NCT05037305

VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey

Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

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

• Pharmacogenomic Testing

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-06-30
• Primary completion: 2026-01-31
• Completion: 2026-04-30
• First posted: 2021-09-08
• Last updated: 2026-03-10

Locations

2 sites across 1 country: United States