The GEM Trial - Genetics Education and Equity in Maternal Fetal Medicine: A Pilot Feasibility Randomized Controlled Trial to Assess Impact of a Video Education Tool (VET) on Decisional Conflict Among Prenatal Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneuploidy
- Sponsor
- Women and Infants Hospital of Rhode Island
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Score on Decisional Conflict Scale (low health literacy version of the tool)
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care.
The secondary aims include assessing the impact of the video educational tool versus standard care on pregnant participants': perception of likelihood of having a baby affected by a genetic problem, intended plan for genetic testing, patient-provider communication, retention of prenatal genetics knowledge, and perception of genetic data privacy.
Participants will be asked to:
- Watch video education (if randomized to this group) and complete a baseline survey at their dating ultrasound regarding knowledge of prenatal genetics, prior experiences, and demographics
- Complete a follow up survey after seeing their prenatal care provider regarding: decisional conflict scale with respect to prenatal genetic testing decision (primary outcome), perception of likelihood of having a baby affected by a genetic problem (secondary outcome) and the type of genetic testing chosen (secondary outcome).
- Complete a second follow up survey six to ten weeks from the second survey to assess: Provider patient communication, retention of genetics knowledge, patient recollection of testing performed, and self-reported out of pocket cost related to genetic testing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient ≥ 18 years of age
- •Preferred language English or Spanish
- •Singleton pregnancy
- •No documentation of genetic screening results or counseling during this pregnancy
- •Gestational age \<24 weeks
Exclusion Criteria
- •Diagnosed with a fetal anomaly
- •Diagnosed with known abnormal nuchal translucency test
- •Diagnosed with fetal loss
- •Use of a donor oocyte (egg) this pregnancy
- •Prior involvement in other research study regarding prenatal genetic testing in the past two years
Outcomes
Primary Outcomes
Score on Decisional Conflict Scale (low health literacy version of the tool)
Time Frame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
The investigators will assess the decisional conflict scale score around the time when patients make a decision about prenatal genetic screening options. The resulting score ranges from 0 to 100, with 0 indicating no decisional conflict (best outcome) and 100 indicating extremely high decisional conflict (worst outcome).
Secondary Outcomes
- Perception of likelihood of having a baby affected by a genetic problem(After enrollment and up to 14 days after their first obstetric appointment in that pregnancy)
- Percent of patients opting to pursue genetic testing(After enrollment and up to 14 days after their first obstetric appointment in that pregnancy)
- Patient-provider communication(Six to ten weeks from follow up survey #1)
- Retention of Prenatal Genetics Knowledge(Six to ten weeks from follow up survey #1)
- Perception of genetic data privacy(Six to ten weeks from follow up survey #1)