An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes

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.

Inclusion Criteria:

- Chronic hepatitis C. This is defined as the documentation of the presence of
circulating hepatitis C virus by a positive hepatitis C Polymerase Chain Reaction
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 Beck Depression
Inventory-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.)