Acute Coronary Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALQuality Improvement Toolkit
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presenting with Acute Coronary Syndrome
Exclusion criteria
* Below the Age of 18 * Patient without Acute Coronary Syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Major Adverse Cardiovascular Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Medication Rates | 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. |
| Discharge Advice Relative to Healthy Lifestyles | 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. |
| In-Hospital and 30-Day Expanded MACE | 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. |
| In-Hospital Medication Rates | 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. |
| Health Related Quality of Life | 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). |
| Impoverishing Effects of an ACS Event | 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. |
| Concordance with locally-defined performance measures and in-hospital and 30-day MACE | 30 Days | To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE. |
Countries
India
Outcome results
None listed