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OpenTrials
Active, Not Recruiting

NCT Number: NCT06110156

Population Health Approach to Optimizing Medications in Older Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Medication Adverse Effects Chemically-Induced Disorders Deprescribing Drug-Related Side Effects and Adverse Reactions Older Adults (65 Years and Older) Polypharmacy Polypharmacy Patients

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Number of all-cause hospitalizations

    Time frame: 12 months after enrollment

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

Secondary outcomes

  1. Total number of medications

    Time frame: Baseline, 12 months

    Total number of medications on the medication list, including prescription medications, over-the-counter medications, vitamins, and supplements at 12 months.

  2. Total number of potentially inappropriate medications

    Time frame: Baseline, 12 months

    Use of any potentially inappropriate medications, defined by the 2019 Beers Criteria Tables 2 and 7

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

    Time frame: 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.

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

    Time frame: Baseline, 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.

  5. Number of times per day the patient is taking medications

    Time frame: Baseline, 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.

  6. Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria

    Time frame: 12 months

    Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria

  7. Number of drug-related problems

    Time frame: Baseline, 12 months

    We will compare the total number of drug-related problems (identified retrospectively by a pharmacist) at baseline and 12 months.

  8. Number of potential pharmacy recommendations

    Time frame: Baseline, 12 months

    We will compare the total number of potential pharmacist recommendations (identified retrospectively by a pharmacist) at baseline and 12 months.

  9. Change in risk prediction model score

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Population Health Approach to Optimizing and Deprescribing Medications in Older Adults

Acronym: POP-MED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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