Hepatocellular Carcinoma Surveillance in Cirrhotics

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04248816
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 615
• Location: 1
• Arms: 3
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 41.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma; Cirrhosis	Behavioral: Usual care; Behavioral: Opt-out; Behavioral: Opt-out + Incentive	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 615 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Screening
• Official Title: Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients
• Actual Study Start Date: Nov 19, 2020
• Actual Primary Completion Date: Nov 26, 2021
• Actual Study Completion Date: Feb 14, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. HCC screening completion [6 months]

   The proportion of subjects who have a surveillance abdominal ultrasound.

Secondary Outcome Measures

1. HCC screening method [6 months]

   The proportion of subjects who have any hepatocellular carcinoma surveillance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shivan J Mehta, Assistant Professor of Medicine, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04248816
• Other Study ID Numbers: 834574; 5P30AG03456-10
• First Posted: Jan 30, 2020
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shivan J Mehta, Assistant Professor of Medicine, University of Pennsylvania: Behavioral Economics; Screening; Outreach
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Aug 1, 2022