Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial

Regina Kuhmmer, Karine Margarites Lima, Rodrigo Antonini Ribeiro, Luciano Serpa Hammes, Gisele Alsina Nader Bastos, Maria Claudia Schardosim Cotta de Souza, Carisi Anne Polanczyk, Guilherme Alcides Flores Soares Rollin, Suhelen Caon, Cátia Moreira Guterres, Leni Everson Araújo Leite, Tássia Scholante Delabary, Maicon Falavigna, Regina Kuhmmer, Karine Margarites Lima, Rodrigo Antonini Ribeiro, Luciano Serpa Hammes, Gisele Alsina Nader Bastos, Maria Claudia Schardosim Cotta de Souza, Carisi Anne Polanczyk, Guilherme Alcides Flores Soares Rollin, Suhelen Caon, Cátia Moreira Guterres, Leni Everson Araújo Leite, Tássia Scholante Delabary, Maicon Falavigna

Abstract

Background: Patient education on pharmacological therapy may increase medication adherence and decrease hospitalizations. Our aim is to evaluate the effectiveness of pharmaceutical care at emergency department discharge in patients with hypertension and/or diabetes.

Methods/design: This is a randomized controlled trial. Participants will be recruited from a public emergency department at Restinga district in Porto Alegre, southern Brazil. A total of 380 patients will be randomly assigned into 2 groups at the moment of emergency department discharge after receiving medical orientations: an intervention group, consisting of a structured individual counseling session by a pharmacist in addition to written orientations, or a control group, consisting only of written information about the disease. Outcomes will be assessed in an ambulatory visit 2 months after the randomization. The primary outcome is the proportion of patients with high medication adherence assessed using the Morisky-Green Test and the Brief Medication Questionnaire. The secondary outcomes are reduction of blood pressure, glycated hemoglobin, fasting plasma glucose, quality of life and number of visits to the emergency department.

Discussion: Pharmaceutical care interventions have shown to be feasible and effective in increasing medication adherence in both hospital outpatient and community pharmacy settings. However, there have been no previous assessments of the effectiveness of pharmacy care interventions initiated in patients discharged from emergency departments. Our hypothesis is that pharmaceutical counseling is also effective in this population.

Trial registration: ClinicalTrials.gov registration number: NCT01978925 (11 November 2013) and Brazilian Registry of Clinical Trials U1111-1149-8922 (5 November 2013).

Figures

Figure 1
Figure 1
Flow diagram of the study design. *Questionnaires: sociodemographic variables; comorbidities; medication adherence; physical activity; alcohol consumption. ‡For patients with hypertension. †For patients with diabetes. ††Anthropometrical assessment: weight, height, waist and hip circumferences. BP = blood pressure; CPG = capillary plasma glucose; HbA1c = glycated hemoglobin.

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Source: PubMed

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