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NCT Number: NCT06771453

GEM: Impact of a Video Education Tool 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.

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Key information

Conditions

Aneuploidy Chromosome Aberrations Decisional Conflict Genetic Counseling Informed Consent Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants

Providence, Rhode Island, 02905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Perception of likelihood of having a baby affected by a genetic problem

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

    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]).

  2. Percent of patients opting to pursue genetic testing

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

    The investigators will assess the percent of participants who decide to pursue screening or diagnostic genetic testing options

  3. Patient-provider communication

    Time frame: Six to ten weeks from follow up survey #1

    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).

  4. Retention of Prenatal Genetics Knowledge

    Time frame: Six to ten weeks from follow up survey #1

    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).

  5. Perception of genetic data privacy

    Time frame: Six to ten weeks from follow up survey #1

    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)

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

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

Acronym: GEM

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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