PGx Testing for Medication Management

Overseen By Thomas Delate, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Pregnant, Dementia, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

600 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It seems the study focuses on adjusting medications based on genetic testing, so you might continue your current meds with possible adjustments.

What data supports the effectiveness of the treatment Pharmacogenomic test for medication management?

Pharmacogenomic (PGx) testing helps tailor medication choices to a person's genetic makeup, which can improve how well drugs work and reduce side effects. It is gaining recognition as a valuable tool for better medication management, with evidence suggesting it can enhance treatment response and patient safety by identifying those at risk for adverse reactions. ^{1 2 3 4 5}

Is pharmacogenomic (PGx) testing safe for humans?

Pharmacogenomic (PGx) testing is generally considered safe and is used to help doctors choose the right medication and dose for patients based on their genes, which can reduce the risk of side effects. ^{1 3 6 7 8}

How is pharmacogenomic testing different from other treatments?

Pharmacogenomic testing is unique because it uses a patient's genetic information to guide medication management, helping to tailor drug choices and dosages to individual genetic profiles, which can improve treatment response and reduce side effects compared to standard treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Alison Quinn, PharmD

Principal Investigator

KPCO

Eligibility Criteria

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.

Inclusion Criteria

Current KPCO member

I take 5 or more medications, and at least 2 could benefit from genetic testing.

I have been prescribed a new medication recommended for genetic testing in the last 3 months.

Exclusion Criteria

I have not been hospitalized in the last 14 days.

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

I have been diagnosed with dementia, delirium, Alzheimer's, or Parkinson's in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants receive the RightMed® PGx test and subsequent counseling of their prescribers by a study pharmacist

6 months

1 visit (virtual) for test kit instructions and follow-up

Follow-up

Participants are monitored for healthcare utilization and expenditures, medication adherence, and medication changes

12 months

Regular monitoring through electronic health records

Treatment Details

Interventions

• Pharmacogenomic test

Trial Overview 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.

Participant Groups

Group I: Testing Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

OneOme, LLC

Industry Sponsor

Trials

3

Recruited

1,100+

Findings from Research

Pharmacogenomic (PGx) testing is increasingly used in psychiatry to help guide medication decisions, potentially improving treatment response and identifying patients at risk for side effects.

Despite its benefits, the implementation of PGx testing in clinical practice faces challenges, and more research is needed to determine the best ways to integrate it into psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. Brown, L., Eum, S., Haga, SB., et al.[2021]

Pharmacogenetic (PGx) testing needs to establish clear links between genetic variations and medication responses in specific populations, along with valid tests to measure these variations, before it can significantly impact clinical practice.

There is a pressing need for research to evaluate whether PGx testing actually improves patient health outcomes and is cost-effective compared to standard care, as this information is crucial for clinicians and payers to adopt PGx testing in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing economic drivers for successful clinical implementation of pharmacogenetic testing. Deverka, PA., McLeod, HL.[2008]

In a study involving 161 participants, returning pharmacogenomic (PGx) testing results for actionable genes led to over 80% of participants feeling satisfied and knowledgeable about how this information could benefit their future medication prescriptions.

Despite the overall positive reception, some participants found the PGx concepts challenging to understand, indicating a preference for in-person discussions when receiving their results, which highlights the need for effective communication in genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. Ohneda, K., Hiratsuka, M., Kawame, H., et al.[2022]

Health professionals showed a positive interest in pharmacogenetic (PGx) testing, but primary care physicians (PCPs) expressed concerns about its clinical utility, insurance coverage, and the complexities of communicating incidental disease risk information.

The study highlighted a need for better educational resources and clear guidelines to help PCPs effectively use PGx testing, as many felt obligated to disclose ancillary disease risks but were unsure how to interpret these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional perspectives about pharmacogenetic testing and managing ancillary findings. Haga, SB., Tindall, G., O'Daniel, JM.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of targeted vs. expanded pharmacogenomic testing: What are we missing? [2023]

2. England pubmed.ncbi.nlm.nih.gov

User considerations in assessing pharmacogenomic tests and their clinical support tools. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Implementation of pharmacogenomics: Where are we now? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Harnessing economic drivers for successful clinical implementation of pharmacogenetic testing. [2008]

6. Germany pubmed.ncbi.nlm.nih.gov

[How to manage polypharmacia?] [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Professional perspectives about pharmacogenetic testing and managing ancillary findings. [2021]