ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-01-16
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06771453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient ≥ 18 years of age
  2. * Preferred language English or Spanish
  3. * Singleton pregnancy
  4. * No documentation of genetic screening results or counseling during this pregnancy
  5. * Gestational age \<24 weeks
  1. * Diagnosed with a fetal anomaly
  2. * Diagnosed with known abnormal nuchal translucency test
  3. * Diagnosed with fetal loss
  4. * Use of a donor oocyte (egg) this pregnancy
  5. * Prior involvement in other research study regarding prenatal genetic testing in the past two years

Contacts and Locations

Study Locations (Sites)

Women and Infants
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: Women and Infants Hospital of Rhode Island

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-16
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-01-16
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Aneuploidy
  • Genetic Counseling
  • Informed Consent
  • Decisional Conflict