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

NCT07406490 | Not Yet Recruiting

• 3 other identifiers: IRB202500471R01DA057886IRB202600334
• Study Type: observational
• Target: 6,466
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hepatitis C Virus (HCV) Infection; HIV (Human Immunodeficiency Virus); Hepatitis C Virus (HCV)

Keywords

Emergency Department; Hepatitis C; Human Immunodeficiency Virus; Implementation Study; Machine Learning; Screening Algorithm; High-Risk Prediction

Outcome Measures

Primary Outcomes (2)

• Proportion of new HCV or HIV diagnoses

  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

  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 Outcomes (4)

• 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

Study Arms (3)

UF Jacksonville North ED

Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage.

Other: 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); Other: HepC-EnD (Targeted Screening)

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: Physician-Initiated Screening (Conventional Screening); Other: HepC-EnD (Targeted Screening)

Interventions

Physician-Initiated Screening (Conventional Screening) OTHER

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.

Also known as: Standard of Care

UF Gainesville ED

FOCUS (Universal Screening) OTHER

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.

Also known as: FOCUS, Universal Screening

UF Jacksonville Downtown ED; UF Jacksonville North ED

HepC-EnD (Targeted Screening) OTHER

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.

Also known as: HepC-EnD

UF Gainesville ED; UF Jacksonville Downtown ED

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients visiting UF Health emergency departments.

You may qualify if:

• years of age

You may not qualify if:

• \< 18 years of age
• Medically unstable

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

UF Health Shands Emergency Room / Trauma Center

Gainesville, Florida, 32608, United States

Location

UF Health Jacksonville Emergency Room

Jacksonville, Florida, 32209, United States

Location

UF Health North Emergency Room

Jacksonville, Florida, 32218, United States

Location

Related Publications (1)

• Jang SC, Lo-Ciganic WH, Hernandez-Con P, Jenjai C, Huang J, Stultz A, Yan S, Wilson DL, Norse A, Guirgis FW, Cook RL, Gage C, Nguyen KA, Hornes P, Wu Y, Nelson DR, Park H. Development and Validation of a Machine Learning-Based Screening Algorithm to Predict High-Risk Hepatitis C Infection. Open Forum Infect Dis. 2025 Aug 15;12(8):ofaf496. doi: 10.1093/ofid/ofaf496. eCollection 2025 Aug.

  PMID: 40874186 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Infections; Acquired Immunodeficiency Syndrome; Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Haesuk Park, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haesuk Park, PhD

CONTACT

352-273-6261; hpark@cop.ufl.edu

Khoa A Nguyen, PharmD

CONTACT

352-273-9418; nguyen.khoa@ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-10

Locations

US (3)