care, are uniquely qualified to lead deprescribing efforts due to their understanding of medication effects in older populations, making them essential advocates for integrating deprescribing into pharmaceutical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Demand for Deprescribing Expertise: Pharmacists as Deprescribing Care Coordinators. Campbell, NL.[2023]

A new implementation strategy for deprescribing potentially inappropriate medications in long-term care for frail older adults was developed, incorporating insights from healthcare professionals and behavioral science.

The strategy includes 11 behavior change techniques and emphasizes a multidisciplinary team approach, led by a nurse, to conduct regular deprescribing reviews, addressing systemic barriers like resource limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary DEprescribing review for Frail oldER adults in long-term care (DEFERAL): Implementation strategy design using behaviour science tools and stakeholder engagement. Heinrich, CH., McHugh, S., McCarthy, S., et al.[2023]

Citations

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

The Effect of Pharmacist-Initiated Deprescribing Interventions in Older People: A Narrative Review of Randomized Controlled Trials. [2023]

2. Hungary pubmed.ncbi.nlm.nih.gov

[Deprescribing: an essential part of rational pharmacotherapy]. [2023]

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

Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of pharmacist-led physician-supported inpatient deprescribing model in older patients admitted to an acute general medical unit. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Deprescribing in the Older Patient: A Narrative Review of Challenges and Solutions. [2021]

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

Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial. [2023]

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

The DE-PHARM Project: A Pharmacist-Driven Deprescribing Initiative in a Nursing Facility. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of pharmacist-led deprescribing in collaborative primary care settings. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Pharmaceutical care for patients and their caregivers in Alzheimer's disease and related disorders: a review and new perspectives]. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Deprescribing for older people living in residential aged care facilities: Pharmacist recommendations, doctor acceptance and implementation. [2023]

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

Building Demand for Deprescribing Expertise: Pharmacists as Deprescribing Care Coordinators. [2023]

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

Multidisciplinary DEprescribing review for Frail oldER adults in long-term care (DEFERAL): Implementation strategy design using behaviour science tools and stakeholder engagement. [2023]