跳至主要内容
临床试验/NCT04248816
NCT04248816已完成不适用

Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 615 人开始时间: 2020年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
615
试验地点
2
主要终点
HCC Screening Completion

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

HCC Screening Completion

时间窗: 6 months

The percentage of subjects who have a surveillance abdominal ultrasound.

次要结局

  • HCC Screening Method(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shivan J Mehta

Assistant Professor of Medicine

University of Pennsylvania

研究点 (2)

Loading locations...

相似试验