<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02256657</url>
  </required_header>
  <id_info>
    <org_study_id>ACS QUIK</org_study_id>
    <secondary_id>1K99HL107749-01A1</secondary_id>
    <secondary_id>R00HL107749-03</secondary_id>
    <nct_id>NCT02256657</nct_id>
  </id_info>
  <brief_title>Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients</brief_title>
  <acronym>ACS QUIK</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of&#xD;
      using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement&#xD;
      toolkit includes standardized admission and discharge sets, clinical pathways and an audit&#xD;
      and feedback program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a cluster randomized, stepped wedge clinical trial assessing implementation and&#xD;
      effect of a locally-developed quality improvement toolkit for patients with acute coronary&#xD;
      syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size&#xD;
      to one of five cohorts. After a four-month baseline period, the quality improvement toolkit&#xD;
      will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these&#xD;
      hospitals will continue to use the quality improvement toolkit through the end of the trial&#xD;
      for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement the&#xD;
      quality improvement toolkit at time points 8, 12, 16, and 20 months respectively, continuing&#xD;
      the use of the toolkits from that time forward to the end of the study. The primary outcome&#xD;
      is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be&#xD;
      continuously collected and compared at one interim time point for safety and efficacy. Final&#xD;
      analysis compares MACE rates before and after implementation of the quality improvement&#xD;
      toolkits, accounting for cluster effects of hospital, cohort and time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-Day Major Adverse Cardiovascular Events</measure>
    <time_frame>30 Days from Hospital Discharge</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-Hospital Medication Rates</measure>
    <time_frame>30 Days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Medication Rates</measure>
    <time_frame>30 Days</time_frame>
    <description>Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Advice Relative to Healthy Lifestyles</measure>
    <time_frame>30 Days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-Hospital and 30-Day Expanded MACE</measure>
    <time_frame>30 Days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance with locally-defined performance measures and in-hospital and 30-day MACE</measure>
    <time_frame>30 Days</time_frame>
    <description>To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>30 Days</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impoverishing Effects of an ACS Event</measure>
    <time_frame>30 Days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">21374</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Step 1: Toolkit Implemented in Month 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quality Improvement Toolkit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step 2: Toolkit Implemented in Month 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quality Improvement Toolkit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step 3: Toolkit Implemented in Month 12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quality Improvement Toolkit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step 4: Toolkit Implemented in Month 16</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quality Improvement Toolkit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step 5: Toolkit Implemented in Month 20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quality Improvement Toolkit</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality Improvement Toolkit</intervention_name>
    <description>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.</description>
    <arm_group_label>Step 1: Toolkit Implemented in Month 4</arm_group_label>
    <arm_group_label>Step 2: Toolkit Implemented in Month 8</arm_group_label>
    <arm_group_label>Step 3: Toolkit Implemented in Month 12</arm_group_label>
    <arm_group_label>Step 4: Toolkit Implemented in Month 16</arm_group_label>
    <arm_group_label>Step 5: Toolkit Implemented in Month 20</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting with Acute Coronary Syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below the Age of 18&#xD;
&#xD;
          -  Patient without Acute Coronary Syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark D Huffman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>PP Mohanan, MD, DM</last_name>
    <role>Study Director</role>
    <affiliation>WestFort Hi-Tech Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Doirairaj Prabhakaran, MD, DM</last_name>
    <role>Study Chair</role>
    <affiliation>Centre for Chronic Disease Control</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Donald Lloyd-Jones, MD, ScM</last_name>
    <role>Study Chair</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Government Medical College Alappuzha</name>
      <address>
        <city>Alappuzha</city>
        <state>Kerala</state>
        <zip>688005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samaritan Hospital</name>
      <address>
        <city>Aluva</city>
        <state>Kerala</state>
        <zip>683562</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Little Flower Hospital &amp; Research Center</name>
      <address>
        <city>Angamaly</city>
        <state>Kerala</state>
        <zip>683572</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baby Memorial Hospital</name>
      <address>
        <city>Calicut</city>
        <state>Kerala</state>
        <zip>673004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College Kozhikode</name>
      <address>
        <city>Calicut</city>
        <state>Kerala</state>
        <zip>673008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro International Cardiac Centre</name>
      <address>
        <city>Calicut</city>
        <state>Kerala</state>
        <zip>673014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sree Narayana Institute of Medical Sciences</name>
      <address>
        <city>Chalakka</city>
        <state>Kerala</state>
        <zip>683594</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rajah Charitable Medical Trust</name>
      <address>
        <city>Chavakkad</city>
        <state>Kerala</state>
        <zip>680506</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KVM Hospital</name>
      <address>
        <city>Cherthala</city>
        <state>Kerala</state>
        <zip>688524</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PVS Memorial Hospital</name>
      <address>
        <city>Cochin</city>
        <state>Kerala</state>
        <zip>682017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sukapuram Hospital</name>
      <address>
        <city>Edapal</city>
        <state>Kerala</state>
        <zip>679576</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irinjalakuda Co-operative Hospital Limited</name>
      <address>
        <city>Irinjalakuda</city>
        <state>Kerala</state>
        <zip>680661</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lal Memorial Hospital</name>
      <address>
        <city>Irinjalakuda</city>
        <state>Kerala</state>
        <zip>680712</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koyili Hospital</name>
      <address>
        <city>Kannur</city>
        <state>Kerala</state>
        <zip>670004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Martin De Porres Hospital</name>
      <address>
        <city>Kannur</city>
        <state>Kerala</state>
        <zip>670301</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pariyaram Medical College Hospital</name>
      <address>
        <city>Kannur</city>
        <state>Kerala</state>
        <zip>670503</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannur Medical College Super Specialty Hospital</name>
      <address>
        <city>Kannur</city>
        <state>Kerala</state>
        <zip>670612</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lourdes Hospital</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakshmi Hospital</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lisie Hospital</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682018</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indira Ghandi Co-operative Hospital</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amrita Institute of Medical Sciences &amp; Research Center</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682041</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malankara Orthodox Syrian Church Medical College Hospital</name>
      <address>
        <city>Kolenchery</city>
        <state>Kerala</state>
        <zip>682311</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AA Rahim Memorial District Hospital</name>
      <address>
        <city>Kollam</city>
        <state>Kerala</state>
        <zip>691001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bishop Benziger Hospital</name>
      <address>
        <city>Kollam</city>
        <state>Kerala</state>
        <zip>691001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. K. Damodaran Memoral Hospital</name>
      <address>
        <city>Kollam</city>
        <state>Kerala</state>
        <zip>691001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Kollam</city>
        <state>Kerala</state>
        <zip>691571</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travancore Medical College</name>
      <address>
        <city>Kollam</city>
        <state>Kerala</state>
        <zip>691589</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Hospital</name>
      <address>
        <city>Kothamangalam</city>
        <state>Kerala</state>
        <zip>686691</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malabar Institute of Medical Sciences</name>
      <address>
        <city>Kottakkal</city>
        <state>Kerala</state>
        <zip>676503</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bharath Cardiovascular Institute</name>
      <address>
        <city>Kottayam</city>
        <state>Kerala</state>
        <zip>686001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.H. Medical Centre Hospital</name>
      <address>
        <city>Kottayam</city>
        <state>Kerala</state>
        <zip>686001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College Kottayam</name>
      <address>
        <city>Kottayam</city>
        <state>Kerala</state>
        <zip>686008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caritas Hospital</name>
      <address>
        <city>Kottayam</city>
        <state>Kerala</state>
        <zip>686630</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KMCT Medical College</name>
      <address>
        <city>Kozhikode</city>
        <state>Kerala</state>
        <zip>673602</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. Memorial Hospital</name>
      <address>
        <city>Malappuram</city>
        <state>Kerala</state>
        <zip>676552</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palakkad Government District Hospital</name>
      <address>
        <city>Palakkad</city>
        <state>Kerala</state>
        <zip>678001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thangam Hospital</name>
      <address>
        <city>Palakkad</city>
        <state>Kerala</state>
        <zip>678004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakshmi Hospital</name>
      <address>
        <city>Palakkad</city>
        <state>Kerala</state>
        <zip>678013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EMS Memorial Hospital</name>
      <address>
        <city>Perintalmanna</city>
        <state>Kerala</state>
        <zip>679322</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramdas Clinic &amp; Nursing Home</name>
      <address>
        <city>Perintalmanna</city>
        <state>Kerala</state>
        <zip>679322</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tellicherry Cooperative Hospital</name>
      <address>
        <city>Thalassery</city>
        <state>Kerala</state>
        <zip>670101</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SK Hospital</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College Thiruvananthapuram</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sree Chitra Institute for Medical Sciences and Technology</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ananthapuri Hospital and Research Institute</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695024</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noorul Islam Institute of Medical Science &amp; Research Foundation</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695123</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sree Gokulam Medical College &amp; Research Foundation</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695607</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>Thodupuzha</city>
        <state>Kerala</state>
        <zip>685584</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santhi Nursing Home</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>679561</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WestFort Hi-Tech Hospital Limited</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jubilee Mission Medical College &amp; Research Institute</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Mission Hospital</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mother Hospital Limited</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aswini Hospital</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daya General Hospital &amp; Specialty Surgery Centre</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680022</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James Hospital</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680307</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amala Institute of Medical Sciences</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680555</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College Thrissur</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680596</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Modern Hospital</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <zip>680664</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pushpagiri Institute of Medical Sciences and Research Centre</name>
      <address>
        <city>Tiruvalla</city>
        <state>Kerala</state>
        <zip>689101</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRS Hospital</name>
      <address>
        <city>Trivandrum</city>
        <state>Kerala</state>
        <zip>695002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerala Institute of Medical Sciences</name>
      <address>
        <city>Trivandrum</city>
        <state>Kerala</state>
        <zip>695029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Lloyd-Jones DM, Prabhakaran D. Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. Am Heart J. 2017 Mar;185:154-160. doi: 10.1016/j.ahj.2016.10.026. Epub 2016 Dec 21.</citation>
    <PMID>28267469</PMID>
  </reference>
  <results_reference>
    <citation>Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Krishnan MN, Natesan S, Gopinath R, Viswanathan S, Stigi J, Joseph J, Chozhakkat S, Lloyd-Jones DM, Prabhakaran D; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):567-578. doi: 10.1001/jama.2017.21906.</citation>
    <PMID>29450524</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Mark Huffman</investigator_full_name>
    <investigator_title>Assistant Professor in Preventive Medicine and Medicine-Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data have been distributed to NHLBI BIOLINCC.</ipd_time_frame>
    <ipd_access_criteria>Access to data will be managed through NLHBI BIOLINCC request process.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02256657
org study id: ACS QUIK
secondary id: 1K99HL107749-01A1
secondary id: R00HL107749-03
nct id: NCT02256657
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: 30-Day Major Adverse Cardiovascular Events
time frame: 30 Days from Hospital Discharge
description: 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.
measure: In-Hospital Medication Rates
time frame: 30 Days
description: 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.
measure: Discharge Medication Rates
time frame: 30 Days
description: Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.
measure: Discharge Advice Relative to Healthy Lifestyles
time frame: 30 Days
description: 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.
measure: In-Hospital and 30-Day Expanded MACE
time frame: 30 Days
description: 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.
measure: Concordance with locally-defined performance measures and in-hospital and 30-day MACE
time frame: 30 Days
description: To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.
measure: Health Related Quality of Life
time frame: 30 Days
description: 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).
measure: Impoverishing Effects of an ACS Event
time frame: 30 Days
description: 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.
arm group label: Step 1: Toolkit Implemented in Month 4
arm group type: Experimental
description: Quality Improvement Toolkit
arm group label: Step 2: Toolkit Implemented in Month 8
arm group type: Experimental
description: Quality Improvement Toolkit
arm group label: Step 3: Toolkit Implemented in Month 12
arm group type: Experimental
description: Quality Improvement Toolkit
arm group label: Step 4: Toolkit Implemented in Month 16
arm group type: Experimental
description: Quality Improvement Toolkit
arm group label: Step 5: Toolkit Implemented in Month 20
arm group type: Experimental
description: Quality Improvement Toolkit
intervention type: Behavioral
intervention name: Quality Improvement Toolkit
description: 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.
arm group label: Step 1: Toolkit Implemented in Month 4
arm group label: Step 2: Toolkit Implemented in Month 8
arm group label: Step 3: Toolkit Implemented in Month 12
arm group label: Step 4: Toolkit Implemented in Month 16
arm group label: Step 5: Toolkit Implemented in Month 20
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark D Huffman, MD, MPH
role: Principal Investigator
affiliation: Northwestern University
last name: PP Mohanan, MD, DM
role: Study Director
affiliation: WestFort Hi-Tech Hospital
last name: Doirairaj Prabhakaran, MD, DM
role: Study Chair
affiliation: Centre for Chronic Disease Control
last name: Donald Lloyd-Jones, MD, ScM
role: Study Chair
affiliation: Northwestern University
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country: India
citation: Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Lloyd-Jones DM, Prabhakaran D. Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. Am Heart J. 2017 Mar;185:154-160. doi: 10.1016/j.ahj.2016.10.026. Epub 2016 Dec 21.
PMID: 28267469
citation: Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Krishnan MN, Natesan S, Gopinath R, Viswanathan S, Stigi J, Joseph J, Chozhakkat S, Lloyd-Jones DM, Prabhakaran D; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):567-578. doi: 10.1001/jama.2017.21906.
PMID: 29450524
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Mark Huffman
investigator title: Assistant Professor in Preventive Medicine and Medicine-Cardiology
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: Yes
ipd description: De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data have been distributed to NHLBI BIOLINCC.
ipd access criteria: Access to data will be managed through NLHBI BIOLINCC request process.