The online version of this article (https://doi.org/10.1186/s12888-018-1594-1) contains supplementary material, which is available to authorized users.
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.
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.
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.
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.
Clinical Trial Registry: NCT01181960. Registered 12 August 2010.
Additional file 1: Table S1. Ethics committees by study site. (DOCX 13 kb)12888_2018_1594_MOESM1_ESM.docx
Additional file 2: Table S2. Outpatient utilization at enrollment and at the 12-month follow-up visit. (DOCX 14 kb)12888_2018_1594_MOESM2_ESM.docx
Additional file 3: Figure S1. Mean change from baseline (enrollment) in Lehman’s Quality of Life Interview scores (12-month follow-up visit). APT, antipsychotic therapy; LAI, long-acting injectable (includes paliperidone palmitate long-acting injectable and risperidone long-acting injectable); QOLI, Quality of Life Interview. Total LAI APT = LAI new users + LAI continuous users. (EPS 2025 kb)12888_2018_1594_MOESM3_ESM.eps
Additional file 4: Figure S2. Mean change from baseline in social engagement and patient–caregiver engagement (12-month follow-up visit). APT, antipsychotic therapy; LAI, long-acting injectable (includes paliperidone palmitate long-acting injectable and risperidone long-acting injectable); QOLI, Quality of Life Interview. Total LAI APT = LAI new users + LAI continuous users. (EPS 2044 kb)12888_2018_1594_MOESM4_ESM.eps
National Council for Community Behavioral Healthcare. Advancing standards of care for people with schizophrenia: Pilot program outcomes & case studies. http://www.thenationalcouncil.org/wp-content/uploads/2012/11/Advancing-Care-for-Schizophrenia-Final-Report-1.pdf. March 2012. Accessed 13 Dec 2017.
Haller CS, Padmanabhan JL, Lizano P, Torous J, Keshavan M. Recent advances in understanding schizophrenia. F1000Prime Rep. 2014;6:–57.
National Insitute of Mental Health. Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Updated February 2016. Accessed 13 Dec 2017.
Gopal S, Hough DW, Xu H, Lull JM, Gassmann-Mayer C, Remmerie BM, et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010;25:247–56. CrossRefPubMed
Risperdal Consta (risperidone) long-acting injection [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; February 2017.
Invega Sustenna (paliperidone palmitate) extended-release injectable suspension, for intramuscular use [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; June 2017.
Parellada E. Long-acting injectable risperidone in the treatment of schizophrenia in special patient populations. Psychopharmacol Bull. 2007;40:82–100. PubMed
Fu DJ, Turkoz I, Simonson RB, Walling DP, Schooler NR, Lindenmayer JP, et al. Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. J Clin Psychiatry. 2015;76:253–62. CrossRefPubMed
Prikryl R, Prikrylova KH, Vrzalova M, Ceskova E. Role of long-acting injectable second-generation antipsychotics in the treatment of first-episode schizophrenia: a clinical perspective. Schizophr Res Treatment. 2012;2012:764–9. CrossRef
Altamura AC, Aguglia E, Bassi M, Bogetto F, Cappellari L, De Giorgi S, et al. Rethinking the role of long-acting atypical antipsychotics in the community setting. Int Clin Psychopharmacol. 2012;27:336–49. PubMed
Olivares JM, Peuskens J, Pecenak J, Resseler S, Jacobs A, Akhras KS, e-STAR Study Group. Clinical and resource-use outcomes of risperidone long-acting injection in recent and long-term diagnosed schizophrenia patients: results from a multinational electronic registry. Curr Med Res Opin. 2009;25:2197–206. CrossRefPubMed
Crivera C, DeSouza C, Kozma CM, Dirani RD, Mao L, Macfadden W. Resource utilization in patients with schizophrenia who initiated risperidone long-acting therapy: results from the schizophrenia outcomes utilization relapse and clinical evaluation (SOURCE). BMC Psychiatry. 2011;11:168. CrossRefPubMedPubMedCentral
Lambert T, Olivares JM, Peuskens J, DeSouza C, Kozma CM, Otten P, et al. Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium. Ann General Psychiatry. 2011;10:10. CrossRef
Lehman AF. Assessment of quality-of-life outcomes in schizophrenic patients. Am J Manag Care. 1999;5:S612–9. PubMed
Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV social and occupational functioning assessment scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000;101:323–9. PubMed
Barrio P, Batalla A, Castellvi P, Hidalgo D, Garcia M, Ortiz A, et al. Effectiveness of long-acting injectable risperidone versus oral antipsychotics in the treatment of recent-onset schizophrenia: a case-control study. Int Clin Psychopharmacol. 2013;28:164–70. PubMed
- The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia
David M. Biondi
- BioMed Central