Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System (HepC-EnD)

April 28, 2026 updated by: University of Florida

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Develop and validate prediction algorithms using machine learning and natural language processing (NLP) to identify patients at high risk of HCV infection
  2. Develop the HCV screening tool prototype HepC-EnD for implementation in EDs
  3. 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.

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.

Study Type

Observational

Enrollment (Estimated)

6466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health Shands Emergency Room / Trauma Center
      • Jacksonville, Florida, United States, 32209
        • UF Health Jacksonville Emergency Room
      • Jacksonville, Florida, United States, 32218
        • UF Health North Emergency Room

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients visiting UF Health emergency departments.

Description

Inclusion Criteria:

  • 18-79 years of age

Exclusion Criteria:

  • < 18 years of age
  • Medically unstable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UF Jacksonville North ED
Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage.
Other: FOCUS (Universal Screening)
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
UF Jacksonville Downtown ED
Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation).
Other: FOCUS (Universal Screening)
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
Other: HepC-EnD (Targeted 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
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).
Other: HepC-EnD (Targeted 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
Other: Physician-Initiated Screening (Conventional Screening)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of new HCV or HIV diagnoses
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 new HCV or HIV diagnoses
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.
6 months pre- and post-implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of BPA alerts among individuals presenting to EDs
Time Frame: 6 months pre- and post-implementation
BPA alert for HepC-End or universal screening
6 months pre- and post-implementation
Proportion of HCV and HIV tests performed among BPA alerts
Time Frame: 6 months pre- and post-implementation
6 months pre- and post-implementation
Proportion of patients linked to care among those with positive HCV and HIV diagnoses
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.
3 months after diagnosis
Composite HCV or HIV Diagnoses
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.
6 months pre- and post-implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Haesuk Park, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202500471
  • R01DA057886 (U.S. NIH Grant/Contract)
  • IRB202600334 (Registry Identifier: IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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