Clinical trial NCT06771453: GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneuploidy
Genetic Counseling
Informed Consent
Decisional Conflict
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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.


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

Primary outcomes:
measure: Score on Decisional Conflict Scale (low health literacy version of the tool)
timeFrame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Secondary outcomes:
measure: Perception of likelihood of having a baby affected by a genetic problem
timeFrame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
measure: Percent of patients opting to pursue genetic testing
timeFrame: After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
measure: Patient-provider communication
timeFrame: Six to ten weeks from follow up survey #1
measure: Retention of Prenatal Genetics Knowledge
timeFrame: Six to ten weeks from follow up survey #1
measure: Perception of genetic data privacy
timeFrame: Six to ten weeks from follow up survey #1
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants
state: Rhode Island
Study officials:
References: