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

Primary Purpose

Aneuploidy, Birth Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aneuploidy focused on measuring patient education, genetic counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Genesis Healthpark- TGH

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Traditional counseling

video group

Arm Description

Patients will undergo routine prenatal care visit with clinical practicioner only

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 22, 2019
Last Updated
May 15, 2020
Sponsor
University of South Florida
Collaborators
Tampa General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03816423
Brief Title
Use of Videos to Improve Patient Knowledge on Prenatal Genetics
Acronym
VPE
Official Title
The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
January 24, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Tampa General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneuploidy, Birth Defect
Keywords
patient education, genetic counseling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional counseling
Arm Type
No Intervention
Arm Description
Patients will undergo routine prenatal care visit with clinical practicioner only
Arm Title
video group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
video
Intervention Description
Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.
Primary Outcome Measure Information:
Title
Knowledge score
Description
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)
Time Frame
same day for both groups
Title
Knowledge score change
Description
Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)
Time Frame
same day for both groups

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla Leavitt, MD, MPH
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Healthpark- TGH
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Videos to Improve Patient Knowledge on Prenatal Genetics

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