Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial.
Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial.
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DOI：
10.1016/j.ahj.2016.10.026
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发表时间：
2017-03
影响因子：
4.8
通讯作者：
Prabhakaran D
中科院分区：
文献类型：
--
作者：
Huffman MD;Mohanan PP;Devarajan R;Baldridge AS;Kondal D;Zhao L;Ali M;Lloyd-Jones DM;Prabhakaran D
缺血性心脏病是印度的主要死亡原因，印度的心肌梗塞可能比世界上任何其他国家都多。我们之前曾报道过，在印度南部的喀拉拉邦，对心肌梗死患者的异质护理，包括最佳护理和不适当护理方面的差距。基于先前的工作，先前非随机化质量改进研究的局限性，以及先前随机试验显示的护理过程措施的有希望的收获，我们和印度心脏学会喀拉拉邦分会试图开发、实施和评估质量改进干预措施，以改善这些患者的护理过程措施和临床结果。在这篇论文中，我们报告了喀拉拉邦急性冠脉综合征质量改善(ACS Quik)群组随机阶梯楔形临床试验(NCT02256657)的基本原理和研究设计，在该试验中，我们计划在63家医院招募15,750名患有急性冠脉综合征的参与者。到目前为止，大多数参与者是男性(76%)，并患有ST段抬高的心肌梗死(63%)。主要结果是30天内发生的主要心血管不良事件，定义为死亡、再发脑梗塞、中风或大出血。我们的次要结果包括与健康相关的生活质量以及个人和家庭层面的成本。我们还描述了阶梯楔形试验设计的主要特点和局限性，这可能对考虑集群随机阶梯楔形试验的其他研究人员或赞助商很重要。
Ischemic heart disease is the leading cause of death in India, and there are likely more myocardial infarctions in India than in any other country in the world. We have previously reported heterogeneous care for patients with myocardial infarction in Kerala, a state in southern India, including both gaps in optimal care and inappropriate care. Based on that prior work, limitations from previous non-randomized quality improvement studies, and promising gains in process of care measures demonstrated from previous randomized trials, we and the Cardiological Society of India – Kerala chapter sought to develop, implement, and evaluate a quality improvement intervention to improve process of care measures and clinical outcomes for these patients. In this paper, we report the rationale and study design for the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) cluster randomized stepped wedge clinical trial (NCT02256657) in which we aim to enroll 15,750 participants with acute coronary syndromes across 63 hospitals. To date, the majority of participants are men (76%) and has ST-segment elevation myocardial infarction (63%). The primary outcome is 30-day major adverse cardiovascular events defined as death, recurrent infarction, stroke, or major bleeding. Our secondary outcomes include health-related quality of life and individual- and household-level costs. We also describe the principal features and limitations of the stepped wedge study design, which may be important for other investigators or sponsors considering cluster randomized stepped wedge trials.