Hepatocellular Carcinoma Surveillance in Cirrhotics

Hepatocellular Carcinoma Clinical Trial

Official title:

Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248816
• Other study ID #: 834574
• Secondary ID: 5P30AG03456-10
• Status: Completed
• Phase: N/A
• Start date: November 19, 2020
• Est. completion date: February 14, 2022

Study information

• Verified date: January 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: February 14, 2022
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma

Intervention

Behavioral:
• Usual care
Subjects will receive outreach through their providers as is standard of care.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC Screening Completion	The percentage of subjects who have a surveillance abdominal ultrasound.	6 months
Secondary	HCC Screening Method	The percentage of subjects who have any hepatocellular carcinoma surveillance.	6 months