ALIGN: Aligning Medications With What Matters Most (Demonstration)

May 10, 2024 updated by: Johns Hopkins University

Demonstration of ALIGN: Aligning Medications With What Matters Most

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ariel Green, MD, MPH, PhD
  • Phone Number: 410-550-6733
  • Email: ariel@jhmi.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • Johns Hopkins Community Physicians
        • Contact:
          • Ariel Green, MD, MPH, PhD
          • Phone Number: 410-550-6733
          • Email: ariel@jhmi.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Delayed intervention (wait list control)

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who stop one or more medications
Time Frame: 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who start one or more new medications
Time Frame: 3 months

The secondary outcome of the proportion of patients who start ≥1 medication will be assessed at 3 months. The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point.

New medications started will be measured using data obtained from the EHR.
3 months
Proportion of patients who stop one or more potentially inappropriate medication (PIM)
Time Frame: 3 months

The secondary outcome of the proportion of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months. Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point.

Discontinued PIM will be measured using data obtained from the EHR.
3 months
Total number of medications
Time Frame: Baseline and 3 months
Total medication count will be measured using data obtained from the EHR.
Baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shared decision-making as assessed by CollaboRATE
Time Frame: Immediately pre-pharmacist intervention, Immediately post-pharmacist intervention
This is an exploratory, patient/care partner-reported outcome measure of shared decision-making. COLLABORATE uses a 9 point Likert scale that includes 3 questions. Score range 0-36. Higher scores represent better outcome.
Immediately pre-pharmacist intervention, Immediately post-pharmacist intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Ariel Green, MD, MPH, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00418404
  • U54AG063546 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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