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Improving Inpatient Screening for Hepatitis C

Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04525690
Enrollment
7634
Registered
2020-08-25
Start date
2020-09-21
Completion date
2021-04-10
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, HCV screening, nudge, defaults

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.

Interventions

BEHAVIORALNudge

Clinicians will receive a default order upon entering the the admission order set. They will have the opportunity to opt-out and not order screening. Clinicians will receive the nudge each time they enter the admission order set for a new, eligible patient.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

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.

Intervention model description

Hospital sites will be cluster randomized to the intervention in 3 month blocks over 6 months, after which both sites will receive the default intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in percentage of eligible patients that receive HCV antibody screening6 monthsThe change in the percentage of eligible hospitalized patients that receive HCV antibody screening

Other

MeasureTime frameDescription
Percentage of patients that are HCV antibody positive9 monthsThe percentage of eligible hospitalized patients that are HCV antibody positive
Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment9 monthsThe percentage of eligible hospitalized patients that have positive HCV testing who receive either linkage to care and/or treatment
Change in the percentage of eligible patients that are viral load positive for HCV9 monthsThe change in the percentage of eligible hospitalized patients that are viral load positive for HCV

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026