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

Last updated: April 7, 2025
Sponsor: Women and Infants Hospital of Rhode Island
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Video Educational Tool Regarding Prenatal Genetics

Clinical Study ID

NCT06771453
1721550
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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 thepast two years

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Video Educational Tool Regarding Prenatal Genetics
Phase:
Study Start date:
January 16, 2025
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Women and Infants

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

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