<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/NCT03005509</url>
  </required_header>
  <id_info>
    <org_study_id>GCF020013-TQI</org_study_id>
    <nct_id>NCT03005509</nct_id>
  </id_info>
  <brief_title>Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India</brief_title>
  <acronym>TQI</acronym>
  <official_title>Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India: Protocol for a Prospective Observational Study to Assess Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Gerard O'Reilly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Trauma Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Monash University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The George Institute for Global Health, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sheth Vadilal Sarabhai General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guru Teg Bahadur Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lokmanya Tilak Municipal Medical College and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centralised Accident and Trauma Services, Delhi, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GVK EMRI: Emergency Management and Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maharashtra Emergency Medical Services, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nathiba Hargovandas Lakhmichand Municipal Medical College, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College of Medical Sciences, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Trauma Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective before-and-after study to evaluate the effect of implementing a Trauma Quality&#xD;
      Improvement protocol on the process of Trauma Quality Improvement meetings and major trauma&#xD;
      patient outcomes at four trauma centres in India.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will be conducted as a prospective before-and-after study at four major trauma&#xD;
      centres in India, with the intervention occurring between pre- and post-intervention phases.&#xD;
      Included in the study will be all patients presenting to any of the four trauma hospitals&#xD;
      with a potentially life-threatening or limb-threatening injury. The intervention will be the&#xD;
      introduction of a structured Trauma Quality Improvement Meeting (TQIM), using a checklist and&#xD;
      training program. The primary outcome will be compliance with the TQIM checklist, measured as&#xD;
      the proportion of discussed cases (trauma deaths) for which problems with care,&#xD;
      preventability and corrective actions were discussed and / or agreed. The secondary outcomes&#xD;
      will include in-hospital risk-adjusted mortality, hospital length of stay and time to&#xD;
      emergency surgery. Data collection will occur at all meetings at the four trauma hospitals at&#xD;
      which trauma deaths are discussed. Data will also be collected in a dedicated trauma&#xD;
      registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TQIM Checklist compliance - preventability</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>TQIM Checklist compliance - % of cases for which it is agreed that care can be improved</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TQIM Checklist compliance - corrective action</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>TQIM Checklist compliance - % of cases (where it is agreed that care can be improved) for which at least one corrective action is agreed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital risk-adjusted mortality</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>In-hospital risk-adjusted mortality: The proportion of deaths amongst those with Injury Severity Score (ISS) &gt;12 and &lt;50.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>Hospital length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to emergency surgery</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>Time from hospital arrival to operating theatre for patients undergoing emergency surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1500</enrollment>
  <condition>Major Trauma</condition>
  <condition>Injuries Major</condition>
  <arm_group>
    <arm_group_label>Pre-intervention group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All injured patients to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority triage category will be eligible for inclusion.&#xD;
The Trauma Quality Improvement Meeting (TQIM) checklist will not be introduced during this phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All injured patients to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority triage category will be eligible for inclusion.&#xD;
The Trauma Quality Improvement Meeting (TQIM) checklist will be used at all Trauma Quality Improvement Meetings (TQIMs)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TQIM checklist</intervention_name>
    <description>The intervention phase will include an intense training period covering:&#xD;
Conduct of Trauma Quality Improvement Meeting (TQIM) (and Trauma Quality Improvement program in general). The training will be delivered using the World Health Organization (WHO) Trauma Quality Improvement Programmes short course and online resources.&#xD;
Implementation of Trauma Quality Improvement Meeting (TQIM) Checklist.</description>
    <arm_group_label>Post-intervention group</arm_group_label>
    <other_name>Structured TQI program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients presenting to any of the four study sites with a potentially&#xD;
             life-threatening or limb-threatening injury. Specifically, all presenting injured&#xD;
             patients triaged as &quot;Red&quot; or &quot;Yellow&quot; according to the Australia-India Trauma Systems&#xD;
             Collaboration (AITSC) Trauma Triage Protocol, will meet the screening criteria for&#xD;
             data collection. Retrospective inclusion in the registry will be continued for all&#xD;
             screened patients presenting to any of the included hospitals with injury (including&#xD;
             near-drowning) as the primary diagnosis and with at least one of the following&#xD;
             criteria:&#xD;
&#xD;
               -  Admission to hospital&#xD;
&#xD;
               -  Death after triage but before admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria for the AITSC Trauma Registry are:&#xD;
&#xD;
               -  Death at scene&#xD;
&#xD;
               -  Alive at triage but not admitted to hospital&#xD;
&#xD;
               -  Isolated poisoning&#xD;
&#xD;
               -  Isolated burns&#xD;
&#xD;
               -  Single digit finger or toe amputations&#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 C Fitzgerald, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Trauma Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vadilal Sarabhai Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lokmanya Tilak Municipal General Hospital</name>
      <address>
        <city>Mumbai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guru Teg Bahadur Hospital</name>
      <address>
        <city>New Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JPN Apex Trauma Centre at All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Trauma Research Institute</investigator_affiliation>
    <investigator_full_name>Dr Gerard O'Reilly</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Quality improvement</keyword>
  <keyword>Injury</keyword>
  <keyword>Injuries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03005509
org study id: GCF020013-TQI
nct id: NCT03005509
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A prospective before-and-after study to evaluate the effect of implementing a Trauma Quality
      Improvement protocol on the process of Trauma Quality Improvement meetings and major trauma
      patient outcomes at four trauma centres in India.
This project will be conducted as a prospective before-and-after study at four major trauma
      centres in India, with the intervention occurring between pre- and post-intervention phases.
      Included in the study will be all patients presenting to any of the four trauma hospitals
      with a potentially life-threatening or limb-threatening injury. The intervention will be the
      introduction of a structured Trauma Quality Improvement Meeting (TQIM), using a checklist and
      training program. The primary outcome will be compliance with the TQIM checklist, measured as
      the proportion of discussed cases (trauma deaths) for which problems with care,
      preventability and corrective actions were discussed and / or agreed. The secondary outcomes
      will include in-hospital risk-adjusted mortality, hospital length of stay and time to
      emergency surgery. Data collection will occur at all meetings at the four trauma hospitals at
      which trauma deaths are discussed. Data will also be collected in a dedicated trauma
      registry.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: TQIM Checklist compliance - preventability
time frame: Up to 14 months
description: TQIM Checklist compliance - % of cases for which it is agreed that care can be improved
measure: TQIM Checklist compliance - corrective action
time frame: Up to 14 months
description: TQIM Checklist compliance - % of cases (where it is agreed that care can be improved) for which at least one corrective action is agreed
measure: In hospital risk-adjusted mortality
time frame: Up to 14 months
description: In-hospital risk-adjusted mortality: The proportion of deaths amongst those with Injury Severity Score (ISS) >12 and <50.
measure: Hospital length of stay
time frame: Up to 14 months
description: Hospital length of stay
measure: Time to emergency surgery
time frame: Up to 14 months
description: Time from hospital arrival to operating theatre for patients undergoing emergency surgery
arm group label: Pre-intervention group
arm group type: No Intervention
description: All injured patients to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority triage category will be eligible for inclusion.
The Trauma Quality Improvement Meeting (TQIM) checklist will not be introduced during this phase.
arm group label: Post-intervention group
arm group type: Other
description: All injured patients to the four intervention sites) and allocated to a red (1st) or yellow (2nd) priority triage category will be eligible for inclusion.
The Trauma Quality Improvement Meeting (TQIM) checklist will be used at all Trauma Quality Improvement Meetings (TQIMs)
intervention type: Other
intervention name: TQIM checklist
description: The intervention phase will include an intense training period covering:
Conduct of Trauma Quality Improvement Meeting (TQIM) (and Trauma Quality Improvement program in general). The training will be delivered using the World Health Organization (WHO) Trauma Quality Improvement Programmes short course and online resources.
Implementation of Trauma Quality Improvement Meeting (TQIM) Checklist.
arm group label: Post-intervention group
other name: Structured TQI program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark C Fitzgerald, MBBS, MD
role: Principal Investigator
affiliation: National Trauma Research Institute
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: National Trauma Research Institute
investigator full name: Dr Gerard O'Reilly
investigator title: Principal Investigator
mesh term: Wounds and Injuries
sharing ipd: No