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.
Coronary heart disease is the leading cause of death in India and typically afflicts people at ages 6-10 years younger than in high-income countries, often presenting as acute events such as heart attacks. Simple, inexpensive inpatient care checklists for healthcare providers have improved heart attack care considerably in high-income countries such as the United States, but these have not been widely developed, implemented, nor studied in India, despite the variability of care, rising burden of disease, and potential for improved clinical outcomes. We believe that the local development, dissemination, and evaluation of such a health care system initiative will not only create new knowledge and improve clinical outcomes in coronary heart disease in India India but will also lead to innovative solutions that may ultimately be applicable to patients in the United States.
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