A randomized controlled trial of an intervention designed to improve the care given in general practice to Type II diabetic patients: patient outcomes and professional ability to change behaviour

AIM: Our objective was to evaluate the effect of training in a patient- centred intervention for GPs and practice nurses on outcomes for patients with Type II diabetes. METHODS: We carried out a randomized controlled trial within general practices as the basis for randomization and a before-and-after design for measures of patient outcome. A parallel process study examined the use of the method by professionals. The study was carried out in 29 general practices in South Glamorgan who had participated for at least 2 years in a local scheme of audit and CME in relation to Type II diabetes care. The subjects were 252 Type II diabetic patients recruited by 15 experimental and 14 control practices. The main outcome measures were changes in glycosylated haemoglobin, patient satisfaction with care and treatment, functional health status and professional ability to apply the intervention. RESULTS: Professionals adopted the innovative method with enthusiasm, but after 2 years only 19% continued to apply the method systematically. The trial was, therefore, unable to demonstrate significant biochemical or functional improvements. This highlights the need to understand the factors associated with professional uptake and subsequent ability to sustain changes in behaviour. CONCLUSIONS: The efficacy of this behavioural intervention remains unproved, despite its acceptability to professional staff. Detailed and prolonged development and testing of behavioural interventions is an essential first step before embarking on randomized controlled trials which involve complex behavioural changes in professionals or patients.