Improving Inpatient Screening for Hepatitis C

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525690
• Other study ID #: 842718
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: April 10, 2021

Study information

• Verified date: August 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7634
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Behavioral:
• Nudge
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.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients that are HCV antibody positive	The percentage of eligible hospitalized patients that are HCV antibody positive	9 months
Other	Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment	The percentage of eligible hospitalized patients that have positive HCV testing who receive either linkage to care and/or treatment	9 months
Other	Change in the percentage of eligible patients that are viral load positive for HCV	The change in the percentage of eligible hospitalized patients that are viral load positive for HCV	9 months
Primary	Change in percentage of eligible patients that receive HCV antibody screening	The change in the percentage of eligible hospitalized patients that receive HCV antibody screening	6 months