Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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 Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
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.
  • 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.
Other
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.
  • 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.

Recruiting Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
Contact:
Sabrina E Holley, MD
615-875-4491
sabrina.e.holley@vumc.org

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Sarah H Jones, MPH
615-936-3976
sarah.h.jones@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Sabrina E Holley, MD
6158754491
sabrina.e.holley@vumc.org

Detailed Description

This study will follow a two-arm unblinded research design. Study inclusion criteria include ability to provide a DNA sample for pharmacogenoetic (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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.