Aligning Medications With What Matters Most (ALIGN)

Johns Hopkins University

Status: Completed

Conditions: Polypharmacy; Alzheimer Disease and Related Dementias

Treatments: Behavioral: Pharmacist-led deprescribing intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04938648

5U54AG063546-02 (U.S. NIH Grant/Contract)

IRB00286353

Details and patient eligibility

About

The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce medication regimen complexity and treatment burden for people living with dementia (PLWD) and their care partners.

Full description

People living with dementia (PLWD) use more medications and have more complex medication regimens than people without dementia. Medication regimen complexity is a major source of burden for family caregivers of PLWD and has been associated with numerous adverse outcomes. Therefore, the investigators propose a novel intervention, ALIGN: Aligning Medications with What Matters Most, to optimize prescribing and reduce medication regimen complexity by focusing on what matters most to the patient and caregiver, beyond rigid adherence to clinical practice guidelines. ALIGN is informed by learnings from OPTIMIZE, the investigator team's patient-centered, pragmatic deprescribing intervention for PLWD in primary care that is currently being prospectively evaluated. OPTIMIZE consists of a patient-level intervention comprised of a deprescribing educational brochure, and a clinician-level intervention comprised of a deprescribing educational session for primary care providers (PCPs), deprescribing "tip sheets" and clinic-level feedback on rates of potentially inappropriate medication prescribing in PLWD. ALIGN builds on OPTIMIZE by more explicitly addressing the informational and decisional needs of caregivers through a shared decision making process facilitated by clinical pharmacists. The investigators propose a pilot study to assess the feasibility and acceptability of ALIGN in two different health care systems, and to identify the most appropriate primary outcome measure for a subsequent embedded pragmatic trial (ePCT). Target enrollment is 60 patient-care partner dyads. Patients will be aged ≥65 years with dementia and >5 chronic medications. Primary outcomes are intervention feasibility and acceptability among patients, care partners and PCPs; and feasibility of the patient-level Medication Regimen Complexity Index and Family Caregiver Medication Administration Hassles Scale at baseline and 3 months. Findings from this pilot study will guide the design, implementation and subsequent evaluation of ALIGN in an ePCT, laying the groundwork to reduce medication regimen complexity and burden for PLWD and their caregivers in diverse primary care settings.

This proposed pragmatic intervention has the following aims:

Specific Aim 1: To assess the feasibility and acceptability of ALIGN in two different health care systems, to guide the subsequent evaluation of the effectiveness of the intervention in an embedded pragmatic trial (ePCT).

Specific Aim 2: To determine the feasibility of the primary and secondary outcome measures for the subsequent ePCT.

1. To determine the feasibility of measuring the primary outcome, the patient-level Medication Regimen Complexity Index (pMRCI), within the existing electronic health record (EHR) systems, and to compare it with a more pragmatic measure, chronic medication count, as the primary outcome measure for the ePCT.
2. To determine the feasibility of measuring the secondary outcome, the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.

Enrollment: 138 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 65 or greater
• Diagnosis of dementia from International Classification of Diseases (ICD) -9 or ICD-10 codes
• At least one other chronic condition
• Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
• Have a primary care physician at the pilot clinic who has enrolled in the study; this will be defined as having had at least 1 previous visit with that physician

Care partners:

• Family or other companions age 21 years or greater who regularly help the patient with managing medications

Exclusion criteria

• As both the pilot and the planned pragmatic trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.
• Individuals who cannot converse comfortably in English will be excluded because the FCMAHS has not been validated in other languages.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention consists of the following: 1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD); 2. dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.

Treatment:

Behavioral: Pharmacist-led deprescribing intervention

Delayed Intervention (wait list control)

Active Comparator group

Description:

The delayed intervention consists of the following: 1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD); 2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.

Treatment:

Behavioral: Pharmacist-led deprescribing intervention