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Completed

NCT Number: NCT04525690

Improving Inpatient Screening for Hepatitis C

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nudge

Behavioral

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.

Primary outcomes

  1. 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

Other outcomes

  1. Percentage of patients that are HCV antibody positive

    Time frame: 9 months

    The percentage of eligible hospitalized patients that are HCV antibody positive

  2. Percentage of patients that have positive HCV testing who receive either linkage to care and/or treatment

    Time frame: 9 months

    The percentage of eligible hospitalized patients that have positive HCV testing who receive either linkage to care and/or treatment

  3. Change in the percentage of eligible patients that are viral load positive for HCV

    Time frame: 9 months

    The change in the percentage of eligible hospitalized patients that are viral load positive for HCV

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2020
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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