Clinical trial NCT04525690: Improving Inpatient Screening for Hepatitis C
Official title: Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis C
HCV screening
nudge
defaults
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 7634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in percentage of eligible patients that receive HCV antibody screening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Percentage of patients that are HCV antibody positive
timeFrame: 9 months
measure: Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment
timeFrame: 9 months
measure: Change in the percentage of eligible patients that are viral load positive for HCV
timeFrame: 9 months
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh S Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Shivan J Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta SJ, Torgersen J, Small DS, Mallozzi CP, McGreevey JD 3rd, Rareshide CAL, Evans CN, Epps M, Stabile D, Snider CK, Patel MS. Effect of a Default Order vs an Alert in the Electronic Health Record on Hepatitis C Virus Screening Among Hospitalized Patients: A Stepped-Wedge Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222427. doi: 10.1001/jamanetworkopen.2022.2427.