Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

NCT02991729 | Completed Results

• 1 other identifier: 15-1745
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneuploidy; Pregnancy Complications

Keywords

Decision aid

Outcome Measures

Primary Outcomes (1)

• Knowledge Score

  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.

  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 (3)

• Decisional Conflict Score

  At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes

• Test Chosen

  At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes

• Supplementary Tests Performed

  22 weeks gestation

Study Arms (2)

Routine care

ACTIVE COMPARATOR

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.

Other: Genetic counseling appointment

Experimental

EXPERIMENTAL

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.

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

Interventions

iPad-based decision aid OTHER

This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.

Experimental

Genetic counseling appointment OTHER

All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.

Experimental; Routine care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 30214066 DERIVED

MeSH Terms

Conditions

Aneuploidy; Pregnancy Complications

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Laura Carlson, MD
• Organization: UNC School of Medicine Maternal Fetal Medicine

lauramosbycarlson@gmail.com

8643503140

Study Officials

• Laura M Carlson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 13, 2016
• Study Start: January 20, 2017
• Primary Completion: January 5, 2018
• Study Completion: January 12, 2018
• Last Updated: October 22, 2020
• Results First Posted: November 12, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)