Evaluating the ability of emergency department clinicians to interpret CT head scans following online training
| ISRCTN | ISRCTN38179700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38179700 |
| IRAS number | 310995 |
| ClinicalTrials.gov number | NCT05427838 |
| Secondary identifying numbers | IRAS 310995, CPMS 52221 |
- Submission date
- 04/04/2022
- Registration date
- 19/05/2022
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Computerised Tomography (CT) head scans are frequently requested by Emergency Department (ED) clinicians as one of the investigations for their patients. This often causes a delay when waiting for specialist radiologists to report the findings of the scan. The purpose of this study is to see if online training can improve the ability of ED clinicians to interpret the scans themselves, to a level sufficient to make clinical decisions based on their findings and to explore what aspects of this process they find most challenging.
Who can participate?
Emergency Department clinicians who are working in the Emergency Departments of participating sites between April to September 2022 (inclusive), who request CT Head scans as part of their routine clinical practice
What does the study involve?
180 ED clinicians will be recruited across 6 hospital sites in the United Kingdom. All will undertake a baseline online assessment to measure their accuracy in interpreting CT head scans. One group will then undertake an online training module, with a subsequent assessment immediately afterwards, then over the following 3 months will record interpretations for 30 CT Head images encountered in their routine clinical practice, and their findings will be compared with the radiology reports for each scan. They will then undertake further online assessments 3 and 6 months after the start of the study. Their overall results will be compared with a control group, who will undergo the same process, but undertake the online training after they have tried to interpret 30 scans in their clinical practice.
What are the possible benefits and risks of participating?
Participants will benefit from online training in the reporting of CT head scans, and will also receive £500 at the end of the study to compensate for their time. There are no obvious risks to undertaking the study, other than the time involved in participating. Participants will continue to base their clinical decisions on radiologist reports, not their own interpretations, so patient care will not be affected by this study.
Where is the study run from?
Oxford University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2021 to June 2026
Who is funding the study?
Small Business Research Initiative (SBRI) (UK)
Who is the main contact?
Dr Alex Novak, alex.novak@ouh.nhs.uk
Jose Martinez, jose.martinez@ouh.nhs.uk
Contact information
Principal Investigator
Emergency Department
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0002-5880-8235 |
|---|---|
| Phone | +44 7944653970 |
| alex.novak@ouh.nhs.uk |
Public
Emergency Department
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 7919131735 |
|---|---|
| jose.martinez@ouh.nhs.uk |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 41484_PIS_V2.0_01Apr22.pdf |
| Scientific title | STEDI 2: Simulation Training in Emergency Department Imaging 2 |
| Study acronym | STEDI 2 |
| Study hypothesis | Can online simulation/training have an impact on the reporting accuracy of Emergency department doctors when interpreting CT head scan images? |
| Ethics approval(s) | 1. Approved 24/03/2022, Health Research Authority REC (Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; hra.approval@nhs.net), ref: 22/HRA/0743 2. Approved 29/03/2022, Oxford University Medical Sciences Interdivisional Research Ethics Committee (MS IDREC, Research Services, Research Governance, Ethics & Assurance Team, University of Oxford, Boundary Brook House, Churchill Drive, Headington, Oxford, OX3 7GB, UK; +44 (0)1865 616575; leah.butts@admin.ox.ac.uk), ref: R80145/RE001 |
| Condition | Clinicians of varying seniority who request CT head scans as part of their routine clinical practice |
| Intervention | This is a prospective observational cohort study to assess the improvement in the image interpretation accuracy and confidence of reporters using online simulation training for CT head scan interpretation. Participants will be randomised to control (see section below – no online training, 30 clinicians, 6 from each site) versus intervention (online training – 150 clinicians) groups. Prior to the start of the study, each participant ID will be randomised to either group in a 1:5 ratio via simple randomisation using an online number generator – the outcome of this allocation will be recorded on a linkage document held by the central study team in Oxford. To minimise bias in recruiting, site Principal Investigators will be unaware of their overall site allocations, but as each participant at their site is enrolled, they will contact the central study team to find out to which group the participant has been allocated. Intervention Group: The trial participants will be required to complete a baseline assessment where users will review a set of scans and provide a diagnosis before submitting the case. Once the baseline assessment is completed, users will have access to training cases where they were provided with the correct answers once they had attempted the case. Once the training was completed, the users will be asked to complete a second assessment. The improvement in diagnostic accuracy pre- and post-training will be measured. Once the ED staff have been trained, they will be asked to evaluate a minimum of 30 CT scans each during their clinical shifts over a 3-month period. They will be asked to record their scan interpretation, the time the scans were performed, and the time they reviewed the scan. They will also be asked to retrospectively document admission details for the case (i.e., date and time of attendance and discharge of the patient), the findings of the standard clinical radiology report, and the time it was issued. The standard clinical radiology report will be considered to be the reference standard for diagnosis. This will allow us to measure the real-world accuracy of ED staff at interpreting CT heads. In addition, the researchers will also be able to measure potential time saving by ED staff interpreting the scans, by comparing the time of the ED clinician compared with the radiology report being issued. At the end of the month period, they will repeat the online assessment to assess their performance, and again after a further 3 months to assess their retention of any improvement in reporting performance. Control Group: To provide a control for comparison as to the relative benefits of the online training phase and the clinical interpretation phase in terms of improving reporting performance, 30 participants (6 clinicians from each site) will be randomised to undertake the clinical interpretation phase prior to the training module. Survey: After each assessment module, participants will be asked to complete an online survey asking questions about the study and how confident they feel about their interpretation accuracy. Statistical Analysis: 1. Baseline accuracy statistics from each participant will be compared to subsequent results from each stage of the study 2. Accuracy statistics will be compared with those of Radiology Consultants and Registrars |
| Intervention type | Behavioural |
| Primary outcome measure | Accuracy of ED clinicians in reporting non-contrast CT head scans (sensitivity and specificity) measured using online assessment at pre/post-training, 3 months, 6 months post-training |
| Secondary outcome measures | 1. Confidence of ED clinicians in reporting non-contrast CT head scans measured using self-reported confidence scores at pre/post-training, 3 months, 6 months post-training 2. Time difference between ED clinician interpretation and final radiology report measured using recorded report times at 3 months post-training 3. Real-world diagnostic accuracy of ED staff at interpreting medical imaging (sensitivity and specificity) measured using comparison of ED findings versus radiology report findings (reference standard) at 3 months post-training 4. Ability of clinicians to retain newly acquired CT reporting skills measured using online assessment at 6 months post-training 5. Factors that influence clinicians’ reporting accuracy (abnormal finding, size of abnormality, image quality, rotation/position, other abnormalities present) measured using online assessment pre- and post-training 6. Factors affecting the uptake of new image reporting roles in the ED clinical population measured using a participant survey at 6 months post-training 7. Potential clinical and health economic impact of introducing CT head reporting into ED clinical practice measured using health economic modelling based on the difference between ED and radiologists report times during the clinical phase 8. Clinicians’ interpretation accuracy with and without undergoing online training (sensitivity, specificity) measured using online assessment at pre-training/clinical phase, 3 months, 6 months post the start of the study |
| Overall study start date | 01/12/2021 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 |
| Total final enrolment | 294 |
| Participant inclusion criteria | 1. Emergency department clinicians who review CT head scans as part of their clinical practice 2. Working in the relevant ED during the clinical phase of the project |
| Participant exclusion criteria | 1. Previous formal postgraduate CT reporting training 2. Previous career to registrar level in radiology/neurosurgery 3. Staff in Emergency Department post for less than 4 months |
| Recruitment start date | 20/04/2022 |
| Recruitment end date | 31/05/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
81a Oxford Road
Banbury
OX16 9AL
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Wexham
Slough
SL2 4HL
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Sponsor information
Hospital/treatment centre
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
England
United Kingdom
| Phone | +44 7944653970 |
|---|---|
| shahista.hussain@ouh.nhs.uk | |
| Website | http://www.ouh.nhs.uk |
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| 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 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? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 01/04/2022 | 11/04/2022 | No | Yes |
| Protocol file | version 2.0 | 01/04/2022 | 11/04/2022 | No | No |
Additional files
Editorial Notes
27/01/2025: The following changes were made:
1. The overall study end date was changed from 30/06/2025 to 30/06/2026.
2. The intention to publish date was changed from 31/01/2025 to 30/06/2026.
12/04/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2024 to 30/06/2025.
2. The total final enrolment was added.
08/04/2024: ClinicalTrials.gov number added.
04/04/2024: The contact confirmed the record is up to date.
30/03/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2023 to 30/09/2024.
2. The intention to publish date was changed from 01/02/2023 to 31/01/2025.
3. The plain English summary was updated to reflect these changes.
07/06/2022: Internal review.
11/04/2022: Trial's existence confirmed by the HRA.
