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An Interactive Informed Consent and Education Program for Pregnant Women

2014年11月5日 更新者:William Grobman、Northwestern University
The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.

研究概览

详细说明

Women face a variety of medical decisions during pregnancy and childbirth. While there are extensive educational resources for pregnant women, modern medicine presents decisions that many women are poorly equipped to make. Issues such as prenatal screening and mode of birth after a cesarean delivery require a significant degree of patient education to enable a truly informed medical decision. Studies have shown that women have a poor understanding of screening for birth defects and mode of birth after a cesarean delivery. Women with a low level of education or poor health literacy are significantly more likely to demonstrate inadequate understanding of prenatal screening. ArchieMD, Inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of medical procedures and educate patients on the consequences of their behavior. We hypothesize that such an interactive medical simulation patient education program can improve patient understanding allowing pregnant women to make informed decisions. In Phase I, we will prototype an interactive patient education program for prenatal screening and amniocentesis.

研究类型

介入性

注册 (实际的)

150

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern Memorial Hospital (NMH)
      • Chicago、Illinois、美国、60611
        • Northwestern Memorial Faculty Foundation (NMFF)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Pregnant woman (6-26 weeks gestation)
  • Over 18 years of age

Exclusion Criteria:

  • Non-English speaking

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Interactive Video
In addition to standard care, the experimental arm will receive an interactive video designed to inform and educate patients about the choices that exist concerning prenatal screening and diagnosis.
15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.
无干预:Control
A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Difference in understanding/knowledge gain as compared to control
大体时间:Post-test and 2 week follow-up
Open-ended and T/F questionnaire designed to determine if the ArchieMD Interactive Informed Consent and Education Program for Pregnant Women improves understanding and expectations of prenatal screening and diagnostic tests in a group of pregnant women patients.
Post-test and 2 week follow-up

次要结果测量

结果测量
措施说明
大体时间
eHEALS
大体时间:Post-test
The eHEALS is a self-report tool that can be administered by a health professional and is based on an individual's perception of her or his own skills and knowledge within each measured domain. The instrument is designed to provide a general estimate of consumer eHealth-related skills that can be used to inform clinical decision making and health promotion planning with individuals or specific populations.
Post-test
Attitudes towards/satisfaction with interactive video
大体时间:Post-test
Multiple-choice questionnaire designed to determine if the ArchieMD Interactive Informed Consent and Education Program for Pregnant Women enhances satisfaction with and attitudes toward the patient education process.
Post-test
REALM
大体时间:Post-test
The REALM (Rapid Estimate of Adult Health Literacy in Medicine) is a word recognition test designed to provide a valid and quick assessment of participant health literacy.
Post-test

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Bill Grobman, M.D., M.B.A、Northwestern University
  • 首席研究员:Michael Wolf, Ph.D, M.P.H、Northwestern University
  • 首席研究员:Robert Levine, M.D.、ArchieMD, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2011年3月1日

研究完成 (实际的)

2011年3月1日

研究注册日期

首次提交

2010年8月3日

首先提交符合 QC 标准的

2010年8月3日

首次发布 (估计)

2010年8月5日

研究记录更新

最后更新发布 (估计)

2014年11月7日

上次提交的符合 QC 标准的更新

2014年11月5日

最后验证

2014年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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