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Pharmacogenomic Testing

PGx Testing for Medication Management

N/A

Waitlist Available

Led By Alison Quinn, PharmD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-79 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after consent

Awards & highlights

Study Summary

This trial will test whether a pharmacogenomic (PGx) approach to prescribing medications, which involves a DNA test and subsequent counseling of patients' prescribers by a study pharmacist, results in lower one-year follow-up healthcare utilization and expenditures compared to control patients who receive usual care.

Who is the study for?

This trial is for KPCO members aged 18-79 who take five or more medications, with at least two recommended for PGx testing. Participants must have an email, speak English/Spanish, and be from specific clinics. Excluded are pregnant women, recent mothers, those in hospice or with certain neurological diagnoses.Check my eligibility

What is being tested?

The study tests if the RightMed PGx test can help reduce healthcare use and costs by guiding medication prescriptions. Patients will either receive this genetic test and pharmacist counseling or usual care without the test.See study design

What are the potential side effects?

Since this trial involves a pharmacogenomic test rather than a drug intervention, there are no direct side effects like you'd expect with medications. However, changes to medication regimens based on the test results could lead to new side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 79 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after consent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after consent

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after consent for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Healthcare expenditures

Healthcare utilization

Secondary outcome measures

Medication adherence

Medication changes

Medication congruence

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TestingExperimental Treatment1 Intervention

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).

Group II: Usual CareActive Control1 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

537 Previous Clinical Trials

24,113,099 Total Patients Enrolled

OneOme, LLCIndustry Sponsor

1 Previous Clinical Trials

350 Total Patients Enrolled

Alison Quinn, PharmDPrincipal InvestigatorKPCO

Media Library

Pharmacogenomic test (Pharmacogenomic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT04120480 — N/A

Overmedication Research Study Groups: Usual Care, Testing

Overmedication Clinical Trial 2023: Pharmacogenomic test Highlights & Side Effects. Trial Name: NCT04120480 — N/A

Pharmacogenomic test (Pharmacogenomic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04120480 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age-based restriction to participating in this research study?

"This study is limited to those aged between 18 and 79. There are 1 trials available for minors with 23 dedicated studies specifically designed for the elderly population."

Answered by AI

Does this clinical trial still require participants?

"The clinicaltrials.gov registry indicates that this medical trial, which was made public on November 15th 2019 and last revised on March 15th 2022, is not presently recruiting participants; yet there are 23 other studies currently seeking candidates."

Answered by AI

Am I eligible to enroll in this research endeavor?

"Patients between 18 and 79 years of age, who take multiple medications on a regular basis, can apply to join this clinical trial. The study is currently looking for up to 600 participants."

Answered by AI

What does this research endeavor seek to accomplish?

"This research will be assessed over a 6 and 12 month period post-consent. Its primary aim is to evaluate healthcare utilization, whilst secondary outcomes include pharmacy expenditure changes in terms of mean/median expenditures from KPCO's perspective, medication adherence as measured by the Mean/Median counts of days covered for targeted medications, and any alterations to medication dosage or type that can be observed during this time frame."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of PGx Testing

2019. "Effectiveness of PGx Testing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04120480.