ED Patient's Perceptions and Acceptability Toward a Novel POC HCV Viral Load Testing

Summary

Participation Requirements

Description

Johns Hopkins Emergency Department-Based Rapid HCV Screening and Linkage to Care Program Johns Hopkins Hospital Emergency Department (JHHED) has implemented an ED-based rapid HCV Screening and Linkage to Care Program since late 2015, after adapting the 2012 Centers for Disease Control and Prevention...

Johns Hopkins Emergency Department-Based Rapid HCV Screening and Linkage to Care Program Johns Hopkins Hospital Emergency Department (JHHED) has implemented an ED-based rapid HCV Screening and Linkage to Care Program since late 2015, after adapting the 2012 Centers for Disease Control and Prevention (CDC) revised HCV testing recommendations. The investigators' program utilizes an integrated, triage nurse driven model to deliver opt-out HCV testing to eligible ED patients. Eligibility was facilitated by electronic health record (EHR) prompts to identify patients over the age of 17 years and no HCV testing history at the institution. For patients who were medically/surgically stable and who did not have altered mental status, an opt-out HCV Ab test offering was delivered by staff. JHHED utilizes the blood-based anti-HCV assay (Abbott Architect) and fingerstick POC HCV assay (OraSure) for HCV Ab testing, depending on the availability of patient's whole blood drawn for his/her ED care. HCV reflex RNA testing is performed for HCV Ab reactive patients tested by blood-based HCV Ab assay. Blood specimens for HCV RNA testing are collected during the ED visit (if possible) for HCV Ab reactive patients tested by POC HCV Ab assay with confirmatory testing performed asynchronous to the ED visit. JHHED utilized dedicated linkage to care program staff that contacted ED patients with HCV Ab reactive results to deliver confirmatory results and facilitate referral to HCV care. The investigators' program staff also identify HCV Ab positive patients without HCV RNA viral load information by screening the ED tracking board (EPIC) to inform ED providers of ordering HCV RNA viral load testing which might need to have blood drawing if there is no blood work ordered in place. Routine Care All JHHED patients are eligible for HCV screening or linkage to care service under the investigators' ED-based rapid HCV Screening and Linkage to Care Program if participants are 18 years and older, no history of HCV diagnosis or testing, and do not have altered mental status. Please see the brief description of the investigators' program above. Recruitment A. Steps for recruiting participants with known HCV antibody positive but no HCV viral load data The ED HCV Screening and Linkage to Care (LTC) Program will screen the ED tracking board (EPIC) for patients who potentially meet study enrollment criteria (i.e. not possessing any exclusion criteria), which is done routinely as a part of standard of care. The ED HCV Screening and LTC team will notify the research coordinator of all eligible patients. Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study. Providers may refer eligible patients to research coordinator after getting permission from patients. Providers who are part of the investigators' study team will refer the eligible patients to research coordinator after patients agree to be approached by the investigators' research coordinator regarding the investigators' study. For providers who are not in the investigators' study team, the recruitment procedure will be that the patient's clinician will request permission from patients and document in the chart regarding the patient's permission to be contacted by the research staff. B. Steps for recruiting participants with newly diagnosed HCV antibody positive identified from ED HCV Screening and Linkage to Care Program Research coordinator will work closely with ED HCV Screening and Linkage to Care Program staff to recruit this subgroup of ED patients. Screening Program staff will notify the research coordinator via pager (or equivalent) when an ED patient is diagnosed with HCV Ab reactive result via the Screening Program. Research coordinator will then approach the treating ED clinician for his/her patients regarding the research opportunity in the investigators' study. Providers may refer eligible patients to research coordinator after getting permission from patients. Providers who are part of the investigators' study team will refer the eligible patients to research coordinator after patients agree to be approached by the investigators' research coordinator regarding the study. For providers who are not in the investigators' study team, the recruitment procedure will be that the patient's clinician will request permission from patients and document in the chart regarding the patient's permission to be contacted by the research staff. Enrollment The research coordinator will obtain oral, informed consent. The process will involve a description of the study as provided in the verbal consent form with a chance to provide answers to any questions about the study. Justification for verbal consent is provided in the electronic Institutional Review Board (e-IRB) application. Specifically, this study poses minimal risk to patients. The consent process will take between approximately 15-20 minutes, based on the requirements of the individual patient. Consented subjects will be given a copy of the oral consent document for participant's information and records. In this consent, the patient will be asked for permission to review patient's medical charts at Johns Hopkins Hospital for the clinical information of the ED visit and subsequent HCV-related visits. In addition, the patient will be asked for permission to allow the investigators to use the remnant blood specimen of this study in the future for an evaluation of an in-house HCV RNA viral load assay. Consented patients will be randomized to one of two groups, HCV POC Testing Group or Standard of Care (SOC) Group. The testing group will receive the POC HCV viral load testing via fingerstick using a novel Xpert HCV Viral Load Finger-stick (Xpert HCV VL FS) point-of-care (POC) test and the reference group will not receive this POC VL testing. Both groups will receive stand of care conventional laboratory-based whole blood HCV VL testing. Consented patients in both groups will fill out a short survey regarding participant's socio-demographic information as well as participant's experience, attitudes, and perceptions regarding HCV testing and care

Tracking Information