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

在德国，在所有院前紧急情况中，50%由护理人员单独处理，50%由额外的急救医生处理。尽管在所有病例中只有1/10的情况下需要医生的手工能力，但仍然出现了对额外医生的高度使用。由于许多急救中心的关闭，急诊病例的稳步增加和合格急诊医生的额外短缺，特别是在农村地区，几乎不可能在急救呼叫和急救医生到达之间保持较短的时间间隔。尽管远程医疗在许多临床医学领域已被证明是有帮助的和提高质量的，但到目前为止，在院前紧急医疗领域，只使用了特定的远程医疗组件，以响应特定疾病(如中风)的独特需求。为了克服这一不足，我们为各种不同的院前急救病例开发了一个全面的远程医疗系统，该系统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件(远程急救医生工作站、服务器基础设施、移动设备和救护车综合传输单元)组成，允许在线和安全地传输所有数据(语言、生命参数、图像和视频流)。经过法律澄清、在两个研究项目中对该系统进行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，只有在为护理人员计划的情况下才使用，只有在需要额外的医生治疗的情况下才使用。到目前为止，&gt；2000最初只有护理人员计划的手术没有不良事件，然而，显示出更好的病史、治疗和文件质量。使用随机对照试验设计，这项包括3000名患者的研究资助方案旨在比较院前基于急诊医生的系统和基于传统急诊医生的系统的特定程序的并发症发生率和护理质量，当排除某些病例(例如，多发创伤和呼吸或心脏骤停)时，约占所有急诊病例的10%。这项RCT是否应该证明，在这些条件下，远程医疗方法关于与基于传统医生的院外急救系统相同的并发症，并且同时在某些方面导致改善的护理质量，它将允许对德国的院外救援服务进行重组。不是50%的紧急病例只有10%需要亲自到场的急救医生，其他需要医生的病例可以在紧急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.