《急诊科和治疗结果的护理协调中检测丙型肝炎（HCV）衔接护理的有效检测（DETECT）试验：一项基于急诊科的丙型肝炎衔接护理策略的随机临床试验的原理和设计》

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C.

机构信息

Division of Infectious Diseases, Denver Health Medical Center and University of Colorado School of Medicine, Denver, CO, USA.

Public Health Institute at Denver Health, Denver, CO, USA.

出版信息

Trials. 2023 Jan 27;24(1):63. doi: 10.1186/s13063-022-07018-w.

DOI:10.1186/s13063-022-07018-w

PMID:36707909

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9880363/

Abstract

BACKGROUND

Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial.

METHODS

The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression.

DISCUSSION

When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV.

TRIAL REGISTRATION

ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867.

摘要

背景

丙型肝炎（HCV）在美国是一个重大的公共卫生问题。虽然早期发现是当务之急，但随后与治疗专家建立联系是将确诊患者与治疗、治愈和预防持续传播联系起来的关键步骤。急诊科（ED）是 HCV 筛查的一个重要临床场所，尽管 HCV 确诊患者的最佳治疗途径仍不清楚。本文描述了在急诊确定 HCV 治疗的有效检测和护理协调（DETECT）进行 HCV 衔接治疗试验的基本原理和设计。

方法

DETECT Hep C 衔接治疗试验将是一项单中心前瞻性比较有效性随机两臂平行组优效性试验，旨在测试 ED 中未接受治疗的 HCV 患者中进行衔接导航和临床医生转介的有效性，主要假设是在以开始治疗作为主要结局时，衔接导航加临床医生转介优于仅临床医生转介。参与者将在丹佛健康医疗中心（丹佛，CO）的 ED 中登记，这是一家拥有约 75000 名成人 ED 就诊量的城市医疗保障医院。该试验旨在招募最多 280 名 HCV RNA 阳性参与者，计划根据 O'Brien 和 Fleming 的方法进行一次中期分析。该试验将进一步告知对衔接治疗、治疗和疾病进展过程中的成本效益、差异和健康社会决定因素的评估。