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Abstract Background Outpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of “real-world” patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual. Methods This study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12. Results A total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort. Conclusion Descriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes. Trial registration Clinical Trial Registry: NCT01181960. Registered 12 August 2010.

Abstract Background Nonadherence to antipsychotic treatment increases the likelihood of relapse and progressive symptomatology in patients with schizophrenia. Atypical long-acting injectables, including paliperidone palmitate (PP), may increase adherence and improve symptoms. This study compared and assessed predictors of treatment patterns and symptom remission among schizophrenia patients treated with PP versus atypical oral antipsychotic therapy (OAT) in community behavioral health organizations (CBHOs). Methods This retrospective cohort analysis evaluated 763 patients with schizophrenia and new (PP-N; N = 174) or continuing (PP-C; N = 308) users of PP, or new users of OAT (N = 281) at enrollment in the REACH-OUT study (2010–2013). Treatment outcomes assessed at 1 year were discontinuation, and adherence, measured by proportion of days covered (PDC) or medication possession ratio (MPR). Remission status was assessed using the Structured Clinical Interview for Symptoms of Remission (SCI-SR). A machine learning platform, Reverse Engineering and Forward Simulation (REFS™), was used to identify predictors of study outcomes. Multivariate Cox and generalized linear regressions estimated the adjusted hazard ratios (HRs) or odds ratios (ORs) with 95% confidence intervals. Results Among PP-N users, 27% discontinued their initial treatment regimen versus 51% (p

Abstract Background Once-monthly paliperidone palmitate (PP1M) is a long-acting injectable antipsychotic that may increase adherence rates, reduce hospitalizations, and lower medical costs compared to oral atypical antipsychotics (OAAs) among schizophrenia patients. However, the impact of PP1M in recently diagnosed patients remains unknown. The present study compared adherence, healthcare resource utilization and Medicaid spending between schizophrenia patients initiating PP1M versus OAA, among patients recently diagnosed (defined using ages 18–25 years as a proxy) and among the overall population. Methods Medicaid data from five states (09/2008–03/2015) were used to identify adults with schizophrenia initiated on PP1M or OAAs (index date) on or after 09/2009. Outcomes were compared between PP1M and OAA groups following inverse probability of treatment weighting (IPTW). Univariate linear and Poisson regression models with nonparametric bootstrap procedures were used to compare the 12-month healthcare resource utilization and costs using rate ratios (RRs) and mean monthly cost differences (MMCDs), respectively. Results Overall, patients initiated on PP1M (N = 2053) were younger (mean age: 41 vs. 44 years) and had more baseline antipsychotic use (88% vs. 62%) compared to OAA patients (N = 22,247). IPTW resulted in balanced baseline characteristics. Among recently diagnosed patients, PP1M was associated with better adherence (PDC ≥ 80%: 29% vs. 21%, P