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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02256657
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mark Huffman, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Behavioral: Quality Improvement Toolkit Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
Actual Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presenting with Acute Coronary Syndrome

Exclusion Criteria:

  • Below the Age of 18
  • Patient without Acute Coronary Syndrome
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256657


Locations
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Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mark Huffman, Assistant Professor in Preventive Medicine and Medicine-Cardiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02256657    
Other Study ID Numbers: ACS QUIK
1K99HL107749-01A1 ( U.S. NIH Grant/Contract )
R00HL107749-03 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data have been distributed to NHLBI BIOLINCC.
Access Criteria: Access to data will be managed through NLHBI BIOLINCC request process.
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases