Warwick Medical School, University of Warwick, Coventry, UK.
Trials. 2012 Sep 12;13:164. doi: 10.1186/1745-6215-13-164.
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
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.
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.
[ClinicalTrials.gov: Identifier NCT00945204].
全球医疗体系正面临着 2 型糖尿病的流行。在英国，临床护理主要由全科医生（GP）提供，而不是由医院专家提供。糖尿病中级护理诊所（ICCD）为支持全科医生管理控制不佳的 2 型糖尿病患者和管理心血管危险因素提供了一种模式。本研究旨在：（1）比较有 ICCD 服务的实践中注册的 2 型糖尿病患者与仅接受常规医院护理的实践中注册的患者；（2）评估干预措施的成本效益；（3）探索患者、卫生专业人员和其他利益相关者的观点和经验。
方法/设计：这是一项在英国三个初级保健信托基金中的普通实践中进行的双臂集群随机对照试验（具有综合经济评估和定性研究）。实践随机分为两组之一，患者被转介到 ICCD（干预组）或医院护理（对照组）。干预组：干预臂中的 GP 实践有机会将患者转介到 ICCD-一个由专科护士和糖尿病专家领导的多学科团队。患者在 ICCD 中接受短期审查和管理，目标是改善糖尿病和心血管危险因素的控制，然后再转回实践。或
标准 GP 护理，根据需要转介至二级护理，但无法获得 ICCD。参与者为年龄在 18 岁或以上的 2 型糖尿病患者，其 GP 难以控制。主要结局是在 18 个月干预期结束时达到三个危险因素目标的参与者比例：HbA1c（≤7.0%）；血压（<140/80）；和胆固醇（<4mmol/l）。主要次要结局是达到个别危险因素目标的参与者比例以及由英国前瞻性糖尿病研究（UKPDS）风险引擎评估的冠心病（CHD）和中风的总体 10 年风险。其他次要结局包括体重指数和腰围、药物使用、报告的吸烟情况、情绪调整、患者满意度和对连续性、成本和健康相关生活质量的看法。我们的目标是随机分配 50 个实践并招募 2555 名患者。
已经随机分配了 49 个实践，已经向试验招募了 1997 名患者，并且已经向定性研究招募了 20 名患者。结果将于 2012 年底公布。
[ClinicalTrials.gov：标识符 NCT00945204]。
