Aligning Medications With What Matters Most

Polypharmacy Clinical Trial

— ALIGN  

Official title:

Align: Aligning Medications With What Matters Most

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938648
• Other study ID #: IRB00286353
• Secondary ID: 5U54AG063546-02
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: May 2, 2022

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease and Related Dementias
• Polypharmacy

Intervention

Behavioral:
• Pharmacist-led deprescribing intervention
1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP

Locations

Country	Name	City	State
United States	Kaiser Permanente	Aurora	Colorado
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Kaiser Permanente, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001. — View Citation

Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0. — View Citation

Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716. — View Citation

George J, Phun YT, Bailey MJ, Kong DC, Stewart K. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004 Sep;38(9):1369-76. doi: 10.1345/aph.1D479. Epub 2004 Jul 20. — View Citation

Group Health Research Institute. The Chronic Care Model. Available at http://www.improvingchroniccare.org/index.php?p=CCM_Gallery&s=149. Accessed August 21, 2020

Kelley AS, McGarry K, Gorges R, Skinner JS. The burden of health care costs for patients with dementia in the last 5 years of life. Ann Intern Med. 2015 Nov 17;163(10):729-36. doi: 10.7326/M15-0381. Epub 2015 Oct 27. — View Citation

Lin PJ, Fillit HM, Cohen JT, Neumann PJ. Potentially avoidable hospitalizations among Medicare beneficiaries with Alzheimer's disease and related disorders. Alzheimers Dement. 2013 Jan;9(1):30-8. doi: 10.1016/j.jalz.2012.11.002. — View Citation

Travis SS, Bernard MA, McAuley WJ, Thornton M, Kole T. Development of the family caregiver medication administration hassles scale. Gerontologist. 2003 Jun;43(3):360-8. doi: 10.1093/geront/43.3.360. — View Citation

Willson MN, Greer CL, Weeks DL. Medication regimen complexity and hospital readmission for an adverse drug event. Ann Pharmacother. 2014 Jan;48(1):26-32. doi: 10.1177/1060028013510898. Epub 2013 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention	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.	A duration of approximately 8 months
Primary	Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response	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	3 months after enrollment
Primary	Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP	We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review	3 months after enrollment
Primary	Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad	We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review	3 months after enrollment
Primary	Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention	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).	3 months after enrollment
Primary	Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention	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).	3 months after enrollment
Primary	Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports	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	Baseline and 3 months after enrollment
Primary	Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations	We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)	3 months after enrollment
Secondary	Total Medication Count	We will measure the total medication count using data obtained from the EHR.	Baseline and 3 months after enrollment
Secondary	Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)	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.	Baseline and 3 months after enrollment
Secondary	Medication Regimen Complexity Index (MRCI)	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.	Baseline and 3 months Baseline and 3 months after enrollment
Secondary	Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)	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.	Baseline and 3 months after enrollment
Secondary	Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)	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.	Baseline and 3 months after enrollment
Secondary	Family Caregiver Medication Administration Hassles Scale (FCMAHS)	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.	Baseline and 3 months after enrollment