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

Women and Infants Hospital of Rhode Island

Status: Active, not recruiting

Conditions: Decisional Conflict; Aneuploidy; Genetic Counseling; Informed Consent

Treatments: Other: Video Educational Tool Regarding Prenatal Genetics

Study type: Interventional

Funder types: Other

Identifiers

NCT06771453

1721550

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Usual Prenatal Care

No Intervention group

Description:

The patient will receive routine prenatal care with no video education.

Video Educational Tool Arm

Experimental group

Description:

The patient receives routine prenatal care plus video education on prenatal genetics.

Treatment:

Other: Video Educational Tool Regarding Prenatal Genetics