3148 — Prospective Randomized Trial of Integrated Care (IC) vs. Usual Care (UC) for Improving Access to HCV Antiviral Therapy
Ho SB, and Groessl EJ, VA San Diego Healthcare System and University of California, San Diego; Brau N, VA Medical Center, Bronx, NY; Cheung RC, VA Palo Alto Healthcare System and Stanford University; Weingart KR, Ward MA, and Sklar M, VA San Diego Healthcare System and University of California, San Diego; Phelps TE, VA Palo Alto Healthcare System; Marcus SG, VA Medical Center, Bronx, NY.; Robinson SK, VA San Diego Healthcare System and University of California, San Diego
HCV patients with psychiatric disorders and substance abuse are considered “high-risk” for initiating antiviral treatment, and new strategies may be required to increase treatment rates. We examined whether an integrated care model could increase the proportion of “high-risk” HCV patients receiving antiviral treatment in the VA system.
Prospective, randomized trial at three VA medical centers located in San Diego, CA, Bronx, NY, and Palo Alto, CA. Patients attending HCV clinics between 5/09-2/11 were recruited with routine psychiatric and substance use disorder screening instruments. A mid-level mental health practitioner was placed in each HCV clinic and provided brief mental health interventions and case management according to protocol.
A total of 1752 unique patients were screened at the three HCV clinics. Of these, 763 (43%) were eligible for antiviral treatment and “high-risk” screen positive, and 361 patients were randomized to either IC or UC. Overall patient characteristics included 63% non-White (39% African American, 18% Hispanic); 51% homeless in prior 5 years; 80% genotype 1; mean BDI score 15.34; Audit C 4+ = 27.7%; PTSD risk = 50.4%. . There was a significant increase in the number of high-risk HCV patients that initiated antiviral therapy, (25.0% IC vs. 16.6% UC) p = 0.049. Adverse event data indicate non-significant trends toward fewer hospitalizations, mean hospitalized days, and mean emergency room for IC patients. The 8 deaths in UC and 2 deaths in IC, were not related to antiviral treatment. Data for individual sites show significant differences at the San Diego site for antiviral treatment initiation (45% IC vs 24% UC) and deaths (0 in IC vs. 4 in UC). Other sites had no significant differences.
Results to date suggest that integrated care models may lead to sizable increases in antiviral treatment initiation and decreased adverse events at certain sites. These rates occurred during a widespread decreases in antiviral therapy for hepatitis C genotype 1 patients in anticipation of more effective therapies. The study will collect longer term outcomes and study the implementation science factors and limited effects at two of the sites.
Integrated care protocols can be effective in increasing HCV antiviral treatment rates in the VA system, and may be important for maximizing the impact of new direct acting antiviral regimens.