[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624196":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":48,"locations":57,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":43,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":119,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"UF Jacksonville North ED",null,"Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage.",[13],"Other: FOCUS (Universal Screening)",{"label":15,"type":10,"description":16,"interventionNames":17},"UF Jacksonville Downtown ED","Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation).",[13,18],"Other: HepC-EnD (Targeted Screening)",{"label":20,"type":10,"description":21,"interventionNames":22},"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).",[23,18],"Other: Physician-Initiated Screening (Conventional Screening)",[25,31,38],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"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.",[20],[30],"Standard of Care",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"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\u002F2 antigen\u002Fantibody 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.",[15,9],[36,37],"FOCUS","Universal Screening",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"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\u002F2 antigen\u002Fantibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed.",[20,15],[43],"HepC-EnD",[45],{"name":46,"affiliation":5,"role":47},"Haesuk Park, PhD","PRINCIPAL_INVESTIGATOR",[49,53],{"name":46,"role":50,"phone":51,"phoneExt":10,"email":52},"CONTACT","352-273-6261","hpark@cop.ufl.edu",{"name":54,"role":50,"phone":55,"phoneExt":10,"email":56},"Khoa A Nguyen, PharmD","352-273-9418","nguyen.khoa@ufl.edu",[58,71,80],{"facility":59,"status":10,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":10},"UF Health Shands Emergency Room \u002F Trauma Center","Gainesville","Florida","32608","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-82.32483,29.65163,{"lat":69,"lon":68},{"facility":72,"status":10,"city":73,"state":61,"zip":74,"country":63,"countryCode":64,"cosmosGeoPoint":75,"geoPoint":79,"contacts":10},"UF Health Jacksonville Emergency Room","Jacksonville","32209",{"type":66,"coordinates":76},[77,78],-81.65565,30.33218,{"lat":78,"lon":77},{"facility":81,"status":10,"city":73,"state":61,"zip":82,"country":63,"countryCode":64,"cosmosGeoPoint":83,"geoPoint":85,"contacts":10},"UF Health North Emergency Room","32218",{"type":66,"coordinates":84},[77,78],{"lat":78,"lon":77},{"type":87,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[89],{"name":90,"class":91},"National Institute on Drug Abuse (NIDA)","NIH","100624196","assessing-performance-of-a-hepatitis-c-emergency-department-hepc-end-screening-tool-it-integration-process-for-electronic-health-record-system-100624196",false,"NCT07406490","Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System","Inclusion Criteria:\n\n* 18-79 years of age\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age\n* Medically unstable",true,"ALL","18 Years","79 Years",{"count":103,"type":104},6466,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.",[108,109,110],"Hepatitis C Virus (HCV)","Hepatitis C Virus (HCV) Infection","HIV (Human Immunodeficiency Virus)",[112,113,114,115,116,117,118],"Emergency Department","Hepatitis C","Human Immunodeficiency Virus","Implementation Study","Machine Learning","Screening Algorithm","High-Risk Prediction","NOT_YET_RECRUITING","2026-04-28",{"date":122,"type":123},"2026-04-29","ACTUAL",{"date":125,"type":104},"2026-07-01",{"date":127,"type":104},"2027-07",{"name":5,"class":6},3]