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

Improved Prenatal Genetic Screening Decision Making Through Interactive Technology

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.

Study Overview

• Status: Completed
• Conditions: Prenatal Disorder
• Intervention / Treatment: Behavioral: Meaning of Screening

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in the intervention group interact with the game technology to learn about prenatal screening, in addition to usual care provided in the clinic.	Behavioral: Meaning of Screening; Interactive technology game providing education about prenatal screening and what the results may mean.
No Intervention: Control; Participants in the control group learn about prenatal screening through usual care in the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Prenatal Screening; Interactive educational technology
• Other Study ID Numbers: R21HD083832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared, only unidentified aggregate data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No