NCT04003454

The DETECT HCV Screening Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147,533 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis C

Interventions

Type	Name	Description
OTHER	HCV 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.

Timeline

• Start date: 2019-11-20
• Primary completion: 2023-07-31
• Completion: 2024-01-31
• First posted: 2019-07-01
• Last updated: 2025-02-06

Locations

3 sites across 1 country: United States