A cluster randomised controlled trial of the clinical and cost-effectiveness of a 'whole systems' model of self-management support for the management of long- term conditions in primary care: trial protocol

The evaluation involves a large-scale, multi-site study of the implementation, effectiveness, and cost-effectiveness of this model of self-management support using a cluster randomised controlled trial in patients with three long-term conditions of diabetes, chronic obstructive pulmonary disease (COPD), and irritable bowel syndrome (IBS). The outcome measures include healthcare utilisation and quality of life. We describe the methods of the cluster randomised trial.If the 'whole systems' model proves effective and cost-effective, it will provide decision-makers with a model for the delivery of self-management support for populations with long-term conditions that can be implemented widely to maximise 'reach' across the wider patient population.ISRCTN: ISRCTN90940049Long-term conditions are increasingly important determinants of quality of life and healthcare costs in populations worldwide [1]. There are major initiatives ongoing to improve quality of care and achieve better health in these populations [2]. Increasing healthcare costs associated with an ageing population and growing awareness of the links between behaviour and health has meant that even greater focus has been placed on self-management, defined as 'the care taken by individuals towards their own health and well being: it comprises the actions they take to lead a healthy lifestyle; to meet their social, emotional and psychological needs; to care for their long-term condition; and to prevent further illness or accidents' [3]. Self-management has the potential to improve population health without incurring major cost increases. In the UK, the influential Wanless report suggested that the future costs of healthcare were very much dependent on 'how well people become fully engaged with their own health' [4], although others have suggested self-management policies are part of an ideological shift from patient rights to individual responsibilities [5].However, realising the potential of self-management requi