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

摘要 手术后常见不良结局，包括死亡、呼吸衰竭和肾衰竭， 这是一个严重的公共卫生挑战。这些不利后果可以通过综合、 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 支持. TECTONICS（手术室远程医疗控制塔：导航）的主要动机 信息，护理和安全）试验的一个重要方面是，多方面的远程医疗解决方案有可能促进 风险的动态评估，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），包括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 远程监控手术室（OR）。这种复杂的远程监控的概念化， OR有点类似于用于忙碌机场的空中交通控制塔。创新的构造 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， 和美国国家科学基金会）已经（i）建立了原型的有用性和可用性 远程医疗ACT;（ii）基于临床医生用户的ACT定制和增强的决策支持警报 反馈;（iii）设计，开发和测试机器学习算法，预测术后不良反应 结果;和（iv）建立了进行原型ACT的真实世界随机试验的可行性。 Tectonics试验逻辑上建立在这些初步研究的基础上。目标1是表明我们可以实现 并维持一个综合的ACT系统。作为其中的一部分，我们将反复评估我们的机器的准确性 学习算法并对其进行修改，以提高患者处于高风险时真实的预测能力 因为经历了负面结果。目的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]）的思维、决策和行为。 这种理解将有助于我们加强ACT系统，改进ACT和 OR，并改善麻醉师和CRNA之间的协作互动。目标3是开展一项 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， 临床结局，如术中知晓、术后谵妄、肾功能衰竭、呼吸衰竭 失败和30天死亡率。Tectonics将是第一个实用和科学严谨的试验， 手术室的远程医疗解决方案，并将告知将这种技术纳入 手术患者的常规护理，包括资源不足的医疗机构。数以百万计的人 每年手术，这种可行的技术应用可能标志着安全性和质量的重大转变， 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.