Can a clinical decision rule help ambulance paramedics identify older adults with a traumatic brain injury who would benefit from being transported to a hospital with onsite neurosurgical services?
| ISRCTN | ISRCTN80889562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80889562 |
| IRAS number | 291682 |
| Secondary identifying numbers | IRAS 291682 |
- Submission date
- 20/07/2021
- Registration date
- 29/07/2021
- Last edited
- 01/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. Historically, it has been described as a disease of the young due to road traffic collisions, sporting injuries, falls from height and violence. However, older adults are becoming a prevalent patient demographic in TBI in high-income countries with ageing populations. This is due to falls from standing height, and the decline older adults experience through the natural process of ageing or long-term health conditions. Older adults who suffer a TBI are typically transported to the hospital by the ambulance service. A challenge facing ambulance paramedics is that these patients with TBI present with mild or no symptoms that reflect the severity of the underlying injury. This has resulted in most patients being transported to a hospital where neurosurgical services are not available onsite. This requires either remote consultation and/or a secondary transfer to a hospital where these services are available.
This study aims to develop a clinical decision rule that ambulance paramedics could use to help identify older adults (60 years or older) with a TBI and triage them to a hospital with neurosurgical services onsite.
Who can participate?
Patients aged 60 years or older with a TBI, suspected TBI or head injury, transported to hospital by the ambulance service
What does the study involve?
The study involves the linking of routinely collected data from ambulance and hospital patient care records. Clinical predictors (age, symptoms, mechanism of injury, etc) available to an ambulance paramedic at the scene of an injury are used to develop a prediction model. This model is then evaluated to determine how accurate it would at identifying patients at the scene of the injury who would likely benefit from being transported to a hospital with neurosurgical services onsite.
What are the possible benefits and risks of participating?
The study is using routinely collected patient data so there will be no immediate benefit for these patients. However, the information generated from this study will help provide a better understanding of the care ambulance paramedics can provide to older adults suffering a TBI. In addition, all appropriate data security and protection standards have been met, and the study is compliant with GDPR. Therefore, there is minimal risk to the patient.
Where is the study run from?
South East Coast Ambulance Service and the University of Surrey (UK)
When is the study starting and how long is it expected to run for?
April 2020 to March 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Jack Barrett
jack.barrett@secamb.nhs.uk
Contact information
Public
Nexus House
4 Gatwick Rd
Crawley
RH10 9BG
United Kingdom
 ORCID ID |
0000-0002-0040-537X |
|---|---|
| Phone | +44 (0)7789650548 |
| jack.barrett@secamb.nhs.uk |
Scientific
Nexus House
4 Gatwick Rd
Crawley
RH10 9BG
United Kingdom
| Phone | +44 (0)7789650548 |
|---|---|
| jack.barrett@secamb.nhs.uk |
Study information
| Study design | Observational multi-centre cohort study using a retrospective linked dataset |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Derivation and narrow validation of a clinical decision rule for paramedics to triage an older adult with a traumatic brain injury |
| Study acronym | CEREBRAL |
| Study hypothesis | In patients 60 years or older with a traumatic brain injury, what are the risk factors that could accurately determine whether a paramedic should transport these patients directly to a major trauma centre for neurosurgical intervention? |
| Ethics approval(s) | Approved 21/07/2021, East Midlands - Derby Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048310; derby.rec@hra.nhs.uk), REC ref: 21/EM/0103 |
| Condition | Traumatic brain injury |
| Intervention | There are five cohorts of patients to be screened during the study period: 1. Head CT positive for traumatic brain injury (TBI) referred and accepted by neurosurgeons: these patients will be transported to the ED of a hospital with neurosurgical services on site either as a primary transfer (closest hospital from the site of injury or a bypass) or a secondary transfer where they have been assessed, and treatment possibly commenced at another emergency department (ED). The neurosurgeon’s online referral platform at South East Coast Ambulance Service NHS Foundation Trust (SECAmb) partner major trauma centres will be screened for eligible patients 2. Head CT positive for TBI referred, but not accepted, by neurosurgeons: these patients will be transported to a study ED with onsite neurosurgeons at SECAmb partner major trauma centres or another study ED where they have undergone a head CT scan, a TBI has been identified and been referred to neurosurgeons for review. However, patients were not accepted by the neurosurgeons, and another team managed their care. These patients will be recorded on the neurosurgeon’s online referral platform. These patients will be screened for eligibility via this platform. Any follow-up data required and not available from the online platform will be requested from the patient’s medical record. 3. Head CT negative for TBI: these patients will have entered a study ED via the ambulance service with a suspected TBI or apparent head injury and would have undergone a head CT scan, but their scan was negative for TBI. The ED database will be screened for eligible patients. 4. Head injury no CT scan: these patients will be transported to a study ED with a documented head injury in their ED or ambulance patient care record but not received a head CT scan. The ED and ambulance database will be screened for eligible patients. 5. Head injury not transported to hospital: these patients would have been seen by a SECAmb clinician and have a head injury documented on their ambulance patient care record. However, they would not have been transported to the hospital and either discharged at the scene or referred to another service. These patients will be screened via the ambulance record system Groups 1 - 4 will have their hospital records linked to their respective ambulance record. Models will then be used to determine whether an ambulance paramedic should transport a patient to a hospital to a hospital with onsite neurosurgical services. |
| Intervention type | Other |
| Primary outcome measure | Patients accepted under neurosurgical services: identification of patients at the scene of their injury with a traumatic brain injury suitable for transportation to a hospital with onsite neurosurgical services through linking hospital and ambulance patient care records at a single timepoint |
| Secondary outcome measures | Collected from hospital and ambulance records at a single timepoint: 1. Patients with positive head CT scans for traumatic brain injury: identification of patients at the scene of their injury who would be suitable for transportation to the nearest hospital for a head CT scan 2. Likelihood of transfer to neurosurgical services: the probability of a patient being admitted to a neurosurgical service based on the initial emergency department they were transported to 3. Unnecessary transportation to the emergency department for head CT scan following an injury: patients with a negative head CT scan following their incident who do not require any other services from the emergency department |
| Overall study start date | 01/04/2020 |
| Overall study end date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1080 |
| Total final enrolment | 2868 |
| Participant inclusion criteria | 1. Aged 60 years or older 2. Has a diagnosis of TBI; Traumatic Brain Injury; head injury, on the hospital admission form 3. Has a head injury recorded on their presenting reason or patient record crew condition code (C13 [Intracranial haemorrhage], M29 [Injury of the head (Disorder)]) on SECAmb patient care record 4. Has been seen, treated, transported, or discharged by a SECAmb clinician 5. Any severity of TBI |
| Participant exclusion criteria | 1. Aged 59 and younger 2. Previous TBI 3. The patient presented to an ambulance service not participating in the study |
| Recruitment start date | 01/09/2021 |
| Recruitment end date | 30/06/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Gatwick Road
Crawley
RH10 9BG
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Margate
CT9 4BG
United Kingdom
Canterbury
CT1 3NG
United Kingdom
Gillingham
ME7 5NY
United Kingdom
London
SE5 9RS
United Kingdom
Sponsor information
Hospital/treatment centre
Nexus House
4 Gatwick Road
Crawley
RH10 6LW
England
United Kingdom
| Phone | +44 (0)300 123 0999 |
|---|---|
| research@secamb.nhs.uk | |
| Website | https://www.secamb.nhs.uk/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/03/2023: The following changes were made to the trial record:
1. Website added.
2. The intention to publish date was changed from 31/03/2023 to 31/08/2023.
30/06/2022: Total final enrolment added.
19/04/2022: The recruitment end date has been changed from 30/04/2022 to 30/06/2022.
22/07/2021: Trial's existence confirmed by East Midlands - Derby Research Ethics Committee.
