RACE-CARS CCC 1/2

项目摘要 每年约有35万人发生院外心脏骤停，平均存活时间为 神经功能良好率仅为9.0%。为了回应明确的公共卫生要求， 根据这些统计数据，该医学研究所在2015年呼吁对实施干预措施进行研究 在社区、紧急医疗服务(EMS)和医院层面上的非物质援助。缺乏一致的使用 全国范围内的有效干预在很大程度上是由于缺乏高质量的随机证据 关于如何在系统(社区)一级实施这些干预措施的试验。建议的区域 心血管紧急情况的处理方法-心脏骤停(RASH-CARS)群组随机试验 旨在开发基于新系统的高质量临床试验证据，说明如何改善患者的结果 奥赫A。赛车的前提是基于先前的观察，显示出相当大的地区性 护理的异质性与结果的差异相关。在北卡罗来纳州的11个县，我们观察到 旁观者CPR和急救人员除颤率的提高，与存活率增加37%相关 在4年内有良好的神经学结果。 Race-Cars是一项为期7年的务实的整群随机(1：1)试验，在北卡罗来纳州的50个县进行，将测试 实施一套定制的、具有战略针对性的社区干预措施可以改善 相对于对照组/标准护理，ol A中神经功能良好的患者可存活至出院。我们的 干预计划将包括4个主要要素：(1)优化的医疗911-派遣性能 快速识别心脏骤停并调度紧急响应，(2)增强型911-调度电话 指导旁观者CPR，(3)通过使用AED提高急救员的表现，以及(4)全面 公共培训心肺复苏术和AED的使用。生活质量和神经功能状态将在6岁和6岁时评估 12个月。赛车将利用我们的全州紧急护理网络，该网络已成功 在过去14年中，在提高紧急心血管护理质量方面进行了合作，并提供了持续的数据 使用CARE登记收集北卡罗来纳州大多数心脏骤停病例。我们将招募约20,000名患者 在研究期间心脏骤停的情况下，为了让我们有90%的能力检测旁观者CPR增加30%， 旁观者或急救者的除颤增加50%，检测的功率增加85% 存活并有良好的神经预后。虽然所有的干预方法都有改进的证据 在之前的观察性研究中，赛车的独特之处在于将这些努力结合到了一个务实的 基于系统的随机实施试验，可根据以下需求和能力/资源进行调整 根据人口密度、人口和社会经济地位的不同而不同的区域。 1

Project Abstract Approximately 350,000 people suffer out-of-hospital cardiac arrest (OHCA) each year, with an average survival rate with good neurological function of only 9.0%. In response to the clear public health imperative signaled by these statistics, the Institute of Medicine in 2015 called for studies on implementation of interventions for OHCA at the community, emergency medical services (EMS), and hospital levels. The lack of consistent use of effective interventions across the country is largely due to the lack of high quality evidence from randomized trials on how to implement these interventions at the systems (community) level. The proposed Regional Approaches to Cardiovascular Emergencies- Cardiac ARreSt (RACE-CARS) cluster-randomized trial has been designed to develop new systems-based high quality clinical trial evidence on how to improve outcomes for OHCA. The premise for RACE-CARS is based on prior observations showing substantial regional heterogeneity in care correlated with variations in outcomes. In 11 North Carolina counties, we observed improved rates of bystander CPR and first responder defibrillation, associated with a 37% increase in survival with good neurologic outcome over a 4-year period. RACE-CARS, a 7-year pragmatic, cluster randomized (1:1) trial of 50 counties in NC, will test whether implementation of a customized set of strategically targeted community-based interventions can improve survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. Our intervention program will consist of 4 main elements: (1) optimized medical 911-dispatch performance with rapid recognition of cardiac arrest and dispatch of emergency response, (2) enhanced 911-dispatch telephone coaching of bystander CPR, (3) improved first responder performance with AED use, and (4) comprehensive public training of CPR and AED use. Quality of life and neurological functional status will be assessed at 6 and 12 months. RACE-CARS will leverage our statewide emergency care network, which has successfully collaborated on improving quality of emergency cardiovascular care over the past 14 years, and ongoing data collection of the majority of cardiac arrests in NC using the CARES registry. We will enroll ~20,000 patients with cardiac arrest over the study period, to give us >90% power to detect a 30% increase in bystander CPR, and 50% increase in bystander or first responder defibrillation, and > 85% power to detect a 33% increase in survival with good neurologic outcome. While all the intervention approaches have evidence for improved outcomes in prior observational studies, RACE CARS is unique in combining these efforts into a pragmatic randomized systems-based implementation trial that can be adjusted to the needs and abilities/resources of regions that vary according to population density, demographic and socioeconomic status. 1