NCT06771453

GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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: 1. 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 2. 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). 3. 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.

Conditions

• Aneuploidy
• Genetic Counseling
• Informed Consent
• Decisional Conflict

Interventions

Type	Name	Description
OTHER	Video Educational Tool Regarding Prenatal Genetics	Video education about prenatal genetics will include content regarding aneuploidy screening and diagnostic testing options, how to make a values-based choice, and specifics of risks/benefits/limitations of each type of testing option.

Timeline

• Start date: 2025-01-16
• Primary completion: 2025-10-01
• Completion: 2026-02-01
• First posted: 2025-01-13
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States