Head injury evaluation and ambulance diagnosis to avoid hospital emergency admission: A HOME feasibility study
| ISRCTN | ISRCTN92566288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92566288 |
| IRAS number | 316547 |
| Secondary identifying numbers | IRAS 316547 |
- Submission date
- 13/09/2022
- Registration date
- 11/01/2023
- Last edited
- 25/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Traumatic Brain Injury (TBI) is widely recognised as one of the most common causes of death and disability, primarily among young adults, and is getting more frequent in the older population. It is a widely held view that TBI is a pathophysiological heterogeneous condition that varies widely in terms of aetiology, severity, clinical presentation and outcomes. This spectrum of severity creates clinical challenges, as many patients with mild TBI may be admitted to a major trauma centre (MTC), resulting in overwhelming MTC resources with minor injuries.
Various validated clinical tools have been developed to determine the need for a CT scan to rule out intracranial lesions in adult patients with a minor head injury. Of these, the Canadian CT head rule (CCHR) was developed through a series of prospective studies involving thousands of patients to determine the need for neuroimaging. CCHR is a highly sensitive rule to assist clinicians in identifying patients with clinically significant head injuries who should undergo CT scanning.
To obtain precise estimates for the diagnostic accuracy of the CCHR that could be used to change clinical practice is likely to require a large, multi-centre study. This would be expensive and time-consuming. Successful delivery of the research would also depend heavily upon adherence to the study protocol, recruitment rate and attrition. Before embarking on such a large study, therefore, it is prudent to evaluate the feasibility of the intended study processes.
Who can participate?
A convenience sample of adult patients with mild TBI
What does the study involve?
Feasibility outcomes will be assessed using screening logs and case report forms completed by paramedics during the course of the study. At the receiving hospital, emergency physicians will assess the patients to determine whether a CT scan is necessary, which may involve using the CCHR. Clinicians at the receiving hospitals will be asked to assess the patients using the CCHR and record their findings to determine inter-observer reliability. We will evaluate the acceptability of the CCHR among participating paramedics. Additionally, we will evaluate the acceptability of trial processes to patients and paramedics using a qualitative approach.
What are the possible benefits and risks of participating?
There are no immediate benefits for individuals who participate in this study. We anticipate that the findings of this study will help to improve the care we provide in the future by providing clinical evidence to conduct further studies in this area. It is unlikely that patients will be at high-risk during this study.
Where is the study run from?
Manchester Royal Infirmary (United Kingdom)
When is the study starting and how long is it expected to run for?
March 2022 to December 2023
Who is funding the study?
The University of Manchester (United Kingdom)
Who is the main contact?
Naif Alqurashi (United Kingdom)
naif.alqurashi@postgrad.manchester.ac.uk
Contact information
Principal Investigator
Emergency Department
Manchester Royal Infirmary
Oxford Rd, Manchester
M13 9WL
United Kingdom
| Phone | 01612765071 |
|---|---|
| richard.body@manchester.ac.uk |
Scientific
Division of Cardiovascular Sciences, Faculty of Biology, Medicine, and Health
Manchester
M13 9WL
United Kingdom
| Phone | 01612765071 |
|---|---|
| naif.alqurashi@postgrad.manchester.ac.uk |
Study information
| Study design | Prospective multi-centre feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Mixed-methods |
| Study setting(s) | Paramedicine |
| Study type | Screening |
| Participant information sheet | 42376 Consent Form V2.0 20Nov2022.pdf |
| Scientific title | Head injury evaluation and ambulance diagnosis to avoid HOspital eMErgency admission: A HOME feasibility study |
| Study acronym | HOME Study |
| Study objectives | The purpose of this study is to establish the feasibility of a fully powered diagnostic test accuracy study to evaluate the accuracy of the Canadian CT head rule when applied by paramedics in the prehospital setting in patients with head injuries |
| Ethics approval(s) | Approved 15/12/2022, North West – Greater Manchester (GM) South (3rd Floor Barlow House, 4 Minshull Street, HRA NRES Centre, Manchester, M1 3DZ, UK; +44 (0)207 104 8014; approvals@hra.nhs.uk, HCRW.approvals@wales.nhs.uk), ref: 22/NW/0358 |
| Health condition(s) or problem(s) studied | Mild traumatic brain injury |
| Intervention | The purpose of this study is to establish the feasibility of a fully powered diagnostic test accuracy study to evaluate the accuracy of the Canadian CT head rule (CCHR) when applied by paramedics in the prehospital setting in patients with head injuries. The CCHR was developed through a series of prospective studies involving thousands of patients to determine the need for neuroimaging. It helps to identify clinically important brain injuries on CT scans that may require neurosurgical intervention. The rule consists of five high-risk clinical factors for neurosurgical intervention, and two medium-risk factors for predicting brain injury on a CT scan and takes into account a number of variables related to the patient's medical history and physical examination. All of the data required for the CCHR are available to paramedics in the prehospital environment. Therefore, it may be possible to apply the CCHR based on prehospital information obtained at the scene. Before embarking on such a large study, therefore, it is prudent to evaluate the feasibility of the intended study processes. A prospective, multi-centre pilot feasibility diagnostic accuracy study will be conducted. A convenience sample of adult patients with mild traumatic brain injury will be transported to study site hospitals. Once the paramedics determine that a patient meets the inclusion criteria, they will be asked to assess the patients in the ambulance using the CCHR and record their interpretation of the decision aid using a paper CRF prior to arriving at a study site hospital. Emergency physicians at the receiving hospitals will be asked to assess the patients using the CCHR and record their findings to determine inter-observer reliability. - Feasibility outcomes will be examined. - We will measure paramedics' attitudes toward the CCHR will be used to evaluate the acceptability of the CCHR. - We will evaluate the acceptability of trial processes to patients and paramedics using a qualitative approach to obtain their perspectives regarding their participation and experiences in the trial. |
| Intervention type | Other |
| Primary outcome measure | Feasibility outcomes: 1. Number of eligible patients approached measured using screening logs and case report forms throughout the enrolment period 2. Proportion of patients approached who consent to participate in the study measured using screening logs and case report forms throughout the enrolment period 3. Completeness of data collection measured using screening logs and case report forms throughout the enrolment period 4. Completeness of follow-up measured using case report forms following hospital discharge or death (if in-hospital) 5. Determination of the inter-observer reliability of the Canadian CT head rule completion between prehospital care providers (during the prehospital phase) and ED physicians (while patients are in the Emergency Department) measured using case report forms 6. Determination of the inter-observer reliability of each component of the Canadian CT head rule between prehospital care providers (in the prehospital phase) and ED physicians (while patients are in the ED) measured using case report forms 7. The diagnostic performance of the Canadian CT head rule, as assessed by paramedics in the prehospital phase, using patient records and case report forms 8. The acceptability of trial processes to patients and paramedics measured using a qualitative approach and clinical sensibility of the Canadian CT head rule measured using a survey method |
| Secondary outcome measures | Presence of traumatic intracranial lesion requiring neurosurgical intervention, defined as any neurosurgical intervention and/or abnormal head CT findings and/or death within 7 days as a result of traumatic brain injury measured using medical records at 7 days after initial admission |
| Overall study start date | 01/03/2022 |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | We anticipate that approximately 1,100 patients will be eligible to participate in this study during the recruitment period. Accounting for the availability of trained paramedics on the study delegation log and concurrent injuries to other body systems that would exclude patients from participating in this study, we anticipate recruiting approximately 100 participants. |
| Key inclusion criteria | 1. Adult patients aged 16 years old and over who receive an emergency ambulance response for a primary complaint of head injury 2. Glasgow coma scoring (GCS) of 13–15 at the time of assessment by treating paramedics 3. Patients who will be transported to the hospital as part of their routine clinical care |
| Key exclusion criteria | 1. Already received care in hospital for their condition and who are undergoing secondary transfer to a specialist centre 2. Penetrating skull injury 3. Trauma to other body regions that would require transport to the hospital 4. Prisoners |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 01/05/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
399 Chorley New Road
Bolton
BL1 5DD
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
University/education
Faculty Research Practice Governance Manager
Manchester
M13 9WL
England
United Kingdom
| Phone | +44 (0)1612755436 |
|---|---|
| fbmhethics@manchester.ac.uk | |
| Website | https://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| 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 | 1. Planned publication in a high-impact peer-reviewed journal 2. Presenting of the study findings at relevant national and international conferences 3. Dissemination through presentations at relevant academic forums 4. The findings of this study will be included in Naif Alqurashi's doctoral thesis |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 20/11/2022 | 20/12/2022 | No | Yes |
| Participant information sheet | version 2.0 | 20/11/2022 | 20/12/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 11/06/2024 | 25/06/2024 | Yes | No |
Additional files
Editorial Notes
25/06/2024: Publication reference added.
05/09/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2023 to 01/09/2023.
2. The recruitment end date was changed from 01/10/2023 to 01/05/2024.
3. The overall end date was changed from 01/12/2023 to 01/07/2024.
4. The plain English summary was updated to reflect these changes.
08/02/2023: The study setting has been changed from ‘Other’.
19/12/2022: Trial's existence confirmed by Health Research Authority.
