title: Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial.
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
  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.
  
  
  BACKGROUND
  This intervention is registered at ClinicalTrials.gov, ID NCT01913860.
authors.affiliation: Discipline of General Practice, School of Medicine, National University of Ireland, Galway, Ireland. sinead.duane@nuigalway.ie.
authors.forename: Sinead
authors.initials: S
authors.lastname: Duane
authors.forename: Aoife
authors.initials: A
authors.lastname: Callan
authors.forename: Sandra
authors.initials: S
authors.lastname: Galvin
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Murphy
authors.forename: Christine
authors.initials: C
authors.lastname: Domegan
authors.forename: Eamon
authors.initials: E
authors.lastname: O'Shea
authors.forename: Martin
authors.initials: M
authors.lastname: Cormican
authors.forename: Kathleen
authors.initials: K
authors.lastname: Bennett
authors.forename: Martin
authors.initials: M
authors.lastname: O'Donnell
authors.forename: Akke
authors.initials: A
authors.lastname: Vellinga
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D011307:Drug Prescriptions; D024881:Drug Resistance, Bacterial; D058006:General Practice; D019983:Guideline Adherence; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D057970:Inappropriate Prescribing; D007494:Ireland; D019212:Multimedia; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D017010:Reminder Systems; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology
chemical_list: D000900:Anti-Bacterial Agents