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Completed

NCT Number: NCT03441672

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meaning of Screening

Behavioral

Interactive technology game providing education about prenatal screening and what the results may mean.

Primary outcomes

  1. Level of knowledge about prenatal screening and prenatal diagnostic testing

    Time frame: Immediately after intervention

    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.

Secondary outcomes

  1. Documentation of decision to undergo prenatal screening

    Time frame: Up to 4 weeks after intervention

    Documentation of participant's decision to complete prenatal screening or not, as pulled from the medical record.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Improved Prenatal Genetic Screening Decision Making Through Interactive Technology

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2018
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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