Trauma Clinical Trial
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.
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.
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