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OpenTrials
Active, Not Recruiting

NCT Number: NCT04120480

Effectiveness of PGx Testing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Polypharmacy

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Support Services

Aurora, Colorado, 80011, United States

About this study

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:

  • Healthcare expenditures: 6- and 12-month changes in total healthcare expenditures from the Kaiser Permanente Colorado (KPCO) perspective
  • Healthcare utilization: 6- and 12-month changes in hospitalizations, emergency room visits, medical office visits, and telephone encounters

Secondary Objectives:

  • Medication changes: Counts of 6-month medication and/or dose adjustments in targeted medications
  • Medication congruence: Description of counts of RightMed test recommendations accepted by prescribers
  • Medication adherence: 6- and 12-month changes in percent of days (PDC) covered for targeted medications
  • Pharmacy expenditures: 6- and 12-month changes in outpatient prescription medication expenditures from the KPCO perspective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-79 years of age
  • Days supply of 5+ medications with 2+ advisable for PGx on the RightMed test
  • English or Spanish speaker
  • Current KPCO member
  • Dispensing 1 med (for advisable for PGx) in the 90 days prior with no dispensing in the previous six months -or- daily dose change (up or down) in the 90 days
  • Prescriber from Smoky Hill, Westminster, Hidden Lake, Skyline, East Denver, or Lakewood clinics
  • Available email address -

Exclusion criteria

  • Pregnant (HCG+ test in the previous 9 months)
  • A live birth in the previous 24 months
  • SNF or hospice stay in the previous 1 month
  • Hospitalization in previous 14 days
  • Diagnosis of dementia, delerium, alzheimer's, or parkinson's in the previous 6 months
  • On the KPCO No Contact List -

Treatment and study plan

Pharmacogenomic test

Diagnostic 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.

Primary outcomes

  1. Healthcare expenditures

    Time frame: 6 and 12 months after consent

    Changes in mean/median total healthcare expenditures from the KPCO perspective

  2. Healthcare utilization

    Time frame: 6 and 12 months after consent

    Changes in the proportion with at least one and mean/median count of hospitalization, emergency room visit, medical office visit, and telephone encounter

Secondary outcomes

  1. Medication changes

    Time frame: 6 months after consent

    Mean/median counts of medication and/or dose adjustments in targeted medications

  2. Medication congruence

    Time frame: 6 months after consent

    Description of counts of RightMed test recommendations accepted by prescribers

  3. Medication adherence

    Time frame: 6 and 12 months after consent

    Mean/median changes in percent of days (PDC) covered for targeted medications

  4. Pharmacy expenditures

    Time frame: 6 and 12 months after consent

    Mean/median changes in outpatient prescription medication expenditures from the KPCO perspective

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • OneOme, LLC

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2019
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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