TraumaMaTOMSNCT03277560
MaTOMS: A Feasibility Study Into Collecting Major Trauma Outcomes
An observational study of Trauma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Trauma
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients aged 2 or over who are admitted to the study centre with a diagnosis that is encompassed by the definition of major trauma (Injury Severity Score greater than or equal to 9) following injury will be eligible for the study as long as they are enrolled less than 4 weeks following the injury and consent to participate.
Who may be able to join
- Male or female
- Over 2 years
- First admission (for a particular set of injuries) to the Major Trauma Centre
- Traumatic injuries with ISS 9 or more as estimated at time of eligibility assessment
- Within 4 weeks of injury
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Non resident in the United Kingdom
- Patient unwilling to give informed consent
- Patient unable to give informed consent and 'consultee' advises they feel patient would not be content to participate
- Inmate in prison and therefore unable to be easily followed up by telephone
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Trauma
- Being tested
- No Intervention as it is an observational study
- Keywords
- Major Trauma Centre, ISS, Outcome Measures
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention as it is an observational studyOther
No Intervention as it is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D
Quality of life
Measured: 12 months
Secondary outcomes (4)
SF12
Quality of Life
Measured: 12 months
GOS-E
Function
Measured: 12 months
FIM
Function
Measured: 12 months
Pain Score
Likert scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study startApr 2013
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liz Tutton, Oxford University Hospitals NHS Trust
- Investigators
- Keith Willett, Principal investigator, Oxford University Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277560
- Sponsor's protocol ID
- 12/SC/0628
- Acronym
- MaTOMS
- Status last verified
- Sep 2017
- First submitted
- 21 Jan 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03277560
- Acronym / sponsor ID
- MaTOMS / 12/SC/0628
- Conditions
- Trauma
- Keywords
- Major Trauma Centre, ISS, Outcome Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients aged 2 or over who are admitted to the study centre with a diagnosis that is encompassed by the definition of major trauma (Injury Severity Score greater than or equal to 9) following injury will be eligible for the study as long as they are enrolled less than 4 weeks following the injury and consent to participate.
Key inclusion criteria (5 listed)
- Male or female
- Over 2 years
- First admission (for a particular set of injuries) to the Major Trauma Centre
- Traumatic injuries with ISS 9 or more as estimated at time of eligibility assessment
- Within 4 weeks of injury
Key exclusion criteria (5 listed)
- The participant may not enter the study if ANY of the following apply:
- Non resident in the United Kingdom
- Patient unwilling to give informed consent
- Patient unable to give informed consent and 'consultee' advises they feel patient would not be content to participate
- Inmate in prison and therefore unable to be easily followed up by telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention as it is an observational studyNo Intervention as it is an observational study | Other | – |
Primary outcome
EQ-5D
Time frame: 12 months
Quality of life
4 secondary outcomes
SF12
Time frame: 12 months
GOS-E
Time frame: 12 months
FIM
Time frame: 12 months
Pain Score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Willett principal investigator
Oxford University Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.