Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle)
Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle)
Background The over use of antimicrobials is recognised as the main selective pressure
 driving the emergence and spread of antimicrobial resistance in human bacterial pathogens.
 Urinary Tract Infections (UTIs) are one of 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 GPs prescribe antimicrobials for UTI that
 are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in
 Ireland.

 Aim 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 SIMPLE study is a randomised three armed intervention with practice level
 randomisation. Adult patients presenting with suspected UTI 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
 summarising recommended first line antimicrobial treatment and, for one intervention arm, a
 recommendation to consider delayed antimicrobial prescribing. For patients multimedia
 applications and information leaflets are included. A minimum of 920 patients will be
 recruited through 30 practices. The primary outcome is change in prescribing of first line
 antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary
 Care in Ireland. The intervention will take place over 15 months. Data will be collected
 through a remote electronic anonymised data extraction system (iPCRN), a text messaging
 system and through GP and patient interviews and surveys. The intervention will be
 strengthened by the implementation of a social marketing framework and an economic
 evaluation.
Today, 80% of antimicrobial prescribing takes place in the community by general practitioners
 (GPs). Ireland is one of only three countries in Europe where the level of outpatient
 antimicrobial prescribing is increasing. Within this context, the inappropriate and
 overprescription of antimicrobials by GPs is a recognized factor contributing to the spread
 of AMR. The Guidelines for Antimicrobial Prescribing in Primary Care in Ireland provide
 advice on the selection of antimicrobial drugs for common infections and recommend the use of
 specific antimicrobials, with reserved drugs for more serious infections. However, despite
 the widespread availability of these guidelines, recent research has identified that less
 than 40% of outpatient prescriptions for urinary tract infections (UTIs) are made out
 according to first-line recommendations.

 Urinary tract infections are predominantly caused by a bacteria; Escherichia coli, and are
 generally treated empirically, prior to the results of antimicrobial susceptibility testing.
 Antimicrobial resistance is now a critical factor in the treatment of UTIs, the second most
 common bacterial infection in primary care.

 Social marketing is the conceptual framework that guided the development of this
 intervention. Formative (qualitative) research explored the culture of antimicrobial
 prescribing from both the GP's and the patient's perspective. Through a series of interviews
 with GPs (n = 15) and focus groups with patients (n = 35), the predictors of a GP's decision
 to prescribe an antimicrobial and the patient's expectation to receive an antimicrobial were
 explored.

 The aim of SIMPle was 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. The primary outcome was to
 increase the number of first-line antimicrobial prescriptions, as recommended in the
 Guidelines for Antimicrobial Prescribing in Primary Care in Ireland (2011), for suspected
 UTIs in primary care by 10% in adult patients.

 Methods The cluster for this intervention is the practice, and all GPs within each practice
 will be invited to participate. The baseline population for recruitment of patients will be
 formed by all practices in the West of Ireland who submit urine samples to the Galway
 University Hospitals (GUH) laboratory. The most popular patient management software system
 was chosen, because the SIMPle study builds on remote data extraction, the provision of audit
 and feedback reports and computer prompts integrated within the GP's patient management
 software system. This study will be undertaken in four phases: Phase 1, baseline data
 collection; Phase 2, GP intervention; Phase 3, patient intervention and Phase 4, endpoint
 data collection. Computerized remote data extraction is facilitated by the Irish Primary Care
 Research Network (iPCRN) and patient data are identified through the appropriate coding of
 suspected UTI consultations in the patient management software system. To promote and
 encourage consultation coding, which is currently not routine practice, the intervention will
 be preceded by a coding workshop at the beginning of Phase 1. All practices will be required
 to register with the iPCRN during or before the coding workshop. Practices will be monitored
 for two months after the delivery of the workshop to establish uptake of coding, whilst also
 facilitating a baseline data collection period (Phase 1). Phase 2 will begin with an
 interactive workshop (intervention arms A and B), which will introduce the intervention
 components specific to each arm. Phase 3 will see the roll-out of the patient education in
 all of the practices. The antimicrobial prescribing within each practice will be monitored
 for six months during Phases 2 and 3 through audit and feedback reports. Evaluation of the
 impact of the intervention will be carried out in Phase 4.

 All patients are eligible if aged 18 years and over and presenting with symptoms of an UTI,
 as determined by the GP through the consultation coding.

 Previous research has established that 56% of UTI patients receive an antimicrobial, with
 only 38% of prescription made out for the recommended first-line treatment.

 Sample size calculations are based on an absolute 10% increase in first-line prescriptions
 according to guidelines (primary outcome). Additional assumptions for sample size
 calculations include power of 80% and α of 5%, Practice attrition is dependent on the
 completeness of consultation coding, which will be monitored and corrected during Phase 1.
Inclusion Criteria:

 -  All adult patients presenting with a suspected urinary tract infection to their
 general practitioner (GP)

 Exclusion Criteria: