Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

Brief Title

Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

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 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.
    


Study Type

Interventional


Primary Outcome

Knowledge Score

Secondary Outcome

 Decisional Conflict Score

Condition

Aneuploidy

Intervention

iPad-based decision aid

Study Arms / Comparison Groups

 Routine care
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

197

Start Date

January 20, 2017

Completion Date

January 12, 2018

Primary Completion Date

January 5, 2018

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
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Laura M Carlson, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02991729

Organization ID

15-1745


Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill

Collaborators

 North Carolina Translational and Clinical Sciences Institute

Study Sponsor

Laura M Carlson, MD, Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

January 2018