The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia

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.

Keywords: Antipsychotic therapy; Community behavioral health organizations; Long-acting injectable; Observational study; Paliperidone palmitate; Patient outcomes; Real world; Risperidone long-acting injectable; Schizophrenia.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by participating ethics committees and institutional review boards (all included in Additional file 1: Table S1), and was conducted in accordance with the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from all subjects prior to study enrollment.

Consent for publication

Not applicable

Competing interests

KJ and DB are employees of Janssen Scientific Affairs, LLC, and are Johnson & Johnson stockholders. LM is an employee of Janssen Research and Development, LLC, and is a Johnson & Johnson stockholder. RM, an employee of Carolina Behavioral Care, participated in the REACH-OUT study. Janssen Pharmaceuticals markets several antipsychotic medications for the treatment of schizophrenia.

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Figures

Fig. 1

Study design. APT, antipsychotic; ASI-Lite, Addiction Severity Index Lite; BL, baseline (enrollment); DAI-10, Drug Attitude Inventory 10-item scale; Dx, diagnosis; LAI, long-acting injectable (includes paliperidone palmitate long-acting injectable and risperidone long-acting injectable); MSQ, Medication Satisfaction Questionnaire; PP LAI, paliperidone palmitate long-acting injectable; RLAI, risperidone long-acting injectable; Tx, treatment. *Entered within 8 weeks of start or switch to RLAI or other antipsychotic, after >24 weeks of continuous RLAI treatment, or any time after initiation of PP LAI. †Asked of cohort that included participants newly initiated on an antipsychotic at baseline

Fig. 2

Comorbid conditions at enrollment (all patients with schizophrenia). Medical (a) and behavioral (b) comorbid conditions. APT, antipsychotic therapy; LAI, long-acting injectable (includes paliperidone palmitate long-acting injectable and risperidone long-acting injectable). Values in bars are n/N. *P < 0.05 vs oral APT

Fig. 3

Proportion of patients hospitalized by time point (all patients with schizophrenia). APT, antipsychotic therapy; LAI, long-acting injectable (includes paliperidone palmitate long-acting injectable and risperidone long-acting injectable). Values in bars are n/N. Hospitalization at enrollment was defined as patients hospitalized in the 6-month pre-enrollment period. Total LAI APT = LAI new users + LAI continuous users

Fig. 4

Proportion of patients “very satisfied” with medication at 12-month follow-up.a APT, antipsychotic therapy; LAI, long-acting injectable (includes paliperidone palmitate long-acting injectable and risperidone long-acting injectable). Values in bars are n/N. Total LAI APT = LAI new users + LAI continuous users. aAll subjects with schizophrenia