Open Access Study protocol

Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial

Sinead Duane1*, Aoife Callan12, Sandra Galvin1, Andrew W Murphy1, Christine Domegan4, Eamon O’Shea23, Martin Cormican56, Kathleen Bennett7, Martin O’Donnell8 and Akke Vellinga15

Author Affiliations

1 Discipline of General Practice, School of Medicine, National University of Ireland, Galway, Ireland

2 Discipline of Economics, JE Cairnes School of Business and Economics, National University of Ireland, Galway, Ireland

3 Irish Centre for Social Gerontology, National University of Ireland, Galway, Ireland

4 Department of Marketing, JE Cairnes School of Business and Economics, National University of Ireland, Galway, Ireland

5 Discipline of Bacteriology, School of Medicine, National University of Ireland, Galway, Ireland

6 Department of Medical Microbiology, University Hospital Galway, Galway, Ireland

7 Department of Pharmacology & Therapeutics, Trinity College Dublin, Dublin, Ireland

8 Health Research Board Clinical Research Facility Galway, National University of Ireland, Galway, Ireland

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Trials 2013, 14:441  doi:10.1186/1745-6215-14-441

Published: 23 December 2013

Abstract

Background

The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens. Urinary tract infections (UTIs) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended. Previous research has identified that a substantial proportion of Irish general practitioners (GPs) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The aim of this trial is to design, implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult (18 years of age and over) patients’ antimicrobial consumption when presenting with a suspected UTI.

Methods/design

The Supporting the Improvement and Management of Prescribing for urinary tract infections (SIMPle) study is a three-armed intervention with practice-level randomization. Adult patients presenting with suspected UTIs in primary care will be included in the study.

The intervention integrates components for both GPs and patients. For GPs the intervention includes interactive workshops, audit and feedback reports and automated electronic prompts summarizing recommended first-line antimicrobial treatment and, for one intervention arm, a recommendation to consider delayed antimicrobial treatment. For patients, multimedia applications and information leaflets are included. Thirty practices will be recruited to the study; laboratory data indicate that 2,038 patients will be prescribed an antimicrobial in the study. The primary outcome is a change in prescribing of first-line antimicrobials for UTIs in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The study will take place over 15 months with a six-month intervention period. Data will be collected through a remote electronic anonymized data-extraction system, a text-messaging system and GP and patient interviews and surveys. The intervention will be strengthened by the implementation of a social marketing framework and an economic evaluation.

Trial registration

This intervention is registered at ClinicalTrials.gov, ID NCT01913860.

Keywords:
Antimicrobial; Intervention; Prescribing; Primary care; Social marketing; Urinary tract infection