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.