Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized
Mark D Huffman1, Padinhare Purayil Mohanan2, Raji Devarajan3
1Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Insights
This study introduces the ACS QUIK trial, a quality improvement intervention for acute coronary syndromes in India. It aims to enhance patient care and reduce major adverse cardiovascular events through a cluster-randomized stepped-wedge design.
Area of Science:
- Cardiology
- Public Health
- Clinical Trials
Background:
- Ischemic heart disease is the leading cause of death in India, with a high burden of myocardial infarctions.
- Previous studies in Kerala revealed suboptimal and inappropriate care for myocardial infarction patients.
- Limitations in prior nonrandomized quality improvement studies necessitate robust trial designs.
Purpose of the Study:
- To develop, implement, and evaluate a quality improvement intervention for acute coronary syndromes (ACS).
- To improve process of care measures and clinical outcomes in ACS patients.
- To assess the effectiveness of a cluster-randomized stepped-wedge design in quality improvement.
Main Methods:
- The ACS QUIK trial is a cluster-randomized stepped-wedge clinical trial (NCT02256657).
- Enrolling 15,750 participants with ACS across 63 hospitals in India.
- Primary outcome: 30-day major adverse cardiovascular events (MACE). Secondary outcomes: quality of life and costs.
Main Results:
- The trial aims to enroll a large cohort, with current participants predominantly male (76%) and diagnosed with ST-segment elevation myocardial infarction (63%).
- The study is designed to measure the impact of the intervention on MACE and other key outcomes.
- Detailed features and limitations of the stepped-wedge design are reported.
Conclusions:
- The ACS QUIK trial addresses critical gaps in care for ischemic heart disease in India.
- The stepped-wedge design offers a novel approach for evaluating quality improvement interventions in a real-world setting.
- Findings will inform future strategies to improve cardiovascular care delivery and outcomes in India.
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.
More Related Videos
18:11A Research Method For Detecting Transient Myocardial Ischemia In Patients With Suspected Acute Coronary Syndrome Using Continuous ST-segment Analysis
Published on: December 28, 2012
06:57Author Spotlight: Advancing Cardiovascular Imaging - Introducing the Spatially Weighted Calcium Score for Early Disease Detection
Published on: September 22, 2023
Related Concept Videos
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:30Acute Coronary Syndrome I: Introduction
01:19Acute Coronary Syndrome II: Pathophysiology and Clinical Manifestations
01:26Acute Coronary Syndrome V: Nursing Management
01:27Coronary Artery Disease V: Interprofessional Care