Effectiveness of PGx Testing

Not Applicable

Active, not recruiting

• Conditions: Polypharmacy

• Registration Number: NCT04120480
• Lead Sponsor: Kaiser Permanente

Brief 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

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2019-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Healthcare expenditures	6 and 12 months after consent	Changes in mean/median total healthcare expenditures from the KPCO perspective
Healthcare utilization	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 Outcome Measures

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

Trial Locations

Locations (1)

Central Support Services; 🇺🇸 Aurora, Colorado, United States