Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK)

描述（由申请人提供）：拟议的申请旨在通过印度喀拉拉邦的一项聚类随机、阶梯楔形临床试验设计，开发、实施和评估质量改进工具包对急性冠状动脉综合征（ACS）后30天主要心血管不良事件发生率的影响。ACS的系统级质量改进举措虽然在高收入国家取得了成功，但在低收入和中等收入国家（LMIC）尚未得到广泛评估，但可能成为心血管实施科学领域的创新来源。该提案将利用喀拉拉邦ACS注册中心的研究基础设施，该注册中心最近完成了过去2年中来自bb50 000名ACS参与者的数据收集。该提案还包含两个子研究，将评估喀拉拉邦ACS患者水平的影响，这可能作为印度和其他低收入和中等收入国家的典范。第一个子研究旨在使用语言验证的西雅图心绞痛问卷（从英语翻译并验证为马拉雅拉姆语，喀拉拉邦当地语言）评估ACS后冠心病特异性生活质量。西雅图心绞痛问卷调查患者的身体限制、症状、治疗满意度和疾病认知。第二个子研究的目的是在最近实施的针对贫困线以下家庭的国家政府保险计划（Rashtriya Swathya Bima Yojna）的背景下，评估ACS事件对个人和家庭层面的贫困影响。该建议还包括在工具包开发中进行定性研究的探索性目标。这一目标将包括质量改进团队成员之间的焦点小组讨论，以确定在开发本地开发的与提供者相关的工具包组件（如临床路径，入院/出院清单）时实现最佳ACS护理的促进因素和障碍，以及在开发与患者相关的工具包组件（出院教育/信息材料）时与患者进行认知访谈。在该奖项的职业发展期间，我将在该领域的全国领导者John Spertus博士的指导下，在St. Luke's/Mid-America Heart Institute进行以患者为中心的ACS注册培训。我将学习研究伦理、项目评估和卫生经济学课程，以补充我之前的训练。我将通过英国国家健康与临床卓越研究所（NICE）的一个部门，与Kalipso Chalkidou博士一起参加培训讲习班/试点，以了解适应当地国家环境和医疗保健系统的循证临床标准和指南的发展。我在印度拥有公共卫生、心脏病学、福格蒂全球卫生培训和心血管流行病学研究的独特组合，这将为该项目提供坚实的基础。指导和咨询团队由美国和印度在全球心血管流行病学、公共卫生、高质量护理和结果方面的领导者组成，并将为我的职业发展和研究本身提供专家指导。发展当地解决方案以改善印度从业人员的ACS护理可能会提供与美国相关并适用的创新想法。因此，该提案旨在改善印度提供的ACS护理，并抓住全球卫生的创新潜力，这是国家卫生研究院的一个专题目标，也是国家卫生和社会福利机构使命的一部分。

DESCRIPTION (provided by applicant): The proposed application aims to develop, implement, and evaluate the impact of a quality improvement toolkit on 30-day major adverse cardiovascular event rates following acute coronary syndrome (ACS) through a cluster-randomized, stepped wedge clinical trial design in Kerala, India. System-level quality improvement initiatives in ACS, while successful in high-income countries, have not been extensively evaluated in low- and middle-income countries (LMIC), yet could be sources of innovation in the field of cardiovascular implementation science. This proposal will leverage the research infrastructure from the Kerala ACS Registry, which recently completed data collection from >25,000 ACS participants over the past 2 years. The proposal also contains 2 sub-studies that will evaluate the patient-level impact of ACS in Kerala, which may serve as a model for India and other LMIC. The first sub-study aims to evaluate coronary heart disease- specific quality of life following ACS using a linguistically-validated Seattle Angina Questionnaire (translated and validated from English to Malayalam, the local language of Kerala). The Seattle Angina Questionnaire surveys patients' physical limitations, symptoms, treatment satisfaction, and disease perception. The second sub-study aims to evaluate individual- and household-level impoverishing effects of an ACS event in the context of the recent implementation of a national government insurance program (Rashtriya Swathya Bima Yojna) for families below the poverty line. The proposal also includes an exploratory aim to perform qualitative research in toolkit development. This aim will incorporate focus group discussions among quality improvement team members to determine facilitators and barriers to optimal ACS care in the development of locally- developed provider-related toolkit components (clinical pathways, admission/discharge checklists, e.g.) as well as cognitive interviews with patients in the development of patient-related toolkit components (discharge education/information materials). During the career development period of this award, I will pursue patient-centered ACS registry training at St. Luke's/Mid-America Heart Institute under Dr. John Spertus, a national leader in the field. I will take courses in research ethics, program evaluation, and health economics to complement my prior training. I will participate in training workshops/pilots with Dr. Kalipso Chalkidou through NICE International, a division of the UK National Institute for Health and Clinical Excellence (NICE), to learn about the development of evidence- informed, clinical standards and guidelines adapted to local country settings and healthcare systems. I have a unique combination of public health, cardiology, and Fogarty global health training and cardiovascular epidemiology research in India that will provide a strong foundation for this project. The mentorship and advisory teams consist of US and Indian leaders in global cardiovascular epidemiology, public health, and quality care and outcomes, and will provide expert guidance for my career development and for the research itself. Relevance Development of local solutions to improving ACS care by Indian practitioners may provide innovative ideas that are relevant to and applicable in the US. As such, this proposal aims to improve the delivery of ACS care in India and capture the innovative potential of global health, a thematic goal of the NIH and part of the mission of the NHLBI.