Aligning Medications With What Matters Most

Not Applicable

Completed

Conditions: Polypharmacy
Alzheimer Disease and Related Dementias

Interventions: Behavioral: Pharmacist-led deprescribing intervention

Registration Number: NCT04938648

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 138

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Intervention (wait list control)	Pharmacist-led deprescribing intervention	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.
Intervention	Pharmacist-led deprescribing intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response	3 months after enrollment	We will measure the number of pharmacist's messages that receive an acknowledgment or response from the PCP based on Electronic Medical Record (EMR) review
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad	3 months after enrollment	We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention	A duration of approximately 8 months	Dyads are comprised of the person living with dementia and their care partner. We will measure the proportion of dyads that opt out of the intervention versus the dyads that agree to participate.
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention	3 months after enrollment	We will measure the amount of indirect time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP	3 months after enrollment	We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention	3 months after enrollment	We will measure the amount of direct time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).
Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations	3 months after enrollment	We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)
Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports	Baseline and 3 months after enrollment	Dyads are comprised of the person living with dementia and their care partner. We will measure the percentage of dyads who complete 2 of 2 pharmacist phone calls based on documented status reports

Secondary Outcome Measures

Name	Time	Method
Total Medication Count	Baseline and 3 months after enrollment	We will measure the total medication count using data obtained from the EHR.
Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)	Baseline and 3 months after enrollment	We will measure the response rate from care partners to complete the FCMAHS over the phone or electronically. The FCMAHS is a validated caregiver-reported outcome measure that assesses burden associated with medication administration. The instrument consists of 24 items and four subscales: Information Seeking/Information Sharing (9 items), Safety Issues (5 items), Scheduling Logistics (7 items) and Polypharmacy (3 items). The total score range is 0-120 with higher scores indicating greater perceived hassle associated with managing some or all aspects of another person's medication regimen.
Family Caregiver Medication Administration Hassles Scale (FCMAHS)	Baseline and 3 months after enrollment	The FCMAHS is a validated caregiver-reported outcome measure that assesses burden associated with medication administration. The instrument consists of 24 items and four subscales: Information Seeking/Information Sharing (9 items), Safety Issues (5 items), Scheduling Logistics (7 items) and Polypharmacy (3 items). The total score range is 0-120 with higher scores indicating greater perceived hassle associated with managing some or all aspects of another person's medication regimen.
Medication Regimen Complexity Index (MRCI)	Baseline and 3 months Baseline and 3 months after enrollment	The MRCI is a validated, widely-used tool that measures medication regimen complexity to identify patients with expected difficulty managing their regimens. The MRCI score is derived from weighted values of regimen components (eg, dosage formulations, frequencies, and specific instructions for use). The score has no upper limit, but higher scores indicate greater medication regimen complexity. Regimen components were combined to compute a total score and averaged.
Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)	Baseline and 3 months after enrollment	The feasibility of measuring this outcome will be determined as follows: Percentage of participants with data elements available vs. unavailable to calculate the pMRCI, within the existing electronic medical record systems. This study assessed the feasibility of measuring the pMRCI and not actually determining the pMRCI. The pMRCI is a validated, widely-used tool that measures medication regimen complexity to identify patients with expected difficulty managing their regimens. Scores are derived from weighted values of regimen components (eg, dosage formulations, frequencies, and specific instructions for use). Higher scores indicate greater medication regimen complexity.
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)	Baseline and 3 months after enrollment	We will measure the time it takes the care partner to complete the FCMAHS over the phone or electronically. The FCMAHS is a validated caregiver-reported outcome measure that assesses burden associated with medication administration. The instrument consists of 24 items and four subscales: Information Seeking/Information Sharing (9 items), Safety Issues (5 items), Scheduling Logistics (7 items) and Polypharmacy (3 items). The total score range is 0-120 with higher scores indicating greater perceived hassle associated with managing some or all aspects of another person's medication regimen.