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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how an educational video affects understanding and attitudes towards pharmacogenomic testing, which examines how genes influence drug responses. Participants will divide into two groups: one will watch the video immediately after receiving their test results, and the other will watch it later. Surveys will track changes in knowledge and attitudes. The trial seeks pregnant women between 12 to 30 weeks along, planning to deliver at Vanderbilt University Medical Center, or children aged 0 to 16 with a chronic health condition. As an unphased trial, this study allows participants to contribute to important educational research without the risks associated with new treatments.

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 prior data suggests that this educational video and pharmacogenomic testing are safe?

Past studies have shown that gene-based testing holds promise for tailoring medicine to individual needs. This testing helps doctors choose the right medicine and dose, reducing the risk of serious side effects. Research has shown that this testing is generally well-tolerated. It primarily involves studying how genes affect drug reactions, so it typically doesn't cause physical side effects, as it focuses on gathering information rather than administering treatment. By understanding how different people process medication, gene-based testing aims to make medicine safer and more effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how educational videos can enhance understanding of pharmacogenomic testing, which is a cutting-edge tool in personalized medicine. Unlike traditional treatments that often follow a one-size-fits-all approach, pharmacogenomic testing tailors medication plans based on an individual's genetic makeup, potentially improving efficacy and reducing side effects. This trial aims to determine if educational support can further empower patients by helping them better understand their test results and the implications for their treatment. By focusing on education, the study hopes to bridge the gap between complex genetic data and practical, personalized healthcare decisions.

What evidence suggests that this educational video is effective for improving knowledge and attitudes about pharmacogenetic testing?

Research has shown that testing a person's genes can enhance healthcare by tailoring treatments to their unique genetic profile. This approach identifies the most effective medications and the correct dosage, reducing the risk of serious side effects. In this trial, participants in both the Intervention arm and the Delayed intervention arm will undergo pharmacogenetic testing. Studies have found that educational videos effectively explain complex topics, such as genetics, in an accessible manner. Participants in this trial will receive an educational video about pharmacogenetic testing and results, which may increase understanding and positive perceptions of personalized medicine for children and pregnant women. ^{1 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6789586/

Pharmacogenomic Testing: Clinical Evidence and ... Abstract. Pharmacogenomics can enhance patient care by enabling treatments tailored to genetic make-up and lowering risk of serious adverse events.

2. genome.gov genome.gov/about-genomics/educational-resources/fact-sheets/pharmacogenomics

Pharmacogenomics Fact Sheet Pharmacogenomic testing involves analyzing a person's DNA to identify genomic variants that may inform which medication or what dosage of a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5491980/

Development and Initial Assessment of a Patient Education ... Educational videos have been as effective as an educational resource and/or decision aid in clinical genetics [12,13,14], and may be ...

4. mayo.edu mayo.edu/research/centers-programs/center-individualized-medicine/patient-care/pharmacogenomics

Center for Individualized Medicine - Pharmacogenomics in ... Pharmacogenomics is the study of how your genes affect your body's response to medicines. Your body has thousands of genes that you inherited from your parents.

5. fda.gov fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations

Table of Pharmacogenetic Associations Pharmacogenetic tests, along with other information about patients and their disease or condition, can play an important role in drug therapy.

6. geneyx.com geneyx.com/blog-archive/pharmacogenomic-testing-can-improve-medication-safety/

How Pharmacogenomic Testing Can Improve Medication ... Pharmacogenetics testing can help predict a patient's response to medication by analyzing how their genetic makeup affects drug metabolism.

7. medicover-genetics.com medicover-genetics.com/our-genetic-tests/pharmacogenomics/pharmacogenomic-diagnostic-testing/

Pharmacogenomic Diagnostic Testing PGx testing identifies genetic variants that influence drug response, enabling more precise, safer, and more effective treatment decisions, whether used ...

8. medicine.duke.edu medicine.duke.edu/divisions/general-internal-medicine/precision-medicine/pharmacogenomics

Pharmacogenomics | Duke Department of Medicine Pharmacogenomics testing is a DNA-based test of genetic variations of genes associated with risk of adverse response or drug response. PHASER.