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Video Education for Prenatal Testing Choices

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ClinicalTrials.gov Identifier: NCT04062968
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Video education Not Applicable

Detailed 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-genetic-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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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-genetic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit.

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).

Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Standardized Video Education on Prenatal Genetic Testing Choices, Decisional Conflict, and Decisional Regret
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
Experimental: Video education
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-genetic-testing-videos .7 They will then complete the study related surveys at their initial obstetric visit.
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 .

No Intervention: Usual care
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).



Primary Outcome Measures :
  1. screening uptake rates [ Time Frame: 24-36 weeks gestation ]
    Genetic screening


Secondary Outcome Measures :
  1. Invasive diagnostic test rates [ Time Frame: 24-36 weeks gestation ]
    Diagnostic testing such as Chorinonic Villus Sampling and amniocentesis

  2. Participant knowledge about prenatal testing [ Time Frame: up to 20 weeks gestation ]
    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.

  3. Decisional conflict [ Time Frame: up to 20 weeks gestation ]
    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.

  4. Decisonal regret [ Time Frame: up to 20 weeks gestation ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062968


Contacts
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Contact: Monica Lutgendorf, MD 619-532-7020 monica.a.lutgendorf.mil@mail.mil

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Monica A Lutgendorf, MD    619-532-7020    monica.a.lutgendorf.mil@mail.mil   
Principal Investigator: Monica A Lutgendorf, MD         
Sub-Investigator: Sharon K Stortz, MD         
Sponsors and Collaborators
United States Naval Medical Center, San Diego

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Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT04062968     History of Changes
Other Study ID Numbers: NMCSD.2016.0070
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No