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Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial - 18/04/17

Doi : 10.1016/j.ahj.2016.10.026 
Mark D. Huffman, MD, MPH a, , Padinhare Purayil Mohanan, MD, DM b, Raji Devarajan, MSc c, Abigail S. Baldridge, MS a, Dimple Kondal, PhD c, Lihui Zhao, PhD a, Mumtaj Ali, MSc d, Donald M. Lloyd-Jones, MD, ScM a, Dorairaj Prabhakaran, MD, DM, MSc c, d
a Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 
b Westfort Hi-Tech Hospital, Ltd, Thrissur, India 
c Centre for Chronic Disease Control, Gurgaon, India 
d Centre for Chronic Conditions and Injuries, Public Health Foundation of India, Gurgaon, India 

Reprint requests: Mark D. Huffman, MD, MPH, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611.Department of Preventive MedicineNorthwestern University Feinberg School of MedicineChicagoIL60611

Abstract

Ischemic heart disease is the leading cause of death in India, and there are likely more myocardial infarctions in India than in any other country in the world. We have previously reported heterogeneous care for patients with myocardial infarction in Kerala, a state in southern India, including both gaps in optimal care and inappropriate care. Based on that prior work, limitations from previous nonrandomized quality improvement studies and promising gains in process of care measures demonstrated from previous randomized trials, we and the Cardiological Society of India—Kerala chapter sought to develop, implement, and evaluate a quality improvement intervention to improve process of care measures and clinical outcomes for these patients. In this article, we report the rationale and study design for the ACS QUIK cluster-randomized stepped-wedge clinical trial (NCT02256657) in which we aim to enroll 15,750 participants with acute coronary syndromes across 63 hospitals. To date, most participants are men (76%) and have ST-segment elevation myocardial infarction (63%). The primary outcome is 30-day major adverse cardiovascular events defined as death, recurrent infarction, stroke, or major bleeding. Our secondary outcomes include health-related quality of life and individual- and household-level costs. We also describe the principal features and limitations of the stepped-wedge study design, which may be important for other investigators or sponsors considering cluster-randomized stepped-wedge trials.

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Plan


 Trial registration: NCT02256657.
 Funding: The study is supported by the National Heart, Lung, and Blood Institute (R00 HL107749), Cardiological Society of India—Kerala chapter, and Northwestern Global Health Initiative. The funders were not involved in the development of the study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The program officer representing the National Heart, Lung, and Blood Institute participated in Data and Safety Monitoring Board activities. The Cardiological Society of India—Kerala chapter contributed support for training activities to develop the trial.


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Vol 185

P. 154-160 - mars 2017 Retour au numéro
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