Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

Summary

Participation Requirements

Description

Hepatocellular cancer (HCC) is the most common (? 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (1...

Hepatocellular cancer (HCC) is the most common (? 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas residents notably Hispanics and African Americans are greatly affected with established HCC risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease. Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic fatty liver disease (NAFLD), are exceptionally common in Texans. The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and suffering related to liver cancer in Texas and the world through five research projects. This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized controlled trial of strategies to increase HCC surveillance. This is the first multi-center outreach intervention aimed at improving surveillance process completion among at-risk patients with cirrhosis. This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. Across these 3 sites, we will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests. This study uses an EMR-enabled case-finding algorithm to identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized cirrhosis, using laboratory data. Over 3000 patients identified by this algorithm will be randomized to: Group 1: Usual care with opportunistic visit-based HCC surveillance. Group 2: Mailed HCC surveillance outreach with patient education and patient navigation services. The Specific Aims are: Aim 1: Compare the clinical effectiveness of the intervention strategies to increase completion of the HCC surveillance process. Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance strategies. Aim 3: Evaluate whether intervention effects are moderated by patient sex, race/ethnicity, socioeconomic status, health care utilization, and documented vs. unrecognized cirrhosis.

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