Evaluation of the Clinical and Cost Effectiveness of Intermediate Care Clinics for Diabetes (ICCD): A Multicentre Cluster Randomised Controlled Trial

BACKGROUND: Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling off. Community based, intermediate care clinics for diabetes (ICCDs) were considered one solution and are functioning across the UK. However, there is no randomised trial evidence for the effectiveness of such clinics. TRIAL DESIGN, METHODS AND FINDINGS: This is a cluster-randomised trial, involving 3 primary care trusts, with 49 general practices randomised to usual care (n=25) or intervention (ICCDs; n=24). All eligible adult patients with T2D were invited; 1997 were recruited and 1280 followed-up after 18-months intervention. PRIMARY OUTCOME: achievement of all three of the NICE targets [(HbA1c ≤ 7.0%/53 mmol/mol; Blood Pressure <140/80 mmHg; cholesterol