Game-Based Decision Aid to Educate Pregnant Women About Prenatal Screening

Prenatal Disorder Clinical Trial

Official title:

Improved Prenatal Genetic Screening Decision Making Through Interactive Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441672
• Other study ID #: R21HD083832
• Secondary ID: R21HD083832
• Status: Completed
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 21, 2018
• Start date: November 1, 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: February 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Significant barriers exist for effectively informing women about prenatal screening in the clinical setting. This project developed and evaluated the efficacy of a game decision aid among pregnant women about prenatal screening in a randomized controlled study.

Description:

Prenatal genetic screening has grown at a rapid rate and whole genome sequence of an unborn fetus is expected to be widely available in the next few years. However, significant barriers remain for effectively informing couples about their risks and options for identifying and managing chromosomal anomalies and heritable conditions during pregnancy. It is widely recognized that current standards for patient education in this domain are largely ineffective. Decisions about prenatal screening are based on pregnant couples' values and knowledge so clinicians are often challenged with being informative but non-directive. Prenatal screening has grown significantly in recent years because the American College of Obstetricians and Gynecologists recommends prenatal care providers now offer all women prenatal genetic screening in the first trimester of pregnancy, regardless of age, or genetic risk status. This has moved the focus of prenatal screening from a subset of higher risk pregnant couples to all pregnant couples and to an earlier time in pregnancy.

To address these information needs, we are undertaking a novel approach to inform couples about screening. "Gaming" tools have demonstrated promising outcomes for improved health care decision-making and compliance with health recommendations. In contrast to other computer applications for the dissemination of information, game technology goes beyond information delivery and engages users in different life choice scenarios. Further, these tools can assess whether the attractiveness (or unattractiveness) of different simulated choices can offer insights about one's values. In this value-laden context, the game allows individuals to explore their personal values in a non-directive fashion and allows a comparison of the game choices and values with an individual's reproductive partner.

The purpose of this application is to 1) develop a prenatal screening gaming application prototype (PS-GAP) and 2) conduct a preliminary assessment of the PS-GAP on knowledge, satisfaction, and decisional conflict about prenatal genetic screening for pregnant women and their partners.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking

• less than 15 weeks gestation

• attending first obstetric visit

• low risk pregnancy

Exclusion Criteria:

• Non-English speaking

• High risk pregnancy

• Past 15 weeks gestation

Related Conditions & MeSH terms

• Prenatal Disorder

Intervention

Behavioral:
• Meaning of Screening
Interactive technology game providing education about prenatal screening and what the results may mean.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of knowledge about prenatal screening and prenatal diagnostic testing	prenatal screening knowledge is measured with a 23-item survey developed by an expert panel of genetic counselors, physicians, social scientists and data collection experts. All questions use a five point likert scale for response.	Immediately after intervention
Secondary	Documentation of decision to undergo prenatal screening	Documentation of participant's decision to complete prenatal screening or not, as pulled from the medical record.	Up to 4 weeks after intervention