Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 7,634
- Locations
- 1
- Primary Endpoint
- Change in percentage of eligible patients that receive HCV antibody screening
Study Overview
Brief Summary
This study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening.
Detailed Description
The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the United States, but direct-acting antiviral medications are now available and can cure the disease in over 95% of those that are treated. The Centers for Disease Control and Prevention (CDC) estimate that 75% of all chronic HCV infections in the United States are among adults born between 1945 and 1965. The CDC and US Preventive Services Task Force (USPTF) therefore recommends birth cohort screening for all adults born in this time period. In 2016, the Commonwealth of Pennsylvania signed into law a requirement that all hospitalized patients born during this time period be offered HCV screening. In this study, a stepped-wedge cluster randomized clinical trial will be conducted to test the effect of defaulting HCV screening into the admission order set to improve screening rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The principal study investigator and data analyst will not have knowledge of when the hospital sites are randomized to the intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
- •Born between 1945 and 1965
Exclusion Criteria
- •Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.
Arms & Interventions
HCV Screening Default-1 Hospital Crossed Over
Upon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening
Intervention: Nudge (Behavioral)
HCV Screening Default-2 Hospitals Crossed Over
Upon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening.
Intervention: Nudge (Behavioral)
Outcomes
Primary Outcomes
Change in percentage of eligible patients that receive HCV antibody screening
Time Frame: 6 months
The change in the percentage of eligible hospitalized patients that receive HCV antibody screening
Secondary Outcomes
No secondary outcomes reported