NCT Number: NCT07406490
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.
Trial opening soon.
Get Notified18 year–79 year
All sexes
Observational
UF Health Shands Emergency Room / Trauma Center, Gainesville, Florida, United States
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:
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.
The investigator's central hypothesis is that the use of HepC-EnD will have lower HCV and HIV screening rates but higher diagnosis rates and will be more cost-effective than universal screening and physician-initiated screening strategies.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Screening for HCV and HIV in patients presenting to the ED occurs when an ED provider initiates screening based on symptoms or clinical judgement. Providers will manually order individual tests in the EHR.
Other names: Standard of Care
During nurse triage, a FOCUS screening question will appear in the EHR and the patient will be asked to opt-in to HCV and HIV testing. For those who consented, if an ED provider enters a phlebotomy order for any reason in the EHR, a BPA will alert the providers to suggest HCV and HIV testing. The provider can decide to "order" or "do not order" for each test individually. Ordered tests automatically trigger the following in the EHR: HCV antibody with reflex to RNA and HIV 1/2 antigen/antibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed. These procedures are currently implemented in clinical practice.
Other names: FOCUS, Universal Screening
HepC-EnD will run in real time once integrated into the hospital's Epic EHR system. When the patient comes to the ED waiting room, a risk score generated from HepC-EnD will be available and determine if the patient is at high risk of HCV infection (> cutoff risk score). If the patient is determined to be at high risk, a HepC-EnD screening question will appear in the EHR during nurse triage and the patient will be asked will be asked to opt-in to HCV and HIV testing. For those who consented, a BPA will alert the ED provider to suggest HCV and HIV testing. The provider can decide to "order" or "do not order" for each test individually. Ordered tests automatically trigger the following in the EHR: HCV antibody with reflex to RNA and HIV 1/2 antigen/antibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed.
Other names: HepC-EnD
Time frame: 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.
Time frame: 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.
Time frame: 6 months pre- and post-implementation
BPA alert for HepC-End or universal screening
Time frame: 6 months pre- and post-implementation
Time frame: 3 months after diagnosis
Linkage to care will be defined as a patient attending a first medical appointment within 3 months of receiving an HCV or HIV diagnosis.
Time frame: 6 months pre- and post-implementation
All HCV and HIV diagnoses will be considered separately and will include both new and repeat diagnoses.
Contact information is provided by the study sponsor or research team.
Haesuk Park, PhD
CONTACT
Khoa A Nguyen, PharmD
CONTACT
University of Florida
Other
Acronym: HepC-EnD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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