Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study.

BACKGROUND: Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I.

OBJECTIVE: To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up.

METHODS: This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255).

RESULTS: 92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group.

CONCLUSIONS: Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I.

DISCLOSURES: This study received funding from the Universidad de Antioquia, Committee for Development Research and Sustainability Program, CODI, (2013-2014 and 2014-2015). Humax Pharmaceutical provided support for the initial development of the EMDADER-TAB trial without commercial interest in the outcomes derived from the trial. Salazar-Ospina reports grants from Credito Beca Francisco José de Caldas Scholarship for Doctoral Programs (528), which also contributed to the support of this study. González-Avendaño is an employee of Humax Pharmaceutical. The other authors have nothing to disclose. Study concept and design were contributed by Benjumea, Faus, and Rodriguez, along with Salazar-Ospina and Amariles. Salazar-Ospina took the lead in data collection, assisted by González-Avendaño, and data interpretation was performed by Salazar-Ospina, Hincapié-García, and González-Avendaño. The manuscript was written primarily by Salazar-Ospina, with assistance from Amariles and González-Avendaño, and revised by all the authors.