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群组随机、阶梯式楔形临床试验设计，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天主要不良心血管事件发生率的影响。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。这项提议将利用喀拉拉邦ACS注册处的研究基础设施，该注册处最近在过去两年中完成了对25,000名ACS参与者的数据收集。该提案还包含两项子研究，将评估喀拉拉邦急性冠脉综合征对患者水平的影响，这可能会成为印度和其他LMIC的典范。第一项子研究旨在使用经过语言验证的西雅图心绞痛问卷(从英语到喀拉拉邦当地语言马来亚语的翻译和验证)来评估急性冠脉综合征后冠心病患者的生活质量。西雅图心绞痛问卷调查了患者的身体限制、症状、治疗满意度和疾病认知。第二项分研究的目的是在最近为贫困线以下的家庭实施国家政府保险计划(Rashtriya Swthya Bima Yojna)的背景下，评估ACS事件对个人和家庭一级的贫困影响。该提案还包括一个探索性目标，即在工具包开发中进行定性研究。这一目标将纳入质量改进团队成员之间的焦点小组讨论，以确定在当地开发的与提供者相关的工具包组件(临床路径、入院/出院核对清单，例如)的开发中促进最佳ACS治疗的因素和障碍。以及在开发与患者相关的工具包组件(出院教育/信息材料)的过程中对患者进行认知访谈。在该奖项的职业发展期间，我将在圣卢克/中美心脏研究所接受以患者为中心的ACS注册培训，师从该领域的全国领先者约翰·斯珀特斯博士。我将学习研究伦理、项目评估和健康经济学等课程，以补充我之前的培训。我将通过英国国家健康与临床卓越研究所(NICE)的分支机构NICE国际，与Kalipso Chalystou博士一起参加培训研讨会/试点，以了解适应当地国家环境和医疗体系的循证、临床标准和指南的制定。我在印度将公共卫生、心脏病学、Fogarty全球健康培训和心血管流行病学研究结合在一起，这将为这个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、公共卫生以及高质量护理和结果方面的领导者组成，将为我的职业发展和研究本身提供专家指导。相关性由印度从业者开发改善急性冠脉综合征护理的本地解决方案可能提供与美国相关并适用于美国的创新想法。因此，这项提议旨在改善在印度提供的急性冠脉综合征治疗，并挖掘全球卫生的创新潜力，这是NIH的一个主题目标，也是NHLBI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.