VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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This study will follow a two-arm unblinded research design. Study inclusion criteria include ability to provide a DNA sample for pharmacogenetic (PGx) testing and willingness to receive the test results. All participants will have PGx testing. Participants will complete a survey at study baseline, which will collect demographic information (age, race/ethnicity), contact and alternative contact information, primary care physician information, socioeconomic details (e.g. insurance information, education, occupation, marital status, and income) health data (e.g. chronic conditions, personal and family history of genetic diseases) and lifestyle data (e.g. smoking, drinking, and physical activity). Parents will complete enrollment surveys on behalf of children. Basic health and pregnancy history will also be collected for pregnant women. Survey questions regarding information and knowledge on PGx testing will be administered at enrollment and again after return of PGx results. Participants will be randomized to either the intervention group or the delayed intervention group. Individuals in the intervention group will be provided an educational video about PGx testing at the time that PGx results are available. Participants in the Delayed intervention group will be provided the educational video after they complete the first follow up survey. The investigators will include questions in the follow-up survey specific to the educational video in the first follow up survey (Intervention group) or the second follow up survey (Delayed intervention group).

Conditions

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Pharmacogenomic Testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All individuals in study will be undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenetic assay used at Vanderbilt University Medical Center. Upon completion of the pharmacogenetic testing, participants will be randomized to view an educational video immediately (intervention group), or after completion of a follow up survey (delayed intervention).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention arm

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 Type OTHER

Educational video

Intervention Type OTHER

The brief educational video provides information about pharmacogenetic testing, the results of pharmacogenetic testing, and how to find these results in the patient portal.

Delayed intervention arm

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.

Group Type OTHER

Educational video

Intervention Type OTHER

The brief educational video provides information about pharmacogenetic testing, the results of pharmacogenetic testing, and how to find these results in the patient portal.

Interventions

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Educational video

The brief educational video provides information about pharmacogenetic testing, the results of pharmacogenetic testing, and how to find these results in the patient portal.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes