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首页> 外文期刊>JMIR Research Protocols >Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement
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Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement

机译：开发，实施和评估多媒体患者决策援助计划，以改革外围插入的中央静脉导管程序的知情同意程序：质量改进方案

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Background Informed consent has considerable clinical, ethical, and legal implications for patient safety and liability. Little information is available about the use of multimedia patient decision aids (PtDA) in the consent process for therapeutic invasive procedures such as the peripherally inserted central venous catheter (PICC). In addition, none of the available studies have designed their multimedia PtDAs based on the Agency for Healthcare Research and Quality’s (AHRQ) comprehensive guide for informed consent. Objective This paper describes a patient-centered, systematic, multidisciplinary approach to develop, implement, and alpha test a multimedia PtDA to reform the informed consent process of a PICC for patients in 10 acute and intensive care units. Methods The development, implementation, and evaluation processes of the PtDA followed the phases in the Multimedia Production Framework: preproduction, production, and postproduction. Within this framework, we applied the criteria for judging the quality of PtDAs, the AHRQ’s Health Literacy Universal Precautions Toolkit, and the AHRQ’s Patient Education Materials Assessment Tool Guide. The methodology was guided by the Interprofessional Shared Decision-Making Model and the AHRQ’s Making Informed Consent an Informed Choice guide. In the preproduction phase, we (1) reviewed the current consent form; (2) observed 18 consent processes; (3) surveyed the vascular access team (N=6 nurses) about their perception of the current process; (4) surveyed 30 patients for knowledge recall and retention, overall satisfaction, and attitude toward using a multimedia PtDA; and (5) wrote and reviewed the script for the multimedia program. The production phase focused on filming the PtDA in English and Spanish languages. The postproduction phase included integrating the multimedia programs into the care processes, developing a modified workflow for the consent process, and alpha testing of the English and Spanish PtDAs by (1) a group of 5 patients for clarity and understandability of the information; (2) nurses using the AHRQ’s Patient Education Materials Assessment Tool Audio and Video; and (3) by the multidisciplinary change team. Results Based on the alpha testing, patients indicated that the content was easy to follow and read; nurses provided positive feedback, and their comments were mainly related to the changes in the workflow in the consent process of the PICC after using the PtDA; and the multidisciplinary change team suggested edits related to changing a few scenes. The final multimedia program consisted of 7 min and 37 s demonstrating detailed information about the PICC. Conclusions A systematic development of PtDAs for nonurgent invasive procedures may eliminate many limitations of the conventional consent process by ensuring comprehensive, standardized, and easy-to-comprehend information and providing sufficient time for the patients to reflect on the information. To be effective, PtDAs should follow a systematic, patient-centered, evidence-based, and rigorous approach in the development, implementation, and evaluation processes.
机译：背景技术知情同意对患者的安全和责任具有重大的临床，伦理和法律影响。关于多媒体患者决策辅助器（PtDA）在治疗性侵入性操作（例如外围插入的中心静脉导管（PICC））的同意过程中使用的信息很少。此外，现有研究均未根据医疗保健研究与质量局（AHRQ）的知情同意综合指南设计其多媒体PtDA。目的本文描述了一种以患者为中心，系统，多学科的方法来开发，实施和alpha测试多媒体PtDA，以改革10个急性和重症监护病房患者的PICC知情同意程序。方法PtDA的开发，实施和评估过程遵循多媒体生产框架中的各个阶段：预生产，生产和后期生产。在此框架内，我们应用了判断PtDA质量的标准，AHRQ的《健康素养通用预防措施工具包》和AHRQ的《患者教育资料评估工具指南》。该方法由专业间共享决策模型和AHRQ的“使知情同意成为知情选择”指南进行指导。在试生产阶段，我们（1）审核了当前的同意书; （2）观察了18个同意过程; （3）对血管通路小组（N = 6名护士）进行了调查，了解他们对当前过程的看法; （4）调查了30名患者的知识记忆和保留，总体满意度以及对使用多媒体PtDA的态度; （5）编写并审查了多媒体程序的脚本。制作阶段的重点是用英语和西班牙语拍摄PtDA。后期制作阶段包括：将多媒体程序集成到护理流程中，为同意流程开发经过修改的工作流程，以及（1）由5名患者组成的小组对英语和西班牙语PtDA进行alpha测试，以使信息清晰易懂。 （2）使用AHRQ的患者教育资料评估工具的音频和视频护士; （3）由多学科的变更小组负责。结果根据阿尔法测试，患者表示内容易于阅读。护士提供了积极的反馈意见，他们的意见主要与使用PtDA后PICC同意过程中工作流程的变化有关;多学科变更小组建议了与变更几个场景有关的编辑。最终的多媒体程序由7分钟和37秒组成，展示了有关PICC的详细信息。结论通过确保全面，标准化和易于理解的信息，并为患者提供足够的时间来反思信息，针对非紧急侵入性程序的PtDA的系统开发可以消除常规同意过程的许多限制。为了有效，PtDA在开发，实施和评估过程中应遵循系统的，以患者为中心，基于证据的严格方法。

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