Clinical trial NCT04120480: Effectiveness of PGx Testing
Official title: Clinical and Economic Effectiveness of Pharmacogenomic (PGx) Testing in Patients With Polypharmacy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polypharmacy
Keywords: Genomics
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: OneOme, LLC
First posted: 2019-10-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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 -

Primary outcomes:
measure: Healthcare expenditures
timeFrame: 6 and 12 months after consent
measure: Healthcare utilization
timeFrame: 6 and 12 months after consent
Secondary outcomes:
measure: Medication changes
timeFrame: 6 months after consent
measure: Medication congruence
timeFrame: 6 months after consent
measure: Medication adherence
timeFrame: 6 and 12 months after consent
measure: Pharmacy expenditures
timeFrame: 6 and 12 months after consent
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Central Support Services
state: Colorado
Study officials:
affiliation: KPCO
name: Alison Quinn, PharmD
role: PRINCIPAL_INVESTIGATOR
References: