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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT02833298

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma HCC Hepatitis C HCV	Behavioral: Automated reminders Behavioral: Patient navigation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Automated reminders Patient will be contacted for automated reminders within one month before the six-month interval indicating they are due for HCC screening.	Behavioral: Automated 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)
Experimental: 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.	Behavioral: Patient 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.

Arm

Intervention/Treatment

Experimental: Automated reminders

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

Behavioral: Automated 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)

Experimental: 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.

Behavioral: Patient 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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.