Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 1
研究概览
简要总结
This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.
详细描述
We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant at less than 24 gestational weeks
排除标准
- •Not able to speak English or Spanish
研究组 & 干预措施
2
Women in this arm view the age-appropriate computerized version of the educational pamphlet on prenatal testing developed and distributed by the State of California
干预措施: Control - computerized age-appropriate prenatal testing educational brochure (Other)
1
Women in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created.
干预措施: PT Tool - interactive, computerized, prenatal testing decision tool (Other)