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

NCT02833298 | Completed DMC

• 1 other identifier: GCO 16-1542
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; HCC; Hepatitis C; HCV

Keywords

Sustained Virological Response; SVR; patient navigation; screening; HCC; HCV

Outcome Measures

Primary Outcomes (1)

• HCC screening rates

  Ratio of Number of on-time screening visits to number of missed screening visits

  every 6 months until death - average of 5 years

Secondary Outcomes (4)

• Adherence to HCC Surveillance

  every 6 months until death - average of 5 years

• Rates of HCC

  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

Study Arms (2)

Automated reminders

EXPERIMENTAL

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

Patient navigation

EXPERIMENTAL

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

Interventions

Automated reminders BEHAVIORAL

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)

Automated reminders

Patient navigation BEHAVIORAL

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.

Patient navigation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ponni Perumalswami, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)