Hepatocellular Carcinoma Surveillance in Cirrhotics
Primary Purpose
Hepatocellular Carcinoma, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
Opt-out
Opt-out + Incentive
Sponsored by
About this trial
This is an interventional screening trial for Hepatocellular Carcinoma focused on measuring Behavioral Economics, Screening, Outreach
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
Sites / Locations
- University of Pennsylvania Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Usual Care
Opt-out
Opt-out + Incentive
Arm Description
Standard of care
Facilitated outreach and opt-out framing
Facilitated outreach and opt-out framing plus a financial incentive
Outcomes
Primary Outcome Measures
HCC Screening Completion
The percentage of subjects who have a surveillance abdominal ultrasound.
Secondary Outcome Measures
HCC Screening Method
The percentage of subjects who have any hepatocellular carcinoma surveillance.
Full Information
NCT ID
NCT04248816
First Posted
January 27, 2020
Last Updated
January 19, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04248816
Brief Title
Hepatocellular Carcinoma Surveillance in Cirrhotics
Official Title
Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
February 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Cirrhosis
Keywords
Behavioral Economics, Screening, Outreach
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Experimental
Arm Description
Standard of care
Arm Title
Opt-out
Arm Type
Experimental
Arm Description
Facilitated outreach and opt-out framing
Arm Title
Opt-out + Incentive
Arm Type
Experimental
Arm Description
Facilitated outreach and opt-out framing plus a financial incentive
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Subjects will receive outreach through their providers as is standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Opt-out
Intervention Description
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
Intervention Name(s)
Opt-out + Incentive
Intervention Description
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.
Primary Outcome Measure Information:
Title
HCC Screening Completion
Description
The percentage of subjects who have a surveillance abdominal ultrasound.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HCC Screening Method
Description
The percentage of subjects who have any hepatocellular carcinoma surveillance.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hepatocellular Carcinoma Surveillance in Cirrhotics
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