Hepatocellular CarcinomaNCT04248816
Hepatocellular Carcinoma Surveillance in Cirrhotics
A study testing Opt-out and Opt-out + Incentive in people with Hepatocellular Carcinoma and Cirrhosis, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cirrhosis
- What is being tested?
- Opt-out and Opt-out + Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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).
Read the 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
- Being tested
- Usual care, Opt-out, Opt-out + Incentive
- Keywords
- Behavioral Economics, Screening, Outreach
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Subjects will receive outreach through their providers as is standard of care.
Opt-outBehavioural
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 + IncentiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Experimental | Standard of care Receives: Behavioral: Usual care |
| Opt-out | Experimental | Facilitated outreach and opt-out framing Receives: Behavioral: Opt-out |
| Opt-out + Incentive | Experimental | Facilitated outreach and opt-out framing plus a financial incentive Receives: Behavioral: Opt-out + Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC Screening Completion
The percentage of subjects who have a surveillance abdominal ultrasound.
Measured: 6 months
Secondary outcomes (1)
HCC Screening Method
The percentage of subjects who have any hepatocellular carcinoma surveillance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start19 Nov 2020
- Primary completion26 Nov 2021
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
- Investigators
- Shivan Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248816
- Sponsor's protocol ID
- 834574
- Other IDs
- 5P30AG03456-10
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2020
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04248816
- Acronym / sponsor ID
- 834574
- Conditions
- Hepatocellular Carcinoma, Cirrhosis
- Keywords
- Behavioral Economics, Screening, Outreach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 14 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Experimental | Behavioral: Usual careStandard of care |
| Opt-out | Experimental | Behavioral: Opt-outFacilitated outreach and opt-out framing |
| Opt-out + Incentive | Experimental | Behavioral: Opt-out + IncentiveFacilitated outreach and opt-out framing plus a financial incentive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careSubjects will receive outreach through their providers as is standard of care. | Behavioural | Usual Care |
| Opt-outResearch 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. | Behavioural | Opt-out |
| Opt-out + IncentiveResearch 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. | Behavioural | Opt-out + Incentive |
Primary outcome
HCC Screening Completion
Time frame: 6 months
The percentage of subjects who have a surveillance abdominal ultrasound.
1 secondary outcome
HCC Screening Method
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shivan Mehta, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-out and Opt-out + Incentive in people with Hepatocellular Carcinoma and Cirrhosis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC Screening Completion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.