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Open Access Study protocol

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

Natalie Armstrong2, Darrin Baines1, Richard Baker2, Richard Crossman1, Melanie Davies3, Ainsley Hardy2, Kamlesh Khunti2, Sudhesh Kumar1, Joseph Paul O’Hare1, Neil Raymond1, Ponnusamy Saravanan1, Nigel Stallard1, Ala Szczepura1*, Andrew Wilson2 and and on behalf of the ICCD Study Group

Author Affiliations

1 Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK

2 Department of Health Sciences, University of Leicester, 24-28 Princess Road West, Leicester, LE1 6TP, UK

3 University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, Leicester Royal Infirmary, Infirmary Square, LE1 5WW, UK

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Trials 2012, 13:164  doi:10.1186/1745-6215-13-164

Published: 12 September 2012

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/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 (<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.

Discussion

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.

Trial registration

[ClinicalTrials.gov: Identifier NCT00945204]

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