Pharmacist-led Deprescribing for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAriel Green, MD, MPH, PhD
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Long-term care, Hospice, Hearing impairment, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.12345
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.15678
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.39101112
Eligibility Criteria
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.
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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.
Trial Timeline
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
Treatment Details
Interventions
- Pharmacist-led deprescribing intervention (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins Bayview Medical CenterBaltimore, MD
Johns Hopkins Community PhysiciansBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
The Effect of Pharmacist-Initiated Deprescribing Interventions in Older People: A Narrative Review of Randomized Controlled Trials. [2023]Background Polypharmacy is common among older people and may be associated with adverse drug events (ADEs) and poor health outcomes. Pharmacists are well-positioned to reduce polypharmacy and potentially inappropriate medications. Objective The objective of this narrative review was to summarize the results from randomized-controlled trials that evaluated pharmacist-led interventions with the goal or effect to deprescribe medications in older individuals. Data Sources We searched Medline, Embase, CINAHL Complete, APA PsycInfo, Web of Science Core Collection, and Cochrane Central Register of Controlled Trials. Data Synthesis Of the 25 studies included, the interventions were conducted in nursing facilities (n = 8), outpatient/community dwellings (n = 8), or community pharmacies (n = 9). Interventions were categorized as comprehensive medication reviews (n = 10), comprehensive medication reviews with pharmacist follow-up (n = 11), and educational interventions provided to patients and/or providers (n = 4). Pharmacist-led interventions had a beneficial effect on 22 out of 32 total medication-related outcomes (eg, number of medications, potentially inappropriate medications, or discontinuation). Most (n = 18) studies reported no evidence of an effect for other outcomes such as health care use, mortality, patient-centered outcomes (falls, cognition, function, quality of life), and ADEs. Discussion Interventions led to improvement in 69% of the medication-related outcomes examined across study settings. Five studies measured ADEs with none accounting for adverse drug-withdrawal events. Large well-designed studies that are powered to find an effect on patient-centered outcomes are needed. Conclusion Pharmacist-led interventions had a significant beneficial effect on medication-related outcomes. There was little evidence of benefit on other outcomes.
[Deprescribing: an essential part of rational pharmacotherapy]. [2023]Deprescribing is a planned, systematic process supervised by a healthcare professional. It is considered to be a fundamental part of good prescribing. Deprescribing can be defined as the complete withdrawal of medications as well as dose reduction. The patient's health status, life expectancy, values, preferences and the therapeutic goals should be given serious consideration while planning the deprescribing process. The main objective of deprescribing may vary but reaching the patients' goals and improving their quality of life remain constant priorities. In our article, based on the international literature, we review potential deprescribing targets such as the characteristics of high-risk patients, medications that should prompt a therapy review and the ideal settings for deprescribing. We also cover the steps, risks and benefits of the process, and discuss the existing specific guidelines and algorithms. We provide information on the enablers and barriers of deprescribing among both patients and healthcare professionals, and discuss international initiatives as well as the future of deprescribing. Orv Hetil. 2023; 164(24): 931-941.
Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. [2023]Deprescribing is a promising approach to addressing the burden of polypharmacy. Few studies have initiated comprehensive deprescribing in the hospital setting among older patients requiring ongoing care in a postacute care (PAC) facility.
Evaluation of pharmacist-led physician-supported inpatient deprescribing model in older patients admitted to an acute general medical unit. [2020]To evaluate the need for and the feasibility of a pharmacist-led physician-supported deprescribing model.
Deprescribing in the Older Patient: A Narrative Review of Challenges and Solutions. [2021]Polypharmacy is a major challenge in healthcare for older people, and is associated with increased risks of adverse outcomes, such as delirium, falls, frailty, cognitive impairment and hospitalization. There is significant public and professional interest in the role of deprescribing in reducing medication-related harms in older people. We aim to provide a narrative review of 1) the safety and efficacy of deprescribing interventions, 2) the challenges and solutions of deprescribing research and implementation in clinical practice, and 3) the benefits of using Computerized Clinical Decision Support Systems (CCDSS) and Quality Indicators (QIs) in deprescribing research and practice. Deprescribing is an established management strategy to minimize polypharmacy and potentially inappropriate medications. There is limited clinical evidence for its efficacy on global and geriatric outcomes. Various challenges at patient, healthcare professional and healthcare system levels may impact on the success of deprescribing interventions in research and practice. Management strategies that target all levels of the healthcare system are required to overcome these challenges. Future studies may consider large multicenter prospective designs to establish the effects and sustainability of deprescribing interventions on clinical outcomes.
Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial. [2023]Polypharmacy is common in older adults with cognitive impairment and multiple chronic conditions, increasing risks of adverse drug events, hospitalization, and death. Deprescribing, the process of reducing or stopping potentially inappropriate medications, may improve outcomes. The OPTIMIZE pragmatic trial examined whether educating and activating patients, family members and clinicians about deprescribing reduces number of chronic medications and potentially inappropriate medications. Acceptability and challenges of intervention delivery in cognitively impaired older adults are not well understood.
The DE-PHARM Project: A Pharmacist-Driven Deprescribing Initiative in a Nursing Facility. [2017]Many residents with life-limiting illnesses are being prescribed and taking potentially inappropriate medications (PIMs) and questionably beneficial medications either near or at the end of life. These medications can contribute to adverse drug reactions, increase morbidity, and increase unnecessary burden and cost. It is crucial that the process of deprescribing be incorporated into the care of these residents. After developing a clinical pharmacist-driven deprescribing initiative in the nursing facility, the objective of this project was to reduce the number of PIMs via accepted recommendations from the clinical pharmacist to the primary team.
Implementation of pharmacist-led deprescribing in collaborative primary care settings. [2022]In many jurisdictions pharmacists share prescribing responsibilities with other members of the primary care team. Responsibility for deprescribing, the healthcare professional supervised withdrawal of medications that are no longer needed, has not been assumed by a specific member of the primary care team. In this commentary we describe implementation of pharmacist-led deprescribing in collaborative primary care settings using the seven components of knowledge translation. Patient and stakeholder engagement shaped the deprescribing intervention. The intervention was implemented in three collaborative primary care clinics in two Canadian provinces. The evaluation included measures of medication appropriateness, patient satisfaction, and healthcare professional satisfaction. Pharmacist-led deprescribing in primary care was acceptable to both patients and healthcare professionals and demonstrated a reduction of medications deemed to confer more risk than benefit. Our findings support successes in pharmacist-led deprescribing. Future work is needed to understand how to successfully implement and evaluate pharmacist-led deprescribing more widely.
[Pharmaceutical care for patients and their caregivers in Alzheimer's disease and related disorders: a review and new perspectives]. [2021]Many arguments support the development of pharmaceutical care in patients with neurocognitive disorders and their caregivers: polypharmacy, drug-related cognitive decline, poor drug adherence, increased use of psychotropic drugs and potentially inappropriate medications. The aim of this narrative review was to identify the pharmacist's roles in caring for patients with Alzheimer's disease and related disorders and their caregivers. Seventeen publications were selected after literature research. The various interventions conducted by pharmacists were as follows: achievement of a medication review that could be focused on the reduction of the anticholinergic burden or the number of psychotropic drugs, therapeutic education of the patient and his caregiver concerning the treatment management, personalized pharmaceutical follow-up, screening and orientation of patients with a cognitive impairment or caregivers with signs of fragility (burden, anxiety or depressive symptoms). The majority of studies targeted the patient care. Other interventional studies will be necessary to evaluate the impact of a pharmaceutical care for the dyad, including the caregiver, on the improvement of drug management but also on clinical outcomes, including the cognitive function, the autonomy, the use of the health care system, the quality of life and the self-efficacy.
Deprescribing for older people living in residential aged care facilities: Pharmacist recommendations, doctor acceptance and implementation. [2023]Deprescribing is an intervention to address the high prevalence of inappropriate polypharmacy in older people living in residential aged care facilities (RACFs). Many deprescribing interventions are complex and involve several stages including initial pharmacist recommendation, subsequent acceptance of the recommendations by a prescriber and the patient, and then actual implementation.
Building Demand for Deprescribing Expertise: Pharmacists as Deprescribing Care Coordinators. [2023]A number of barriers to deprescribing exist, with knowledge, skills, and self-efficacy often highlighted by prescribers within an interrupted, siloed nature of the existing health care system. Thus, deprescribing is not likely to occur without a change in the system. Pharmacists are extremely well positioned to positively impact the deprescribing process, and particularly senior care pharmacists given familiarity with population-specific pharmacodynamic and pharmacokinetic characteristics of medications. Similarly, our health care partners have endorsed pharmacists to not only collaborate but to drive the deprescribing trials. Therefore, no other profession is better positioned to advocate for the value of deprescribing as a core component of the pharmaceutical care process.
Multidisciplinary DEprescribing review for Frail oldER adults in long-term care (DEFERAL): Implementation strategy design using behaviour science tools and stakeholder engagement. [2023]Deprescribing is a strategy for reducing the use of potentially inappropriate medications for older adults. Limited evidence exists on the development of strategies to support healthcare professionals (HCPs) deprescribing for frail older adults in long-term care (LTC).