TECTONICS (Telemedicine Control Tower for the OR: Navigating Information, Care and Safety) trial

摘要 手术后常见的不良后果包括死亡、呼吸衰竭和肾功能衰竭，以及 这是一个严重的公共卫生挑战。这样的不利后果可以通过综合的、 协作式医疗信息技术解决方案，为临床医生提供认知和计算能力 支持。构造运动的主要动因(远程医疗战区控制塔：导航 信息、护理和安全)试验表明，多方面的远程医疗解决方案有可能促进 动态评估风险，诊断阴性患者轨迹，并实施循证实践。 患者的最终结果将是改善安全性和结局。我们的远程医疗解决方案，称为 麻醉控制塔(ACT)，包含来自电子设备的实时患者数据集成 健康记录、临床医生决策支持、预测不良结果的机器学习算法，以及 对手术室(OR)进行远程监控。这种复杂的远程监控的概念化 OR有点类似于繁忙机场的空中交通管制塔。创新构造学 试验将建立在一系列初步研究的基础上(由医疗保健研究和质量机构资助， 和国家科学基金会)，已经(I)建立了原型的有用性和可用性 远程医疗ACT；(2)根据临床医生用户定制和增强ACT的决策支持警报 反馈；(Iii)设计、开发和测试预测术后不良反应的机器学习算法 结果；以及(Iv)确定了进行ACT原型的真实世界随机试验的可行性。 构造学试验建立在这些初步研究的基础上，合乎逻辑。目标1是为了表明我们可以实施 并维持一个完整的ACT系统。作为这项工作的一部分，我们将反复评估我们机器的准确性 学习算法，并对其进行修改，以提高其在患者处于高风险时的实时预测能力 因为你经历了消极的结果。目标2是了解ACT系统如何影响临床医生的 (麻醉师和注册护士麻醉师[CRNAs])思考、决策和行为。 这种理解将有助于我们加强ACT系统，改进ACT和ACT中的工作流程 或者，并改善麻醉师和CRNAs之间的协作交互。目标3是进行一项 严格的临床试验。我们将评估ACT系统对手术室护理质量的影响，以及 临床结果如术中意识、术后神志不清、肾功能衰竭、呼吸 失败，以及30天的死亡率。构造学将是第一次实际和科学上严格的 为手术室提供远程医疗解决方案，并将告知将这种技术纳入 外科病人的常规护理，包括资源不足的医疗保健环境。数百万人正在接受 每年手术，这种可行的技术应用可能标志着安全和质量的重大转变 围手术期护理，并转化为实质性的社会收益。

Abstract Adverse outcomes, including death, respiratory failure and renal failure, are common after surgery, and represent a serious public health challenge. Such adverse outcomes can be mitigated through integrated, collaborative health information technology solutions that provide clinicians cognitive and computational support. The chief motivation for the TECTONICS (Telemedicine Control Tower for the OR: Navigating Information, Care and Safety) trial is that a multi-faceted telemedicine solution has the potential to facilitate the dynamic assessment of risk, diagnose negative patient trajectories, and implement evidence-based practices. The net result for patients would be improved safety and outcomes. Our telemedicine solution, called the Anesthesiology Control Tower (ACT), encompasses real-time patient data integration from the electronic health record, clinician decision support, machine learning algorithms that predict adverse outcomes, and remote monitoring for the operating room (OR). This conceptualization of sophisticated remote monitoring for the OR is somewhat analogous to an air traffic control tower for a busy airport. The innovative TECTONICS trial will build on a series of preliminary studies (funded by the Agency for Healthcare Research and Quality, and the National Science Foundation) that have (i) established the usefulness and usability of a prototype telemedicine ACT; (ii) customized and enhanced decision-support alerts for the ACT, based on clinician user feedback; (iii) designed, developed, and tested machine learning algorithms that predict adverse postoperative outcomes; and (iv) established the feasibility of conducing a real-world randomized trial of the prototype ACT. The TECTONICS trial builds logically on these preliminary studies. Aim 1 is to show that we can implement and sustain an integrated ACT system. As part of this, we will iteratively assess the accuracy of our machine learning algorithms and modify them to improve their ability to predict in real time when patients are at high risk for experiencing negative outcomes. Aim 2 is to understand how the ACT system affects clinicians’ (anesthesiologists and certified registered nurse anesthetists [CRNAs]) thinking, decision-making and behavior. This understanding will help us to enhance the ACT system, improve workflow processes in the ACT and in the OR, and improve collaborative interactions between anesthesiologists and CRNAs. Aim 3 is to conduct a rigorous clinical trial. We will evaluate the impact of the ACT system on the quality of care in the OR, and clinical outcomes such as intraoperative awareness, and postoperative delirium, renal failure, respiratory failure, and 30-day mortality. TECTONICS will be the first practical and scientifically rigorous trial of a telemedicine solution for the operating room, and will inform the usefulness of incorporating such technology in routine care of surgical patients, including under-resourced healthcare settings. With many millions undergoing surgery yearly, this feasible application of technology could signal a major shift in the safety and quality of perioperative care, and translate into substantial societal gain.