Effectiveness of PGx Testing

NCT04120480 | Active Not Recruiting

• 1 other identifier: 1448074-3
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy

Keywords

Genomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Medication changes

  6 months after consent

• Medication congruence

  6 months after consent

• Medication adherence

  6 and 12 months after consent

• Pharmacy expenditures

  6 and 12 months after consent

Study Arms (2)

Testing

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Pharmacogenomic test DIAGNOSTIC_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.

Testing

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Kaiser Permanente: lead
• OneOme, LLC: collaborator

Study Sites (1)

Central Support Services

Aurora, Colorado, 80011, United States

Location

MeSH Terms

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Alison Quinn, PharmD

  KPCO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: November 15, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)