Clinical trial NCT02991729: Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening
Official title: Use of a Novel Decision Aid for Prenatal Aneuploidy Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneuploidy
Pregnancy Complications
Keywords: Decision aid
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2016-12-13
Enrollment: 197
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Pregnancy at less than 22 weeks gestation
* English or Spanish speaking
* Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy screening

Exclusion Criteria:

* Known fetal anomalies
* Known multiple gestations
* Prior genetic counseling or aneuploidy screening in current pregnancy

Primary outcomes:
measure: Knowledge Score
timeFrame: At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes
Secondary outcomes:
measure: Decisional Conflict Score
timeFrame: At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes
measure: Test Chosen
timeFrame: At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes
measure: Supplementary Tests Performed
timeFrame: 22 weeks gestation
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura M Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson LM, Harris S, Hardisty EE, Hocutt G, Vargo D, Campbell E, Davis E, Gilmore K, Vora NL. Use of a novel computerized decision aid for aneuploidy screening: a randomized controlled trial. Genet Med. 2019 Apr;21(4):923-929. doi: 10.1038/s41436-018-0283-2. Epub 2018 Sep 14.