Uncomplicated Urinary Tract Infection Clinical Trial
Official title:
Supporting the Improvement and Management of Prescribing for Urinary Tract Infections (SIMPle): Protocol for a Randomised Complex Intervention
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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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