Effectiveness of PGx Testing

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04120480
• Other study ID #: 1448074-3
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
United States	Central Support Services	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	OneOme, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare expenditures	Changes in mean/median total healthcare expenditures from the KPCO perspective	6 and 12 months after consent
Primary	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	Medication changes	Mean/median counts of medication and/or dose adjustments in targeted medications	6 months after consent
Secondary	Medication congruence	Description of counts of RightMed test recommendations accepted by prescribers	6 months after consent
Secondary	Medication adherence	Mean/median changes in percent of days (PDC) covered for targeted medications	6 and 12 months after consent
Secondary	Pharmacy expenditures	Mean/median changes in outpatient prescription medication expenditures from the KPCO perspective	6 and 12 months after consent