Hepatocellular Carcinoma Surveillance in Cirrhotics

Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients

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 Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Cirrhosis
• Intervention / Treatment: Behavioral: Usual care; Behavioral: Opt-out; Behavioral: Opt-out + Incentive

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 Type: Interventional
• Enrollment (Actual): 615
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Usual Care; Standard of care	Behavioral: Usual care; Subjects will receive outreach through their providers as is standard of care.
EXPERIMENTAL: Opt-out; Facilitated outreach and opt-out framing	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.
EXPERIMENTAL: Opt-out + Incentive; Facilitated outreach and opt-out framing plus a financial incentive	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC Screening Completion	The percentage of subjects who have a surveillance abdominal ultrasound.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC Screening Method	The percentage of subjects who have any hepatocellular carcinoma surveillance.	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2020
• Primary Completion (ACTUAL): November 26, 2021
• Study Completion (ACTUAL): February 14, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Behavioral Economics; Outreach
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 834574; 5P30AG03456-10 (OTHER_GRANT: National Institute on Aging)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No