Scuffham Paul A, Mihala Gabor, Ward Lauren, McMurray Anne, Connor Martin
Centre for Applied Health Economics, School of Medicine, Menzies Health Institute Queensland, Griffith University, Nathan, Australia.
Centre for Health Innovation, Griffith University and the Gold Coast Health and Hospital Service, Gold Coast, Australia.
BMJ Open. 2017 Jul 2;7(6):e016776. doi: 10.1136/bmjopen-2017-016776.
Chronic diseases are the leading cause of illness, disability and death in Australia. The prevalence and associated health expenditure are projected to soar. There is no 'whole system' approach to healthcare in Australia. To overcome this fragmentation, the Gold Coast Hospital and Health Service (GCHHS) is developing a new model known as Gold Coast Integrated Care (GCIC). To evaluate GCIC a 4-year pilot trial commenced in March 2015. This protocol paper describes the evaluation of GCIC.
A pragmatic non-randomised controlled clinical trial is conducted to test the hypothesis that GCIC will result in improved health and well-being at no additional cost to the healthcare system. Using a mixed methods approach, impact, outcome and process evaluations will be undertaken to assess the effectiveness and acceptability, including the balance of costs between primary and public secondary care sectors, staff and training requirements, clinical service delivery, and trial implementation.Fifteen general practices have agreed to deliver GCIC. One thousand five hundred of their adult patients with treated chronic diseases, high risk of hospitalisation or healthcare utilisation were recruited to the intervention arm. Approximately 3000 patients not associated with the participating general practices were identified as controls using propensity matching which will provide service utilisation and disease data for usual care.Baseline data and follow-up observations are collected annually until the end of 2018. Quantitative analyses will measure patient healthcare costs, utilisation of health services, and health outcomes, and general practice clinical service delivery according to clinical guidelines (number of foot exams, HbA1c tests). Qualitative analyses will focus on patient and staff experiences, satisfaction, engagement and implementation of the programme as planned.
Approval was received from the GCHHS and Griffith University. The study is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000821493). Findings will be communicated via yearly reports to funding bodies and scientific publications.
ACTRN12616000821493; Pre-results.
慢性病是澳大利亚疾病、残疾和死亡的主要原因。其患病率及相关医疗支出预计将飙升。澳大利亚的医疗保健缺乏“全系统”方法。为克服这种碎片化状况，黄金海岸医院与健康服务机构（GCHHS）正在开发一种名为黄金海岸综合护理（GCIC）的新模式。为评估GCIC，于2015年3月启动了一项为期4年的试点试验。本方案文件描述了对GCIC的评估。
开展一项务实的非随机对照临床试验，以检验GCIC在不增加医疗系统成本的情况下能改善健康和福祉这一假设。采用混合方法，进行影响、结果和过程评估，以评估其有效性和可接受性，包括初级和公立二级医疗部门之间的成本平衡、人员和培训需求、临床服务提供以及试验实施情况。15家普通诊所已同意提供GCIC。招募了1500名患有慢性病、住院风险高或医疗利用率高的成年患者作为干预组。使用倾向匹配法确定了约3000名与参与试验的普通诊所无关的患者作为对照组，这将提供常规护理的服务利用率和疾病数据。每年收集基线数据和随访观察结果，直至2018年底。定量分析将衡量患者的医疗保健成本、医疗服务利用率、健康结果，以及普通诊所根据临床指南提供的临床服务（足部检查次数、糖化血红蛋白检测次数）。定性分析将侧重于患者和工作人员的体验、满意度、参与度以及该项目按计划的实施情况。
已获得GCHHS和格里菲斯大学的批准。该研究已在澳大利亚新西兰临床试验注册中心注册（ACTRN12616000821493）。研究结果将通过年度报告传达给资助机构并发表科学论文。
ACTRN12616000821493；预结果。
