Randomised controlled study on quality of care using either a telemedical or conventional physician based out-of-hospital emergency system

在德国，所有院前紧急情况中，50%由护理人员单独处理，50%由额外的急诊医生处理。尽管在所有病例中，只有十分之一的病例需要医生的手动能力，但这种对额外医生的高度使用还是发生了。由于许多急救中心的关闭，急诊病例的稳步增加和合格的急诊医生的进一步短缺，特别是在农村地区，在紧急呼叫和急诊医生到达之间保持短时间间隔几乎是不可能的。尽管远程医疗已被证明在临床医学的许多领域具有帮助和提高质量的作用，但到目前为止，在院前急诊医学领域，仅使用了针对基于特定疾病（例如中风）的独特需求的特定远程医疗组成部分。为了克服这方面的不足，我们开发了一套全面的远程医疗系统，以应付各种院前紧急情况，与现有的地面和空中救援系统协同工作。该系统由硬件和软件组成（远程急救医生工作站、服务器基础设施、移动和救护车综合传输单元），允许在线和安全传输所有数据（语言、重要参数、图像和视频流）。经过法律澄清、两个研究项目的评估和进一步的技术开发，该系统自2014年4月1日起用于常规护理。然而，目前该系统是现有救援设备的附加设备，只有在医护人员计划的情况下才需要额外的医生治疗时才会使用。到目前为止，bbb2000最初仅由护理人员计划的手术没有出现不良事件，但显示出更好的病史、治疗和文件质量。与此同时，被医生束缚的时间减少了50%。本研究申请采用随机对照试验设计，包括3000名患者，旨在比较院前急诊远程医疗医生系统与传统急诊医生系统在排除约占所有急诊病例10%的某些病例（如多发创伤和呼吸或心脏骤停）时的特定程序并发症发生率和护理质量。如果这项随机对照试验表明，在这些条件下，远程医疗方法在并发症方面与传统的以医生为基础的院外急救系统相当，同时在某些方面提高了护理质量，那么它将允许对德国院外救援服务进行重组。在所有紧急病例中，只有大约10%的病例需要一名在场的急诊医生，而不是50%，其他需要医生的病例可以在急诊远程医疗医生的帮助下进行治疗。

In Germany out of all prehospital emergencies 50% are managed by paramedics alone, 50% by additional emergency physicians. This high use of additional physicians occurs in spite of the fact that in only 1/10 of all cases the manual abilities of a physician are needed. Due to the closing down of many emergency care centers, the steady increase of emergency cases and additional shortage of qualified emergency physicians it is especially in rural areas nearly impossible to maintain a short time interval between emergency call and arrival of an emergency physician.Although telemedicine has been proven to be helpful and quality-improving in many Areas of clinical medicine, so far, in the field of prehospital emergency medicine only specific telemedicine components responding to a unique need based on a specific disease (e.g. stroke) were used. To overcome this shortage, we developed a holistic telemedicine system for a broad spectrum of different prehospital emergency cases, which acts synergistically to the existing ground- and air-based rescue systems. This systems consists of hard- and software components (work-station for the tele-emergency physician, server-infrastructure, mobile and in the ambulance integrated transfer unit), which allows for an online and safe transfer of all data (language, vital parameter, images and videostream). After legal clarification, evaluation of the system in two research projects and further technical development this system is used for routine care since April, 1rst 2014. However, at present the system, which is an add-on to the already existing rescue devices, is only used, if in situations planned for paramedics only the need for additional physician treatment occurs. So far, the > 2000 initially paramedics-only planned operations were without adverse events, however, showed a better medical history, treatment and documentation quality. At the same time the physician tied-up period was reduced by 50%.Using a randomized controlled trial design this research grant proposal including 3000 patients aims for comparing the procedure-specific complication rate and quality of care of a prehospital emergency telemedicine physician based system with a conventional emergency physician based system, when excluding certain cases (e.g. multiple trauma and respiratory or cardiac arrest) accounting for about 10% of all emergency cases.Should this RCT demonstrate that under these conditions the telemedicine approach is with respect to complications equivalent to the conventional physician based out-of-hospital emergency system and at the same time leads to an improved quality of care in some aspects, it would allow a restructuring of the German out-of-hospital rescue service. Instead of 50% only about 10% of all emergency cases would be in need of a physically present emergency physician, the other cases in need of a physician could be treated with the help of an emergency telemedicine physician.