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

August 15, 2018 updated by: Mark Huffman, Northwestern University

Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Alappuzha, Kerala, India, 688005
        • Government Medical College Alappuzha
      • Aluva, Kerala, India, 683562
        • Samaritan Hospital
      • Angamaly, Kerala, India, 683572
        • Little Flower Hospital & Research Center
      • Calicut, Kerala, India, 673004
        • Baby Memorial Hospital
      • Calicut, Kerala, India, 673008
        • Government Medical College Kozhikode
      • Calicut, Kerala, India, 673014
        • Metro International Cardiac Centre
      • Chalakka, Kerala, India, 683594
        • Sree Narayana Institute of Medical Sciences
      • Chavakkad, Kerala, India, 680506
        • Rajah Charitable Medical Trust
      • Cherthala, Kerala, India, 688524
        • KVM Hospital
      • Cochin, Kerala, India, 682017
        • PVS Memorial Hospital
      • Edapal, Kerala, India, 679576
        • Sukapuram Hospital
      • Irinjalakuda, Kerala, India, 680661
        • Irinjalakuda Co-operative Hospital Limited
      • Irinjalakuda, Kerala, India, 680712
        • Lal Memorial Hospital
      • Kannur, Kerala, India, 670004
        • Koyili Hospital
      • Kannur, Kerala, India, 670301
        • St. Martin De Porres Hospital
      • Kannur, Kerala, India, 670503
        • Pariyaram Medical College Hospital
      • Kannur, Kerala, India, 670612
        • Kannur Medical College Super Specialty Hospital
      • Kochi, Kerala, India, 682018
        • Lisie Hospital
      • Kochi, Kerala, India, 682012
        • Lourdes Hospital
      • Kochi, Kerala, India, 682016
        • Lakshmi Hospital
      • Kochi, Kerala, India, 682020
        • Indira Ghandi Co-operative Hospital
      • Kochi, Kerala, India, 682041
        • Amrita Institute of Medical Sciences & Research Center
      • Kolenchery, Kerala, India, 682311
        • Malankara Orthodox Syrian Church Medical College Hospital
      • Kollam, Kerala, India, 691001
        • AA Rahim Memorial District Hospital
      • Kollam, Kerala, India, 691001
        • Bishop Benziger Hospital
      • Kollam, Kerala, India, 691001
        • Dr. K. Damodaran Memoral Hospital
      • Kollam, Kerala, India, 691571
        • Holy Cross Hospital
      • Kollam, Kerala, India, 691589
        • Travancore Medical College
      • Kothamangalam, Kerala, India, 686691
        • St. Joseph's Hospital
      • Kottakkal, Kerala, India, 676503
        • Malabar Institute of Medical Sciences
      • Kottayam, Kerala, India, 686001
        • Bharath Cardiovascular Institute
      • Kottayam, Kerala, India, 686001
        • S.H. Medical Centre Hospital
      • Kottayam, Kerala, India, 686008
        • Government Medical College Kottayam
      • Kottayam, Kerala, India, 686630
        • Caritas Hospital
      • Kozhikode, Kerala, India, 673602
        • KMCT Medical College
      • Malappuram, Kerala, India, 676552
        • C.H. Memorial Hospital
      • Palakkad, Kerala, India, 678001
        • Palakkad Government District Hospital
      • Palakkad, Kerala, India, 678004
        • Thangam Hospital
      • Palakkad, Kerala, India, 678013
        • Lakshmi Hospital
      • Perintalmanna, Kerala, India, 679322
        • EMS Memorial Hospital
      • Perintalmanna, Kerala, India, 679322
        • Ramdas Clinic & Nursing Home
      • Thalassery, Kerala, India, 670101
        • Tellicherry Cooperative Hospital
      • Thiruvananthapuram, Kerala, India, 695006
        • SK Hospital
      • Thiruvananthapuram, Kerala, India, 695011
        • Medical College Thiruvananthapuram
      • Thiruvananthapuram, Kerala, India, 695011
        • Sree Chitra Institute for Medical Sciences and Technology
      • Thiruvananthapuram, Kerala, India, 695024
        • Ananthapuri Hospital and Research Institute
      • Thiruvananthapuram, Kerala, India, 695123
        • Noorul Islam Institute of Medical Science & Research Foundation
      • Thiruvananthapuram, Kerala, India, 695607
        • Sree Gokulam Medical College & Research Foundation
      • Thodupuzha, Kerala, India, 685584
        • St. Mary's Hospital
      • Thrissur, Kerala, India, 679561
        • Santhi Nursing Home
      • Thrissur, Kerala, India, 680002
        • WestFort Hi-Tech Hospital Limited
      • Thrissur, Kerala, India, 680005
        • Jubilee Mission Medical College & Research Institute
      • Thrissur, Kerala, India, 680007
        • Elite Mission Hospital
      • Thrissur, Kerala, India, 680012
        • Mother Hospital Limited
      • Thrissur, Kerala, India, 680020
        • Aswini Hospital
      • Thrissur, Kerala, India, 680022
        • Daya General Hospital & Specialty Surgery Centre
      • Thrissur, Kerala, India, 680307
        • St. James Hospital
      • Thrissur, Kerala, India, 680555
        • Amala Institute of Medical Sciences
      • Thrissur, Kerala, India, 680596
        • Government Medical College Thrissur
      • Thrissur, Kerala, India, 680664
        • Modern Hospital
      • Tiruvalla, Kerala, India, 689101
        • Pushpagiri Institute of Medical Sciences and Research Centre
      • Trivandrum, Kerala, India, 695002
        • PRS Hospital
      • Trivandrum, Kerala, India, 695029
        • Kerala Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presenting with Acute Coronary Syndrome

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Step 1: Toolkit Implemented in Month 4
Quality Improvement Toolkit
Behavioral: Quality 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.
Experimental: Step 2: Toolkit Implemented in Month 8
Quality Improvement Toolkit
Behavioral: Quality 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.
Experimental: Step 3: Toolkit Implemented in Month 12
Quality Improvement Toolkit
Behavioral: Quality 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.
Experimental: Step 4: Toolkit Implemented in Month 16
Quality Improvement Toolkit
Behavioral: Quality 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.
Experimental: Step 5: Toolkit Implemented in Month 20
Quality Improvement Toolkit
Behavioral: Quality 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-Day Major Adverse Cardiovascular Events
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.
30 Days from Hospital Discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Hospital Medication 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 in-hospital medication prescription rates.
30 Days
Discharge Medication 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.
30 Days
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 discharge advice relative to healthy lifestyles.
30 Days
In-Hospital and 30-Day Expanded MACE
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.
30 Days
Concordance with locally-defined performance measures and in-hospital and 30-day 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.
30 Days
Health Related Quality of Life
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).
30 Days
Impoverishing Effects of an ACS Event
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.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mark D Huffman, MD, MPH, Northwestern University
  • Study Director: PP Mohanan, MD, DM, WestFort Hi-Tech Hospital
  • Study Chair: Doirairaj Prabhakaran, MD, DM, Centre for Chronic Disease Control
  • Study Chair: Donald Lloyd-Jones, MD, ScM, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACS QUIK
  • 1K99HL107749-01A1 (U.S. NIH Grant/Contract)
  • R00HL107749-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.

IPD Sharing Time Frame

Data have been distributed to NHLBI BIOLINCC.

IPD Sharing Access Criteria

Access to data will be managed through NLHBI BIOLINCC request process.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Quality Improvement Toolkit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe