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Effectiveness of PGx Testing

NCT04120480 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Polypharmacy

Interventions

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.

Sponsors & Collaborators

  • OneOme, LLC

    collaborator INDUSTRY

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Alison Quinn, PharmD · KPCO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2026-06-30
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120480 on ClinicalTrials.gov