The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial

项目总结 确定未诊断的丙型肝炎病毒(丙型肝炎病毒)感染和有效的护理联系是一个关键的公众 健康优先。在美国，超过300万人慢性感染丙型肝炎病毒，其中 大多数(&gt；50%)仍未确诊。疾病控制和预防中心与美国预防 服务工作组建议对1945至1965年间出生的所有人(即“出生队列”)进行筛查。 和非出生队列具有已知的丙型肝炎病毒感染风险的个人(例如，注射毒品的人)增加 诊断、治疗和治愈，同时扭转发病率、发病率、死亡率和医疗保健不断上升的趋势 与丙型肝炎病毒感染相关的费用。急诊科(EDs)一直是传染病的主要焦点 疾病筛查，包括人类免疫缺陷病毒(艾滋病毒)感染和最近的丙型肝炎病毒 感染。这一重点是因为美国每年有超过1.35亿人次的急诊室就诊， 急诊室为服务不足和有风险的患者提供了很大比例的服务，急诊室是遗漏的常见地点。 诊断机会。我们的研究团队在基于ED的艾滋病毒和丙型肝炎筛查方面开创了先河 自2004年以来，首要目标是确定最有效和最高效的筛查方法 在急诊室的高危人群中。为了加强我们的工作，我们提出了以下具体目标：(1) 比较非基于风险(非靶向)和基于风险(靶向)的丙型肝炎病毒筛查的有效性 整合到城市急救系统中；(2)比较联动导航加临床医生转诊与 仅为急诊室中确定的丙型肝炎病毒感染患者转介临床医生；以及(3)估计规划成本和 计划基于ED的丙型肝炎病毒筛查和与护理的联系的长期结果和成本效益。正在做 因此，我们将进行以下研究：(A)多中心前瞻性语用随机有效性 测试非靶向丙型肝炎病毒筛查是否与新诊断的丙型肝炎病毒感染显著相关的试验 与有针对性的丙型肝炎病毒筛查相比；(B)明确的单中心前瞻性务实随机 有效性试验，以测试联动导航是否显著增加新诊断的比例 完成对丙型肝炎病毒感染的初级护理访问并在丙型肝炎护理连续过程中进展的患者 与标准临床医生转诊相比；(C)使用时间运动方法的嵌套前瞻性队列研究 以及估计每次筛查每个新诊断的丙型肝炎病毒感染的直接成本的实际试验费用 方法；和(D)对两个临床试验的结果进行分析，以确定蒙特卡罗过渡态的参数 丙型肝炎病毒筛查、治疗和疾病进展的模拟模型，以测试非靶向丙型肝炎病毒 筛查与联动导航相结合将产生最好的结果，并具有成本效益。这个项目将 是迄今为止在急诊室对丙型肝炎病毒筛查进行的最大和最全面的评估，结果将 大大提高我们对如何提供有效、快速的丙型肝炎病毒筛查和联动护理的理解 ED患者，并将对美国的丙型肝炎疫情产生持续而强大的影响。

PROJECT SUMMARY Identification of undiagnosed hepatitis C virus (HCV) infection and effective linkage-to-care is a critical public health priority. In the United States, over 3 million individuals are chronically infected with HCV, of which the majority (>50%) remain undiagnosed. The Centers for Disease Control and Prevention and U.S. Preventive Services Task Force recommend screening all individuals born from 1945 through 1965 (i.e., “birth cohort”) and non-birth cohort individuals with known risks for HCV infection (e.g., people who inject drugs) to increase diagnoses, treatment, and cure, while reversing the increasing incidence, morbidity, mortality, and healthcare costs associated with HCV infection. Emergency departments (EDs) have been a major focus of infectious diseases screening, including human immunodeficiency virus (HIV) infection and, more recently, HCV infection. This focus is prompted by the fact that over 135 million ED visits occur annually in the United States, EDs serve large proportions of underserved and at-risk patients, and EDs are common sites of missed diagnostic opportunities. Our research team has pioneered investigations in ED-based HIV and HCV screening since 2004 with the overarching goal of determining the most effective and efficient methods of screening among high-risk populations in EDs. To build on our work, we propose the following specific aims: (1) to compare the effectiveness of non-risk-based (nontargeted) and risk-based (targeted) HCV screening when integrated into urban EDs; (2) to compare the effectiveness of linkage navigation plus clinician referral versus clinician referral alone for HCV-infected patients identified in EDs; and (3) to estimate programmatic costs and project long-term outcomes and cost effectiveness of ED-based HCV screening and linkage to care. In doing so, we will perform the following studies: (a) a multi-center prospective pragmatic randomized effectiveness trial to test whether nontargeted HCV screening is significantly associated with newly-diagnosed HCV infection when compared to targeted HCV screening; (b) a distinct single-center prospective pragmatic randomized effectiveness trial to test whether linkage navigation significantly increases the proportion of newly diagnosed patients who complete primary care visits for HCV infection and progress through the HCV Care Continuum when compared to standard clinician referral; (c) a nested prospective cohort study using time-motion methods and actual trial expenses to estimate direct costs per newly-diagnosed HCV infection for each screening method; and (d) an analysis with results from both clinical trials to parameterize a Monte Carlo transition-state simulation model of HCV screening, treatment, and disease progression to test whether nontargeted HCV screening coupled with linkage navigation will yield the best outcomes and be cost effective. This project will be the largest and most comprehensive evaluation of HCV screening in EDs to date, the results will substantially improve our understanding of how to provide effective rapid HCV screening and linkage-to-care of ED patients, and will have a sustained and powerful influence on the HCV epidemic in the United States.