Abstract
BackgroundBipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. Pharmacists can contribute to the management of BD-I, mainly with the use of effective and safe drugs, and improve the patient’s life quality through pharmaceutical care. Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses; however, to our knowledge, there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD. The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I.Methods/designRandomized, controlled, prospective, single-center clinical trial with duration of 12 months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic. Patients diagnosed with BD-I aged between 18 and 65 years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic (Antioquia, Colombia) will be included. Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists, or into the control group who will receive usual care and verbal-written counseling regarding BD. Study outcomes will be assessed at baseline and at 3, 6, 9, and 12 months after randomization. The primary outcome will be to measure the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits. Effectiveness, safety, adherence, and quality of life will be assessed as secondary outcomes. Statistical analyses will be performed using two-tailed McNemar tests, Pearson chi-square tests, and Student’s t-tests; a P value <0.05 will be considered as statistically significant.DiscussionAs far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence.Trial registrationRegistration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011.
Highlights
Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals
As far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with Bipolar disorder (BD)-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence
Study setting The study is conducted in outpatients with BD-I who attend psychiatric consultation in the Hospital Order San Juan de Dios, which belongs to the San Juan de Dios Clinic (SJDC), an institution recognized for its dedication to mental illness care
Summary
Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. With the goal of contributing to controlling, reducing, and improving the current and future conditions of patients with any kind of mental disorder, there is a need for monitoring and following up on the outcomes obtained by psychiatrists using drug therapy [2]. These proposals should involve all phases of the health-disease process: education, mental health promotion, prevention, diagnosis, treatment, and rehabilitation of mental illness [2]. The bipolar spectrum (BD-I, BD-II, cyclothymia, and others not specified) varies from 3% to 6.5% [8]
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