Conducting a Complex Intervention Trial in General Practice: Lessons Learnt from the Patient Engagement and Coaching for Health (PEACH) Study in Patients with Type 2 Diabetes

Abstract

Developing and conducting a complex intervention trial in general practice is expensive and challenging, yet it is often perceived as the gold standard for the clinical researcher. Because of its complexity and costs, researchers often avoid conducting a properly designed randomised controlled trial (RCT). Some researchers design and implement a RCT in haste without the rigour and fidelity of the intervention which are required for the trial results to be meaningful and be able to be published in a high impact journal. Utilising the UK Medical Research Council (MRC) framework of design and evaluation of complex interventions to improve health, a multidisciplinary team of researchers led by the General Practice and Primary Health Care research unit at The University of Melbourne developed and conducted a clustered randomised controlled trial aiming to improve the health outcomes of patients with poorly controlled type 2 Diabetes in a disadvantaged community. The PEACH intervention trial involved training practice nurses based in general practices to telephone and coach the patients over 18 months to improve their Diabetes care. This research workshop will showcase the journey of the PEACH study from the design to the implementation and reporting of the results which was published in the 2013 September edition of the British Medical Journal. Participants of this workshop will be able to engage in critical analysis of the different phases of this trial. Finally lessons learnt from conducting such a large scale trial in general practice and primary care will be shared.