Hepatocellular Carcinoma Surveillance in Cirrhotics

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Cirrhosis
• Interventions: Behavioral: Usual care; Behavioral: Opt-out + Incentive; Behavioral: Opt-out

• Registration Number: NCT04248816
• Lead Sponsor: University of Pennsylvania

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).

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2020-11-19
• Primary Completion: 2021-11-26
• Study Completion: 2022-02-14
• Results First Submitted: 2022-11-22
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Results First Posted: 2023-02-14
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual care	Standard of care
Opt-out + Incentive	Opt-out + Incentive	Facilitated outreach and opt-out framing plus a financial incentive
Opt-out	Opt-out	Facilitated outreach and opt-out framing

Primary Outcome Measures

Name	Time	Method
HCC Screening Completion	6 months	The percentage of subjects who have a surveillance abdominal ultrasound.

Secondary Outcome Measures

Name	Time	Method
HCC Screening Method	6 months	The percentage of subjects who have any hepatocellular carcinoma surveillance.

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States