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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG03456-10 | Other Grant/Funding Number | National Institute on Aging |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Experimental | Standard of care |
|
| Opt-out | Experimental | Facilitated outreach and opt-out framing |
|
| Opt-out + Incentive | Experimental | Facilitated outreach and opt-out framing plus a financial incentive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | Subjects will receive outreach through their providers as is standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCC Screening Completion | The percentage of subjects who have a surveillance abdominal ultrasound. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HCC Screening Method | The percentage of subjects who have any hepatocellular carcinoma surveillance. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HCC Screening Completion | The percentage of subjects who have a surveillance abdominal ultrasound. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
6 months
Adverse events were not monitored or assessed as the intervention involves receiving a gift card and/or a letter by mail. Receiving mail has few risks and is unlikely to cause serious adverse events. No drug, medical device or medical procedure was under investigation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shivan Mehta | University of Pennsylvania | 215-898-6027 | shivan.mehta@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2021 | Nov 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Opt-out | Behavioral | 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 + Incentive | Behavioral | 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. |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
|
|
| Secondary | HCC Screening Method | The percentage of subjects who have any hepatocellular carcinoma surveillance. | Posted | Number | 95% Confidence Interval | Percentage of patients | 6 months |
|
|
|
| 2 |
| 123 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 6 | 245 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 12 | 247 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |