基于初级保健团队的胰岛素转换能否改善 2 型糖尿病成人的结局：迈向胰岛素的阶梯式随机对照试验方案。
Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol.
机构信息
General Practice and Primary Healthcare Academic Center, University of Melbourne, 200 Berkeley St, Carlton, VIC 3053, Australia.
出版信息
Implement Sci. 2014 Feb 14;9:20. doi: 10.1186/1748-5908-9-20.
BACKGROUND
Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.
METHODS
This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.
DISCUSSION
The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.
背景
2 型糖尿病（T2D）给人类和医疗保健带来了巨大的负担。其进行性意味着越来越难以实现正常血糖水平，但这对于避免长期血管并发症至关重要。近一半的 T2D 患者血糖水平未达标。胰岛素在实现血糖目标方面非常有效，但胰岛素的起始通常会被延迟，尤其是在初级保健中。鉴于获得专科资源的机会有限以及糖尿病的流行程度，初级保健必须成为胰岛素起始的常规实践。这也将支持糖尿病患者的综合整体护理。我们的 Stepping Up 计划基于全科医生（GP）和执业护士（PN）的护理模式，由内分泌专家和认证的糖尿病教育者 - 注册护士提供适当的支持。初步研究表明，该模式有助于将胰岛素起始的技术工作整合到持续的通科护理中。
方法
本研究方案是一项集群随机对照试验，旨在检验 Stepping Up 计划提高 GP-PN 团队在启动胰岛素治疗和改善 T2D 患者血糖结果方面的作用。将从 74 家普通诊所招募年龄在 18 至 80 岁之间、服用两种或更多种口服降糖药且过去六个月内 HbA1c≥7.5%的 224 名 T2D 患者。随机分组单位为诊所。主要结局是糖化血红蛋白（HbA1c）的变化（作为连续变量测量）。我们假设干预组在 12 个月随访时的 HbA1c 平均绝对差值比对照组低 0.5%。次要结局包括成功转用胰岛素的参与者人数和达到 HbA1c<7.0%的比例。我们还将收集患者心理社会结局和医疗保健利用和成本的数据。
讨论
该研究是一项具有重要实际意义的转化研究，对 T2D 患者、医疗保健专业人员和医疗保健资金提供者具有重要意义，因为它可以更好地利用稀缺的医疗保健资源，改善及时获得可以改善疾病结局的治疗的机会。
试验注册
澳大利亚和新西兰临床试验注册中心 ACTRN12612001028897。
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