Deprescribing Intervention for Polypharmacy

(POP-MED Trial)

Overseen By An Nguyen, OTD, OTR/L, BCG

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Substance use disorder, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michelle Keller, PhD, MPH

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for older adults (65+) who are at high risk of medication-related issues due to polypharmacy, as determined by a predictive model. They must be under the care of a primary clinician within the Cedars-Sinai Health System and enrolled in certain health programs. One group specifically includes those with Mild Cognitive Impairment or Dementia.

Inclusion Criteria

I am 65 years old or older.

Patients will be invited to enroll in the study if they are identified as having a high risk of experiencing polypharmacy-related adverse events, based on an evaluation of factors such as age, sex, recent healthcare encounters, current and past medications, laboratory tests results and diagnoses.

You have a designated primary care provider who utilizes the MyCSLink electronic health record system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a patient-tailored deprescribing assessment and intervention, including medication reconciliation and shared decision-making.

12 months

Monthly follow-ups

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with outcome measures assessed at 12 months.

12 months

Treatment Details

Interventions

• Patient-tailored deprescribing assessment and intervention

Trial Overview The study tests a personalized approach to reducing unnecessary medications in elderly patients. It's set up as a randomized controlled pilot with four groups: two will receive the deprescribing intervention and two will serve as controls for comparison.

Participant Groups

Group I: Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis) Experimental Treatment 1 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, 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 II: Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis) Experimental Treatment 1 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, 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 III: Usual care (MCI and Dementia diagnosis) Active Control 1 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.

Group IV: Usual care (no MCI and Dementia diagnosis) Active Control 1 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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+