Study protocol
Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol
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* Corresponding author: Maria Rubio-Valera mrubio@sjd-ssm.com
1 Sant Joan de Déu – Serveis de Salut Mental, Fundació Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain
2 Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria RedIAPP (RD06/0018/0017), Spain
3 Estades en Pràctiques Tutelades Unit, School of Pharmacy, University of Barcelona, Barcelona, Spain
4 ABS Just Oliveres, DAP L'Hospitalet, Àmbit Costa de Ponent, Institut Català de la Salut, L'Hospitalet, Spain
5 ABS Bartomeu Fabrés Anglada, DAP Baix Llobregat Litoral, Àmbit Costa de Ponent, Institut Català de la Salut, Gavà, Spain
BMC Public Health 2009, 9:284 doi:10.1186/1471-2458-9-284
Published: 5 August 2009Abstract
Background
Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression.
Methods/design
A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75) diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain). Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9), anxiety (STAI-S), health-related quality of life (EuroQol-5D), satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI).
Discussion
This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical intervention programme in the context of primary care.
Trial registration
NCT00794196