NCT04248816

Hepatocellular Carcinoma Surveillance in Cirrhotics

Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatocellular Carcinoma
• Cirrhosis

Interventions

Type	Name	Description
BEHAVIORAL	Usual care	Subjects will receive outreach through their providers as is standard of care.
BEHAVIORAL	Opt-out	Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip for them to get it done at a health system facility.
BEHAVIORAL	Opt-out + Incentive	Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip plus an unconditional $20 incentive for them to get it done at a health system facility.

Timeline

• Start date: 2020-11-19
• Primary completion: 2021-11-26
• Completion: 2022-02-14
• First posted: 2020-01-30
• Last updated: 2023-02-14
• Results posted: 2023-02-14

Locations

1 site across 1 country: United States