title: Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Registration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011.
authors.forename: Andrea
authors.initials: A
authors.lastname: Salazar-Ospina
authors.affiliation: Grupo Promoción y Prevención Farmacéutica, Facultad de Química Farmacéutica, Universidad de Antioquia UdeA, Calle 70 No 52-21, Medellín, Colombia. pedro.amariles@udea.edu.co.
authors.forename: Pedro
authors.initials: P
authors.lastname: Amariles
authors.forename: Dora M
authors.initials: DM
authors.lastname: Benjumea
authors.forename: Francisco
authors.initials: F
authors.lastname: Gutierrez
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Faus
authors.forename: Luis F
authors.initials: LF
authors.lastname: Rodriguez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D016009:Chi-Square Distribution; D002985:Clinical Protocols; D003105:Colombia; D003157:Community Pharmacy Services; D003299:Cooperative Behavior; D005260:Female; D006801:Humans; D033183:Interdisciplinary Communication; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents