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 independent investigator period of this award, I will use the training and preparation for the past two years to execute this complex, yet feasible and important, clinical trial across 60 sites in Kerala, India to improve heart attack quality of care and outcomes in a middle-income country setting such as India using innovative methods for improved causal inference. I have developed a sustainable, effective, and model relationship with the Cardiological Society of India-Kerala Chapter, including key leaders such as co-investigator and past-president, Dr. P.P. Mohanan, based on our collaborative publications, focus group discussions and in-depth interviews, and investigators’ meetings during my repeated trips to Kerala. I have a unique combination of public health, cardiology, and Fogarty global health field training and cardiovascular epidemiology research in India that provides 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, who will provide expert guidance for the execution of this trial.
|Effective start/end date||7/21/14 → 6/30/17|
- National Heart, Lung, and Blood Institute (5R00HL107749-05)
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