1VA San Diego Healthcare System, San Diego, CA; University of California, San Diego, San Diego, CA. Electronic address: email@example.com.
2James J. Peters VA Medical Center, Bronx, NY; Icahn School of Medicine at Mount Sinai, New York, NY.
3VA Palo Alto Healthcare System, Palo Alto, CA; Stanford University, Stanford, CA.
4VA San Diego Healthcare System, San Diego, CA; University of California, San Diego, San Diego, CA.
5VA San Diego Healthcare System, San Diego, CA.
6VA Palo Alto Healthcare System, Palo Alto, CA.
7James J. Peters VA Medical Center, Bronx, NY.
8Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA; Boston University, Boston, MA.
BACKGROUND AND AIMS:
Patients with hepatitis C virus (HCV) infection with psychiatric disorders and/or substance abuse face significant barriers to antiviral treatment. New strategies might be needed to improve treatment rates and outcomes. We investigated whether an integrated care (IC) protocol, which includes multi-disciplinary care coordination and patient case management, could increase the proportion of patients with chronic HCV infection who receive antiviral treatment (a combination of interferon-based and direct acting antiviral agents) and achieve a sustained virologic response (SVR).
We performed a prospective, randomized trial at 3 medical centers in the US. Participants (n=363 patients attending HCV clinics) had been screened and tested positive for depression, post-traumatic stress disorder, and/or substance use; they were randomly assigned (1:1) to groups that received IC or usual care (controls) from March 2009 through February 2011. A mid-level mental health practitioner was placed in each HCV clinic to provide IC with brief mental health interventions and case management, according to formal protocol. The primary endpoint was SVR.
Of the study participants, 63% were non-White, 51% were homeless in the last 5 years, 64% had psychiatric illness, 65% were substance abusers within 1 year before enrollment, 57% were at risk for post-traumatic stress disorder, 71% had active depression, 80% were infected with HCV genotype 1, and 23% had advanced fibrosis. Over a mean follow-up period of 28 months, a greater proportion of patients in the IC group began receiving antiviral therapy (31.9% vs 18.8% for controls; P=.005) and achieved a SVR (15.9% vs 7.7% of controls; odds ratio=2.26; 95% confidence interval, 1.15-4.44; P=.018). There were no differences in serious adverse events between groups.
Integrated care increases the proportions of patients with HCV infection and psychiatric illness and/or substance abuse who begin antiviral therapy and achieve SVRs, without serious adverse events.