Clinical trial NCT04938648: Aligning Medications With What Matters Most
Official title: Align: Aligning Medications With What Matters Most
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Alzheimer Disease and Related Dementias
Keywords: Deprescribing
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Institute on Aging (NIA)
First posted: 2021-06-24
Enrollment: 138
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient and care partner dyads are randomly assigned to receive the pharmacist-led intervention immediately after an educational mailing or to a delayed intervention control group that will receive the pharmacist-led component 3 months after the mailing.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
timeFrame: A duration of approximately 8 months
measure: Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
timeFrame: 3 months after enrollment
measure: Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
timeFrame: 3 months after enrollment
measure: Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
timeFrame: 3 months after enrollment
measure: Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
timeFrame: 3 months after enrollment
measure: Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
timeFrame: 3 months after enrollment
measure: Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports
timeFrame: Baseline and 3 months after enrollment
measure: Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Total Medication Count
timeFrame: Baseline and 3 months after enrollment
measure: Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)
timeFrame: Baseline and 3 months after enrollment
measure: Medication Regimen Complexity Index (MRCI)
timeFrame: Baseline and 3 months Baseline and 3 months after enrollment
measure: Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
timeFrame: Baseline and 3 months after enrollment
measure: Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
timeFrame: Baseline and 3 months after enrollment
measure: Family Caregiver Medication Administration Hassles Scale (FCMAHS)
timeFrame: Baseline and 3 months after enrollment
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ariel Green, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
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