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Use of Videos to Improve Patient Knowledge on Prenatal Genetics (VPE)

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ClinicalTrials.gov Identifier: NCT03816423
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Tampa General Hospital
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
This is a randomized control trial of a low-to-middle income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effect of a prenatal genetic screening video on patient knowledge in the context of informed consent for prenatal genetic screening.

Condition or disease Intervention/treatment Phase
Aneuploidy Birth Defect Other: video Not Applicable

Detailed Description:

Hypothesis: Pregnant women undergoing counseling for prenatal screening for aneuploidy will obtain more knowledge from the informed consent process if this process includes a video compared to pregnant women that undergo traditional counseling alone.

Randomization will be achieved by using sequentially numbered sealed opaque envelops with carbon copy inside envelope. We will use a random number table to generate randomization and use block randomization using 4 random sequences per block with 1:1 allocation. Patients will be randomized into two arms: one arm, group A, will undergo the traditional informed consent process, the second arm, group B, will receive the counseling by video followed by traditional counseling. Patients will be approached to enroll in the study the day of the prenatal visit at Genesis Healthpark OBGYN clinic. Once enrolled, they will complete a demographic questionnaire and a modified Maternal Serum Screening Knowledge Questionnaire (MSSKQ) prior to their prenatal visit to measure baseline knowledge on prenatal genetic screening for aneuploidy and birth defects.

Background information: Pregnant patients are traditionally counseled about the risks of their offspring to have a chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing to exclude aneuploidy should be offered to all pregnant women early in their pregnancy. As part of an informed consent process, women may agree to undergo aneuploidy screening, diagnostic testing or no screening at all. On the other hand, some women may consider this a mandatory screening test while others may not know that a definitive diagnostic test should be offered to all pregnant patients, regardless of their age and other risk factors.

Because of this, prenatal screening is often viewed as part of routine required testing, and women may not understand the voluntary nature of testing. Additionally prenatal screening is becoming more complex with new modalities and marketing pressures that may not be fully understood by patients and providers. New tests such as cell free DNA (cfDNA) testing are widely available, and involve complex genetic and statistical methodologies. Use of a decision-support education has been shown to decrease use of testing, and may result in more informed testing decisions Prior studies have demonstrated an increase in informed decisions when patients have been educated on prenatal testing options using a decision-support guide. A standardized education video on prenatal screening may enhance patient's understanding and knowledge of testing and support more informed decisions with decreased conflict.

In the study by Goel et al, the Maternal Serum Screening Knowledge Questionnaire (MSSKQ) was designed and validated as a tool to assess knowledge and level of informed consent in women receiving counseling on prenatal genetic screening. The scores increased with age, level of education, family income and having received written material on maternal serum screening.

The literature varies in the retention of consents across all fields of medicine. It is known that all adults learn and retain information in various ways. It was found that students remember only 10% of what they read; 20% of what they hear; 30%, if they see visuals related to what they are hearing; 50%, if they watch someone do something while explaining it; but almost 90%, if they do the job themselves even if only as a simulation

It has been previously shown that adding an audio-visual component to the consent has improved the patient's retention of the consent however the studies available are weak and contain many biases (5). Data on the outcome of retention in a low to middle income and low literacy population is poor. There is a need for a randomized controlled trial to assess retention of knowledge after informed consent for genetic screening for aneuploidy during pregnancy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Primary purpose: measure knowledge on prenatal genetic screening

After providing consent, participants will be randomized to video education or traditional care during routine prenatal visit. Randomization will be completed using a random number table. Participants 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-genetictesting-videos

Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
No Intervention: Traditional counseling
Patients will undergo traditional counseling during prenatal care visit with provider only
Experimental: video group
Participants 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-genetictesting-videos
Other: video
After providing consent, participants will be randomized to video education or traditional care during routine prenatal visit. Randomization will be completed using a random number table. Participants 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-genetictesting-videos




Primary Outcome Measures :
  1. Knowledge [ Time Frame: same 1 day as intervention or no intervention ]

    Once enrolled, participants will complete a demographic questionnaire and a modified Maternal Serum Screening Knowledge Questionnaire (MSSKQ) prior to their prenatal visit to measure baseline knowledge on prenatal genetic screening for aneuploidy and birth defects.

    All participants will complete the MSSKQ after prenatal care visit on the same day



Secondary Outcome Measures :
  1. Participant's decision [ Time Frame: up to 6 weeks after initial visit- record only ]
    Will review the choice for genetic screening for aneuploidy



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:   Yes
Criteria

Inclusion Criteria:

  • pregnancy, english or spanish-speaking

Exclusion Criteria:

  • minors <18 years old,
  • > 23 completed weeks of gestational age,
  • prior genetic counseling, s
  • screening or testing during current pregnancy
  • fetus with known ultrasound abnormality

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): NCT03816423


Contacts
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Contact: Karla Leavitt, MD, MPH 7874759828 kleavitt@health.usf.edu

Sponsors and Collaborators
University of South Florida
Tampa General Hospital
Investigators
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Principal Investigator: Karla Leavitt, MD, MPH University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03816423     History of Changes
Other Study ID Numbers: 00035994
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 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

Keywords provided by University of South Florida:
patient education
genetic counseling

Additional relevant MeSH terms:
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Aneuploidy
Congenital Abnormalities
Chromosome Aberrations
Pathologic Processes