Educational Video for Pharmacogenomics

(MPRINT Trial)

Recruiting at 1 trial location

Overseen By Sarah H Jones, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Transplant, Recent transfusion, IVF, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

500 Participants Needed

Trial Summary

What is the purpose of this trial?

The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. The unique physiology of childhood and pregnancy demand validation of pharmacogenetic signals prior to clinical implementation. These knowledge gaps are compounded for individuals from minority populations, who have been underrepresented and thus underserved by genomic research and specifically pharmacogenetic studies. The primary objective of this project is to advance research and support clinical implementation in pharmacogenetics for children and pregnant women. This work will illuminate knowledge of, attitudes about, and priorities for pharmacogenetics, and will assess the impact of a brief educational video on knowledge and attitudes around pharmacogenetic testing. The investigators will assess the knowledge and attitudes regarding pharmacogenetic testing among diverse cohorts of children with chronic conditions and pregnant women, before and after receiving pharmacogenetic test results. Participants will be randomized to view an educational video about pharmacogenetic testing either at the time of receiving their pharmacogenetic test results, or at a later time. The investigators will perform surveys before and after pharmacogenomic testing and return of results, and before and after watching the educational video.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the educational video for pharmacogenomics treatment?

Pharmacogenomic testing, which the educational video aims to explain, can improve how well drugs work and reduce side effects by tailoring treatments to a person's genetic makeup. This approach has been shown to enhance drug response and prevent adverse reactions in various studies. ^{1 2 3 4 5}

Is pharmacogenomic testing safe for humans?

Pharmacogenomic testing is generally considered safe as it is a genetic test that helps predict how individuals might respond to certain medications, potentially preventing harmful drug reactions. However, it is important to note that while it can reduce the risk of adverse drug reactions, it does not replace the need for regular medical monitoring. ^{2 6 7 8 9}

How is pharmacogenomic testing different from other treatments?

Pharmacogenomic testing is unique because it uses a person's genetic information to predict how they will respond to certain medications, allowing for personalized treatment plans. This approach can help prevent adverse drug reactions and improve drug effectiveness, unlike traditional treatments that do not consider genetic differences. ^{2 3 5 10 11}

Eligibility Criteria

This trial is for English or Spanish-speaking adult women who are 12 to 30 weeks pregnant, receiving care at VUMC, and planning to deliver there. They must consent to pharmacogenomic testing and allow access to their medical records. Women with recent transfusions, prior genetic testing, or those using assisted reproductive technologies can't participate.

Inclusion Criteria

Maternal: Primary care at VUMC

I am a woman aged 18 or older.

Maternal: Allow access to their medical record

Exclusion Criteria

Maternal: Stem cell or solid organ transplant

I cannot provide a DNA sample for testing.

My child has had a stem cell or solid organ transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey and PGx Testing

Participants complete a baseline survey collecting demographic and health information, and undergo pharmacogenetic testing

1-2 weeks

1 visit (in-person or virtual)

Educational Intervention

Participants are randomized to receive an educational video about pharmacogenetic testing either at the time of receiving their PGx results or after the first follow-up survey

1 week

1 visit (virtual)

Follow-up

Participants complete follow-up surveys to assess changes in knowledge and attitudes regarding pharmacogenetic testing

2-4 weeks

2 visits (virtual)

Treatment Details

Interventions

• Educational video
• Pharmacogenomic Testing

Trial Overview The study aims to understand how children and pregnant women think about genetic tests that predict drug reactions (pharmacogenetics). It involves watching an educational video on this topic either when getting test results or later on. The impact of the video on knowledge and attitudes will be measured through surveys.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

All individuals in the Intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Upon completion of the testing, they will be provided a link to an educational video about pharmacogenetic testing and results. Surveys will be performed before and after the pharmacogenetic testing.

Group II: Delayed intervention arm Experimental Treatment 1 Intervention

All individuals in the Delayed intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Surveys will be performed before and after the pharmacogenetic testing. Upon completion of the first follow up survey, they will be provided a link to an educational video about pharmacogenetic testing and results. A second follow up survey will then be completed.

Pharmacogenomic Testing is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Pharmacogenomic Testing for:

• Guiding medication selection and dosing based on genetic variations

Approved in Canada as Pharmacogenetic Testing for:

• Informing drug dosing and monitoring for efficacy and safety in children and pregnant women

Approved in European Union as Pharmacogenomic Testing for:

• Personalized medicine through genetic-guided drug therapy

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

Pharmacogenetic and pharmacogenomic testing can help explain why individuals respond differently to medications, potentially leading to more personalized and effective treatments.

Successful genetic tests have already been implemented in clinical practice to reduce adverse drug reactions and enhance treatment efficacy, highlighting the importance of genetic factors in medication response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetics and pharmacogenomics: a clinical reality. Ferraldeschi, R., Newman, WG.[2011]

A staggering 99% of veterans using VHA pharmacy services are projected to carry at least one actionable pharmacogenetic variant, indicating a high potential for personalized medicine to improve drug prescribing.

Over half of the veterans (54.8%) received at least one level A drug that could be influenced by these genetic variants, suggesting that pharmacogenetic testing could significantly impact treatment decisions for commonly prescribed medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users. Chanfreau-Coffinier, C., Hull, LE., Lynch, JA., et al.[2020]

Pharmacogenomic testing helps predict how individuals will respond to certain medications based on their genetic makeup, which can guide personalized medication management and improve treatment outcomes.

The document serves as a resource for laboratories to establish clinical pharmacogenomic testing, outlining best practices for interpreting results and ensuring accurate reporting, despite challenges in predicting drug response for some genes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacogenomic testing and reporting: A technical standard of the American College of Medical Genetics and Genomics (ACMG). Tayeh, MK., Gaedigk, A., Goetz, MP., et al.[2023]

Pharmacogenomics, which examines how genetic differences affect drug responses, has the potential to significantly enhance patient care by personalizing medication choices.

Preemptive pharmacogenomics testing before prescribing medications can improve drug effectiveness and lower the risk of adverse reactions, but its widespread use in clinical practice is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Therapeutic Odyssey: Preemptive Pharmacogenomics Utility in Patient Care. Lazaridis, KN.[2017]

A study involving 370 pharmacists in the West Bank of Palestine revealed that 60% felt pharmacogenomics was not adequately covered in their pharmacy education, highlighting a significant gap in knowledge.

Despite recognizing the importance of pharmacogenomics for improving drug therapy management (94% agreement), only 38% of pharmacists could identify relevant medications, indicating a critical need for enhanced education and training in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the need for pharmacogenomics education among pharmacists in the West Bank of Palestine. Jarrar, Y., Musleh, R., Ghanim, M., et al.[2021]

Pharmacogenomics can help predict adverse drug reactions (ADRs) by identifying genetic variations that affect how individuals respond to medications, addressing a significant issue in drug safety.

The review highlights successful examples of pharmacogenomics influencing clinical practice and discusses future areas where it could improve drug safety, while also acknowledging the challenges in implementing these tests in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. Lee, JW., Aminkeng, F., Bhavsar, AP., et al.[2021]

Pharmacogenetic testing can enhance the effectiveness of medications and reduce the risk of adverse effects by tailoring treatments to individual genetic profiles, but its practical application is still limited.

Currently, there are few established examples of pharmacogenetic testing in clinical practice, and more research is needed to provide reliable evidence for its use across a broader range of medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacogenetic aspects of current pharmacotherapy]. Slanar, O., Zima, T.[2015]

Pharmacogenetic testing can help reduce adverse drug reactions (ADRs), but current evidence supporting its clinical value is limited, with only thiopurine methyltransferase (TPMT) showing clear benefits.

Pharmacogenetics should be seen as an additional tool rather than a replacement for clinical monitoring, as it cannot prevent all ADRs and the demand for such testing remains low among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetics, adverse drug reactions and public health. Kollek, R., van Aken, J., Feuerstein, G., et al.[2018]

Pharmacogenomics aims to identify genetic variations that influence how individuals respond to medications, potentially preventing harmful drug reactions and improving treatment outcomes.

Current research shows promising results, such as the strong link between genetic factors and adverse reactions like abacavir hypersensitivity, but more comprehensive studies are needed to confirm these findings and establish clinical guidelines for pharmacogenetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions and pharmacogenomics: recent advances. Alfirevic, A., Pirmohamed, M.[2019]

Pharmacogenetics aims to identify genetic variations that influence how individuals respond to medications, which can range from pain relievers to cancer treatments.

The review highlights the importance of integrating pharmacogenomic technologies in drug development to create effective medications and corresponding diagnostic tests for personalized treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating pharmacogenomics into drug development. Ferentz, AE.[2007]

Pharmacogenetics helps us understand how genetic differences influence how patients respond to cancer medications, which is crucial since the right dosage can mean the difference between effective treatment and harmful side effects.

By studying both patient and tumor genetics, researchers aim to personalize drug dosages, leading to more effective treatments with fewer adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetics and cancer therapy. Relling, MV., Dervieux, T.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacogenetics and pharmacogenomics: a clinical reality. [2011]

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

Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users. [2020]

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

Clinical pharmacogenomic testing and reporting: A technical standard of the American College of Medical Genetics and Genomics (ACMG). [2023]

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

Improving Therapeutic Odyssey: Preemptive Pharmacogenomics Utility in Patient Care. [2017]

5. India pubmed.ncbi.nlm.nih.gov

Assessment of the need for pharmacogenomics education among pharmacists in the West Bank of Palestine. [2021]

6. Denmark pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. [2021]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[Pharmacogenetic aspects of current pharmacotherapy]. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenetics, adverse drug reactions and public health. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions and pharmacogenomics: recent advances. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Integrating pharmacogenomics into drug development. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Pharmacogenetics and cancer therapy. [2017]