Population Health Approach to Optimizing Medications in Older Adults (POP-MED)

Population Health Approach to Optimizing and Deprescribing Medications in Older Adults

This randomized controlled pragmatic pilot study is aimed at examining the feasibility and acceptability of a population health-based deprescribing intervention that leverages the a registry and polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.

Study Overview

• Status: Not yet recruiting
• Conditions: Medication Adverse Effects
• Intervention / Treatment: Behavioral: Patient-tailored deprescribing assessment and intervention

Detailed Description

This pilot clinical trial is aimed at examining the feasibility and acceptability of a medication management intervention that uses risk stratification to identify older adults (including older adults with Mild Cognitive Impairment or Alzheimer's Disease and Related Dementias) at greatest risk for polypharmacy-related adverse events. The intervention will use a risk prediction model to identify potential study participants for inclusion and will enroll these study participants and their care partners into a polypharmacy clinic. The study will stratify patients by cognitive impairment status. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients will be invited to enroll in the study if they are in the top quintile of risk selected by a risk prediction model of polypharmacy-related adverse events. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
• 65 years of age or older
• Have a primary care clinician within the Cedars-Sinai Health System who uses MyCSLink (electronic health record used by Cedars-Sinai).
• Part of a Cedars-Sinai Health System population health registry (e.g., enrolled in an Accountable Care Organization, Medicare Advantage plan, or Primary Care First program)
• Diagnosis of Mild Cognitive Impairment or Dementia at baseline (for one intervention group) on the problem list

Exclusion criteria include:

• Patients for whom there is an active substance use disorder (defined by a physician) and thus for whom the intervention may not be appropriate
• Patients with an organ transplant, who are typically followed by a specialty pharmacist
• Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 12 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis); Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the primary care clinician (PCP). Once the PCP has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with a diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.	Behavioral: Patient-tailored deprescribing assessment and intervention; Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors (clinical, socioeconomic), identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results of the comprehensive medication review with the primary care clinician. Once the primary care clinician has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling (including Motivational Interviewing) and will follow-up with the patient at least once per month via video visit or phone to assess side effects, adverse effects, and provide support.
No Intervention: Usual care (MCI and Dementia diagnosis); Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with a diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.
Experimental: Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis); Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the primary care clinician (PCP). Once the PCP has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with NO diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.	Behavioral: Patient-tailored deprescribing assessment and intervention; Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors (clinical, socioeconomic), identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results of the comprehensive medication review with the primary care clinician. Once the primary care clinician has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling (including Motivational Interviewing) and will follow-up with the patient at least once per month via video visit or phone to assess side effects, adverse effects, and provide support.
No Intervention: Usual care (no MCI and Dementia diagnosis); Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with NO diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite measure of healthcare utilization	We will sum up the number of same-hospital all-cause emergency department (ED) and inpatient visits for each study participant in all arms at 12 months.	12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of medications	Total number of medications on the medication list, including prescription medications, over-the-counter medications, vitamins, and supplements at 12 months.	Baseline, 12 months
Use of any potentially inappropriate medications	Use of any potentially inappropriate medications, defined by the 2022 Beers Criteria Tables 2 and 7	Baseline, 12 months
Total number of potentially inappropriate medications	Total number of of potentially inappropriate medications at baseline and 12 months using Beers Tables 2 and 7	Baseline, 12 months
Number of medications with a dose reduction >10% over 12 months	We will sum up the number of medications where the study participant has achieved at >10% dose reduction compared to baseline for each study participant at baseline and 12 months in both study arms.	12 months
Number of re-prescription of any medications over 12 months	We will sum up the number of medications where the study participant has had any re-prescription of medications which were discontinued for 90 days or more by 12 months in all study arms.	Baseline, 12 months
Medication regimen simplification, measured by counting the number of times per day medications are taken, at baseline and 12 months	Each study participant will be coded on a continuous scale the number of times a day medications are taken based on the prescription instructions at baseline and 12 months in all study arms.	Baseline, 12 months
Medicare adherence	Each study participant will be coded on a continuous scale extracted by comparing EHR prescriptions and pharmacy claims fills at baseline and 12 months in all study arms.	Baseline, 12 months
Change in risk prediction model score	Each study participant's information will be run through the risk prediction model at the end of the study to see if there is a meaningful change (10% or more change) in the risk prediction score from baseline to the end of the study period.	12 months
Number of drug-related problems	We will compare the total number of drug-related problems (identified retrospectively by a pharmacist) at baseline and 12 months.	Baseline, 12 months
Number of potential pharmacy recommendations	We will compare the total number of potential pharmacist recommendations (identified retrospectively by a pharmacist) at baseline and 12 months.	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Polypharmacy; Older adults; Deprescribing
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: STUDY00002921; K01AG076865 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No