Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients with Chest Pain (CARE-CP)

项目总结 美国700万急诊科患者目前的护理模式 胸痛是异质性的，从医疗质量或经济角度来看是不可持续的。胸痛 是急诊科就诊的第二大常见原因，也是短期住院的最常见原因。在.期间 这些住院患者接受深入的评估(压力测试、计算机断层扫描冠状动脉 血管造影术或有创血管造影术)，但最终有10%的人被诊断为急性冠状动脉综合征(ACS)。 这些评估每年花费30亿美元，在没有明确证据表明改善的情况下，会使卫生系统的资源紧张 健康结果或患者经历。我们的初步数据显示，中等风险患者(35%的患者 有胸痛的)可以作为门诊患者使用心血管动态快速评估进行安全管理 (护理)战略作为住院的替代方案。在护理策略上，病人会从急症室出院 并在72小时内接受门诊随访，重点是心血管风险的医疗管理 影响因素(如高血压、糖尿病)，并决定是否需要进一步的心脏检测。这一战略 旨在提高以患者为中心的结果，同时安全和公平地减少医院资源的使用。 然而，中等风险患者的门诊和住院策略之间存在平衡。的确有 评价门诊胸痛评估的有效性和以患者为中心的前瞻性数据缺乏 中等风险患者的治疗策略。因此，目前还不清楚是否使用门诊胸痛管理 与传统的策略(CARE)相比，策略(CARE)将安全地降低医疗保健利用率，并受到患者的青睐 住院策略。为了解决这一关键证据差距，我们提出了第一个前瞻性多点随机 在中等风险患者中测试门诊与住院策略。我们经验丰富的研究团队将 将502名患者以1：1的比例随机分配到三个急诊地点的护理或住院管理臂，这些患者有以下病史 心血管临床试验的高招聘率和富有成效的合作。主要结果将是 30天内的无住院天数(HFD)。以患者为中心的结果，如患者满意度和 体验和自付费用将按30天进行评估。其他终端包括为期一年的HFD、 30天和1年心血管HFD，无创和有创心脏测试率，心血管 再次住院和心血管疾病重复急诊。将对患者进行安全监测： 心血管死亡，心肌梗死，以及30天后非计划的冠状动脉血运重建。这部小说 试验通过提供如何最好地评估中等风险ED患者的指导，解决了一个关键的证据缺口 伴随着剧烈的胸痛。如果没有这种指导，护理模式很可能仍然是异质的、低效的、非 以病人为中心，没有最高水平的证据指导。我们假设这项试验的数据将 支持广泛实施护理战略，这可以提高护理的质量和价值 在美国和其他地方数以百万计的患者。

PROJECT SUMMARY Current care patterns for the 7 million patients visiting Emergency Departments (EDs) in the United States with chest pain are heterogenous and not sustainable from a healthcare quality or economic perspective. Chest pain is the second most common cause of ED visits and most common reason for short-stay hospitalizations. During these hospitalizations patients undergo in-depth evaluations (stress testing, computed tomography coronary angiography, or invasive angiography), but ultimately <10% are diagnosed with acute coronary syndrome (ACS). These evaluations cost $3 billion annually and strain health system resources without clear evidence of improved health outcomes or patient experience. Our preliminary data suggest that moderate risk patients (35% of patients with chest pain) can be safely managed as outpatients using a cardiovascular ambulatory rapid evaluation (CARE) strategy as an alternative to hospitalization. In the CARE strategy, patients are discharged from the ED and receive outpatient clinic follow-up within 72 hours focused on medical management for cardiovascular risk factors (e.g., hypertension, diabetes) and determining whether further cardiac testing is needed. This strategy aims to enhance patient-centered outcomes while safely and equitably decreasing hospital resource utilization. However, equipoise exists between outpatient and hospitalization strategies for moderate risk patients. There is a paucity of prospective data evaluating the efficacy and patient-centeredness of outpatient chest pain evaluation strategies in moderate risk patients. Thus, it is unclear whether use of an outpatient chest pain management strategy (CARE) will safely reduce healthcare utilization and be preferred by patients compared to a traditional hospitalization strategy. To address this key evidence gap, we propose the first prospective multisite randomized trial testing outpatient vs hospitalization strategies in moderate risk patients. Our experienced research team will randomize 502 patients 1:1 to the CARE or hospitalization management arms at three ED sites with a history of high recruitment rates and productive collaborations in cardiovascular clinical trials. The primary outcome will be hospital-free days (HFD) over a 30-day period. Patient-centered outcomes, such as patient satisfaction and experience and out-of-pocket cost will be assessed at 30-days. Additional endpoints include HFD over 1-year, 30-day and 1-year cardiovascular HFD, rates of noninvasive and invasive cardiac testing, cardiovascular rehospitalizations, and cardiovascular repeat ED visits. Patients will be monitored for safety: the composite of cardiovascular death, myocardial infarction, and unplanned coronary revascularization at 30-days. This novel trial addresses a key evidence gap by providing guidance on how best to evaluate moderate risk ED patients with acute chest pain. Without this guidance care patterns are likely to remain heterogeneous, inefficient, non- patient-centered, and unguided by the highest level of evidence. We hypothesize that data from this trial will support widespread implementation of a CARE strategy, which could improve the quality and value of care for millions of patients in the U.S. and beyond.