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

140 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Video Educational Tool for prenatal patients?

Research shows that video education can help patients make informed decisions by improving their understanding and reducing uncertainty. For example, a study on prenatal genetic testing found that a video educational tool increased patient knowledge and reduced decisional conflict, which is the uncertainty about choosing between different options. ^{1 2 3 4 5}

How does the Video Educational Tool treatment differ from other treatments for decisional conflict in prenatal patients?

The Video Educational Tool is unique because it uses a standardized video format to educate prenatal patients, which can improve knowledge and reduce decisional conflict by providing clear, consistent information compared to traditional pamphlets or leaflets. ^{1 3 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

An interactive videodisc program for low back pain patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of a decision aid for prenatal testing of fetal abnormalities: a cluster randomised trial [ISRCTN22532458]. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Enhanced decision-making: the use of a videotape decision-aid for patients with prostate cancer. [2019]

5. United States 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. [2019]

6. England 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. [2006]

7. England 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. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Psychometric Assessment of the Mandarin Version of the Decisional Conflict Scale with Pregnant Women Making Prenatal Test Decisions. [2022]