GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients
NCT ID: NCT06771453
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2025-01-16
2026-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Usual Prenatal Care
The patient will receive routine prenatal care with no video education.
No interventions assigned to this group
Video Educational Tool Arm
The patient receives routine prenatal care plus video education on prenatal genetics.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Locations
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Women and Infants
Providence, Rhode Island, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1721550
Identifier Type: -
Identifier Source: org_study_id
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