Population Health Approach to Optimizing Medications in Older Adults

NCT ID: NCT06110156

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-12-01

Brief Summary

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

Detailed Description

This pilot clinical trial will examine 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 enroll them 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.

Conditions

Medication Adverse Effects; Older Adults (65 Years and Older); Polypharmacy; Polypharmacy Patients; Deprescribing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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 prescriber. Once the prescriber 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.

Group Type: EXPERIMENTAL

Patient-tailored deprescribing assessment and intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 prescriber. Once the prescriber 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.

Group Type: EXPERIMENTAL

Patient-tailored deprescribing assessment and intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients will be invited to enroll in the study if they are in the top decile 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

• 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
• Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 6 months
• Patients who previously indicated in the EHR that they wish to opt out of participating in research studies.
• Patients enrolled in CS360, a program for highly complex medical patients, who already receive polypharmacy services.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michelle Keller

Research Scientist I

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Keller, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

K01AG076865

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002921

Identifier Type: -

Identifier Source: org_study_id