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ALIGN: Aligning Medications With What Matters Most (Demonstration)

NCT06335953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-11-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

Pharmacist-led deprescribing intervention

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.

Sponsors & Collaborators

Principal Investigators

  • Ariel Green, MD, MPH, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2025-09-16
Completion
2025-10-18

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335953 on ClinicalTrials.gov