Samuel B Ho1, Norbert Bräu2, Ramsey Cheung3, Lin Liu4, Courtney Sanchez5, Marisa Sklar5, Tyler E Phelps6, Sonja G Marcus7, Michelene M Wasil5, Amelia Tisi7, Lia Huynh8, Shannon K Robinson9, Allen L Gifford10, Steven M Asch11, Erik J Groessl12. 1. Gastroenterology Section, Medicine Service, VA San Diego Healthcare System, San Diego, California; Division of Gastroenterology, Department of Medicine, University of California, San Diego, San Diego, California. Electronic address: samuel.ho2@va.gov. 2. Infectious Disease Section, James J. Peters VA Medical Center, Bronx, New York; Divisions of Infectious Disease and Liver Disease, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Gastroenterology Section, Medicine Service, VA Palo Alto Healthcare System, Palo Alto, California; Division of Gastroenterology and Hepatology, Stanford University, Stanford, California. 4. Division of Biostatistics, Department of Family Medicine and Public Health, University of California, San Diego, San Diego, California. 5. Research Service, VA San Diego Healthcare System, San Diego, California. 6. Gastroenterology Section, Medicine Service, VA Palo Alto Healthcare System, Palo Alto, California. 7. Research Service, James J. Peters VA Medical Center, Bronx, New York. 8. Research Service, VA Palo Alto Healthcare System, Palo Alto, California. 9. Department of Psychiatry, VA San Diego Healthcare System, San Diego, California; Department of Psychiatry, University of California, San Diego, San Diego, California. 10. Infectious Disease Section, Medicine Service, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts; Departments of Health Policy and Management and Medicine, Boston University, Boston, Massachusetts. 11. Research Service, VA Palo Alto Healthcare System, Palo Alto, California; Division of General Medical Disciplines, Department of Medicine, Stanford University, Stanford, California. 12. Division of Health Services Research & Development, Research Service, VA San Diego Healthcare System, San Diego, California; Division of Behavioral Medicine, Department of Family Medicine and Public Health, University of California, San Diego, San Diego, California.
Abstract
BACKGROUND & AIMS:Patients with hepatitis C virus (HCV) infection with psychiatric disorders and/or substance abuse face significant barriers to antiviral treatment. New strategies are needed to improve treatment rates and outcomes. We investigated whether an integrated care (IC) protocol, which includes multidisciplinary care coordination and patient case management, could increase the proportion of patients with chronic HCV infection who receiveantiviral treatment (a combination of interferon-based and direct-acting antiviral agents) and achieve a sustained virologic response (SVR). METHODS: We performed a prospective randomized trial at 3 medical centers in the United States. 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 assigned randomly to groups that received IC or usual care (controls) from March 2009 through February 2011. A midlevel mental health practitioner was placed at each HCV clinic to provide IC with brief mental health interventions and case management, according to formal protocol. The primary end point was SVR. RESULTS:Of the study participants, 63% were non-white, 51% were homeless in the past 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. CONCLUSIONS: Integrated care increases the proportion of patients with HCV infection and psychiatric illness and/or substance abuse who begin antiviral therapy and achieve SVRs, without serious adverse events. ClinicalTrials.gov # NCT00722423.
RCT Entities:
BACKGROUND & AIMS:Patients with hepatitis C virus (HCV) infection with psychiatric disorders and/or substance abuse face significant barriers to antiviral treatment. New strategies are needed to improve treatment rates and outcomes. We investigated whether an integrated care (IC) protocol, which includes multidisciplinary 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). METHODS: We performed a prospective randomized trial at 3 medical centers in the United States. 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 assigned randomly to groups that received IC or usual care (controls) from March 2009 through February 2011. A midlevel mental health practitioner was placed at each HCV clinic to provide IC with brief mental health interventions and case management, according to formal protocol. The primary end point was SVR. RESULTS: Of the study participants, 63% were non-white, 51% were homeless in the past 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. CONCLUSIONS: Integrated care increases the proportion of patients with HCV infection and psychiatric illness and/or substance abuse who begin antiviral therapy and achieve SVRs, without serious adverse events. ClinicalTrials.gov # NCT00722423.
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