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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aneuploidy; Informed Consent; Genetic Counseling; Decisional Conflict
• Intervention / Treatment: Other: Video Educational Tool Regarding Prenatal Genetics

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Prenatal Care; The patient will receive routine prenatal care with no video education.
Experimental: Video Educational Tool Arm; The patient receives routine prenatal care plus video education on prenatal genetics.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of likelihood of having a baby affected by a genetic problem	The investigators will use a Likert scale to assess patient's perception of likelihood of having a baby affected by a genetic problem (score ranges from 1 [not likely at all] to 4 [very likely]).	After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Percent of patients opting to pursue genetic testing	The investigators will assess the percent of participants who decide to pursue screening or diagnostic genetic testing options	After enrollment and up to 14 days after their first obstetric appointment in that pregnancy
Patient-provider communication	The investigators will use a modified doctor-patient communication questionnaire to assess how patients perceived communication and comprehension of counseling with their prenatal care provider (score 0 to 8, with higher score reflecting better communication).	Six to ten weeks from follow up survey #1
Retention of Prenatal Genetics Knowledge	The investigators will assess prenatal genetics knowledge remote from the intervention to assess retention of its content (score 0 to 12 with a higher score reflecting more knowledge). The questionnaire was created by the investigators. It is six questions that query the participants on key content highlighted in the educational intervention; the content covered is also considered standard of care to receive in counseling in routine prenatal care (for those who were not randomized to the intervention).	Six to ten weeks from follow up survey #1
Perception of genetic data privacy	The investigators will assess on a Likert scale how important privacy of participants' own genetic data and that of their baby were in making a decision about prenatal genetic testing (score 0 to 8 with higher score reflecting more importance)	Six to ten weeks from follow up survey #1

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Pathological Conditions, Signs and Symptoms; Aneuploidy
• Other Study ID Numbers: 1721550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No