Video Education for Prenatal Testing Choices

Pregnancy Clinical Trial

Official title:

The Effect of Standardized Video Education on Prenatal Genetic Testing Choices, Decisional Conflict, and Decisional Regret

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062968
• Other study ID #: NMCSD.2016.0070
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: August 2020

Study information

• Verified date: August 2020
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the investigator's study is to assess the effect of a standardized prenatal testing educational video on the use of prenatal genetic testing and decision-making.

Description:

This is a prospective randomized trial of video education on prenatal testing vs. usual care, with the goal to assess women's prenatal testing choices, understanding of testing options and decisional conflict and regret. Participants will be recruited from a convenience sample of patients presenting for prenatal care at Naval Medical Center San Diego (NMCSD).

While receiving prenatal care at NMCSD, all women are offered the option of screening for aneuploidy (serum screen (with or without nuchal translucency ultrasound) or cell free DNA testing) or diagnostic testing (chorionic villous sampling or amniocentesis) or no testing in pregnancy.

After providing consent, participants will be randomized to video education or usual care. Randomization will be completed using a random number table. Women randomized to the intervention group (video education) will view the prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-gen etic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit. The educational video was created with input from clinicians including licensed genetic counselors, obstetricians, maternal fetal medicine physicians, and patients. Extensive testing and reviewing was completed to ensure adequate comprehension by a wide range of audiences and minimize counseling bias. Women randomized to the control group will receive routine prenatal care with no additional study intervention other than completion of the study related surveys at baseline (initial prenatal testing). Current national guidelines recommend offering all women prenatal diagnosis and prenatal screening at the beginning of the pregnancy.1

The primary outcome for this study will be screening uptake rates, and will be based on review of the patient's electronic medical record. Secondary outcomes will include invasive diagnostic test rates, participant knowledge about testing (as assessed using the Maternal Serum Screening Knowledge Questionnaire,2 and decisional conflict (as assessed by the Decisional Conflict Scale) and decisional regret (as assessed by the Decision Regret Scale). These assessments will be conducted at time of prenatal testing (< 20 weeks). (Appendix A)

The study questionnaire will include a check box for participants to indicate if they would be willing to participate in a follow on qualitative study to assess participant's personal experience related to their method of education about prenatal testing. This component of the study will aim to determine personal and social reasoning behind their decisions, and to further explore their experience, beliefs and behaviors. Interested participants from each group (both intervention and control) will be contacted to arrange a telephone or in person interview. (Appendix C) Participants will be interviewed in person or over the phone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: August 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years of age

• Gestational age less than or equal to 20 weeks

• Singleton gestation

• Not completed aneuploidy screening in this pregnancy

• Available to watch the 15 minute video

• Ability to read, write, and understand English

Exclusion Criteria:

• Pregnant women not eligible for care at Military Treatment Facility

• Less than 18 years of age

• Gestational age greater than 20 weeks

• Multiple gestation

• Aneuploidy testing in current pregnancy

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Video education
Prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video "How to Decide About Prenatal Genetic Testing," available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos .

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening uptake rates	Genetic screening	24-36 weeks gestation
Secondary	Invasive diagnostic test rates	Diagnostic testing such as Chorinonic Villus Sampling and amniocentesis	24-36 weeks gestation
Secondary	Participant knowledge about prenatal testing	Assessed by using the Maternal Serum Screening knowledge Questionnaire. Scores range from 0 to 15, reflecting the number of correct answers. A score of zero would indicate zero correct answers, where a score of 15 would indicate all answers were correct. Higher scores are considered better outcome indicating higher knowledge.	up to 20 weeks gestation
Secondary	Decisional conflict	Assessed by the Decisional Conflict Scale. Questions are scored on a Likert scale of 1 to 5, with 1 equating to Strongly Agree and 5 equating to Strongly Disagree. Thus, lower scores indicate lower decisional conflict. Subscale Decisional Uncertainty score range 3 to 15. Subscale Percieved Effective Decision range 4 to 20.	up to 20 weeks gestation
Secondary	Decisonal regret	Assessed by the Decisional Regret Scale. Questions are scored on a Likert scale of 1 to 5, with 1 equating to Strongly Agree and 5 equating to Strongly Disagree. Thus, lower scores indicate lower decisional regret. Decisional Regret scores range 0 to 100.	up to 20 weeks gestation