Acute Coronary Syndrome Quality Improvement in Kerala (ACS-QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
Open BioLINCC Study See bottom of this webpage for request information
November 2014-December 2017
December 6, 2018
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Specific Consent Restrictions
To assess the implementation and effect of a locally-developed quality improvement toolkit on 30-day major adverse cardiovascular events for patients with acute coronary syndrome (ACS) in Kerala, India.
Improving quality of care and outcomes for patients with acute myocardial infarction (MI), particularly in low-and middle-income countries is a global health priority. In 2015, there were an estimated 7.3 million fatal myocardial infarctions globally, and South Asia was estimated to have the world’s high age-standardized incidence rate of MI. Previous publications from the Kerala Acute Coronary Syndrome (ACS) Registry demonstrated wide heterogeneity in process and outcomes measures across hospitals in the Indian state of Kerala. In addition, previous quality improvement randomized trials have shown favorable effects on process measures in low-and middle-income countries such as Brazil and China.
Patients included in this study were adult patients (18+) presenting with Acute Coronary Syndrome (ACS) in 63 hospitals in Kerala, India. Participants were eligible to participate if they presented with or were transferred for evaluation and management of either non-ST-segment elevation myocardial infarction or ST-segment myocardial infarction. 22,557 participants from the 63 hospitals were recruited for the trial. Of these, 21, 374 were eligible and 21,079 participants had complete outcome data.
The 63 hospitals were recruited from the 125 hospitals that had previously participated in the Kerala Acute Coronary Syndrome (ACS) Registry. Hospitals were required to identify two (2) individuals to serve on a quality improvement team in order to be eligible for participation in the trial.
The ACS QUIK study was a large, pragmatic, cluster randomized, stepped wedge clinical trial with a primary outcome of 30-day major adverse cardiovascular event (MACE), which include death, reinfarction, stroke, or major bleeding.
Hospitals were randomized, after stratification for size, to one of five cohorts. After a four-month baseline period of usual care, the quality improvement toolkit was implemented in all the hospitals in cohort 1. Cohort 1 continued to use the quality improvement toolkit through the end of the trial for all ACS patients. Cohorts 2 through 5 implemented the quality improvement toolkit at time points: 8, 12, 16, and 20 months respectively, continuing the use of the toolkits from that time forward to the end of the trial.
The quality improvement toolkit consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training. The audit and feedback reports were based on key data elements used by the American College of Cardiology and American Heart Association. The reports, which included site-specific performance measures, were sent monthly to site investigators for review and comparison to other hospitals in the cohort/trial. Training was provided for the interpretation of these reports and use for informing quality improvement team meetings. Standardized admission and discharge order sets included translated and culturally adapted patient education materials related to: tobacco cessation, dietary advice, and physical activity.
The 30-day composite event rates among patients was 6.4% in the control phase (usual care) compared to 5.3% in the intervention phase. The difference between the two groups was determined to be not statistically significant after adjusting for cluster and temporal trends.
Huffman MD, Mohanan PP, Devarajan R, et al. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018;319(6):567-578.
Requests for Open BioLINCC Studies are submitted through this website. Click the Request button to begin.
Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 392.3 KB)
- ACS QUIK Case Report Forms (PDF - 1.9 MB)
- ACS QUIK Datasets Descriptions (PDF - 84.5 KB)
- ACS QUIK Protocol (PDF - 961.7 KB)
Persons using assistive technology may not be able to fully access information in the study documents. For assistance, Contact BioLINCC and include the web address and/or publication title in your message. If you need help accessing information in different file formats such as PDF, XLS, DOC, see Instructions for Downloading Viewers and Players.