title: Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals.
abstract: BACKGROUND
  New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care.
  
  
  OBJECTIVE
  To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes.
  
  
  METHODS
  We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the intervention and cost of service use.
  
  
  CONCLUSIONS
  Consistent with UK Medical Research Council guidance and building on previous development research, this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care.
  
  
  BACKGROUND
  ISRCTN66498413.
authors.affiliation: Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne NE2 4AX, England. justin.presseau@ncl.ac.uk.
authors.forename: Justin
authors.initials: J
authors.lastname: Presseau
authors.forename: Gillian
authors.initials: G
authors.lastname: Hawthorne
authors.forename: Falko F
authors.initials: FF
authors.lastname: Sniehotta
authors.forename: Nick
authors.initials: N
authors.lastname: Steen
authors.forename: Jill J
authors.initials: JJ
authors.lastname: Francis
authors.forename: Marie
authors.initials: M
authors.lastname: Johnston
authors.forename: Joan
authors.initials: J
authors.lastname: Mackintosh
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Grimshaw
authors.forename: Eileen
authors.initials: E
authors.lastname: Kaner
authors.forename: Marko
authors.initials: M
authors.lastname: Elovainio
authors.forename: Mark
authors.initials: M
authors.lastname: Deverill
authors.forename: Tom
authors.initials: T
authors.lastname: Coulthard
authors.forename: Heather
authors.initials: H
authors.lastname: Brown
authors.forename: Margaret
authors.initials: M
authors.lastname: Hunter
authors.forename: Martin P
authors.initials: MP
authors.lastname: Eccles
mesh_terms: D001835:Body Weight; D002985:Clinical Protocols; D003365:Costs and Cost Analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D019317:Evidence-Based Medicine; D006442:Glycated Hemoglobin; D015438:Health Behavior; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D009042:Motivation; D010353:Patient Education as Topic / Q000458:organization & administration*; D011320:Primary Health Care / Q000458:organization & administration*; D012107:Research Design; D013222:State Medicine; D006113:United Kingdom
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents