title: A cluster randomized controlled trial of the effectiveness and cost-effectiveness of intermediate care clinics for diabetes (ICCD): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.
  
  
  METHODS
  This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or
  
  
  METHODS
  Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.
  
  
  CONCLUSIONS
  Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.
  
  
  BACKGROUND
  [ClinicalTrials.gov: Identifier NCT00945204].
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Natalie
authors.initials: N
authors.lastname: Armstrong
authors.forename: Darrin
authors.initials: D
authors.lastname: Baines
authors.forename: Richard
authors.initials: R
authors.lastname: Baker
authors.forename: Richard
authors.initials: R
authors.lastname: Crossman
authors.forename: Melanie
authors.initials: M
authors.lastname: Davies
authors.forename: Ainsley
authors.initials: A
authors.lastname: Hardy
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Khunti
authors.forename: Sudhesh
authors.initials: S
authors.lastname: Kumar
authors.forename: Joseph Paul
authors.initials: JP
authors.lastname: O'Hare
authors.forename: Neil
authors.initials: N
authors.lastname: Raymond
authors.forename: Ponnusamy
authors.initials: P
authors.lastname: Saravanan
authors.forename: Nigel
authors.initials: N
authors.lastname: Stallard
authors.forename: Ala
authors.initials: A
authors.lastname: Szczepura
authors.forename: Andrew
authors.initials: A
authors.lastname: Wilson
mesh_terms: D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control; D003153:Community Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000191:economics / Q000453:epidemiology / Q000628:therapy*; D058006:General Practice; D017048:Health Care Costs; D007380:Intermediate Care Facilities / Q000191:economics; D010348:Patient Care Team; D011320:Primary Health Care; D012017:Referral and Consultation; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology