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

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 non-randomized 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 paper, we report the rationale and study design for the Acute Coronary Syndrome Quality Improvement in Kerala (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, the majority of participants are men (76%) and has 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.

Comparative Effectiveness of Reperfusion Strategies in Patients with ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Trial

“…We obtained the ACS QUIK study data from the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC; National Heart, Lung, and Blood Institute, Bethesda, Maryland). The design and primary results of the trial have been previously published [ 13 14 ]. In brief, 63 hospitals in Kerala, India participated in a cluster randomized, stepped-wedge clinical trial to evaluate the impact of a locally adapted quality improvement toolkit to improve ACS outcomes [ 15 ].…”

Presentation, management and outcomes of acute coronary syndrome: a registry study from Kenyatta National Hospital in Nairobi, Kenya

“…These include ACS quality-improvement randomised, control trials, such as the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS), 15 the Clinical Pathways for Acute Coronary Syndromes, phases 2 and 3 (CPACS-2 and -3) 16 in China, and the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) study in India. 17 These multi-institutional randomised, control trials have investigated the impact of quality-improvement tools such as clinical pathways, audits and performance feedback on both processes of care and outcomes, with the goal of improving ACS management. Such future efforts within sub-Saharan Africa could be instrumental in identifying unique solutions tailored to the needs and capacity of the region to improve ACS care.…”

Facilitators, context of and barriers to acute coronary syndrome care at Kenyatta National Hospital, Nairobi, Kenya: a qualitative analysis

“…We also assessed the acceptability of initiatives to improve quality of care of ACS, such as checklists, audits and feedback reports, which have been shown to improve processes of care in ACS management. 7 , 8 …”