Hepatocellular Carcinoma Surveillance in Cirrhotics

Study Overview
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Brief Summary
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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
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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).

Official Title
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Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients

Conditions
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Hepatocellular Carcinoma, Cirrhosis

Intervention / Treatment
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* Behavioral: Usual care
* Behavioral: Opt-out
* Behavioral: Opt-out + Incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Economics, Screening, Outreach