Effectiveness of PGx Testing

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Polypharmacy

Intervention / Treatment
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* Diagnostic Test: Pharmacogenomic test


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genomics