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

NCT06771453 | Active Not Recruiting

• 1 other identifier: 1721550
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Score on Decisional Conflict Scale (low health literacy version of the tool)

  The investigators will assess the decisional conflict scale score around the time when patients make a decision about prenatal genetic screening options. The resulting score ranges from 0 to 100, with 0 indicating no decisional conflict (best outcome) and 100 indicating extremely high decisional conflict (worst outcome).

  After enrollment and up to 14 days after their first obstetric appointment in that pregnancy

Secondary Outcomes (5)

• Perception of likelihood of having a baby affected by a genetic problem

  After enrollment and up to 14 days after their first obstetric appointment in that pregnancy

• Percent of patients opting to pursue genetic testing

  After enrollment and up to 14 days after their first obstetric appointment in that pregnancy

• Patient-provider communication

  Six to ten weeks from follow up survey #1

• Retention of Prenatal Genetics Knowledge

  Six to ten weeks from follow up survey #1

• Perception of genetic data privacy

  Six to ten weeks from follow up survey #1

Study Arms (2)

Usual Prenatal Care

NO INTERVENTION

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

Video Educational Tool Arm

EXPERIMENTAL

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

Other: Video Educational Tool Regarding Prenatal Genetics

Interventions

Video Educational Tool Regarding Prenatal Genetics OTHER

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.

Video Educational Tool Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Aneuploidy

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 13, 2025
• Study Start: January 16, 2025
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)