NCT04120480

Effectiveness of PGx Testing

Clinical and Economic Effectiveness of Pharmacogenomic (PGx) Testing in Patients With Polypharmacy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinical and economic effectiveness of a pharmacogenomic (PGx) approach to prescribing medications in patients with high-risk polypharmacy in an integrated healthcare delivery system. Investigators hypothesize that patients who receive the RightMed® PGx test from OneOme, LLC with subsequent counseling of their prescribers by a study pharmacist, as needed, on the appropriateness of their prescribed medications will experience lower one-year follow-up healthcare utilization and expenditures compared to control patients who receive usual care.

Detailed description

The purpose of this study is to determine the clinical and economic effectiveness of a pharmacogenomic (PGx) approach to prescribing medications in patients with high-risk polypharmacy in an integrated healthcare delivery system. Investigators hypothesize that patients who receive the RightMed® PGx test from OneOme, LLC with subsequent counseling of their prescribers by a study pharmacist, as needed, on the appropriateness of their prescribed medications will experience lower one-year follow-up healthcare utilization and expenditures compared to control patients who receive usual care. Primary Objectives: 1. Healthcare expenditures: 6- and 12-month changes in total healthcare expenditures from the Kaiser Permanente Colorado (KPCO) perspective 2. Healthcare utilization: 6- and 12-month changes in hospitalizations, emergency room visits, medical office visits, and telephone encounters Secondary Objectives: 1. Medication changes: Counts of 6-month medication and/or dose adjustments in targeted medications 2. Medication congruence: Description of counts of RightMed test recommendations accepted by prescribers 3. Medication adherence: 6- and 12-month changes in percent of days (PDC) covered for targeted medications 4. Pharmacy expenditures: 6- and 12-month changes in outpatient prescription medication expenditures from the KPCO perspective

Conditions

• Polypharmacy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pharmacogenomic test	The RightMed test is an end-to-end solution which includes sample collection, PGx testing services, data analysis, and clinical interpretation that helps prescribers select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on FDA medication labels. The RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1) Green - use as directed; 2) Yellow - use with caution; and 3) Red - adjust dose or choose alternative mediation.

Timeline

• Start date: 2019-11-15
• Primary completion: 2026-06-30
• Completion: 2027-12-31
• First posted: 2019-10-09
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States