Use of Videos to Improve Patient Knowledge on Prenatal Genetics

Study Overview
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Brief Summary
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This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal genetic screening and testing options.

Detailed Description
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During pregnancy, women are routinely counseled about the risks of their offspring to have a chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing options to exclude aneuploidy should be offered to all pregnant women early in their pregnancy. A standardized educational video on prenatal screening may enhance a patient's understanding and knowledge of testing and support more informed decisions. The objective of this study is to evaluate and compare patient knowledge scores on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.

Official Title
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The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial

Conditions
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Aneuploidy, Birth Defect

Intervention / Treatment
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* Other: video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnancy, english or spanish-speaking Exclusion Criteria: minors <18 years old, > 21 completed weeks of gestational age, prior genetic counseling during current pregnancy fetus with known ultrasound abnormality

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Primary purpose: assess and compare patient knowledge on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video. All participants will complete a 15-item questionnaire on prenatal genetic screening options at baseline and after routine prenatal care visit. Participants randomized to the control group, will have a routine prenatal care appoinment, while the intervention group will watch a pre-appointment 4.5 minute educational video entitled How to decide about prenatal genetic testing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional counseling<br>Patients will undergo routine prenatal care visit with clinical practicioner only | |
| Experimental: video group<br>Participants randomized to the intervention group (video education) will view the prenatal screening video How to Decide About Prenatal Genetic Testing, followed by a routine prenatal appointment. | Other: video<br>* Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge score | Evaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the Maternal Serum Screening Knowledge Score Questionnaire (MSSKQ) | same day for both groups | 
| Knowledge score change | Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire (MSSKQ) | same day for both groups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient education, genetic counseling