Hepatocellular Carcinoma Surveillance in Cirrhotics

NCT ID: NCT04248816

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 615 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2022-02-14

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).

Conditions

Hepatocellular Carcinoma; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Standard of care

Group Type: EXPERIMENTAL

Usual care

Intervention Type: BEHAVIORAL

Subjects will receive outreach through their providers as is standard of care.

Opt-out

Facilitated outreach and opt-out framing

Group Type: EXPERIMENTAL

Opt-out

Intervention Type: BEHAVIORAL

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

Facilitated outreach and opt-out framing plus a financial incentive

Group Type: EXPERIMENTAL

Opt-out + Incentive

Intervention Type: BEHAVIORAL

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.

Interventions

Usual care

Subjects will receive outreach through their providers as is standard of care.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Shivan J Mehta

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5P30AG03456-10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

834574

Identifier Type: -

Identifier Source: org_study_id