VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey

NCT05037305 | Active Not Recruiting

• 1 other identifier: VUMCIRB:212241
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pharmacogenomic Testing

Keywords

pharmacogenomic; PGx; pediatric; maternal

Outcome Measures

Primary Outcomes (1)

• Participants' opinions of pharmacogenetic testing changes after results are received

  * Opinion of Knowledge of Pharmacogenetics (PGx) and Related Terminology is being collected in 3 ways. Ten words or phrases will be assessed using a 5-variable ordinal scale ('Not at all familiar' to 'Extremely familiar'). One question will use a 4-variable ordinal scale (Very well, somewhat well, a little, not at all). Another question will use a 5-option Likert scale (A lot, somewhat, a little, not at all, don't know). * Opinion of the Usefulness of PGx Testing is being collected using 12 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree'). * Opinion of What Can be Learned from PGx Test Results is being collected using 9 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree'). For all 3 above, responses reflect relative value, not absolute value, so are not additive and there are no total scores.

  Baseline to post-return of PGx results, approximately 2- 4 weeks

Secondary Outcomes (2)

• Participants gain an improved knowledge of pharmacogenetics after educational intervention

  Baseline to post-return of PGx results, approximately 2-4 weeks

• Researchers gain a better understanding of the concerns about and perceptions of pharmacogenetic testing among pregnant women and parents of children with chronic conditions

  Baseline to post-return of PGx results, approximately 2- 4 weeks

Study Arms (2)

Intervention arm

OTHER

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.

Other: Educational video

Delayed intervention arm

OTHER

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.

Other: Educational video

Interventions

Educational video 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; Intervention arm

Eligibility Criteria

• Gender Eligibility Details: Adult pregnant women, and children (regardless of sex)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• Stem cell or solid organ transplant
• Recent transfusion within the previous 2 months
• Inability to provide DNA sample for testing

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (2)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Medicine

Model Details: 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).

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: September 8, 2021
• Study Start: June 30, 2022
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: It will become available once any manuscripts are accepted for publication. It will be available for a reasonable amount of time.
• Access Criteria: Qualified Researchers

Locations

US (2)