Clinical trial NCT06110156: Population Health Approach to Optimizing Medications in Older Adults
Official title: Population Health Approach to Optimizing and Deprescribing Medications in Older Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Medication Adverse Effects
Older Adults (65 Years and Older)
Polypharmacy
Polypharmacy Patients
Deprescribing
Keywords: Older adults
Polypharmacy
Deprescribing
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Primary outcomes:
measure: Number of all-cause hospitalizations
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Total number of medications
timeFrame: Baseline, 12 months
measure: Total number of potentially inappropriate medications
timeFrame: Baseline, 12 months
measure: Number of medications with a dose reduction >10% over 12 months
timeFrame: 12 months
measure: Number of medications discontinued for 90 days or more which are re-prescribed
timeFrame: Baseline, 12 months
measure: Number of times per day the patient is taking medications
timeFrame: Baseline, 12 months
measure: Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria
timeFrame: 12 months
measure: Number of drug-related problems
timeFrame: Baseline, 12 months
measure: Number of potential pharmacy recommendations
timeFrame: Baseline, 12 months
measure: Change in risk prediction model score
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Michelle Keller, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: