<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/NCT03277560</url>
  </required_header>
  <id_info>
    <org_study_id>12/SC/0628</org_study_id>
    <nct_id>NCT03277560</nct_id>
  </id_info>
  <brief_title>MaTOMS: A Feasibility Study Into Collecting Major Trauma Outcomes</brief_title>
  <acronym>MaTOMS</acronym>
  <official_title>MaTOMS: A Feasibility Study Into the Validity and Acceptability of Routine Collection of Outcome Data in Major Trauma Patients in a Major Trauma Centre in England</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Major Trauma Outcome Measures Study (MaTOMS): A feasibility Study into using outcome measures&#xD;
      in major trauma patients.&#xD;
&#xD;
      At present patients who suffer major trauma (multiple, serious injuries that could result in&#xD;
      death or serious disability e.g. serious head injuries and multiple fractures), are now able&#xD;
      to survive due to advances in modern medicine. Unfortunately they may be left with long term&#xD;
      disabilities such as problems with performing day to day activities. We currently do not know&#xD;
      how bad these disabilities are or have any way of judging any differences between the&#xD;
      outcomes of different hospitals.&#xD;
&#xD;
      MaTOMS is a feasibility study taking place in one hospital, the John Radcliffe Hospital which&#xD;
      aims to help answer these questions by developing a set of structured interviews that can be&#xD;
      used after an injury to find out about patient outcomes. It will identify how difficult or&#xD;
      easy it is to collect the data and information outlined in this project, and whether the&#xD;
      types of data and information collected as part of the interviews are a good indicator of a&#xD;
      patient's outcomes.&#xD;
&#xD;
      Over 30 months the study will recruit up to 100 patients who are aged 2 years and over who&#xD;
      have been admitted following major trauma. Major trauma will be defined as a score of 9 or&#xD;
      more on the Injury Severity Score, a widely used system to stratify those who suffer an&#xD;
      injury.&#xD;
&#xD;
      Those who agree to take part following a consent process will undergo structured interviews&#xD;
      both in hospital and twice via telephone in the year following discharge. Some participants&#xD;
      will take part in an additional interview either asking about their experience of answering&#xD;
      the questions during the structured interview or exploring their experience and feelings&#xD;
      about their traumatic injury to see if our structured interviews are missing any aspect of&#xD;
      their experience.&#xD;
&#xD;
      The main objectives for this feasibility study is to test the feasibility of routine&#xD;
      collection of outcome measurement data following major trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose and design&#xD;
&#xD;
      Historically much of the literature into major trauma refers to outcomes and mortality&#xD;
      synonymously. However there is a growing recognition that as trauma systems mature and more&#xD;
      patients lives are saved, the focus has to shift from amenable mortality to improving patient&#xD;
      morbidity. Other than mortality it is not currently possible to ascertain the outcomes of&#xD;
      patients with major trauma in England as there is no international consensus on which outcome&#xD;
      measures should be collected for major trauma patients, nor a collection process in place.&#xD;
&#xD;
      Patients who suffer major trauma are often left with significant long term morbidity with one&#xD;
      paper suggesting 42% are unable to return to work at 1 year and another suggesting full&#xD;
      recovery is only present in 30% at 5 years. It is important for patients and the public that&#xD;
      any outcome measures that are implemented can allow the identification of good or inadequate&#xD;
      treatment so that attention can be addressed to improving the quality of care. None of these&#xD;
      exist at present and this feasibility study aims to help identify and develop these for&#xD;
      possible national implementation.&#xD;
&#xD;
      The study is designed as an observational feasibility study as the way outcomes will be&#xD;
      assessed is via a structured interview either face to face or by telephone made up of&#xD;
      questions from existing outcome measure instruments and the practicalities of collection of&#xD;
      data and identification of the best instruments need to be made prior to any larger study.&#xD;
      The instruments have been chosen from those that are known to measure outcomes in one or more&#xD;
      domains of the World Health Organisation International Classification of Functioning,&#xD;
      Disability and Health (WHO ICF) and that have been previously used to measure outcome in&#xD;
      major trauma patients in the literature and have been recommended by a workshop of clinicians&#xD;
      and other stakeholders.&#xD;
&#xD;
      The study is designed as an observational feasibility study as the way outcomes will be&#xD;
      assessed is via a structured interview either face to face or by telephone made up of&#xD;
      questions from existing outcome measure instruments and the practicalities of collection of&#xD;
      data and identification of the best instruments need to be made prior to any larger study.&#xD;
      The instruments have been chosen from those that are known to measure outcomes in one or more&#xD;
      domains of the World Health Organisation International Classification of Functioning,&#xD;
      Disability and Health (WHO ICF) and that have been previously used to measure outcome in&#xD;
      major trauma patients in the literature and have been recommended by a workshop of clinicians&#xD;
      and other stakeholders.&#xD;
&#xD;
      The design of the study has been influenced by existing protocols by which major trauma&#xD;
      patients are routinely followed up in Victoria State in Australia. The main difference is&#xD;
      that whilst the Australian protocols involved optout consent, this study will involve&#xD;
      informed consent or in the case of those who are unable to consent, their Consultee (either&#xD;
      personal or nominated) will be asked to advise whether they think the patient would be&#xD;
      content to participate. Children aged 2 or more will be included in this study with their&#xD;
      parents providing informed consent.&#xD;
&#xD;
      This study will build on the current literature as it will allow the assessment of the&#xD;
      feasibility of assessing outcomes in an English Major Trauma Centre and the identification of&#xD;
      the most suitable instruments. The study will also measure each instruments and their&#xD;
      validity &amp; sensitivity to change and allow an estimation of the costs and other logistics&#xD;
      surrounding the routine collection of this data in England to be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF12</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GOS-E</measure>
    <time_frame>12 months</time_frame>
    <description>Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FIM</measure>
    <time_frame>12 months</time_frame>
    <description>Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>12 months</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Trauma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention as it is an observational study</intervention_name>
    <description>No Intervention as it is an observational study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged 2 or over who are admitted to the study centre with a diagnosis that is&#xD;
        encompassed by the definition of major trauma (Injury Severity Score greater than or equal&#xD;
        to 9) following injury will be eligible for the study as long as they are enrolled less&#xD;
        than 4 weeks following the injury and consent to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Over 2 years&#xD;
&#xD;
          -  First admission (for a particular set of injuries) to the Major Trauma Centre&#xD;
&#xD;
          -  Traumatic injuries with ISS 9 or more as estimated at time of eligibility assessment&#xD;
&#xD;
          -  Within 4 weeks of injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant may not enter the study if ANY of the following apply:&#xD;
&#xD;
          -  Non resident in the United Kingdom&#xD;
&#xD;
          -  Patient unwilling to give informed consent&#xD;
&#xD;
          -  Patient unable to give informed consent and 'consultee' advises they feel patient&#xD;
             would not be content to participate&#xD;
&#xD;
          -  Inmate in prison and therefore unable to be easily followed up by telephone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Willett</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oxford University Hospital Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oxford University Hospital Trust</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 21, 2015</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Liz Tutton</investigator_full_name>
    <investigator_title>Senior Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Major Trauma Centre</keyword>
  <keyword>ISS</keyword>
  <keyword>Outcome Measures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03277560
org study id: 12/SC/0628
nct id: NCT03277560
lead sponsor: 
has dmc: Yes
Major Trauma Outcome Measures Study (MaTOMS): A feasibility Study into using outcome measures
      in major trauma patients.

      At present patients who suffer major trauma (multiple, serious injuries that could result in
      death or serious disability e.g. serious head injuries and multiple fractures), are now able
      to survive due to advances in modern medicine. Unfortunately they may be left with long term
      disabilities such as problems with performing day to day activities. We currently do not know
      how bad these disabilities are or have any way of judging any differences between the
      outcomes of different hospitals.

      MaTOMS is a feasibility study taking place in one hospital, the John Radcliffe Hospital which
      aims to help answer these questions by developing a set of structured interviews that can be
      used after an injury to find out about patient outcomes. It will identify how difficult or
      easy it is to collect the data and information outlined in this project, and whether the
      types of data and information collected as part of the interviews are a good indicator of a
      patient's outcomes.

      Over 30 months the study will recruit up to 100 patients who are aged 2 years and over who
      have been admitted following major trauma. Major trauma will be defined as a score of 9 or
      more on the Injury Severity Score, a widely used system to stratify those who suffer an
      injury.

      Those who agree to take part following a consent process will undergo structured interviews
      both in hospital and twice via telephone in the year following discharge. Some participants
      will take part in an additional interview either asking about their experience of answering
      the questions during the structured interview or exploring their experience and feelings
      about their traumatic injury to see if our structured interviews are missing any aspect of
      their experience.

      The main objectives for this feasibility study is to test the feasibility of routine
      collection of outcome measurement data following major trauma.
Purpose and design

      Historically much of the literature into major trauma refers to outcomes and mortality
      synonymously. However there is a growing recognition that as trauma systems mature and more
      patients lives are saved, the focus has to shift from amenable mortality to improving patient
      morbidity. Other than mortality it is not currently possible to ascertain the outcomes of
      patients with major trauma in England as there is no international consensus on which outcome
      measures should be collected for major trauma patients, nor a collection process in place.

      Patients who suffer major trauma are often left with significant long term morbidity with one
      paper suggesting 42% are unable to return to work at 1 year and another suggesting full
      recovery is only present in 30% at 5 years. It is important for patients and the public that
      any outcome measures that are implemented can allow the identification of good or inadequate
      treatment so that attention can be addressed to improving the quality of care. None of these
      exist at present and this feasibility study aims to help identify and develop these for
      possible national implementation.

      The study is designed as an observational feasibility study as the way outcomes will be
      assessed is via a structured interview either face to face or by telephone made up of
      questions from existing outcome measure instruments and the practicalities of collection of
      data and identification of the best instruments need to be made prior to any larger study.
      The instruments have been chosen from those that are known to measure outcomes in one or more
      domains of the World Health Organisation International Classification of Functioning,
      Disability and Health (WHO ICF) and that have been previously used to measure outcome in
      major trauma patients in the literature and have been recommended by a workshop of clinicians
      and other stakeholders.

      The study is designed as an observational feasibility study as the way outcomes will be
      assessed is via a structured interview either face to face or by telephone made up of
      questions from existing outcome measure instruments and the practicalities of collection of
      data and identification of the best instruments need to be made prior to any larger study.
      The instruments have been chosen from those that are known to measure outcomes in one or more
      domains of the World Health Organisation International Classification of Functioning,
      Disability and Health (WHO ICF) and that have been previously used to measure outcome in
      major trauma patients in the literature and have been recommended by a workshop of clinicians
      and other stakeholders.

      The design of the study has been influenced by existing protocols by which major trauma
      patients are routinely followed up in Victoria State in Australia. The main difference is
      that whilst the Australian protocols involved optout consent, this study will involve
      informed consent or in the case of those who are unable to consent, their Consultee (either
      personal or nominated) will be asked to advise whether they think the patient would be
      content to participate. Children aged 2 or more will be included in this study with their
      parents providing informed consent.

      This study will build on the current literature as it will allow the assessment of the
      feasibility of assessing outcomes in an English Major Trauma Centre and the identification of
      the most suitable instruments. The study will also measure each instruments and their
      validity & sensitivity to change and allow an estimation of the costs and other logistics
      surrounding the routine collection of this data in England to be made.
observational model: Cohort
time perspective: Prospective
measure: EQ-5D
time frame: 12 months
description: Quality of life
measure: SF12
time frame: 12 months
description: Quality of Life
measure: GOS-E
time frame: 12 months
description: Function
measure: FIM
time frame: 12 months
description: Function
measure: Pain Score
time frame: 12 months
description: Likert scale
intervention type: Other
intervention name: No Intervention as it is an observational study
description: No Intervention as it is an observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Keith Willett
role: Principal Investigator
affiliation: Oxford University Hospital Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Oxford University Hospitals NHS Trust
investigator full name: Liz Tutton
investigator title: Senior Research Fellow
mesh term: Wounds and Injuries