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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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