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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02256657
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-03
• Study Start: 2014-11
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21374

Inclusion Criteria

• Presenting with Acute Coronary Syndrome

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.
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.
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.
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.

Trial Locations

Locations (62)

Government Medical College Alappuzha; 🇮🇳 Alappuzha, Kerala, India

Samaritan Hospital; 🇮🇳 Aluva, Kerala, India

Little Flower Hospital & Research Center; 🇮🇳 Angamaly, Kerala, India

Baby Memorial Hospital; 🇮🇳 Calicut, Kerala, India

Government Medical College Kozhikode; 🇮🇳 Calicut, Kerala, India

Metro International Cardiac Centre; 🇮🇳 Calicut, Kerala, India

Sree Narayana Institute of Medical Sciences; 🇮🇳 Chalakka, Kerala, India

Rajah Charitable Medical Trust; 🇮🇳 Chavakkad, Kerala, India

KVM Hospital; 🇮🇳 Cherthala, Kerala, India

PVS Memorial Hospital; 🇮🇳 Cochin, Kerala, India

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