Patient Centered Virtual Multimedia Interactive Informed Consent (VIC)

以患者为中心的虚拟多媒体交互式知情同意书 (VIC)

• 批准号: 8903647
• 负责人: Fuad Abujarad
• 金额: $ 15万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8903647
• 关键词: Patient; Centered; Virtual; Multimedia; Interactive

 DESCRIPTION (provided by applicant): The informed consent process protects patients and ensures ethical conduct of research. For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives to medical procedures or clinical research as well as a patient's rights and responsibilities. Patient safety and quality of care are at risk if the informed consent process is not delivered in way that assures patient comprehension. To minimize cost and risks, many providers opt for electronic informed consent that doesn't go beyond the paper based informed consent process. While it is an effort at improvement, this method still does not enhance patient comprehension or the quality of care. Adoption of methods that allow researchers to conduct brief and virtual interviews with participants to complete the informed consent process using tablet computers (e.g. iPads) with a comprehensive multimedia library (e.g. video clips, animations, presentations, etc.) to explains the risks, benefits, and alternatives of the clinical care will enhance patient comprehension. The goal of this project is to help make the conduct of patient centered outcomes research (PCOR) more efficient and more widely implemented by engaging key stakeholders, including patients, through the development and evaluation of a new mobile health (mHealth) informed consent tool to disseminate PCOR findings in informed consent research. Therefore we propose to enhance the traditional informed consent process by developing the Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC). VIC will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. The overarching motivation for the development of VIC is to create a reusable infrastructure for integrating the informed consent process into clinical care and the clinical workflow in a way that enhances patient comprehension while improving the efficiency of obtaining patient consent. VIC will be tested in an existing clinical research study to demonstrate that it can facilitate the study of complex interventions in real-world clinical settins. Our aims are: 1) To develop, test and refine the Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) to enhance patient comprehension while improving the efficiency of obtaining patient consent; 2) To evaluate the effectiveness of VIC compared to a standard PI/coordinator-delivered consent in a real-world clinical research study.

 描述(由申请人提供)：知情同意程序保护患者并确保研究的合乎道德的进行。为了让患者充分理解知情同意程序的内容，它应该清楚地解释医疗程序或临床研究的目的、过程、风险、好处和替代方案，以及患者的权利和责任。如果知情同意过程不以确保患者理解的方式进行，患者的安全和护理质量将面临风险。为了将成本和风险降至最低，许多供应商选择电子知情同意，而不是超出基于纸质的知情同意流程。虽然这是一种改进的努力，但这种方法仍然不能提高患者的理解或护理质量。采用允许研究人员对参与者进行简短和虚拟访谈的方法，以使用具有全面多媒体库(例如视频剪辑、动画、演示文稿等)的平板电脑(例如iPad)完成知情同意过程。解释临床护理的风险、益处和替代方案，将增进患者的理解。该项目的目标是通过开发和评估新的移动健康(MHealth)知情同意工具，通过在知情同意研究中传播以患者为中心的结果研究结果，帮助更有效地实施以患者为中心的结果研究(PCOR)，并通过参与包括患者在内的关键利益相关者来更广泛地实施。因此，我们建议通过开发以患者为中心的虚拟多媒体交互知情同意工具(VIC)来改进传统的知情同意过程。VIC将被开发为以患者为中心的基于网络的移动应用程序，并将能够在移动设备上运行。开发VIC的主要动机是创建一个可重复使用的基础设施，将知情同意过程集成到临床护理和临床工作流程中，以增强患者的理解，同时提高获得患者同意的效率。VIC将在现有的临床研究研究中进行测试，以证明它可以促进在现实世界临床环境中进行复杂干预的研究。我们的目标是：1)开发、测试和改进以患者为中心的虚拟多媒体交互知情同意工具(VIC)，以增强患者的理解，同时提高获得患者同意的效率；2)在现实世界的临床研究中，与标准的PI/协调员提供的同意相比，评估VIC的有效性。