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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04120480
Other study ID # 1448074-3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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 -

Study Design


Related Conditions & MeSH terms


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
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