An Interactive Informed Consent Program for Cardiac Procedures

描述（由申请人提供）：知情同意已成为医患互动的重要组成部分。知情同意程序不仅要求向患者提供有关拟议治疗的信息，而且要求以一种可理解的方式提供这些信息，以便患者能够对医疗替代方案做出有意义的选择。知情同意原则的核心是患者了解手术/治疗及其益处和风险的概念。不幸的是，情况往往并非如此。事实上，几项研究表明，许多患者不理解、不记得，甚至不阅读同意书。为了确保对知情同意的理解，需要应用现有知情过程的教学替代方案。ArchieMD公司开发了一个全面的交互式医疗模拟环境，它有可能以视觉方式向患者传达复杂的信息，以提高对外科手术过程的理解。在第一阶段，ArchieMD将使用该环境作为开发心导管置入术交互式知情同意程序原型的基础。该原型将由密歇根大学在前瞻性随机对照研究中进行评估，比较标准口头知情同意和交互式多媒体知情同意的心导管手术。该项目将通过提高知情同意期间所取得的理解的质量来促进公共卫生。这可能改善患者的医疗决策，减少医疗诉讼，并提高临床试验的登记。

DESCRIPTION (provided by applicant): Informed consent has become an essential component of the doctor-patient interaction. The informed consent process requires that patients not only be given information about proposed medical treatment, but that it be presented in an understandable way so the patient can make meaningful choices about medical alternatives. At the heart of the informed consent doctrine, is the notion that the patient understands the procedure/therapy as well as its benefits and risks. Unfortunately, this is frequently not the case. Indeed, several studies suggest that many patients do not understand, recall, or even read the consent form. To ensure understanding of informed consent, didactic alternatives to the current informed process need to be applied. 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 surgical procedures. In Phase I, ArchieMD will use this environment as a basis for developing a prototype interactive informed consent program for cardiac catheterization. This prototype will be evaluated by the University of Michigan in prospective, randomized controlled study comparing standard verbal informed consent to interactive multimedia informed consent for a cardiac catheterization procedure. This project will contribute to public health by improving the quality of understanding achieved during informed consent. This may improved patients medical decision- making, decrease medical litigation, and improve enrollment for clinical trials.