Antimicrobial resistance (AMR) is an important and complex public health problem
. The spread of AMR has led to the increased use of reserved antimicrobial agents
 in an era where few new antimicrobial agents are in production
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
[5, 6]. Within this context, the inappropriate and over-prescription of antimicrobials by GPs is a recognized factor contributing to the spread of AMR
[7–10]. 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[6, 13, 14], and are generally treated empirically, prior to the results of antimicrobial susceptibility testing
[11, 12, 15]. Antimicrobial resistance is now a critical factor in the treatment of UTIs
[9, 12, 16], the second most common bacterial infection in primary care
[6, 12, 13, 15, 17].
Changing prescribing and consumption antimicrobial behaviours
Antimicrobial resistance is complex
[7, 18], dynamic
 and continuous
, meaning that no single solution will manage the problem effectively. Multifaceted interventions aimed at multiple stakeholders (GP, patients and the wider community) have been shown to be successful in reducing inappropriate prescribing
[2, 21–23] and can bring about social change by addressing local barriers to change
. Patients may have preconceived expectations of the consultation
, determined by their prior experience within the practice and the treatment of a recurring condition in some cases
. However, a review of patient-orientated interventions to improve antimicrobial prescribing concluded that change is better achieved by encouraging health professionals rather than by educating patients about the negative aspects of antimicrobials
. The GP’s decision to prescribe antimicrobials should be a balance between the treatment of the individual in the short term and its harmful impact on society in the long term
[19, 26]. General practitioners prescribe antimicrobials to treat (bacterial) infection, to guard against the risk of a missed diagnosis
, or because they believe the patient expects this outcome from the consultation
; therefore, to obtain a behavioural change, many factors need to be addressed
Educational interventions aimed at the prescriber, the GP, have shown some successes. Improvements in overall prescribing practices in primary care have been linked with the use of small interactive workshops with health care professionals, which provide a greater change in prescribing behaviours when compared with a passive lecture-style format
[28–31]. An interactive workshop style is more likely to identify multifactorial causes in inappropriate prescribing, leading to the provision of tailored behavioural change methods for GPs
. Electronic prescribing prompts have successfully increased GP adherence to prescribing guidelines for a range of common illnesses
[32–34]. Electronic prompts have also been successful in increasing the use of specific antimicrobial drug choices, such as first-line antimicrobial treatment for common infections
. Currently, prescribing prompts are not commonly available within GP patient management software systems in Ireland.
The use of audit and feedback of information in conjunction with other intervention methods (delayed prescribing, educational material or electronic prompts) has also proven effective in improving GPs antimicrobial prescribing behaviours
[2, 36]. General practitioners in the UK receive routine feedback on their prescribing practices and are among the lowest community prescribers of antimicrobials in Europe
[30, 37]. Currently, Irish GPs cannot readily access information on their prescribing practices, despite evidence to suggest that feedback can successfully reduce antimicrobial prescribing in the Irish primary care setting
The use of delayed antimicrobial prescribing for viral infections in primary care in the UK has been credited with achieving a 50% reduction in antimicrobial use
[22, 38, 39]. Empirical antimicrobial treatment for UTIs is currently recommended in the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland
. However, in at least 50% of patients with UTIs, an antimicrobial may not be required, as the infection resolves naturally
[40–42]. Qualitative studies investigating attitudes to delayed antimicrobial prescribing in primary care have indicated that both patients and GPs are satisfied with this treatment format and welcome this 'safety net’ approach as a feasible treatment strategy
Between the GP and patient, the communication of such treatment strategies as delayed prescribing can be viewed as part of a shared decision-making process
. A shared decision-making process can empower patients through a greater understanding of the issues involved
[46, 47]. Shared decision making with delayed prescribing allows patients to prioritize what they value most; increasing their chances of a quick recovery or reducing their chances of side effects and reconsultations in the future
The leading systematic review in the area of complex prescribing interventions in primary care called for innovative intervention methods to be developed
. Around 75% of a general practice’s registered patients will wait in the practice waiting room each year and the demand for easy-to-understand healthcare information is increasing
. The use of informative material in GPs waiting rooms, such as educational videos and interactive games, to create awareness and explain the problems associated with the overuse of antimicrobials in primary care, has also been recommended through the European Antibiotics Awareness Day
Educational videos displayed in the practice waiting room can also increase patients’ understanding and satisfaction of their care, as well as empowering patients to discuss their treatments further with the GP
[51, 52]. Previous research examined the effectiveness of a multimedia campaign in comparison with a static educational brochure to improve treatment for chronic illness in practice waiting rooms with patients with low health literacy
[53, 54]. This approach was considered novel, effective and acceptable in improving health care management, by empowering patients to discuss making positive changes to their treatment with their GP
. Audiovisual messages played in practice waiting rooms have also proven effective in increasing patient uptake of vaccines
Mobile phone technology can facilitate rapid and cost-effective access to a study group of interest to facilitate data collection. Previous programmes have successfully used text messages to assess consumption and adherence to antimicrobial treatments with 72% patient participation for follow-up
Intervention development overview
Social marketing is the conceptual framework that guided the development of this intervention, by integrating knowledge from such disciplines as psychology, anthropology and sociology
[57–59] with commercial marketing techniques
[59–63]. Social marketing interventions address three key areas: understanding current behaviours; identifying determinants and identifying mechanisms for change
Owing to the intricate factors that influence the decision to prescribe an antimicrobial, not all strategies will work with all GPs in all regions
. The SIMPle study focuses on behavioural changes that are feasible and self-sustaining, given the available resources. The appropriateness of changes and their feasibility within the GP practice setting were also considered
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 = 16) 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 questions were guided by a combination of theoretical frameworks, the transtheoretical model
 and the buyer behaviour decision-making model
, which together explored six key areas: the stage of change, consequences, trade-offs, other influences, segmentation and competition
As a result of this formative research process, five core outcomes were achieved:
The expectations of the patient relating to the UTI consultation with GPs were characterized.
The factors that impact the GPs decision to prescribe an antimicrobial were defined.
The key messages central to the design and development of this intervention were specified for both the GP and the patient.
The results supported the development of quantitative evaluation components, such as a baseline questionnaire to monitor changes in knowledge, attitudes and awareness for both GP and patient.
The behavioural theoretical framework underpinning the design and development of this complex intervention was defined.
The multiple interactive components of this intervention were informed by both the peer-reviewed literature and formative research. In short, the SIMPle study will integrate:
A professional development programme for the GP, which includes interactive workshops, audit and feedback reports on antimicrobial prescribing and electronic antimicrobial prescribing prompts to improve the quality of prescribing. The quality of prescribing is defined within this study as the prospective prescribing of first-line antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland.
Delayed antimicrobial prescribing for UTIs in one study arm, to decrease the consumption of antimicrobials.
A supportive framework to inform patients of AMR through multimedia applications within the waiting room of the GP.
Novel e-health technology, which includes an electronic data extraction system that will remotely collect anonymized data from all consultations with patients diagnosed with a UTI by the GPs and mobile health technology to monitor and record antimicrobial consumption behaviour of patients.
By integrating this intervention into routine care and making all material freely available at the end of the intervention, the SIMPle study strives to be sustainable and self-promoting and, thereby, implemented in primary care in Ireland beyond the intervention period.
Aim and objectives
Aim of the SIMPle study
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.
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.
To compare the effect of the intervention on the frequency of antimicrobial prescribing and antimicrobial consumption in patients presenting with a UTI.
To measure the uptake and impact of delayed antimicrobial prescribing for UTIs and the impact of this treatment approach on UTI GP reconsultation visits.
To assess a change in cognitive beliefs (knowledge and attitudes) of GPs related to antimicrobial prescribing.
To conduct a cost-effectiveness and process evaluation of the SIMPle intervention.
To compare the prescribing rates of the intervention arms with regional UTI antimicrobial prescribing rates.