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

测试胸痛患者的心血管动态快速评估 (CARE-CP)

• 批准号: 10660650
• 负责人: Simon A Mahler
• 金额: $ 40万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10660650
• 关键词: Testing; Cardiovascular; Ambulatory; Rapid; Evaluation

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.

项目摘要 美国急诊科（ED）700万患者的当前护理模式， 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 是艾德就诊的第二大常见原因，也是短期住院的最常见原因。期间 这些住院患者接受了深入的评估（压力测试、计算机断层扫描冠状动脉成像、 血管造影术或侵入性血管造影术），但最终<10%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，并在没有明显证据表明改善的情况下使卫生系统资源紧张 健康结果或患者体验。我们的初步数据表明，中度风险患者（35%的患者） 胸痛）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 （CARE）策略作为住院治疗的替代方案。在CARE策略中，患者从艾德出院 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 因素（例如，高血压、糖尿病），并确定是否需要进一步的心脏检查。这一战略 旨在提高以病人为中心的结果，同时安全和公平地减少医院资源的利用。 然而，中度风险患者的门诊和住院策略之间存在平衡。有 缺乏前瞻性数据来评估门诊胸痛评估的有效性和以患者为中心 中度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 战略（关怀）将安全地减少医疗保健的利用，并由患者的首选相比，传统的 住院策略。为了解决这一关键证据缺口，我们提出了第一个前瞻性多中心随机 在中度风险患者中测试门诊与住院策略的试验。我们经验丰富的研究团队将 在3个艾德研究中心将502例有以下病史的患者以1：1的比例随机分配至CARE或住院管理组： 心血管临床试验的高招募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 经验和自付费用将在30天内进行评估。其他终点包括1年内的HFD， 30-日和1年心血管HFD，无创和有创心脏检查率，心血管 再住院和心血管重复艾德访视。将对患者进行安全性监测： 30天时心血管死亡、心肌梗死和计划外冠状动脉血运重建。这本小说 一项试验通过提供关于如何最好地评估中度风险艾德患者的指导，解决了关键证据缺口 急性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、非常规的。 以病人为中心，不受最高证据的指导。我们假设这项试验的数据将 支持广泛实施一项护理战略，这可以提高护理的质量和价值， 在美国和其他地方的数百万患者。