Hepatocellular Carcinoma Surveillance in Cirrhotics

University of Pennsylvania

Status: Completed

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Behavioral: Opt-out + Incentive; Behavioral: Usual care; Behavioral: Opt-out

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04248816

834574

5P30AG03456-10 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 615 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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615 participants in 3 patient groups

Usual Care

Experimental group

Description:

Standard of care

Treatment:

Behavioral: Usual care

Opt-out

Experimental group

Description:

Facilitated outreach and opt-out framing

Treatment:

Behavioral: Opt-out

Opt-out + Incentive

Experimental group

Description:

Facilitated outreach and opt-out framing plus a financial incentive

Treatment:

Behavioral: Opt-out + Incentive