Video Education for Decisional Conflict in Prenatal Patients

(GEM Trial)

Overseen By Melissa L Russo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Fetal anomaly, Abnormal nuchal translucency, Fetal loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a video education tool increases confidence and knowledge in pregnant individuals making decisions about prenatal genetic testing. Participants will either watch the video or receive standard prenatal care. The study also examines how the video influences their understanding of genetic risks, communication with healthcare providers, and knowledge about prenatal genetics over time. Pregnant individuals less than 24 weeks along, carrying one baby, and who have not yet undergone genetic testing or counseling, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to research that could enhance prenatal care education for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this video educational tool is safe for prenatal patients?

Previous studies have shown that using videos to teach about prenatal genetics is safe for participants. For example, videos explaining genetic tests improved understanding and reduced regret about testing choices. This suggests that most people find these educational tools helpful and safe.

No reports indicate negative effects from watching an educational video. The video aims to provide information and assist with decision-making, not to alter health, making harm very unlikely.

Overall, video education is considered safe and well-received by those considering prenatal genetic testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the video educational tool for prenatal patients because it offers a unique way to address decisional conflict in prenatal care. Unlike standard prenatal care, which typically involves in-person consultations and printed materials, this approach uses engaging video content to provide detailed information on prenatal genetics. This method can enhance understanding and empower patients to make more informed decisions about their prenatal care. By potentially reducing anxiety and confusion, the video tool could lead to improved patient satisfaction and better health outcomes.

What evidence suggests that this video educational tool is effective for reducing decisional conflict in prenatal patients?

Research has shown that video tools can greatly improve understanding of prenatal genetic testing. In this trial, participants in the Video Educational Tool Arm will receive routine prenatal care plus video education on prenatal genetics. Studies have found that these videos help pregnant women learn more about genetic conditions and testing choices. Specifically, one study discovered that video education boosted patients' knowledge and attitudes about prenatal genetic testing and privacy. Another report noted that animated videos increased understanding among pregnant women about genetic counseling. Overall, video tools can simplify complex information, aiding expectant mothers in making informed decisions about genetic testing. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals deciding on prenatal genetic testing. They must be at the stage of receiving a dating ultrasound and able to complete surveys. There are no specific exclusion criteria provided, but participants typically need to meet certain health and demographic requirements.

Inclusion Criteria

Gestational age is less than 24 weeks

Preferred language is English or Spanish

Singleton pregnancy

Exclusion Criteria

Use of a donor oocyte (egg) this pregnancy

My unborn baby has been diagnosed with a health condition.

I have not participated in genetic testing studies during pregnancy in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants 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

1 day

1 visit (in-person)

Follow-up Survey #1

Participants complete a follow-up survey after seeing their prenatal care provider regarding decisional conflict scale with respect to prenatal genetic testing decision, perception of likelihood of having a baby affected by a genetic problem, and the type of genetic testing chosen

Up to 14 days after first obstetric appointment

1 visit (virtual)

Follow-up Survey #2

Participants 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

6-10 weeks from Follow-up Survey #1

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Video Educational Tool

Trial Overview The study tests if a video educational tool can help reduce decisional conflict in pregnant patients choosing prenatal genetic tests compared to standard care. It also looks at how the tool affects their understanding of genetics, communication with providers, and perception of privacy.

How Is the Trial Designed?

Group I: Video Educational Tool Arm Experimental Treatment 1 Intervention

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

Group II: Usual Prenatal Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Published Research Related to This Trial

The use of a standardized educational video on prenatal genetic testing significantly improved patient knowledge, as evidenced by higher scores on the Maternal Serum Screening Knowledge Questionnaire (MSSKQ) by an average of 2.9 points.

Despite increasing knowledge, the video education group had a 39% lower likelihood of opting for prenatal testing, indicating that better understanding led to more informed decisions that aligned with personal values, while also reducing decisional conflict and regret.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial on the Effect of Standardized Video Education on Prenatal Genetic Testing Choices: Uptake of Genetic Testing. Stortz, SK., Mulligan, S., Snipes, M., et al.[2023]

The interactive multimedia decision aid (IMDA) did not significantly change the overall uptake of prenatal screening tests for Down syndrome compared to traditional methods (leaflet and video) among 201 women studied.

Despite no difference in screening uptake, a high percentage of women (86.6%) found the IMDA user-friendly, with younger women (under 35) showing greater acceptance, likely due to their higher computer usage and knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial comparing an interactive multimedia decision aid with a leaflet and a video to give information about prenatal screening for Down syndrome. Leung, KY., Lee, CP., Chan, HY., et al.[2006]

The interactive web-based decision aid was well-received by pregnant women, helping them clarify their views and engage their partners in the decision-making process regarding prenatal screening for fetal anomalies.

The study, involving interviews with 17 pregnant women in Sweden, showed that the decision aid promoted conscious decision-making about screening, indicating its potential value in enhancing informed choices among expectant parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'It made you think twice' - an interview study of women's perception of a web-based decision aid concerning screening and diagnostic testing for fetal anomalies. Åhman, A., Sarkadi, A., Lindgren, P., et al.[2018]

A computerized interactive video program was developed to assist patients in making informed decisions about low back surgery, based on a shared decision-making model and input from both patients and physicians.

After viewing the program, 75% of patients felt the information was appropriate, and the percentage of undecided patients about their treatment decreased from 29% to 17%, indicating the program effectively enhanced patient understanding and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interactive videodisc program for low back pain patients. Spunt, BS., Deyo, RA., Taylor, VM., et al.[2019]

The videotape decision-aid was developed through expert input and patient focus groups, and it was tested on 32 men aged 50-85, showing moderate effectiveness in improving recall of prostate cancer treatment options.

After watching the videotape, participants felt more empowered to take an active role in their treatment decisions, suggesting that such decision-aids can enhance patient engagement in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced decision-making: the use of a videotape decision-aid for patients with prostate cancer. Schapira, MM., Meade, C., Nattinger, AB.[2019]

A randomized controlled trial in Victoria, Australia, is testing whether a decision aid for prenatal testing improves informed decision-making and reduces decisional conflict among women compared to a standard pamphlet, involving 159 women and 50 General Practitioners.

The study aims to measure the effectiveness of the decision aid by comparing the percentage of women making informed choices and their decisional conflict scores at 14 and 24 weeks of gestation, potentially enhancing the prenatal testing experience and informing maternity care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a decision aid for prenatal testing of fetal abnormalities: a cluster randomised trial [ISRCTN22532458]. Nagle, C., Lewis, S., Meiser, B., et al.[2021]

In a study of 226 men aged 50 and older, those who watched a 23-minute video about PSA testing showed significantly greater increases in knowledge and were more likely to decline the test compared to those who accessed information online.

While both methods were rated similarly in terms of convenience and satisfaction, the video format was more effective in educating participants about the benefits and risks of PSA screening, with 98.2% of the video group reviewing the material compared to only 53.5% of the internet group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing internet and video to facilitate patient education for men considering the prostate specific antigen test. Frosch, DL., Kaplan, RM., Felitti, VJ.[2019]

The Mandarin version of the decisional conflict scale (M-DCS) has been validated as a reliable tool for assessing the decisional conflict faced by Chinese women with high-risk pregnancies regarding prenatal testing for Down syndrome, based on a study of 240 participants.

The M-DCS demonstrated strong psychometric properties, including high internal consistency (Cronbach's α of 0.94) and a satisfactory fit for its five-factor model, making it a valuable resource for healthcare providers and researchers in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Assessment of the Mandarin Version of the Decisional Conflict Scale with Pregnant Women Making Prenatal Test Decisions. Xiang, JM., Sun, K., Zhao, Q., et al.[2022]

Citations

1. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-06170-8

Effects of an animated educational video on knowledge of cell ... Reports from developed countries have found that various tools in prenatal genetic counseling can improve the knowledge of pregnant women who ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560615/

Patients' experiences using an educational virtual assistant ... This observational study aimed to capture patients' experiences after reviewing carrier screening (CS) and/or noninvasive prenatal cell‐free DNA ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04420858

Study Details | NCT04420858 | Effect of Video Education ... Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics. Conditions. AneuploidyGenetic DiseasePregnancy Related.

4. gimopen.org gimopen.org/article/S2949-7744(24)00967-1/fulltext

Informal prenatal genetic screening education: What can ... The goal of this article is to explore what online education and decision support tools are freely available to patients about prenatal screening.

5. journals.lww.com journals.lww.com/jpbs/fulltext/2024/16003/effectiveness_of_video_assisted_teaching_programme.319.aspx

Effectiveness of Video Assisted Teaching Programme on ... The present study aims to assess the Effectiveness of video assisted teaching programme on level of knowledge and attitude regarding prenatal genetic testing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06771453

GEM: Impact of a Video Education Tool on Decisional ... Video education about prenatal genetics will include content regarding aneuploidy screening and diagnostic testing options, how to make a values-based choice, ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06842-z

Supplementing provider counseling with an educational video ... A video explaining prenatal genetic tests resulted in increased knowledge scores, decreased testing uptake, and decreased decisional regret [17] ...