ALIGN: Aligning Medications With What Matters Most (Demonstration)

NCT06335953 | Completed DMC

• 2 other identifiers: IRB00418404U54AG063546
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Alzheimer's Disease and Related Dementias; Mild Cognitive Impairment

Keywords

Deprescribing

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who stop one or more medications

  The primary outcome for the study will be the proportion of patients who stop ≥1 medication, assessed at 3 months. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).

  3 months

Secondary Outcomes (3)

• Proportion of patients who start one or more new medications

  3 months

• Proportion of patients who stop one or more potentially inappropriate medication (PIM)

  3 months

• Total number of medications

  Baseline and 3 months

Other Outcomes (1)

• Shared decision-making as assessed by CollaboRATE

  Immediately pre-pharmacist intervention, Immediately post-pharmacist intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Pharmacist-led deprescribing intervention

Delayed intervention (wait list control)

ACTIVE COMPARATOR

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.

Behavioral: Pharmacist-led deprescribing intervention

Interventions

Pharmacist-led deprescribing intervention BEHAVIORAL

The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.

Delayed intervention (wait list control); Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins Community Physicians

Baltimore, Maryland, 21209, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Ariel Green, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: May 7, 2024
• Primary Completion: September 16, 2025
• Study Completion: October 18, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)