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").
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
147,533
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.
Denver Health Medical Center
Denver, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
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
Time frame: 1 day from ED visit
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
Time frame: 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
Time frame: 1 day from ED visit
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