An interventional study of Pharmacogenomic test in Polypharmacy, sponsored by Kaiser Permanente. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention
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.
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:
Secondary Objectives:
Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Healthcare expenditures
Changes in mean/median total healthcare expenditures from the KPCO perspective
Time frame: 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
Time frame: 6 and 12 months after consent
Medication changes
Mean/median counts of medication and/or dose adjustments in targeted medications
Time frame: 6 months after consent
Medication congruence
Description of counts of RightMed test recommendations accepted by prescribers
Time frame: 6 months after consent
Medication adherence
Mean/median changes in percent of days (PDC) covered for targeted medications
Time frame: 6 and 12 months after consent
Pharmacy expenditures
Mean/median changes in outpatient prescription medication expenditures from the KPCO perspective
Time frame: 6 and 12 months after consent
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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