Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients
- Conditions
- Acute Coronary Syndrome
- Interventions
- Behavioral: Quality Improvement Toolkit
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21374
- Presenting with Acute Coronary Syndrome
- Below the Age of 18
- Patient without Acute Coronary Syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Step 2: Toolkit Implemented in Month 8 Quality Improvement Toolkit Quality Improvement Toolkit Step 1: Toolkit Implemented in Month 4 Quality Improvement Toolkit Quality Improvement Toolkit Step 3: Toolkit Implemented in Month 12 Quality Improvement Toolkit Quality Improvement Toolkit Step 4: Toolkit Implemented in Month 16 Quality Improvement Toolkit Quality Improvement Toolkit Step 5: Toolkit Implemented in Month 20 Quality Improvement Toolkit Quality Improvement Toolkit
- 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)
Noorul Islam Institute of Medical Science & Research Foundation
🇮🇳Thiruvananthapuram, Kerala, India
Aswini Hospital
🇮🇳Thrissur, Kerala, India
Ananthapuri Hospital and Research Institute
🇮🇳Thiruvananthapuram, Kerala, India
WestFort Hi-Tech Hospital Limited
🇮🇳Thrissur, Kerala, India
Santhi Nursing Home
🇮🇳Thrissur, Kerala, India
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
Sree Narayana Institute of Medical Sciences
🇮🇳Chalakka, Kerala, India
Rajah Charitable Medical Trust
🇮🇳Chavakkad, Kerala, India
PVS Memorial Hospital
🇮🇳Cochin, Kerala, India
Sukapuram Hospital
🇮🇳Edapal, Kerala, India
Irinjalakuda Co-operative Hospital Limited
🇮🇳Irinjalakuda, Kerala, India
Lal Memorial Hospital
🇮🇳Irinjalakuda, Kerala, India
Koyili Hospital
🇮🇳Kannur, Kerala, India
Kannur Medical College Super Specialty Hospital
🇮🇳Kannur, Kerala, India
Lourdes Hospital
🇮🇳Kochi, Kerala, India
Lakshmi Hospital
🇮🇳Palakkad, Kerala, India
Amrita Institute of Medical Sciences & Research Center
🇮🇳Kochi, Kerala, India
Malankara Orthodox Syrian Church Medical College Hospital
🇮🇳Kolenchery, Kerala, India
Bishop Benziger Hospital
🇮🇳Kollam, Kerala, India
Dr. K. Damodaran Memoral Hospital
🇮🇳Kollam, Kerala, India
Malabar Institute of Medical Sciences
🇮🇳Kottakkal, Kerala, India
S.H. Medical Centre Hospital
🇮🇳Kottayam, Kerala, India
Caritas Hospital
🇮🇳Kottayam, Kerala, India
C.H. Memorial Hospital
🇮🇳Malappuram, Kerala, India
Palakkad Government District Hospital
🇮🇳Palakkad, Kerala, India
Thangam Hospital
🇮🇳Palakkad, Kerala, India
Tellicherry Cooperative Hospital
🇮🇳Thalassery, Kerala, India
SK Hospital
🇮🇳Thiruvananthapuram, Kerala, India
Medical College Thiruvananthapuram
🇮🇳Thiruvananthapuram, Kerala, India
Pariyaram Medical College Hospital
🇮🇳Kannur, Kerala, India
KVM Hospital
🇮🇳Cherthala, Kerala, India
St. Martin De Porres Hospital
🇮🇳Kannur, Kerala, India
Government Medical College Kozhikode
🇮🇳Calicut, Kerala, India
Government Medical College Kottayam
🇮🇳Kottayam, Kerala, India
Bharath Cardiovascular Institute
🇮🇳Kottayam, Kerala, India
KMCT Medical College
🇮🇳Kozhikode, Kerala, India
Metro International Cardiac Centre
🇮🇳Calicut, Kerala, India
PRS Hospital
🇮🇳Trivandrum, Kerala, India
Holy Cross Hospital
🇮🇳Kollam, Kerala, India
Lisie Hospital
🇮🇳Kochi, Kerala, India
Travancore Medical College
🇮🇳Kollam, Kerala, India
Elite Mission Hospital
🇮🇳Thrissur, Kerala, India
Indira Ghandi Co-operative Hospital
🇮🇳Kochi, Kerala, India
St. Joseph's Hospital
🇮🇳Kothamangalam, Kerala, India
EMS Memorial Hospital
🇮🇳Perintalmanna, Kerala, India
St. James Hospital
🇮🇳Thrissur, Kerala, India
Amala Institute of Medical Sciences
🇮🇳Thrissur, Kerala, India
Sree Gokulam Medical College & Research Foundation
🇮🇳Thiruvananthapuram, Kerala, India
Ramdas Clinic & Nursing Home
🇮🇳Perintalmanna, Kerala, India
St. Mary's Hospital
🇮🇳Thodupuzha, Kerala, India
Pushpagiri Institute of Medical Sciences and Research Centre
🇮🇳Tiruvalla, Kerala, India
Modern Hospital
🇮🇳Thrissur, Kerala, India
Jubilee Mission Medical College & Research Institute
🇮🇳Thrissur, Kerala, India
Kerala Institute of Medical Sciences
🇮🇳Trivandrum, Kerala, India
Daya General Hospital & Specialty Surgery Centre
🇮🇳Thrissur, Kerala, India
Mother Hospital Limited
🇮🇳Thrissur, Kerala, India
AA Rahim Memorial District Hospital
🇮🇳Kollam, Kerala, India
Sree Chitra Institute for Medical Sciences and Technology
🇮🇳Thiruvananthapuram, Kerala, India
Government Medical College Thrissur
🇮🇳Thrissur, Kerala, India