Clinical trial NCT04248816: Hepatocellular Carcinoma Surveillance in Cirrhotics
Official title: Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Cirrhosis
Keywords: Behavioral Economics
Screening
Outreach
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-01-30
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

Detailed description: There is a substantial burden of HCC-related morbidity and mortality: The age-adjusted incidence rates of HCC have tripled in the US since the 1980s due to the burden of hepatitis C virus (HCV) and the epidemic of non-alcoholic fatty liver disease (NAFLD). The overwhelming majority of HCC in the US occurs in the setting of cirrhosis. Early diagnosis of HCC dictates survival: The American Association for the Study of Liver Diseases (AASLD) recommends biannual HCC surveillance for all patients with cirrhosis using an abdominal ultrasound. These guidelines seek to maximize early diagnosis of HCC which leads to earlier detection and improved survival because early-stage HCC is curable, with 70% 5-year survival compared to 5% in advanced disease.

HCC surveillance rates are suboptimal: Despite longstanding published guidelines for HCC surveillance, adherence is low, with surveillance rates ranging from 15-30% in the US. Two RCTs have tested interventions to increase HCC surveillance, including electronic reminders for primary care providers and mailed reminders (with or without navigators), but neither has been scalable, produced durable responses, or increased surveillance rates above 50%.

This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

Eligibility criteria: Inclusion Criteria:

* Patients who are 18+ years old
* Current diagnosis of cirrhosis or advanced fibrosis
* 1 or more visits to a Penn Gastroenterology/Hepatology practice in the preceding two years
* Currently followed by Penn Gastroenterology/Hepatology
* Must live in the Philadelphia Metropolitan Statistical Area

Exclusion Criteria:

* History of HCC or other liver carcinoma diagnosis
* History of liver transplant
* Completed HCC screening within the past 7 months
* Have a future screening scheduled
* Have a different screening modality recommended by their physician (MRI, CT, etc.)
* Patients with metastatic cancer
* Patients receiving hospice care

Primary outcomes:
measure: HCC Screening Completion
timeFrame: 6 months
Secondary outcomes:
measure: HCC Screening Method
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: