title: 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.
abstract: BACKGROUND
  Patients with long-term conditions are increasingly the focus of quality improvement activities in health services to reduce the impact of these conditions on quality of life and to reduce the burden on care utilisation. There is significant interest in the potential for self-management support to improve health and reduce utilisation in these patient populations, but little consensus concerning the optimal model that would best provide such support. We describe the implementation and evaluation of self-management support through an evidence-based 'whole systems' model involving patient support, training for primary care teams, and service re-organisation, all integrated into routine delivery within primary care.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN: ISRCTN90940049.
authors.affiliation: Primary Care Research Group, Community Based Medicine, University of Manchester, 5th Floor Williamson Building, Oxford Road, Manchester M13 9PL, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
authors.forename: Anne
authors.initials: A
authors.lastname: Kennedy
authors.forename: David
authors.initials: D
authors.lastname: Reeves
authors.forename: Anne
authors.initials: A
authors.lastname: Rogers
authors.forename: Tom
authors.initials: T
authors.lastname: Blakeman
authors.forename: Carolyn
authors.initials: C
authors.lastname: Chew-Graham
authors.forename: Robert
authors.initials: R
authors.lastname: Bowen
authors.forename: Martin
authors.initials: M
authors.lastname: Eden
authors.forename: Caroline
authors.initials: C
authors.lastname: Gardner
authors.forename: Mark
authors.initials: M
authors.lastname: Hann
authors.forename: Victoria
authors.initials: V
authors.lastname: Lee
authors.forename: Rebecca
authors.initials: R
authors.lastname: Morris
authors.forename: Joanne
authors.initials: J
authors.lastname: Protheroe
authors.forename: Gerry
authors.initials: G
authors.lastname: Richardson
authors.forename: Caroline
authors.initials: C
authors.lastname: Sanders
authors.forename: Angela
authors.initials: A
authors.lastname: Swallow
authors.forename: David
authors.initials: D
authors.lastname: Thompson
mesh_terms: D002908:Chronic Disease / Q000534:rehabilitation*; D002985:Clinical Protocols; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D003920:Diabetes Mellitus / Q000628:therapy*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D011320:Primary Health Care; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy*; D011788:Quality of Life; D012648:Self Care / Q000191:economics*