Digital trauma handover

ISRCTN	ISRCTN12983121
DOI	https://doi.org/10.1186/ISRCTN12983121
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	339900
Protocol serial number	EDGE 173654, CPMS 66642
Sponsor	Queen Mary University of London
Funders	Rosetrees Trust, ZOLL Medical Corporation

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Zane Perkins
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
Email	z.perkins@qmul.ac.uk

Study information

Primary study design	Observational
Study design	Prospective observational mixed-methods study
Secondary study design	Prospective qualitative study
Study type	Participant information sheet
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(s)	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)
Key secondary outcome measure(s)	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.
Completion date	30/11/2025

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	60
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

United Kingdom
England

Study participating centre

Barts and the London NHS Trust

Alexandra House
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.