Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6,466
- 试验地点
- 3
- 主要终点
- Proportion of new HCV or HIV diagnoses
研究概览
简要总结
The goal of this observational study is to develop, implement, and evaluate a machine learning algorithm-based Hepatitis C Emergency Department (HepC-EnD) screening tool for use in emergency departments (EDs) to identify patients at high risk of hepatitis C virus (HCV) infection. HepC-EnD will be integrated into the University of Florida Health electronic health record (EHR) system as a best practice alert (BPA) pop-up for ED providers, notifying them of patients at high risk for HCV infection and recommending both HCV and human immunodeficiency virus (HIV) screening. Investigators aim to enhance the screening and diagnosis of individuals who may otherwise remain undiagnosed and untreated.
The implementation outcomes (e.g., usability) and effectiveness outcomes (e.g., HCV screening and diagnosis rates) of HepC-EnD targeted screening will be compared with universal screening (FOCUS) and conventional physician-initiated screening programs in EDs.
详细描述
HCV infection has markedly increased in the United States, primarily resulting from injection drug use associated with the ongoing opioid epidemic. Despite the availability of highly effective direct-acting antiviral therapy, more than half of individuals with chronic HCV remain undiagnosed, leading to significant morbidity and mortality. EDs represent a critical setting for HCV and HIV screening, as they are currently the most common setting for missed diagnostic opportunities. However, universal ED-based screening programs are often costly and unsustainable. Moreover, existing targeted screening programs are limited, and have not been systematically developed or rigorously evaluated in clinical practice. Thus, there is a critical public health need to develop innovative, tailored, effective, and sustainable screening strategies to enhance HCV screening in EDs.
This study will accomplish three specific aims:
- Develop and validate prediction algorithms using machine learning and natural language processing (NLP) to identify patients at high risk of HCV infection
- Develop the HCV screening tool prototype HepC-EnD for implementation in EDs
- Compare the usability, effectiveness, and cost-effectiveness of an automated HepC-EnD prompt for HCV (with HIV) testing versus universal and physician-initiated screening strategies
This study is guided by multiple implementation science frameworks, including the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, Proctor's Implementation Outcomes, and Five Rights, which will greatly increase the tool's utility, sustainability, and generalizability.
The investigators will conduct a quasi-experimental study to compare HepC-EnD to two existing screening strategies across three UF Health EDs over 12 months (6 months pre-implementation and 6 months post-implementation). UF Jacksonville Downtown ED will transition from universal screening (FOCUS) to HepC-EnD. UF Jacksonville North ED will continue FOCUS throughout the study period to serve as a control. UF Gainesville ED will pilot HepC-EnD, as FOCUS has not previously been implemented at that site. The study will evaluate the effectiveness of HepC-EnD's within-site and between-site comparisons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-79 years of age
排除标准
- •< 18 years of age
- •Medically unstable
研究组 & 干预措施
UF Jacksonville North ED
Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage.
干预措施: FOCUS (Universal Screening) (Other)
UF Jacksonville Downtown ED
Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation).
干预措施: FOCUS (Universal Screening) (Other)
UF Jacksonville Downtown ED
Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation).
干预措施: HepC-EnD (Targeted Screening) (Other)
UF Gainesville ED
Patients presenting to UF Gainesville ED (pre-implementation) and patents presenting to UF Gainesville ED who opt-in for HCV during nurse triage (post-implementation).
干预措施: Physician-Initiated Screening (Conventional Screening) (Other)
UF Gainesville ED
Patients presenting to UF Gainesville ED (pre-implementation) and patents presenting to UF Gainesville ED who opt-in for HCV during nurse triage (post-implementation).
干预措施: HepC-EnD (Targeted Screening) (Other)
结局指标
主要结局
Proportion of new HCV or HIV diagnoses
时间窗: Time Frame: 6 months pre- and post-implementation
Proportion of positive results among performed tests. HCV diagnosis is defined as a positive RNA test result. HIV diagnosis is defined as an acute (i.e., antigen positive but antibody negative) or established (i.e., antibody positive) infection.
Absolute number of new HCV or HIV diagnoses
时间窗: 6 months pre- and post-implementation
Absolute number of positive results among performed tests. HCV diagnosis is defined as a positive RNA test result. HIV diagnosis is defined as an acute (i.e., antigen positive but antibody negative) or established (i.e., antibody positive) infection.
次要结局
- Proportion of BPA alerts among individuals presenting to EDs(6 months pre- and post-implementation)
- Proportion of HCV and HIV tests performed among BPA alerts(6 months pre- and post-implementation)
- Proportion of patients linked to care among those with positive HCV and HIV diagnoses(3 months after diagnosis)
- Composite HCV or HIV Diagnoses(6 months pre- and post-implementation)