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

确定急诊科的有效检测和 HCV 治疗结果的护理协调 (DETECT) 试验

• 批准号: 9673534
• 负责人: JASON HAUKOOS
• 金额: $ 9.29万
• 依托单位: DENVER HEALTH AND HOSPITAL AUTHORITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-03-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9673534
• 关键词: Accident and Emergency department; Advisory Committees; Attention; Birth; Caring; Centers for Disease Control and Prevention (U.S.); Chronic; Clinical; Clinical Trials; Communicable Diseases; Continuity of Patient Care; Counseling; Coupled; Data; Diagnosis; Diagnostic; Direct Costs; Disease Progression; Effectiveness; Emergency Care; Emergency Department patient; Emergency department visit; Ensure; Epidemic; Evaluation; Geography; Goals; HCV screening; HIV; HIV/HCV; Health Care Costs; Healthcare Systems; Hepatitis C; Hepatitis C Incidence; Hepatitis C Prevalence; Hepatitis C Therapy; Hepatitis C Transmission; Hepatitis C virus; Incidence; Individual; Injecting drug user; Institution; Interdisciplinary Study; Investigation; Link; Methods; Modeling; Morbidity - disease rate; Motion; Newly Diagnosed; Outcome; Patient risk; Patients; Population; Populations at Risk; Prevention; Preventive service; Primary Health Care; Prospective cohort study; Public Health; Public Health Practice; Quality-Adjusted Life Years; Randomized; Randomized Clinical Trials; Research; Research Infrastructure; Risk; Site; Structure; System; Testing; Treatment outcome; Underserved Population; United States; Virus Diseases; Visit; Vulnerable Populations; Work; base; care coordination; clinical care; clinically relevant; cohort; comparative; compare effectiveness; cost; cost effective; cost effectiveness; cost-effectiveness ratio; disorder prevention; effectiveness trial; health economics; high risk population; improved; incremental cost-effectiveness; injection drug use; models and simulation; mortality; primary outcome; prospective; public health priorities; relative effectiveness; screening; secondary outcome; time use; transmission process

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.

项目摘要 识别未确诊的丙型肝炎病毒（HCV）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300万个体慢性感染HCV，其中 大多数（>50%）仍未确诊。美国疾病控制和预防中心和美国预防 服务工作组建议对1945年至1965年出生的所有人进行筛查（即，“出生队列”） 和已知有HCV感染风险的非出生队列个体（例如，注射毒品的人）， 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增加的趋势 与HCV感染有关的费用。急诊科（ED）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（HIV）感染和最近的HCV感染 感染这种关注是由以下事实引起的：在美国，每年有超过1.35亿的艾德就诊， ED为大部分服务不足和高危患者提供服务，ED是错过的常见部位 诊断机会。我们的研究团队开创了基于ED的HIV和HCV筛查的研究 自2004年以来，其总体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。为了进一步发展我们的工作，我们提出以下具体目标：（1） 比较非基于风险（非靶向）和基于风险（靶向）HCV筛查的有效性， 整合到城市急诊科;（2）比较链接导航加临床医生转诊与 临床医生转诊单独为HCV感染的患者确定在急诊科;和（3）估计程序的成本， 项目的长期成果和成本效益的ED为基础的HCV筛查和联系的照顾。做 因此，我们将进行以下研究：（a）多中心前瞻性实用随机有效性 一项测试非靶向HCV筛查是否与新诊断的HCV感染显著相关的试验 当与靶向HCV筛查相比时;（B）一个独特的单中心前瞻性实用随机 有效性试验，以测试是否联动导航显着增加新诊断的比例 完成HCV感染的初级保健访视并通过HCV护理连续体进展的患者 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 和实际试验费用，以估计每次筛查的每例新诊断HCV感染的直接成本 方法;和（d）分析两项临床试验的结果，以参数化Monte Carlo过渡状态 HCV筛查、治疗和疾病进展的模拟模型，以测试非靶向HCV是否 筛选与联系导航相结合将产生最佳结果，并具有成本效益。该项目将 是迄今为止对ED中HCV筛查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的快速丙型肝炎病毒筛查和与护理联系的理解 艾德患者，并将对美国的HCV流行产生持续而强大的影响。