Configuring services so that all people with type 2 diabetes mellitus (T2DM) can benefit from good quality, target-driven and patient-focused care is a major challenge to healthcare systems such as the UK National Health Service (NHS), especially given the increased and increasing prevalence. In recent years there has been a shift in place of care from hospital to general practice . Although the new contract for general practices set targets for the control of diabetes, concerns were voiced about whether primary care could continue to cope without additional support . Currently, about 70 to 80% of people in the United Kingdom (UK) with T2DM are managed entirely in primary care. There is long-standing and continued evidence of deficiencies in provision of care and significant variations between general practices [3, 4]. More recently, differences in quality of care and outcomes have been reported depending on the model of care adopted or staff levels of experience [5, 6]. Practices in areas of high deprivation and mix of ethnicity are less likely to achieve adequate levels of control [7–9].
There is evidence from randomized controlled trials that intensive management of T2DM can reduce complications such as retinopathy, nephropathy and neuropathy, as well as reducing the risk of cardiovascular disease . Benefits are seen from improved glycemic control, lower blood pressure and better management of lipids [11–13]. Patients with improved glycemic control also consistently report better functional status and wellbeing [14–16].
It is less clear how benefits seen in individual explanatory trials might be realized in a new integrated service model. A Cochrane review found evidence that structured recall, patient education, and support from specialist nurses can lead to better outcomes , and a trial in Danish general practice found that intensive patient-focused management led to significant risk reduction . Economic modeling also suggests that intensive control of risk factors is likely to be cost-effective in the UK . Although the evidence indicates that access to multidisciplinary, community-based services can support general practices in achieving good clinical control of their diabetic patients, and possibly improve patient outcomes, it is unclear what the optimum combination or model might be for service provision.
One method suggested is introduction of intermediate care clinics for diabetes (ICCD). The intermediate care model aims to deliver high-quality care nearer to the patient through multidisciplinary, locality-based teams, with the added opportunity for developing professional expertise in the community and hopefully reducing care costs. A common approach is for medical care to be provided by general practitioners (GPs) with a special interest (GPwSI) in diabetes  working with community-based specialist teams. ICCDs began to be introduced in the UK in 2004. A descriptive evaluation found that intermediate care clinics were popular with patients and practitioners and appeared to reduce outpatient attendances by 25% . However, inherent in the ICCD model is a trade-off between the higher levels of technical expertise available in the clinic versus a reduction in the continuity of care as previously provided solely by the GP practice. Continuity of care has been shown to be related to glycemic control . The costs of the two models will also differ, and the cost-effectiveness of ICCD introduction remains unclear.
To date, there have been a number of other ICCD services established in the UK, although the staffing and organization of these varies and none has been introduced under trial conditions with an integral economic evaluation. One service, set up in Cardiff, Wales, has reported some consideration of costs and benefits, although no data on the impact of this ICCD model on costs and patient outcomes are available . Other initiatives include Somerset Community Health ; an ICCD service established in Southampton ; and an ICCD team set up in Lambeth, London . The latter has reported that the service is marginally cost saving . No other evaluations have been published.
The present study protocol describes a cluster randomized controlled trial of an ICCD intervention set up in three Primary Care Trusts (PCTs) to improve outcomes for primary care patients with T2DM. In accordance with the Medical Research Council’s framework for development and evaluation of complex interventions the trial intervention built on published and ongoing formative research [28, 29].
Practices recruited to the study are randomized to either usual care or intervention arm, with the latter having access to the new ICCD clinics. In participating practices, patients with T2DM are invited to take part in the trial. Recruited patients in both arms are given a baseline assessment by a study nurse. This includes measurement of HbA1c, body mass index (BMI), waist circumference, blood pressure, urine and lipids. Participating patients are asked to attend a follow-up assessment 18 months after their baseline assessments, when the same measurements are repeated. Questionnaires about quality of life, satisfaction with current services, continuity of care and health service use and personal costs are completed at baseline and follow-up. An integral economic evaluation measures costs in both groups, with a comparative assessment of marginal costs and outcomes. To deal with possible selection bias, risk factor control of all patients with T2DM in intervention and control practices will be compared using anonymised GP data. Additionally, a qualitative study is exploring the views of patients, health professionals and other stakeholders using semi-structured interviews.
The overall aim is to conduct a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of community-based intermediate care clinics in the management of T2DM. Specific objectives are to:
Compare the following in patients with T2DM registered with practices that have access to ICCD with those that have access only to usual care:
control of cardiovascular risk factors including glycemic, blood pressure and lipid control, and cardiovascular risk assessed by UKPDS risk engine;
quality of life;
satisfaction with services and continuity of care;
referral patterns and non attendance rates;
annual cost per patient with diabetes.
Estimate the difference in the cost of the resources used by patients in each arm of the trial, and the cost-effectiveness of the ICCD intervention.
Explore the views and experiences of patients, health professionals and other stakeholders.