Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening (DAAS)

University of North Carolina (UNC)

Status: Completed

Conditions: Aneuploidy; Pregnancy Complications

Treatments: Other: Genetic counseling appointment; Other: iPad-based decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT02991729

15-1745

Details and patient eligibility

About

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.

Full 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.

Enrollment: 197 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

Routine care

Active Comparator group

Description:

These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.

Treatment:

Other: Genetic counseling appointment

Experimental

Experimental group

Description:

These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.

Treatment:

Other: iPad-based decision aid

Other: Genetic counseling appointment