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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

Must not have

Hospitalization in previous 14 days

SNF or hospice stay in the previous 1 month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after consent

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am between 18 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been hospitalized in the last 14 days.

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I have not stayed in a skilled nursing facility or hospice in the last month.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Healthcare expenditures

Healthcare utilization

Secondary study objectives

Medication adherence

Medication changes

Medication congruence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met