Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia.
Western Sydney Local Health District, Sydney, Australia.
BMC Fam Pract. 2020 Feb 14;21(1):36. doi: 10.1186/s12875-020-01105-0.
Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months.
Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary.
Despite extensive research with surrogate outcomes, to the authors' knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease.
Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).
心血管疾病（CVD），包括冠心病（CHD）和中风，是全球范围内导致死亡和残疾的主要原因。很大一部分死亡率发生在有既往 CHD 的人群中，因此需要有效的、可扩展的策略来预防相关死亡和住院。本研究旨在确定以 CHD 患者为重点的实践层面合作质量改进计划是否能降低无计划 CVD 住院率和主要心血管不良事件发生率，并提高 24 个月时达到风险因素目标的患者比例。
采用整群随机对照试验（cRCT），对 50 家初级保健实践（n~10000 例患者）进行为期 24 个月的随访，评估初级保健质量改进计划的有效性。符合条件的实践将按 1:1 随机分配参加干预（合作质量改进计划）或对照（标准护理）方案。根据意向治疗，将根据随机分组评估结果。主要结局是 2 年内无计划 CVD 住院患者的比例。次要结局包括主要心血管不良事件的比例、接受指南推荐药物处方的患者比例、达到国家风险因素目标的患者比例以及有慢性疾病管理计划或审查的患者比例。使用对数二项式回归或稳健泊松回归分析（如果必要），对住院患者（以及二进制次要结局）比例的差异进行分析。
尽管已经进行了广泛的替代结局研究，但据作者所知，这是第一项在初级保健环境中评估基于数据的合作质量改进干预对 CHD 患者住院、CVD 事件和心血管风险的有效性的随机对照试验。使用数据链接收集结局将使评估这种潜在有效的策略成为可能，以改善心脏病患者的风险和结局管理。
澳大利亚新西兰临床试验注册（ANZCTR）编号 ACTRN12619001790134（2019 年 12 月 20 日）。
