Clinical Trial: Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Use of a Novel Decision Aid for Prenatal Aneuploidy Screening

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 Summary: 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.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Knowledge score [ Time Frame: At completion of genetic counseling, 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decisional conflict score [ Time Frame: At completion of genetic counseling, 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 (following completion of the decision aid in the intervention arm, and following completion of genetic counseling in both arms) will be compared. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.
  • Test chosen [ Time Frame: At completion of 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 [ Time Frame: 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.
  • Time of genetic counseling appointment [ Time Frame: At completion of genetic counseling, approximately 10-60 minutes ]
    Mean duration of the genetic counseling appointments will be compared between the intervention arm and the routine care arm. This will be measured in minutes.


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: December 8, 2016
Date Started: January 20, 2017
Date Completion: December 2017
Last Updated: May 7, 2017
Last Verified: May 2017