Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

Not Applicable

Completed

Conditions: Aneuploidy
Pregnancy Complications

Interventions: Other: iPad-based decision aid
Other: Genetic counseling appointment

Registration Number: NCT02991729

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 197

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	iPad-based decision aid	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.
Experimental	Genetic counseling appointment	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.
Routine care	Genetic counseling appointment	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.

Primary Outcome Measures

Name	Time	Method
Knowledge Score	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	All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.

Secondary Outcome Measures

Name	Time	Method
Decisional Conflict Score	At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes	A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.
Test Chosen	At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes	For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.
Supplementary Tests Performed	22 weeks gestation	Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.