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An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes

NCT00722423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2015-10-15

Study results available
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Summary

This is a prospective randomized controlled trial comparing two different clinic models for patients with hepatitis C. These patients commonly have mental health problems that are barriers to receiving HCV treatment. Patients giving informed consent will be randomized to a usual care HCV clinic vs. a HCV clinic with the addition of an on-site mental health practitioner who will address psychiatric and substance use issues with the goal of enabling patients to undergo effective antiviral therapy. The major outcome of the study is the number of patients in each group who are "cured" with antiviral therapy. Patients in both groups receive current standard of care.

Conditions

  • Hepatitis C

Interventions

BEHAVIORAL

Integrated care model

The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.

BEHAVIORAL

Usual Care Model

Sponsors & Collaborators

Principal Investigators

  • Samuel B Ho, MD · VA San Diego Healthcare System, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-07-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00722423 on ClinicalTrials.gov