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 <154 mg/dl (4 mmol/l)]. PRIMARY OUTCOME was achieved in 14.3% in the intervention arm vs. 9.3% in the control arm (p=0.059 after adjustment for covariates). The odds ratio (95% CI) for achieving primary outcome in the intervention group was 1.56 (0.98, 2.49). Primary care and community clinic costs were significantly higher in the intervention group, but there were no significant differences in hospital costs or overall healthcare costs. An incremental cost-effectiveness ratio (ICER) of +£7,778 per QALY gained, indicated ICCD was marginally more expensive at producing health gain. CONCLUSIONS: Intermediate care clinics can contribute to improving target achievement in patients with diabetes. Further work is needed to investigate the optimal scale and organisational structure of ICCD services and whether, over time, their role may change as skill levels in primary care increase. TRIAL REGISTRATION: ClinicalTrials.gov NCT00945204; National Research Register (NRR) M0014178167.

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.

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].

Assessment of key influences on asthma inhaler device selection.

AIM: To identify factors that influenced trained asthma practice nurses' inhaler device selection and the relative importance they placed on these factors in clinical practice. METHOD: Questionnaires were sent to 1,500 randomly selected, trained asthma nurses working in primary care. A second, open-ended questionnaire was sent to 300 of these nurses. RESULTS: The response rate was 38% (573) for the first questionnaire and 21% (64) for the second questionnaire. Patient-related factors had the greatest influence on device selection. Other important factors were ease of inhaler use, the patient's lifestyle and inspiratory flow. Less important considerations were device availability, the size, shape and colour of the inhaler and recommendations from others. CONCLUSION: Many factors influence device selection. Nurses considered some of the factors identified as important when selecting a device, but not others. Nurses should be aware of potential influences on device selection and should consider their professional accountability in all patient interactions.