The DETECT HCV Screening Trial

Study Overview
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Brief Summary
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The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - Screening Trial).

Detailed Description
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The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study. This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).

Official Title
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The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: HCV Screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present to EDs during study enrollment period Clinically stable per screening nurse or physician assessment Able to provide consent for medical care Exclusion Criteria: Younger than 18 years of age Are unable to consent for care (i.e., altered mentation, critical illness, or injury) Have already participated in the trial Self-Identify as already living with HCV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nontargeted Screening<br>The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening. | Other: HCV Screening<br>* The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED.<br>|
| Other: Targeted Screening<br>The targeted HCV screening arm will consist of implementation of risk-based rapid opt-out HCV screening using current recommendations for HCV screening by the CDC, USPSTF, and AASLD-IDSA. Targeted HCV screening will consist of offering HCV testing to those identified with the following specific risk characteristics, adapted from the above recommendations: born between 1945 - 1965 (birth cohort); injection drug use (IDU); intranasal drug use;tattoo or piercing in an unregulated setting; or blood transfusion or organ recipient before 1992. | Other: HCV Screening<br>* The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly diagnosed active HCV | Confirmed cases of newly diagnosed active HCV, defined as patients who test positive for HCV antibody and measurable HCV RNA, and without a prior HCV diagnosis, stratified by study arm | 1 day from ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV test acceptance | Defined by the proportion of patients who agree to HCV testing, as measured by the proportion of those who consent among patients offered HCV testing, stratified by study arm | 1 day from ED visit | 
| HCV test completion | Defined by the proportion of patients who complete HCV testing, as measured by the proportion of rapid HCV tests completed among patients who accepted testing, stratified by study arm | 1 day from ED visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Screening, Emergency Department, Risk