The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147,533
- 试验地点
- 3
- 主要终点
- Newly diagnosed active HCV
研究概览
简要总结
The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial").
详细描述
The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study.
This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to EDs during study enrollment period
- •Clinically stable per screening nurse or physician assessment
- •Able to provide consent for medical care
排除标准
- •Younger than 18 years of age
- •Are unable to consent for care (i.e., altered mentation, critical illness, or injury)
- •Have already participated in the trial
- •Self-Identify as already living with HCV
研究组 & 干预措施
Nontargeted Screening
The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening.
干预措施: HCV Screening (Other)
Targeted Screening
The targeted HCV screening arm will consist of implementation of risk-based rapid opt-out HCV screening using current recommendations for HCV screening by the CDC, USPSTF, and AASLD-IDSA. Targeted HCV screening will consist of offering HCV testing to those identified with the following specific risk characteristics, adapted from the above recommendations: born between 1945 - 1965 ("birth cohort"); injection drug use (IDU); intranasal drug use;tattoo or piercing in an unregulated setting; or blood transfusion or organ recipient before 1992.
干预措施: HCV Screening (Other)
结局指标
主要结局
Newly diagnosed active HCV
时间窗: 1 day from ED visit
Confirmed cases of newly diagnosed active HCV, defined as patients who test positive for HCV antibody and measurable HCV RNA, and without a prior HCV diagnosis, stratified by study arm
次要结局
- HCV test acceptance(1 day from ED visit)
- HCV test completion(1 day from ED visit)
研究者
Jason Haukoos
Professor & Director of Research, Department of Emergency Medicine, Denver Health
Denver Health and Hospital Authority
