Interactive video to provide patient information on ECT

描述（由申请人提供）：在美国，决定是否进行医学检查，程序或治疗的权利是通过知情同意的过程来体现的。知情同意原则规定，只要符合以下三个核心标准，有能力的个人有权作出“正确”或“错误”的决定：（1）相关医疗信息已以可理解的方式披露;（2）患者有作出决定的精神能力;（3）决定是自愿的。获得患有严重精神疾病的人的知情同意的过程可能特别困难。对于患有严重抑郁症的患者，无论是否有精神病特征，都不清楚患者如何解释在没有疾病的情况下容易理解的信息。确保知情同意电休克治疗（ECT）是特别成问题的。这是一个建议，开发一个基于计算机的互动视频的患者考虑ECT作为一种治疗。它将1）以易于理解的电视新闻纪录片形式提供有关ECT的公平和平衡的医疗信息，2）进行互动练习，以探索患者对治疗方案和后果的理解，以及3）为无法理解视频演示的患者提供“适应性学习模式”。该计划将通过向临床医生提供关于患者对（a）ECT适应症，（B）实际程序和（c）风险和受益的理解的反馈来增强知情同意过程。临床医生将根据他们与患者的互动以及交互式计算机程序提供的附加信息最终决定患者是否真正给予知情同意。本第一阶段提案将开发交互式视频系统，用于（a）ECT适应症。将评估可行性和用户满意度。

DESCRIPTION (provided by applicant): In the United States, the right to determine if medical tests, procedures or treatments are to be conducted is manifest through the process of informed consent. The doctrine of informed consent specifies that competent individuals have the right to make a "right" or "wrong" decision so long as the following 3 core criteria are met: (1) relevant medical information has been disclosed in understandable terms, (2) the patient has the mental capacity to make the decision, and (3) the decision is voluntary. The process of obtaining informed consent with a person who has a serious mental illness can be especially difficult. For patients with severe depression, with or without psychotic features, it is unclear how a patient would interpret information that would otherwise be easily understood in the absence of the illness. Insuring informed consent for electro-convulsive therapy (ECT) is particularly problematic. This is a proposal to develop a computer-based interactive video for patients considering ECT as a treatment. It will 1) provide fair and balanced medical information about ECT in an easy to understand television-news documentary format, 2) conduct interactive exercises to explore the patients understanding of treatment options and consequences, and 3) provide an "adaptive learning mode" for patients who are unable to understand the video presentation. This program will augment the process of informed consent by providing feedback to the clinician regarding the patients' comprehension of the (a) indications for ECT, (b) actual procedure, and (c) risks and benefits. The clinician will ultimately decide if the patient is truly giving informed consent based on their interactions with the patient as well the additional information provided by the interactive computer program. This Phase I proposal will develop the interactive video system for (a) indications for ECT. Feasibility and user satisfaction will be assessed.