Digital trauma handover
| ISRCTN | ISRCTN12983121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12983121 |
| IRAS number | 339900 |
| Secondary identifying numbers | EDGE 173654, CPMS 66642 |
- Submission date
- 19/05/2025
- Registration date
- 20/05/2025
- Last edited
- 16/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Time is critical in trauma care. Delays, even minutes, can significantly affect outcomes, especially in patients with life-threatening bleeding. This study tests a real-time digital handover system to improve how trauma teams receive patient information from London’s Air Ambulance, aiming to reduce delays in treatment for seriously injured patients. The system helps transmit key patient information (injury details, vital signs, treatments) directly from the ambulance team to the hospital before the patient arrives.
Who can participate?
Trauma clinicians (doctors, registrars, paramedics) and trauma patients aged 16 years and over
What does the study involve?
Clinicians complete a risk perception questionnaire after each trauma case, fill out a usability questionnaire every 2 months and take part in interviews to give feedback on system use and impact. There is no direct patient intervention - only data from standard care used with consent.
What are the possible benefits and risks of participating?
The findings will inform the development of a clinical decision support system using AI and lead to future trials focused on improving trauma care efficiency and outcomes. Patient and clinician data will be anonymised and securely stored. There are no changes to current patient care or treatment.
Where is the study run from?
Queen Mary University London (UK)
When is the study starting and how long is it expected to run for?
February 2025 to November 2025
Who is funding the study?
1. Rosetrees Trust (UK)
2. ZOLL Medical Corporation
Who is the main contact?
Dr Zane Perkins, z.perkins@qmul.ac.uk
Contact information
Public, Scientific, Principal Investigator
Centre for Trauma Sciences
Blizard Institute
Queen Mary University of London
4 Newark Street
London
E1 2AT
United Kingdom
| Phone | +44 (0)2073777000 |
|---|---|
| z.perkins@qmul.ac.uk |
Study information
| Study design | Prospective observational mixed-methods study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Prospective qualitative study |
| Study setting(s) | Hospital, Paramedicine |
| Study type | Other, Safety, Efficacy |
| Participant information sheet | Not available in web format |
| Scientific title | Digital decision support to reduce time to treatment in trauma |
| Study objectives | 1. To implement and evaluate a real-time digital handover system, to streamline the transition of care from the pre-hospital setting to the major trauma centre (secondary care). 2. To assess the accuracy of experienced clinicians in evaluating significant risks in trauma patients. |
| Ethics approval(s) |
Approved 24/02/2025, Health and Social Care Research Ethics Committee B (HSC REC B) (Office for Research Ethics Committees Northern Ireland (ORECNI), Lissue Industrial estate West, 5 Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 (0)28 95361400; info.orecni@hscni.net), ref: 25/NI/0019 |
| Health condition(s) or problem(s) studied | Traumatic injury |
| Intervention | The study comprises a mixed methodology approach with five components: 1. Clinical risk perception questionnaire 2. Clinician usability questionnaire 3. Semi-structured clinician interview 4. Quantitative evaluation 5. Hazard analysis Clinicians complete a risk perception questionnaire after each trauma case, fill out a usability questionnaire every 2 months and take part in interviews to give feedback on system use and impact. There is no direct patient intervention - only data from standard care used with consent. |
| Intervention type | Other |
| Primary outcome measure | 1. Usability measured by the System Usability Scale score and the PAAS Mental Effort Scale at each trauma team activation 2. Perceived usefulness and acceptability based on a semi-structured interview at 2-monthly intervals (beginning, middle, and end of study) |
| Secondary outcome measures | 1. Clinician risk perception: clinicians’ estimates of patient risks will be measured using a 0-100% probability scale immediately post-resuscitation 2. Clinician risk perception performance: clinician risk estimates will be compared to documented (true) patient outcomes to assess accuracy 3. The patient risks and outcomes that will be measured are: 3.1. In-hospital mortality 3.2. Trauma-induced coagulopathy (TIC), defined as an admission Prothrombin Time ratio (PTr) >1.2 3.3. Significant haemorrhage (≥4 units of blood transfused within 4 hours post-injury) The patient outcome data used for comparisons are standard clinical indicators routinely collected during trauma care. This study will not involve any additional data collection directly from patients. Instead, it will utilise retrospective data analysis of existing clinical records to determine the accuracy of clinicians' risk assessments. |
| Overall study start date | 24/02/2025 |
| Completion date | 30/11/2025 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 60 trauma clinicians across 300 activations by Londons Air Ambulance |
| Key inclusion criteria | 1. Trauma clinicians: Consultant, Specialist Registrar (resident), or paramedics who have direct involvement in initial assessment, management of adult trauma patients transported by London's Air Ambulance to the Royal London Hospital. 2. Trauma patients: Aged 16 years or over with traumatic injury |
| Key exclusion criteria | Trauma clinicians: 1. Consent: clincians who decline to consent or participate 2. Involvement: clinicians not involved in the initial care of adult trauma patients Trauma patients: 1. Aged under 16 years 2. Presenting with injuries: burns, hangings, drownings, or acute psychotic episodes without physical injuries |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Sponsor information
University/education
JRMO
Research Services
Dept. W
69-89 Mile End Road
London
E1 4UJ
England
United Kingdom
| Phone | +44 (0)2078827275/6574 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Teresa Rosenbaum Golden Charitable Trust, Rosetrees
- Location
- United Kingdom
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- ZOLL, Zoll Medical Corp., ZOLL Medical, ZMC
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The results will be disseminated through: 1. Presentations at academic conferences 2. Integration into student academic work, including dissertations and theses 3. Publications in peer-reviewed journals |
| IPD sharing plan | All data from clinician participants within the study will be fully anonymised. Routine clinical outcome data will be retrospectively captured from Bart's Health NHS trust electronic healthcare records. Patient-level data will be pseudo-anonymised and assigned an identifier case record number prior to full anonymisation. The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository - Barts Cancer Centre Information Technology infrastructure - Safe Haven. |
Editorial Notes
16/07/2025: The completion date was changed from 31/10/2025 to 30/11/2025.
01/07/2025: Internal review.
19/05/2025: Study's existence confirmed by Health and Social Care Research Ethics Committee B.
