Hepatocellular Carcinoma, Cirrhosis
Conditions
Keywords
Behavioral Economics, Screening, Outreach
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).
Interventions
BEHAVIORALUsual care
Subjects will receive outreach through their providers as is standard of care.
BEHAVIORALOpt-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.
BEHAVIORALOpt-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.
Sponsors
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCC Screening Completion | 6 months | The percentage of subjects who have a surveillance abdominal ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCC Screening Method | 6 months | The percentage of subjects who have any hepatocellular carcinoma surveillance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Standard of care
Usual care: Subjects will receive outreach through their providers as is standard of care. | 116 |
| Opt-out Facilitated outreach and opt-out framing
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. | 224 |
| Opt-out + Incentive Facilitated outreach and opt-out framing plus a financial incentive
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. | 222 |
| Total | 562 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible post-randomization | 7 | 21 | 25 |
Baseline characteristics
| Characteristic | Usual Care | Opt-out | Opt-out + Incentive | Total |
|---|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 11.6 | 61.4 years STANDARD_DEVIATION 10.9 | 62.9 years STANDARD_DEVIATION 11 | 62.1 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 7 Participants | 11 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 213 Participants | 207 Participants | 526 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 88 Participants | 94 Participants | 228 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 11 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) White | 66 Participants | 116 Participants | 104 Participants | 286 Participants |
| Sex: Female, Male Female | 50 Participants | 101 Participants | 92 Participants | 243 Participants |
| Sex: Female, Male Male | 66 Participants | 123 Participants | 130 Participants | 319 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 123 | 6 / 245 | 12 / 247 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
HCC Screening Completion
The percentage of subjects who have a surveillance abdominal ultrasound.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | HCC Screening Completion | 27.6 Percentage of participants |
| Opt-out | HCC Screening Completion | 54.5 Percentage of participants |
| Opt-out + Incentive | HCC Screening Completion | 54.1 Percentage of participants |
Secondary
HCC Screening Method
The percentage of subjects who have any hepatocellular carcinoma surveillance.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | HCC Screening Method | 32.8 Percentage of patients |
| Opt-out | HCC Screening Method | 59.4 Percentage of patients |
| Opt-out + Incentive | HCC Screening Method | 57.2 Percentage of patients |