Effectiveness of PGx Testing

Not Applicable

Active, not recruiting

• Conditions: Polypharmacy
• Interventions: Diagnostic Test: Pharmacogenomic test

• 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

Arm && Interventions

Group	Intervention	Description
Testing	Pharmacogenomic test	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).

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