PDF(Pubmed)
Abstract：
BACKGROUND: Coronary heart disease (CHD) is the leading cause of deaths and disability worldwide. Cardiac rehabilitation (CR) effectively reduces the risk of future cardiac events and is strongly recommended in international clinical guidelines. However, CR program quality is highly variable with divergent data systems, which, when combined, potentially contribute to persistently low completion rates. The QUality Improvement in Cardiac Rehabilitation (QUICR) trial aims to determine whether a data-driven collaborative quality improvement intervention delivered at the program level over 12 months: (1) increases CR program completion in eligible patients with CHD (primary outcome), (2) reduces hospital admissions, emergency department presentations and deaths, and costs, (3) improves the proportion of patients receiving guideline-indicated CR according to national and international benchmarks, and (4) is feasible and sustainable for CR staff to implement routinely.
METHODS: QUICR is a multi-centre, type-2, hybrid effectiveness-implementation cluster-randomized controlled trial (cRCT) with 12-month follow-up. Eligible CR programs (n = 40) and the individual patient data within them (n ~ 2,000) recruited from two Australian states (New South Wales and Victoria) are randomized 1:1 to the intervention (collaborative quality improvement intervention that uses data to identify and manage gaps in care) or control (usual care with data collection only). This sample size is required to achieve 80% power to detect a difference in completion rate of 22%. Outcomes will be assessed using intention-to-treat principles. Mixed-effects linear and logistic regression models accounting for clusters within allocated groupings will be applied to analyse primary and secondary outcomes.
CONCLUSIONS: Addressing poor participation in CR by patients with CHD has been a longstanding challenge that needs innovative strategies to change the status-quo. This trial will harness the collaborative power of CR programs working simultaneously on common problem areas and using local data to drive performance. The use of data linkage for collection of outcomes offers an efficient way to evaluate this intervention and support the improvement of health service delivery.
METHODS: Primary ethical approval was obtained from the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH01093), along with site-specific governance approvals.
BACKGROUND: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623001239651 (30/11/2023) ( https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386540&isReview=true ).
METHODS: QUICR is a multi-centre, type-2, hybrid effectiveness-implementation cluster-randomized controlled trial (cRCT) with 12-month follow-up. Eligible CR programs (n = 40) and the individual patient data within them (n ~ 2,000) recruited from two Australian states (New South Wales and Victoria) are randomized 1:1 to the intervention (collaborative quality improvement intervention that uses data to identify and manage gaps in care) or control (usual care with data collection only). This sample size is required to achieve 80% power to detect a difference in completion rate of 22%. Outcomes will be assessed using intention-to-treat principles. Mixed-effects linear and logistic regression models accounting for clusters within allocated groupings will be applied to analyse primary and secondary outcomes.
CONCLUSIONS: Addressing poor participation in CR by patients with CHD has been a longstanding challenge that needs innovative strategies to change the status-quo. This trial will harness the collaborative power of CR programs working simultaneously on common problem areas and using local data to drive performance. The use of data linkage for collection of outcomes offers an efficient way to evaluate this intervention and support the improvement of health service delivery.
METHODS: Primary ethical approval was obtained from the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH01093), along with site-specific governance approvals.
BACKGROUND: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623001239651 (30/11/2023) ( https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386540&isReview=true ).
摘要：
背景：冠心病（CHD）是全球范围内导致死亡和残疾的主要原因。心脏康复（CR）可有效降低未来心脏事件的风险，在国际临床指南中强烈建议。然而,CR程序质量在数据系统不同的情况下变化很大，which,当合并时，可能导致完成率持续较低。心脏康复质量改善（QUICR）试验旨在确定数据驱动的协作质量改善干预措施是否在12个月内以计划水平实施：（1）增加符合资格的CHD患者的CR计划完成（主要结果），（2）减少住院人数，急诊科的介绍和死亡，和成本，（3）根据国家和国际基准，提高接受指南指定CR的患者比例，（4）对于CR员工来说，日常实施是可行和可持续的。
方法：QUICR是一个多中心，2型，混合有效性-实施集束随机对照试验（cRCT），随访12个月。从澳大利亚两个州（新南威尔士州和维多利亚州）招募的合格CR计划（n=40）和其中的个体患者数据（n〜2,000）以1：1的比例随机分配到干预措施（使用数据识别和管理护理差距的协作质量改进干预措施）或控制（仅收集数据的常规护理）。该样本量需要达到80%的功率来检测22%的完成率差异。结果将使用意向治疗原则进行评估。混合效应线性和逻辑回归模型将用于分析主要和次要结果。
结论：解决冠心病患者CR参与不良的问题是一项长期挑战，需要创新策略来改变现状。该试验将利用CR程序的协作能力，同时在常见问题领域工作，并使用本地数据来提高性能。使用数据链接收集结果为评估这种干预措施和支持改善卫生服务提供了一种有效的方法。
方法：获得北悉尼地方卫生区人类研究伦理委员会（2023/ETH01093）的主要伦理批准，以及特定于站点的治理批准。
背景：澳大利亚新西兰临床试验注册（ANZCTR）ACTRN12623001239651（30/11/2023）（https://anzctr.org。au/Trial/Registration/TrialReview.aspx?id=386540&isReview=true)。
方法：QUICR是一个多中心，2型，混合有效性-实施集束随机对照试验（cRCT），随访12个月。从澳大利亚两个州（新南威尔士州和维多利亚州）招募的合格CR计划（n=40）和其中的个体患者数据（n〜2,000）以1：1的比例随机分配到干预措施（使用数据识别和管理护理差距的协作质量改进干预措施）或控制（仅收集数据的常规护理）。该样本量需要达到80%的功率来检测22%的完成率差异。结果将使用意向治疗原则进行评估。混合效应线性和逻辑回归模型将用于分析主要和次要结果。
结论：解决冠心病患者CR参与不良的问题是一项长期挑战，需要创新策略来改变现状。该试验将利用CR程序的协作能力，同时在常见问题领域工作，并使用本地数据来提高性能。使用数据链接收集结果为评估这种干预措施和支持改善卫生服务提供了一种有效的方法。
方法：获得北悉尼地方卫生区人类研究伦理委员会（2023/ETH01093）的主要伦理批准，以及特定于站点的治理批准。
背景：澳大利亚新西兰临床试验注册（ANZCTR）ACTRN12623001239651（30/11/2023）（https://anzctr.org。au/Trial/Registration/TrialReview.aspx?id=386540&isReview=true)。
