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临床试验/NCT03441672
NCT03441672已完成不适用

Improved Prenatal Genetic Screening Decision Making Through Interactive Technology

University of Utah0 个研究点目标入组 79 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
79
主要终点
Level of knowledge about prenatal screening and prenatal diagnostic testing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •English speaking
  • •less than 15 weeks gestation
  • •attending first obstetric visit
  • •low risk pregnancy

排除标准

  • •Non-English speaking
  • •High risk pregnancy
  • •Past 15 weeks gestation

研究组 & 干预措施

Intervention

Experimental

Participants in the intervention group interact with the game technology to learn about prenatal screening, in addition to usual care provided in the clinic.

干预措施: Meaning of Screening (Behavioral)

Control

No Intervention

Participants in the control group learn about prenatal screening through usual care in the clinic.

结局指标

主要结局

Level of knowledge about prenatal screening and prenatal diagnostic testing

时间窗: 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.

次要结局

  • Documentation of decision to undergo prenatal screening(Up to 4 weeks after intervention)

研究者

申办方类型
Other
责任方
Sponsor

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