Clinical trial NCT05037305: VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey
Official title: Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pharmacogenomic Testing
Keywords: pharmacogenomic
PGx
pediatric
maternal
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Participants' opinions of pharmacogenetic testing changes after results are received
timeFrame: Baseline to post-return of PGx results, approximately 2- 4 weeks
Secondary outcomes:
measure: Participants gain an improved knowledge of pharmacogenetics after educational intervention
timeFrame: Baseline to post-return of PGx results, approximately 2-4 weeks
measure: Researchers gain a better understanding of the concerns about and perceptions of pharmacogenetic testing among pregnant women and parents of children with chronic conditions
timeFrame: Baseline to post-return of PGx results, approximately 2- 4 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: