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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a genetic test (pharmacogenomic test) can improve medication management for individuals taking multiple medications. It evaluates whether this approach can reduce healthcare visits and costs over a year compared to usual care. Participants in the test group will use a kit to collect a genetic sample, which helps tailor their medications more effectively. Individuals taking five or more medications, with at least two that could benefit from genetic testing, may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance personalized medicine and improve healthcare outcomes.

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 prior data suggests that this pharmacogenomic test is safe for medication management?

Research has shown that pharmacogenomic (PGx) testing is generally well-received by patients. Studies suggest that PGx testing can customize medications to reduce unwanted side effects, ensuring medicines match a person's genetic makeup and avoiding negative reactions.

PGx testing makes medications not only more effective but also safer. The test helps doctors choose drugs less likely to cause problems based on the patient's genetic information.

Previous research has linked PGx-guided treatments to better outcomes for some medications, including reducing potential side effects and improving patient response to treatments. Overall, PGx testing serves as a useful tool in managing medications safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenomic testing for medication management because it personalizes treatment based on a patient’s genetic makeup. Unlike standard care, which often involves a trial-and-error approach to finding the right medication and dose, this test can predict how a patient will respond to certain medications. This means that healthcare providers can tailor prescriptions more accurately, potentially reducing side effects and increasing effectiveness. This approach could lead to more efficient and effective healthcare by ensuring patients receive the most compatible medications from the start.

What evidence suggests that this pharmacogenomic test is effective for medication management in high-risk polypharmacy patients?

Research has shown that pharmacogenomic (PGx) testing can customize medications based on a person's unique genetic profile. This trial includes a testing arm where participants undergo PGx testing to potentially improve medication management. This method aims to reduce unnecessary side effects and enhance medication effectiveness. One study found that using PGx testing to manage medications improved health outcomes and reduced healthcare costs. Another study highlighted how PGx testing can create personalized medication plans, increasing medication safety and effectiveness. Overall, these findings suggest that PGx testing could be a valuable tool for managing complex medication needs, especially for those taking multiple medications. ^{1 2 6 7 8}

Who Is on the Research Team?

Alison Quinn, PharmD

Principal Investigator

KPCO

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3969027/

The Potential Impact of Pharmacogenetic Testing on ... In this paper, we discuss the potential mechanisms by which PGx testing may affect medication-taking behavior – either positively or negatively.

2. nature.com nature.com/articles/s41397-024-00350-1

Clinical and economic outcomes of a pharmacogenomics ... Results show pharmacogenomics-enriched comprehensive medication management can favorably impact healthcare utilization in a self-insured employer population.

3. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3704

Navigating Pharmacogenomic Testing in Practice: Who to Test ... There is increasing attention on the clinical utility and value of pharmacogenetic (PGx) testing to individualize medication management.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360024002429

Trends in and predictors of patient pharmacogenomic test ... This could improve our understanding of the impact PGx testing has on medication safety and effectiveness. Long-term clinical outcome and cost data for PGx ...

5. ajmc.com ajmc.com/view/pharmacogenomics-for-improved-outcomes-and-decreased-costs-in-health-care

Pharmacogenomics for Improved Outcomes and ... Pharmacogenomics (PGx) involves the study of patients' unique genes to predict their individual response to drugs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943113/

Implementation of Pharmacogenomics Testing in Daily ... Many studies, including randomized clinical trials, have demonstrated that PGx-guided treatment can improve clinical outcomes for some drugs ( ...

7. gimjournal.org gimjournal.org/article/S1098-3600(24)00242-9/fulltext

Trends in and predictors of patient pharmacogenomic test ... Pharmacogenomic (PGx) testing in the clinical setting can maximize treatment effectiveness and minimize adverse drug reactions. More than 60 medications have ...

8. nature.com nature.com/articles/s41397-024-00326-1

a reality for future health care | The Pharmacogenomics ... The use of pre-emptive pharmacogenetic/omic (PGx) testing can improve drug therapeutic efficacy, safety, and compliance by guiding the selection ...