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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
100
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Number of all-cause hospitalizations
Number of all-cause inpatient visits (including observation visits) 12 months after enrollment.
Time frame: 12 months after enrollment
Total number of medications
Total number of medications on the medication list, including prescription medications, over-the-counter medications, vitamins, and supplements at 12 months.
Time frame: Baseline, 12 months
Total number of potentially inappropriate medications
Use of any potentially inappropriate medications, defined by the 2019 Beers Criteria Tables 2 and 7
Time frame: Baseline, 12 months
Number of medications with a dose reduction >10% over 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.
Time frame: 12 months
Number of medications discontinued for 90 days or more which are re-prescribed
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.
Time frame: Baseline, 12 months
Number of times per day the patient is taking medications
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.
Time frame: Baseline, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria
Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria
Time frame: 12 months
Number of drug-related problems
We will compare the total number of drug-related problems (identified retrospectively by a pharmacist) at baseline and 12 months.
Time frame: Baseline, 12 months
Number of potential pharmacy recommendations
We will compare the total number of potential pharmacist recommendations (identified retrospectively by a pharmacist) at baseline and 12 months.
Time frame: Baseline, 12 months
Change in risk prediction model score
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.
Time frame: 12 months