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

Primary Purpose

Hepatocellular Carcinoma, HCC, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated reminders
Patient navigation
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring Sustained Virological Response, SVR, patient navigation, screening, HCC, HCV

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Automated reminders

Patient navigation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence to HCC Surveillance
Percentage for patients completing timely screening visit
Rates of HCC
New incidences of HCC
Incidence of Death
Incidence of death
Incidence of liver transplant

Full Information

First Posted
July 12, 2016
Last Updated
October 10, 2018
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02833298
Brief Title
Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening
Official Title
Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, HCC, Hepatitis C, HCV
Keywords
Sustained Virological Response, SVR, patient navigation, screening, HCC, HCV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automated reminders
Arm Type
Experimental
Arm Description
Patient will be contacted for automated reminders within one month before the six-month interval indicating they are due for HCC screening.
Arm Title
Patient navigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Automated reminders
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Patient navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
HCC screening rates
Description
Ratio of Number of on-time screening visits to number of missed screening visits
Time Frame
every 6 months until death - average of 5 years
Secondary Outcome Measure Information:
Title
Adherence to HCC Surveillance
Description
Percentage for patients completing timely screening visit
Time Frame
every 6 months until death - average of 5 years
Title
Rates of HCC
Description
New incidences of HCC
Time Frame
every 6 months until death - average of 5 years
Title
Incidence of Death
Description
Incidence of death
Time Frame
every 6 months until death - average of 5 years
Title
Incidence of liver transplant
Time Frame
every 6 months until death - average of 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ponni Perumalswami, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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