An Integrated Care Model for Improving HCV Patient Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00722423
First received: July 23, 2008
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Hepatitis C
Behavioral: Integrated care model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An Integrated Care Model for Improving HCV Patient Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • sustained virologic response rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Additional year added to VA San Diego site only.


Secondary Outcome Measures:
  • antiviral treatment rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Additional year added to VA San Diego site only.

  • depression scores [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Additional year added to VA San Diego site only.

  • substance abuse rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Additional year added to VA San Diego site only.


Estimated Enrollment: 448
Study Start Date: May 2009
Study Completion Date: May 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
integrated care
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.

Detailed Description:

Impact for Veterans: Treatments are available that can often eliminate the hepatitis C virus (HCV) in infected veterans, resulting in increased life expectancy and quality of life. However, many veterans do not get treated or fail treatment because of a variety of factors. Using a new protocol-based model of care that centers around integrating psychiatric care and case management into VA HCV clinics, it may be possible to increase treatment rates, improve rates of sustained viral response (SVR), and improve health outcomes for veterans with hepatitis C.

Background: The prevalence of hepatitis C virus (HCV) infection among VA patients is 3x higher than in the general population. VA patients with HCV have characteristics linked to increased risk for progression to cirrhosis, such as male sex, high body mass index, tobacco or marijuana use, and a history of heavy alcohol use. Antiviral treatment is the only evidence-based treatment that has been shown to eradicate the HCV virus and reduce the progression of liver fibrosis. However, recent VA data indicate that only about 14% of all HCV-infected VA patients have ever received antiviral therapy. Barriers to receiving antiviral treatment include factors such as pre-existing psychiatric illness, ongoing substance abuse, and other medical co-morbidity. Patients with psychiatric and substance use histories have benefitted from an integrated care approach to HCV care, but a more rigorous study design is required to demonstrate effectiveness.

Primary Objective: To determine the effectiveness of a protocol-based integrated care model for increasing treatment rates and the number of patients with successful antiviral treatment as measured by an increase in percentage of all new HCV patients achieving a sustained virologic response (SVR). We hypothesize that this model will increase the proportion of patients who are fully evaluated for treatment, who initiate treatment, and who complete treatment compared with patients that receive usual care. Secondary Objectives: Assess the effects of an integrated care model on patient involvement in care (appointment attendance) and PROs (substance abuse, depression, anxiety). We hypothesize that veterans managed with the integrated care model will have better attendance at HCV clinic appointments, have improved rates of drug and alcohol abstinence, and fewer psychological symptoms.

Project Methods: The intervention is an integrated clinical care model developed and initially studied at the Minneapolis VA HCV Clinic. The preliminary study found that integrated care resulted in higher treatment rates, higher SVRs, reduced substance use, and improved psychological functioning. Thus, we will use a more rigorous randomized design to study the effectiveness of this intervention at 3 major VA medical centers. All clinic patients will be screened for depression, anxiety, PTSD, or recent SUDs and all patients that screen positive on 1 or more of these measures will be asked to participate. Preliminary data suggest that 85% of HCV clinic patients screen positive on at least one measure. Eligible patients will be randomized to either usual or integrated care at each site. 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. Clinical data will be obtained from VA medical records by the study coordinator at each site. PROs will be assessed using validated measures. Data will be analyzed using hierarchical linear modeling (HLM) techniques.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C. This is defined as the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C PCR test that is compatible with chronic hepatitis. (Note: no requirement is made for the presence of abnormal liver function tests).
  • Patients may be treatment na ve or have received and failed prior antiviral treatment.
  • Age 18-75 years.
  • Patient must be able to give informed consent.
  • All antiviral treatments are administered according to accept standards of care at each site, with appropriate pre-treatment evaluation and on-treatment management and precautions. Liver biopsies are an accepted standard of care for patients with chronic hepatitis C and are obtained as clinically indicated.
  • Patients must meet screening criteria for "high risk" for mental health and substance use problems. "High risk HCV patient" is defined as a patient with BDI-II>10 at screening; active drug use indicated by positive urine screen, self-reported use within 6 months on drug use questionnaire or AUDIT-C test >4, or positive PTSD screen.

Exclusion Criteria:

  • Patient unable or unwilling to participate.
  • Decompensated liver disease, with active or recent encephalopathy, variceal bleeding, or ascites or CHILD-PUGH class B or C. (Note: patients with a history of decompensated cirrhosis in the past with resolution who are otherwise antiviral treatment candidates in the opinion of the treating physician will be considered candidates.)
  • Other significant near term life-threatening diseases (malignancy, unstable angina, severe chronic obstructive pulmonary disease, pulmonary fibrosis, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722423

Locations
United States, California
VA Palo Alto Health Care System (154C)
Palo Alto, California, United States, 94304-1290
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: Samuel B Ho, MD VA San Diego Healthcare System, San Diego
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00722423     History of Changes
Other Study ID Numbers: IIR 07-101
Study First Received: July 23, 2008
Last Updated: May 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hepatitis C
integrated care
alpha interferon
mental health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 20, 2014