VPE: Use of Videos to Improve Patient Knowledge on Prenatal Genetics

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT03816423

Collaborator

Tampa General Hospital (Other)

106

Enrollment

Location

Arms

11.4

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aneuploidy Birth Defect	Other: video	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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".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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 30, 2019

Actual Primary Completion Date :

Jan 24, 2020

Actual Study Completion Date :

May 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Traditional counseling Patients will undergo routine prenatal care visit with clinical practicioner only
Experimental: video group 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 Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.

Arm

Intervention/Treatment

No Intervention: Traditional counseling

Patients will undergo routine prenatal care visit with clinical practicioner only

Experimental: video group

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

Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.

Outcome Measures

Primary Outcome Measures

Knowledge score [same day for both groups]
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)
Knowledge score change [same day for both groups]
Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genesis Healthpark- TGH	Tampa	Florida	United States	33609

Sponsors and Collaborators

University of South Florida
Tampa General Hospital

Investigators

Principal Investigator: Karla Leavitt, MD, MPH, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of South Florida

ClinicalTrials.gov Identifier:

NCT03816423

Other Study ID Numbers:

00035994

First Posted:

Jan 25, 2019

Last Update Posted:

May 19, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of South Florida

patient education

genetic counseling

Additional relevant MeSH terms:

Congenital Abnormalities

Aneuploidy

Study Results

No Results Posted as of May 19, 2020