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

Cedars-Sinai Medical Center

Status: Invitation-only

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

Treatments: Behavioral: Patient-tailored deprescribing assessment and intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06110156

STUDY00002921

K01AG076865 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Patient-tailored deprescribing assessment and intervention

Usual care (MCI and Dementia diagnosis)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Patient-tailored deprescribing assessment and intervention

Usual care (no MCI and Dementia diagnosis)

No Intervention group

Description:

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.