Improving Inpatient Screening for Hepatitis C

Not Applicable

Completed

• Conditions: Hepatitis C
• Interventions: Behavioral: Nudge

• Registration Number: NCT04525690
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-25
• Study Start: 2020-09-21
• Primary Completion: 2021-04-10
• Study Completion: 2021-04-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7634

Inclusion Criteria

• Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
• Born between 1945 and 1965

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Exclusion Criteria

• Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCV Screening Default-2 Hospitals Crossed Over	Nudge	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.
HCV Screening Default-1 Hospital Crossed Over	Nudge	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

Primary Outcome Measures

Name	Time	Method
Change in percentage of eligible patients that receive HCV antibody screening	6 months	The change in the percentage of eligible hospitalized patients that receive HCV antibody screening

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States