Clinical trial NCT02582918: Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
Official title: Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Liver Neoplasms
Keywords: Randomized Controlled Trial
Mass Screening
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Parkland Health and Hospital System
name: Michael E. DeBakey VA Medical Center
First posted: 2015-10-21
Enrollment: 2871
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through this project the investigators 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 at UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. The study population will include adult patients with documented or unrecognized cirrhosis and at least one outpatient clinic visit in year prior to randomization. Patients will be identified using an EMR-enabled case identification algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or, mailed HCC surveillance outreach with patient education and patient navigation services (Group 2).

Detailed 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 (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.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>21 years old)
* Documented cirrhosis
* Unrecognized cirrhosis
* An outpatient visit in year prior to randomization
* English or Spanish speaking

Exclusion Criteria:

* History of HCC
* History of liver transplantation
* Child Pugh C cirrhosis
* Significant comorbid conditions with life expectancy \< 1 year, (e.g., extrahepatic malignancy)

Primary outcomes:
measure: Completion of HCC surveillance process
timeFrame: 3 years post randomization
measure: Patient satisfaction and acceptability
timeFrame: 3 years post randomization
Secondary outcomes:
measure: Early HCC
timeFrame: 3 years post randomization
measure: One-time Screening
timeFrame: Outcomes will be adjudicated 6 months after randomization.
measure: Repeat Screening
timeFrame: Outcomes will be adjudicated 12 months after randomization.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Amit G Singal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singal AG, Reddy S, Radadiya Aka Patel H, Villarreal D, Khan A, Liu Y, Cerda V, Rich NE, Murphy CC, Tiro JA, Kramer JR, Hernaez R. Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2818-2825.e1. doi: 10.1016/j.cgh.2021.12.014. Epub 2021 Dec 10.