Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- HCC screening rates
研究概览
简要总结
Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV) infection in the United States have advanced liver disease. Patients with advanced fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are clinically cured of HCV continue to have an elevated risk of developing hepatocellular carcinoma (HCC). According to guidelines from several professional societies and from the American Association for the Study of Liver Diseases (AASLD), in particular, patients with advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening has risen dramatically in recent years due to the confluence of three factors: Increased screening for HCV, which has allowed more people to realize that they have this often "silent" infection; the availability of safe and highly effective direct acting antiviral drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to achieve an SVR; and the long duration of HCV infection in many patients, which has allowed enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in the era of DAAs and to promote HCC screening, the objective of this study is to conduct a randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC screening between patients randomized to either personalized patient navigation or automated reminders (e.g. electronic or mailed). Both interventions represent improved care over current standard of care (no patient navigation or automated reminders). There is no evidence to suggest one intervention is better than the other. Healthcare providers who agree to participate in the study will be contacted to confirm the liver disease status of their patients and during the clinical trial the providers of patients in both arms of the trial will be sent reminders about the need to schedule patients for screening visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥21 years old
- •history of HCV infection treated in 2011 or after with direct acting antiviral therapy
- •achieved ≥SVR-12 as defined as no detectable virus 12 weeks or longer after the cessation of therapy
- •FIB-4 ≥3.25
- •no history of HCC prior to treatment
- •HCV provider deems a subject eligible for HCC surveillance according to AASLD criteria
- •able to understand and speak English
- •willing to sign the informed consent
- •have a working phone number or e-mail to reach them
- •no history of liver transplantation.
排除标准
- 未提供
研究组 & 干预措施
Automated reminders
Patient will be contacted for automated reminders within one month before the six-month interval indicating they are due for HCC screening.
干预措施: Automated reminders (Behavioral)
Patient navigation
The patient navigator will coordinate with the provider and subject to schedule the appropriate office visit and imaging for HCC screening as needed within one month before the test is due.
干预措施: Patient navigation (Behavioral)
结局指标
主要结局
HCC screening rates
时间窗: every 6 months until death - average of 5 years
Ratio of Number of on-time screening visits to number of missed screening visits
次要结局
- Adherence to HCC Surveillance(every 6 months until death - average of 5 years)
- Incidence of Death(every 6 months until death - average of 5 years)
- Incidence of liver transplant(every 6 months until death - average of 5 years)
- Rates of HCC(every 6 months until death - average of 5 years)
