Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients (ACS QUIK)

Northwestern University

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Behavioral: Quality Improvement Toolkit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02256657

1K99HL107749-01A1 (U.S. NIH Grant/Contract)

R00HL107749-03 (U.S. NIH Grant/Contract)

ACS QUIK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21,374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting with Acute Coronary Syndrome

Exclusion criteria

• Below the Age of 18
• Patient without Acute Coronary Syndrome

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21,374 participants in 5 patient groups

Step 1: Toolkit Implemented in Month 4

Experimental group

Description:

Quality Improvement Toolkit

Treatment:

Behavioral: Quality Improvement Toolkit

Step 2: Toolkit Implemented in Month 8

Experimental group

Description:

Quality Improvement Toolkit

Treatment:

Behavioral: Quality Improvement Toolkit

Step 3: Toolkit Implemented in Month 12

Experimental group

Description:

Quality Improvement Toolkit

Treatment:

Behavioral: Quality Improvement Toolkit

Step 4: Toolkit Implemented in Month 16

Experimental group

Description:

Quality Improvement Toolkit

Treatment:

Behavioral: Quality Improvement Toolkit

Step 5: Toolkit Implemented in Month 20

Experimental group

Description:

Quality Improvement Toolkit

Treatment:

Behavioral: Quality Improvement Toolkit