Population Health Approach to Optimizing Medications in Older Adults

NCT06110156 | Active Not Recruiting

• 2 other identifiers: STUDY00002921K01AG076865
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Older adults; Polypharmacy; Deprescribing

Outcome Measures

Primary Outcomes (1)

• Number of all-cause hospitalizations

  Number of all-cause inpatient visits (including observation visits) 12 months after enrollment.

  12 months after enrollment

Secondary Outcomes (9)

• Total number of medications

  Baseline, 12 months

• Total number of potentially inappropriate medications

  Baseline, 12 months

• Number of medications with a dose reduction >10% over 12 months

  12 months

• Number of medications discontinued for 90 days or more which are re-prescribed

  Baseline, 12 months

• Number of times per day the patient is taking medications

  Baseline, 12 months

Study Arms (4)

Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis)

EXPERIMENTAL

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.

Behavioral: Patient-tailored deprescribing assessment and intervention

Usual care (MCI and Dementia diagnosis)

NO INTERVENTION

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.

Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis)

EXPERIMENTAL

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.

Behavioral: Patient-tailored deprescribing assessment and intervention

Usual care (no MCI and Dementia diagnosis)

NO INTERVENTION

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.

Interventions

Patient-tailored deprescribing assessment and intervention 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.

Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis); Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Methods

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Michelle Keller, PhD, MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist I

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: May 19, 2025
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)