Hepatitis C
Conditions
Keywords
Hepatitis C, Screening, Emergency Department, Risk
Brief summary
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
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).
Interventions
OTHERHCV Screening
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.
Sponsors
Johns Hopkins University
University of Mississippi Medical Center
Boston University
Boston Medical Center
University of Cincinnati
Alameda County Medical Center
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Newly diagnosed active HCV | 1 day from ED visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV test acceptance | 1 day from ED visit | 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 |
| HCV test completion | 1 day from ED visit | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Initiation of treatment with Direct-Acting Antivirals (DAAs) | 12 months following HCV diagnosis | Measured by indication of initiation of treatment with DAAs among those identified with active HCV |
| HCV genotype among those identified with active HCV | 12 months following HCV diagnosis | Measured by HCV genotyping among those identified with active HCV |
| Sustained virologic response at 12 weeks after treatment completion (SVR12) | 12 months following HCV diagnosis | Measured by undetectable HCV RNA 12 weeks after completion of DAAs among those identified with active HCV |
| Completion of treatment with Direct-Acting Antivirals (DAAs) | 12 months following HCV diagnosis | Measured by indication of completion of treatment with DAAs among those identified with active HCV |
| Completion of an evaluation by an HCV treatment expert | 12 months following HCV diagnosis | Measured by indication of a completed visit with an HCV treatment expert among those identified with active HCV |
| Fibrosis staging | 12 months following HCV diagnosis | Measured by standard of care fibrosis staging approaches (e.g. biopsy, ultrasound, FibroTest, etc.) among those identified with active HCV |
Countries
United States
Outcome results
None listed