VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey
United States798 participantsStarted 2022-06-30
Plain-language summary
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.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Maternal
Inclusion Criteria:
* Provide consent in English or Spanish
* Primary care at VUMC
* Adult women aged 18 and older
* Currently pregnant 12 to 30 weeks gestational age
* Completed or scheduled first prenatal visit at VUMC clinic
* Intent to deliver at VUMC or affiliate
* Agrees to receive findings from pharmacogenomic testing
* Allow access their medical record
Exclusion Criteria:
* Stem cell or solid organ transplant
* Recent transfusion within the previous 2 months
* Inability to provide DNA sample for testing
* Prior pharmacogenomic testing
* Pregnant women undergoing in vitro fertilization or assisted reproductive technologies
Pediatric
Inclusion Criteria:
* Provide consent (parent/guardian) and/or assent (child) in English or Spanish
* Primary care or subspecialty care at VUMC
* Aged 0 to 16
* Parent (0-16 years) and child (12-16 years) agree for both parent and child to receive findings from pharmacogenomic testing
* Parent (0-16 years) and child (12-16 years) allow access their medical record
* Have a chronic health condition.
Exclusion:
* Stem cell or solid organ transplant
* Recent transfusion within the previous 2 months
* Inability to provide DNA sample for testing
* Prior pharmacogenomic testing
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants' opinions of pharmacogenetic testing changes after results are received
Timeframe: Baseline to post-return of PGx results, approximately 2- 4 weeks