NCT02991729

Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

Use of a Novel Decision Aid for Prenatal Aneuploidy Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.

Detailed description

184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based decision aid in addition to routine counseling or routine counseling only during a single study visit. This decision aid was developed at a 10th grade literacy level using input from Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20 English and Spanish speaking women of varying education levels. Following completion of genetic counseling, participants will complete several surveys assessing knowledge and decision conflict. Data will be abstracted regarding demographics, screening and diagnostic testing uptake, and testing results.

Conditions

• Aneuploidy
• Pregnancy Complications

Interventions

Type	Name	Description
OTHER	iPad-based decision aid	This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
OTHER	Genetic counseling appointment	All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.

Timeline

• Start date: 2017-01-20
• Primary completion: 2018-01-05
• Completion: 2018-01-12
• First posted: 2016-12-13
• Last updated: 2020-10-22
• Results posted: 2019-11-12

Locations

1 site across 1 country: United States