Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial

• Published in: Trials Vol. 15; no. 1; p. 174
• Main Authors: Salazar-Ospina, Andrea, Amariles, Pedro, Benjumea, Dora M, Gutierrez, Francisco, Faus, Maria J, Rodriguez, Luis F
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20.05.2014; BioMed Central
• Subjects: Adolescent; Adult; Aged; Analysis; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; Bipolar Disorder - diagnosis; Bipolar Disorder - drug therapy; Bipolar Disorder - psychology; Chi-Square Distribution; Clinical Protocols; Clinics; Colombia; Community Pharmacy Services; Cooperative Behavior; Female; Health aspects; Humans; Interdisciplinary Communication; Male; Methods; Middle Aged; Outpatients; Prospective Studies; Psychiatric Status Rating Scales; Research Design; Study Protocol; Time Factors; Treatment Outcome; Young Adult; Colombia
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-15-174

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. 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. Randomized, 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. 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 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. Registration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011.