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道德行为，为使患者充分理解知情同意程序的内容，应清楚地解释医疗程序的目的、过程、风险、益处和替代方案。如果未以确保患者理解的方式提供知情同意书，则临床研究以及患者的权利和责任将面临风险。为了最大限度地降低成本和风险，许多提供者选择电子知情同意书。不超出纸张范围虽然这是一种改进，但这种方法仍然不能提高患者的理解或护理质量，使研究人员能够使用平板电脑对参与者进行简短的虚拟访谈来完成知情同意过程。 （例如 iPad）和综合多媒体库（例如视频剪辑、动画、演示文稿等）来解释临床护理的风险、益处和替代方案，将增强患者的理解。该项目的目标是帮助进行临床护理。以患者为中心的结果研究通过开发和评估新的移动医疗（mHealth）知情同意工具来传播 PCOR 在知情同意研究中的发现，让包括患者在内的关键利益相关者参与进来，以更有效、更广泛地实施 PCOR。因此，我们建议加强传统的知情同意。以患者为中心的虚拟多媒体交互式知情同意工具（VIC）开发的同意工具同意流程将被开发为以患者为中心的基于网络的移动应用程序，并且能够在移动设备上运行。维克是创建一个可重复使用的基础设施，将知情同意流程整合到临床护理和临床工作流程中，从而增强患者的理解，同时提高获得患者同意的效率，VIC 将在现有的临床研究中进行测试，以证明它可以促进患者的知情同意。我们的目标是：1）开发、测试和完善以患者为中心的虚拟多媒体交互式知情同意工具（VIC），以增强患者的理解，同时提高获得患者同意的效率；评估有效性VIC 与真实世界临床研究中标准 PI/协调员提供的同意书进行比较。