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Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC.
Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to:
Through three specific aims, this effectiveness research randomized controlled trial will:
The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.
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As the risk of HCC is significant in those with cirrhosis regardless of age, gender, or race, we will include adult patients with cirrhosis of all ages (> 21 years old), both sexes, and all races/ethnicities who speak English or Spanish.
Our study leverages Parkland's electronic medical record (EMR) and uses a novel EMR-enabled case-finding algorithm to identify patients with known cirrhosis, using ICD-9 codes, as well as those with unrecognized but suspected cirrhosis, using a set of laboratory data.
Patients with ICD-9 codes for cirrhosis or cirrhosis complication will be eligible for study enrollment if they meet the following criteria:
Patients with an AST to platelet ratio index (APRI) > 1.5 in combination with a platelet count < 300, and aspartate aminotransferase (AST) < 1,000 during study enrollment will be eligible.
We will exclude patients who have known HCC or a suspicious appearing mass on imaging within six months prior to ascertainment of eligibility, as these patients require further diagnostic testing instead of routine screening. We will exclude patients with Child Pugh class C cirrhosis or other significant comorbid conditions with a life expectancy less than one year, (e.g., extrahepatic malignancy) because HCC screening is not recommended in these subgroups of patients.
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1,800 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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