Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK)

描述（由申请人提供）：申报的申请旨在通过在印度喀拉拉邦进行的随机分组、阶梯楔形临床试验设计，开发、实施和评价质量改进工具包对急性冠脉综合征（ACS）后30天主要不良心血管事件发生率的影响。ACS的系统级质量改进举措虽然在高收入国家取得了成功，但尚未在低收入和中等收入国家（LMIC）进行广泛评估，但可能是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登记处的研究基础设施，该登记处最近完成了过去2年中超过25，000名ACS参与者的数据收集。 该提案还包含2项子研究，将评估喀拉拉邦ACS的患者水平影响，这可能作为印度和其他LMIC的模型。第一项子研究旨在使用经语言学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，喀拉拉邦的当地语言）评价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、治疗满意度和疾病感知。第二个子研究的目的是评估个人和家庭层面的ACS事件的影响，在最近实施的国家政府保险计划（Rashtriya Swathya比马Yojna）的贫困线以下的家庭。该提案还包括一个探索性目标，即在工具包开发方面进行定性研究。这一目标将在质量改进团队成员中纳入焦点小组讨论，以确定在开发本地开发的提供者相关工具包组件（例如，临床路径、入院/出院检查表）时实现最佳ACS护理的促进因素和障碍。以及在开发患者相关工具包组件（出院教育/信息材料）时与患者进行认知访谈。 在此奖项的职业发展期间，我将在圣卢克/中美洲心脏研究所接受以患者为中心的ACS登记培训，由该领域的国家领导人John Spertus博士领导。我将参加研究伦理，项目评估和卫生经济学课程，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）的一个部门NICE International与Kasso Chalkidou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保健系统的循证临床标准和指南的发展。 我有一个独特的公共卫生，心脏病学和福格蒂全球健康培训和心血管流行病学研究在印度的组合，将为这个项目提供一个强大的基础。导师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，优质护理和成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。相关性发展当地的解决方案，以改善ACS护理的印度从业者可能会提供创新的想法，是相关的，并适用于美国。因此，该提案旨在改善印度ACS护理的提供，并抓住全球卫生的创新潜力，这是NIH的主题目标和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.