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

N. Armstrong, Darrin Baines, R. Baker, R. Crossman, M. Davies, A. Hardy, K. Khunti, S. Kumar, J.P. O’Hare, N. Raymond, P. Saravanan, N. Stallard, Ala Szczepura, A. Wilson, ICCD Study Group

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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/Design: 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 Control group: 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 (
Original languageEnglish
Article number164
Publication statusPublished - 12 Sept 2012

Bibliographical note

This project is funded by the National Institute for Health Research Service Delivery and Organization Programme (project number SDO/110/2005). The authors would like to acknowledge the additional flexibility and sustainability funding provided by NHS Leicester City, Thames Valley Diabetes Research Network (TVDRN), CLRN (West Midlands South) and DIERT charity. Please note Coventry author Dr Baines was working at the University of Warwick at the time of publication.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


  • Type 2 diabetes
  • Models of care
  • Intermediate care clinic
  • Cardiovascular risk
  • Multidisciplinary team
  • General practitioners
  • Community care
  • Hospital interface


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