Stemming the Tide of Antibiotic Resistance (STAR): A protocol for a trial of a complex intervention addressing the 'why' and 'how' of appropriate antibiotic prescribing in general practice

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Abstract
After some years of a downward trend, antibiotic prescribing rates in the community have tended to level out in many countries. There is also wide variation in antibiotic prescribing between general practices, and between countries. There are still considerable further gains that could be made in reducing inappropriate antibiotic prescribing, but complex interventions are required. Studies to date have generally evaluated the effect of interventions on antibiotic prescribing in a single consultation and pragmatic evaluations that assess maintenance of new skills are rare. This paper describes the protocol for a pragmatic, randomized evaluation of a complex intervention aimed at reducing antibiotic prescribing by primary care clinicians. We developed a Social Learning Theory based, blended learning program (on-line learning, a practice based seminar, and context bound learning) called the STAR Educational Program. The 'why of change' is addressed by providing clinicians in general practice with information on antibiotic resistance in urine samples submitted by their practice and their antibiotic prescribing data, and facilitating a practice-based seminar on the implications of this data. The 'how of change' is addressed through context-bound communication skills training and information on antibiotic indication and choice. This intervention will be evaluated in a trial involving 60 general practices, with general practice as the unit of randomization (clinicians from each practice to either receive the STAR Educational Program or not) and analysis. The primary outcome will be the number of antibiotic items dispensed over one year. An economic and process evaluation will also be conducted. This trial will be the first to evaluate the effectiveness of this type of theory-based, blended learning intervention aimed at reducing antibiotic prescribing by primary care clinicians. Novel aspects include feedback of practice level data on antimicrobial resistance and prescribing, use of principles from motivational interviewing, training in enhanced communication skills that incorporates context-bound experience and reflection, and using antibiotic dispensing over one year (as opposed to antibiotic prescribing in a single consultation) as the main outcome. Current Controlled Trials ISRCTN63355948.