Effectiveness of PGx Testing

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Polypharmacy
• Intervention / Treatment: Diagnostic test: Pharmacogenomic test

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

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Central Support Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-79 years of age
2. Days supply of 5+ medications with 2+ advisable for PGx on the RightMed test
3. English or Spanish speaker
4. Current KPCO member
5. 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
6. Prescriber from Smoky Hill, Westminster, Hidden Lake, Skyline, East Denver, or Lakewood clinics
7. Available email address -

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testing; Participants randomized to this arm will be sent a kit to collect a genetic sample from a swab of their mouths. The kit will have instructions on how to collect the genetic sample and how to send it in a postage-paid envelope to the testing laboratory (OneOme). OneOme will process the sample and The study pharmacist will scan the results and enter any related information into the participant's KPCO electronic health record. If any changes to the participant's medication(s) are recommended (for example: a dose decrease or increase, stop taking your current medication and start another), the study pharmacist will contact the participant's KPCO prescriber directly to discuss the recommendations. The prescriber may contact the participant to change the participant's medication(s).	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.
No Intervention: Usual Care; Participants randomized to this arm will NOT be tested. They will receive usual care and the research will not involve study visits or in-person contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare expenditures	Changes in mean/median total healthcare expenditures from the KPCO perspective	6 and 12 months after consent
Healthcare utilization	Changes in the proportion with at least one and mean/median count of hospitalization, emergency room visit, medical office visit, and telephone encounter	6 and 12 months after consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication changes	Mean/median counts of medication and/or dose adjustments in targeted medications	6 months after consent
Medication congruence	Description of counts of RightMed test recommendations accepted by prescribers	6 months after consent
Medication adherence	Mean/median changes in percent of days (PDC) covered for targeted medications	6 and 12 months after consent
Pharmacy expenditures	Mean/median changes in outpatient prescription medication expenditures from the KPCO perspective	6 and 12 months after consent

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: OneOme, LLC
• Investigators: Principal Investigator: Alison Quinn, PharmD, KPCO

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Genomics
• Other Study ID Numbers: 1448074-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No