ISRCTN ISRCTN17968752
DOI https://doi.org/10.1186/ISRCTN17968752
Secondary identifying numbers v1 19Dec18, v2 18Sep19
Submission date
18/01/2019
Registration date
18/01/2019
Last edited
04/06/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Serious injuries are a major health problem in England, responsible for 3,000 deaths and 8,000 disabilities each year. Treatment in specialist hospitals, called major trauma centres, can improve survival following such injuries. In order to benefit from this expert care, ambulance crews must first correctly identify suitable patients at the scene of injury and then transport them to a major trauma centre, potentially bypassing closer non-specialist hospitals.

The presence of serious injury is not always obvious and assessment can be difficult. Taking patients with minor injuries to the major trauma centre could waste time, money and resources; denying treatment to those who require it by overstretching the capacity of the major trauma centre. It could also inconvenience patients and their families by taking them further from home. In contrast, failing to recognise serious injury could result in less effective treatment or increased harm.

The term ‘triage’ means to sort patients in terms of priority. Ambulance crews currently use a ‘triage tool’ to help them to recognise whether a patient is seriously injured or not. The tool is a checklist of patient and injury features, for example the presence of low blood pressure, that indicate that care in a major trauma centre care might be beneficial. Unfortunately, research has suggested that current tools are not very accurate, as they could miss patients with serious injury and often unnecessarily direct patients with more minor injuries to a major trauma centre. This study aims to develop a new and more accurate tool that will help to ensure that the right patient gets to the right place at the right time.

Who can participate?
Any patient seen by one of the 4 participating Ambulance Services, who is suspected of suffering a major trauma, will be subject to the use of the new major trauma triage tool (during the 4 month intervention phase of the study)

What does the study involve?
We will carefully study existing triage tools used in England and world-wide. We will also use data already collected by ambulance services and the English national major trauma database (the Trauma Audit and Research Network, TARN) to investigate what factors are important for detecting serious injury at the scene of the incident. Additionally we will develop a computer model that simulates the costs and outcomes of using different triage tools. Together, we will take this information to a group of experts and ask them to develop a new triage tool.

We will then test the experts’ triage tool, together with other existing tools, to see how they perform. In order to do this we will link data that is routinely collected by the Yorkshire, West Midlands, South Western and London Ambulance services, with hospital information collected by TARN. It has been suggested that identifying major trauma in older people is particularly difficult, so we will also specifically focus on this age group. We will then take the best-performing tool and introduce it into practice in an area of each ambulance service, to see how it works in real life. To find out about the experiences and views of patients, and paramedics using the tool, we will carry out interviews and focus groups. We will also consult with major trauma specialists, service managers and other stakeholders to assess the possible impact of the tool.

We have talked to patients affected by serious injury, and a group of patients involved in research about emergency care, while developing these research ideas. Members of these groups have agreed to join an advisory panel to help guide any future study. We have included a lay person with personal experience of major trauma as part of our research team alongside specialists in emergency medicine, pre-hospital practice, and major trauma. We have also consulted national specialist groups and gained support from participating ambulance services.

What are the possible benefits and risks of participating?
Patients may be correctly identified as suffering a true major trauma by the use of the new tool (which could have a potential positive impact on their overall care), whereas under previous tools, they may not.
Equally, the new tool may fail to recognise true major trauma patients (which could have a potential negative impact on their overall care), when the previous used tool would have correctly identified them.

Where is the study run from?
The University of Sheffield’s Clinical Trials Research Unit (CTRU) is the leading centre.
The 4 Ambulance Services involved are:
Yorkshire Ambulance Service NHS Trust
West Midlands Ambulance Service NHS Trust
London Ambulance Service NHS Trust
South West Ambulance Service NHS Foundation Trust

When is the study starting and how long is it expected to run for?
From November 2018 to August 2022

Who is funding the study?
The study is funded by the National Institute of Health Research, Health Technology Assessment programme.

Who is the main contact?
Dr Sam Keating
Email: s.m.keating@sheffield.ac.uk

Study website

Contact information

Dr Samuel Keating
Public

Clinical Trials Research Unit
ScHARR
University of Sheffield
Room 2027
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

ORCiD logoORCID ID 0000-0003-3685-2849
Phone 0114 22 25156
Email s.m.keating@sheffield.ac.uk

Study information

Study designPhase One: review and development by expert consensus Phase Two: prospective cohort Phase Three: non-randomized interventional
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleMATTS (Major Trauma Triage Tool Study): identification, development, validation and evaluation of major trauma triage tools
Study acronymMATTS
Study hypothesisTo develop an accurate, acceptable and usable pre-hospital triage tool to identify patients with major trauma who benefit from MTC care.
Ethics approval(s)Approved 28/06/2019, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 1048 088; nrescommittee.yorkandhumber-bradfordleeds@nhs.net), ref: 19/YH/0197
ConditionMajor trauma
InterventionMATTS is a programme of research in 3 phases, that will be conducted over 31 months in total, whose overall aim is to establish a new and improved major trauma triage tool for use in NHS settings.

Phase 1 involves establishing which major trauma triage tools are currently in use in NHS settings, gathering data around their use and performance, gathering feedback on major trauma triage from key stakeholders, and then convening an expert consensus panel to design a new and improved major trauma triage tool.

Phase 2 involves gathering data from 4 Ambulance Services (and the Hospital sites they deliver patients to) on all major trauma patients, then modelling the performance of a short list of triage tools (including our new tool), then further refining the tool which will be implemented for use in Phase 3.

Phase 3 involves training ambulance staff from the 4 participating Ambulance Services to use our new major trauma triage tool, then gathering ambulance service and hospital data around its performance, for a period of 4 months. The patients who will be screened using the new triage tool will be followed up in Hospital until the end of that specific episode.
Intervention typeOther
Primary outcome measureThe performance of the new major trauma triage tool will be defined by its over and under triage rates, with regard to identifying a case of true major trauma as defined by expert consensus panel. This will be measured only once, after the patients have been screened by the new major trauma triage tool, been received in a Hospital site, and their episode has concluded.
Secondary outcome measuresThe performance of the new major trauma triage tools will be defined by sensitivity, specificity, predictive values, and c-statistics with their 95% confidence intervals (95% CI), with regard to identifying a case of true major trauma as defined by expert consensus panel. This will be measured only once, after the patients have been screened by the new major trauma triage tool, been received in a Hospital site, and their episode has concluded.
Overall study start date01/11/2018
Overall study end date31/08/2022

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participantsApproximately 57,000 in phase 2 and 100,00 in phase 3
Total final enrolment38010
Participant inclusion criteriaPatients who have experienced major trauma in participating trauma networks
Participant exclusion criteriaN/A
Recruitment start date01/09/2019
Recruitment end date01/11/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

West Midlands Ambulance Service NHS Foundation Trust
Trust Headquarters
Millennium Point
Waterfront Business Park
Waterfront Way
Brierley Hill
West Midlands
DY5 1LX
United Kingdom
London Ambulance Service NHS Trust
Headquarters: Waterloo
220 Waterloo Road
London
SE1 8SD
United Kingdom
Yorkshire Ambulance Service NHS Trust
Trust Headquarters
Brindley Way
Wakefield 41 Business Park
Wakefield
WF2 0XQ
United Kingdom
South West Ambulance Service NHS Foundation Trust
South Western Ambulance Service NHS Foundation Trust
Abbey Court
Eagle Way
Exeter
EX2 7HY
United Kingdom
The University of Sheffield
Western Bank
Sheffield
S10 2TN
United Kingdom

Sponsor information

The University of Sheffield
University/education

Western Bank
Sheffield
S10 2TN
England
United Kingdom

Website www.sheffield.ac.uk
ROR logo "ROR" https://ror.org/05krs5044

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date18/06/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe study protocol with be registered with an international research registry (ClinicalTrials.gov) and will be made available in the open access University electronic repository. Results of the study will be disseminated in high profile peer-reviewed scientific journals and relevant academic conferences. Authorship will include funded co-applicants, clinical collaborators, research paramedics and the study manager, according to International Committee of Medical Journal Editors (ICMJE) guidelines.

Details of the study, including regularly updated progress reports, will be available on a dedicated study website hosted by the CTRU. Plain English study progress reports will be provided to collaborators, patient advocacy groups, local PPI panels and our service user advisory group. Study developments will also be communicated through social media including twitter. The lay SMG member and service user advisory group will contribute to writing any scientific publications, particularly plain English summaries and conference presentations.

At the end of the study a report will be submitted to the trial funders with full details of study progress and study findings. It is anticipated that this report will be independently peer reviewed and the final accepted report published as a “gold” open access monograph in the Health Technology Assessment journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from the Trial Manager, Dr Sam Keating (s.m.keating@sheffield.ac.uk).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version v2 18/09/2019 13/02/2020 No No
HRA research summary 28/06/2023 No No
Results article 21/05/2024 04/06/2024 Yes No

Additional files

ISRCTN17968752_ PROTOCOL_v2_18Sep19.docx
Uploaded 13/02/2020

Editorial Notes

04/06/2024: Publication reference added.
18/04/2024: The intention to publish date has been changed from 01/12/2022 to 18/06/2024. Total final enrolment added.
21/06/2021: The following changes have been made:
1. The overall trial end date has been changed from 31/05/2021 to 31/08/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/06/2021 to 01/12/2022.
13/02/2020: Uploaded protocol version 2 18/09/2019 (not peer-reviewed)
05/11/2019: The ethics approval was added.
25/01/2019: Internal review.