Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Not Applicable

Completed

• Conditions: HCC; Hepatocellular Carcinoma; Hepatitis C; HCV
• Interventions: Behavioral: Patient navigation; Behavioral: Automated reminders

• Registration Number: NCT02833298
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-14
• Study Start: 2016-11
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient navigation	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.
Automated reminders	Automated reminders	Patient will be contacted for automated reminders within one month before the six-month interval indicating they are due for HCC screening.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rates of HCC	every 6 months until death - average of 5 years	New incidences of HCC
Adherence to HCC Surveillance	every 6 months until death - average of 5 years	Percentage for patients completing timely screening visit
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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States