HCC, HCV, Hepatitis C, Hepatocellular Carcinoma
Conditions
Keywords
Sustained Virological Response, SVR, patient navigation, screening, HCC, HCV
Brief summary
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.
Interventions
BEHAVIORALAutomated reminders
At the time consent is obtained, members of the research team will collect data about how a subject prefers to be contacted for automated reminders (i.e. text messages, postcard, email, MyChart)
BEHAVIORALPatient navigation
The patient navigator will attempt to provide a reminder to the subject one to three days before the scheduled imaging and also offer to accompany the subject to the test.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCC screening rates | every 6 months until death - average of 5 years | Ratio of Number of on-time screening visits to number of missed screening visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to HCC Surveillance | every 6 months until death - average of 5 years | Percentage for patients completing timely screening visit |
| Rates of HCC | every 6 months until death - average of 5 years | New incidences of HCC |
| Incidence of Death | every 6 months until death - average of 5 years | Incidence of death |
| Incidence of liver transplant | every 6 months until death - average of 5 years | — |
Countries
United States
Outcome results
None listed