Clinical trial NCT06335953: ALIGN: Aligning Medications With What Matters Most (Demonstration)
Official title: Demonstration of ALIGN: Aligning Medications With What Matters Most
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polypharmacy
Alzheimer's Disease and Related Dementias
Mild Cognitive Impairment
Keywords: Deprescribing
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-03-28
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: PLWD have high rates of polypharmacy. This is due to the high degree of comorbid illnesses and challenging behavioral and psychological symptoms such as apathy and agitation. Guidelines written for individual conditions increase polypharmacy and potentially inappropriate medication (PIM) use, in which risks of medications outweigh benefits, or medications may not align with treatment goals. PIM in PLWD include anticholingerics, psychotropics and opioids, which are prescribed to PLWD in rates that far exceed use in the general older adult population, in spite of the association with harms such as falls, negative cognitive effects, cardiac conduction abnormalities, respiratory suppression and death. Polypharmacy and PIM use among PLWD is associated with adverse drug events, emergency department visits, hospitalizations, and treatment burden, suggesting that in some situations, "the cure may have become the disease."

The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD. In keeping with principles of person-centered care, people should be on the medicines that will help achieve the persons goals, but not medicines that are likely to be harmful or unhelpful.

Deprescribing statins, antihypertensives, and psychotropic medications in older adults has been shown to be safe, and may lead to improved quality of life, reductions in falls, and improvements in cognitive and psychomotor function. Lessons from successful interventions include the need to target primary care clinicians and patients, and to target more than one class of medications. Most deprescribing interventions have occurred in hospitals, long-term care facilities, or home healthcare, not in primary care - typically the first point of contact with the health care system for PLWD. Few deprescribing studies have addressed care partners of PLWD, despite the enormous strain faced due to medication-related tasks and the person's specific informational and decisional needs and conflicts. These are gaps that the proposed research would address.

The investigator's previous research has shown that care partners want primary care providers (PCPs) to discuss medication-related goals of care as dementia progresses, and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD. But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations. Pharmacists are ideally suited to help address these problems by providing evidence-based, individualized deprescribing recommendations without increasing demands on PCP time.

The clinical trial consists of the following strategies: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD; 2) telehealth visit in which a pharmacist discusses benefits and harms of the 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 deprescribing recommendations that are actionable for the PCP. Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar. Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patient/care partner.

The trial is designed as a cluster-randomized trial with a delayed (waitlist) control where the unit of randomization will be the clinic. The investigators will enroll 280 patients with 140 per group (intervention group and waitlist control group). PLWD may enroll independently or together with a care partner. Care partners are not required to participate but may do so independently or with the PLWD if desired. Each participant will be in the study approximately 3 months (intervention period and additional follow-up).

This protocol employs a pragmatic design. The intervention is delivered by clinical pharmacists who are integrated in primary care clinics or practice through a centralized telemedicine model.

Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list
* Five or more medications
* Only active patients, defined as having \>1 visit to the primary care clinic within the past year will be included

Care partners:

* Family or other companions \>21 years old who regularly help the patient manage medications.

Exclusion Criteria:

* As the pragmatic trial will be based on primary care, individuals residing in long-term care facilities or enrolled in hospice will be excluded.
* Participants must hear well enough to communicate by telephone in English.

Primary outcomes:
measure: Proportion of patients who stop one or more medications
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of patients who start one or more new medications
timeFrame: 3 months
measure: Proportion of patients who stop one or more potentially inappropriate medication (PIM)
timeFrame: 3 months
measure: Total number of medications
timeFrame: Baseline and 3 months
Other outcomes:
measure: Shared decision-making as assessed by CollaboRATE
timeFrame: Immediately pre-pharmacist intervention, Immediately post-pharmacist intervention
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ariel Green, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
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