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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07406490
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
6,466 participants (estimated)

Arms

  • Arm: UF Jacksonville North ED
    Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage.
  • Arm: UF Jacksonville Downtown ED
    Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation).
  • Arm: 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).

Primary Outcome Measure

Proportion of new HCV or HIV diagnoses [ Time Frame: Time Frame: 6 months pre- and post-implementation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UF Health Shands Emergency Room / Trauma CenterGainesvilleFlorida32608-
UF Health Jacksonville Emergency RoomJacksonvilleFlorida32209-
UF Health North Emergency RoomJacksonvilleFlorida32218-

Find similar trials in Gainesville, FL

By research site
UF Health Shands Emergency Room / Trauma Center· Gainesville, FLUF Health Jacksonville Emergency Room· Jacksonville, FLUF Health North Emergency Room· Jacksonville, FL

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