NCT Number: NCT02256657
The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program.
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All sexes
Interventional
Not applicable
Government Medical College Alappuzha, Alappuzha, Kerala, India
This study is a cluster randomized, stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size to one of five cohorts. After a four-month baseline period, the quality improvement toolkit will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement 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 study. The primary outcome is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be continuously collected and compared at one interim time point for safety and efficacy. Final analysis compares MACE rates before and after implementation of the quality improvement toolkits, accounting for cluster effects of hospital, cohort and time.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The quality improvement toolkit is comprised of standardized admission and discharge checklists, clinical pathways, an audit and feedback mechanism through electronic data capture, and a monthly report used in conjunction with root cause analysis meetings. Quality improvement toolkits are implemented by individual hospitals.
Time frame: 30 Days from Hospital Discharge
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on 30-day major adverse cardiovascular events (MACE [death, reinfarction stroke, or major bleeding]) in patients admitted with acute coronary syndrome, adjusted for hospital, time, and step.
Time frame: 30 Days
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital medication prescription rates.
Time frame: 30 Days
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.
Time frame: 30 Days
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge advice relative to healthy lifestyles.
Time frame: 30 Days
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital and 30-day expanded MACE.
Time frame: 30 Days
To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.
Time frame: 30 Days
To evaluate health related quality of life in post-ACS patients (30-days) using a translated and validated version of the Seattle Angina Questionnaire (SAQ).
Time frame: 30 Days
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 for families below the poverty line.
Northwestern University
Other
Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
Acronym: ACS QUIK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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