An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

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.
    

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.
    

Intervention name(s): Integrated care model; Usual Care Model
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hepatitis C; integrated care; alpha interferon; mental health