- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314437
5 Minute 'HOT' Trauma CT Rates Of Detection Study
Randomised Trial (With Integrated Pilot) Evaluating Whether a Standardised Approach, Educational Package (Including Checklist) Improve Recognition of Major Life-threatening Injuries in the Hot Reporting of Trauma Scans
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a randomised controlled trial to evaluate whether a standardised approach, educational package (with checklist) may improve recognition of major life-threatening injuries in the hot reporting of trauma scans. A pilot study with 20 participants allocated to the two groups on 1:1 ratio which will receive the education package, will inform feasibility of the larger study.
The larger study will recruit 300 participants, 100 on each group on 1:1:1 ratio, to evaluate the primary objective.
Participants will be clinicians who volunteer to participate in an online educational package. Participant data will be collected by the online platform under a unique identifier. Results will then be extracted from the platform and then associated with the demographic data on the trust system.
Following application of inclusion and exclusion criteria, participants will be allocated into one of three groups, and assigned a participant number. The test data set will consist of cases that have been pseudo anonymised with the key stored on trust systems.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul Jenkins, BMBS, BSc (Hons), FRCR, EBIR
- Phone Number: +441752430838
- Email: pjenkins1@nhs.net
Study Locations
-
-
Devon
-
Plymouth, Devon, United Kingdom, PL6 8DH
- University Hospitals Plymouth
-
Contact:
- Paul Jenkins, BMBS, BSc (Hons), FRCR, EBIR
- Phone Number: 30838 +441752430838
- Email: pjenkins1@nhs.net
-
Contact:
- Gabriela Di Scenza, MBBS, BA (Hons), PGCert
- Phone Number: +447973177122
- Email: gabriela.discenza1@nhs.net
-
Principal Investigator:
- Paul Jenkins, BMBS, BSC (Hons), FRCR, EBIR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical professionals involved in trauma image review.
- This includes clinicians who are emergency department doctors, radiologists and other specialties.
- Non-radiologist clinicians will be participating completing the hot reports, radiologists will be evaluating their submissions and assessing their accuracy.
Exclusion Criteria:
- Unable to review CT imaging due to lack of previous experience or disability that prevents them from doing so.
- Under 18 years old.
- Not a medical professional or clinician.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 3 Control Group
No intervention.
Control Group.
|
|
|
Experimental: Group 1 Intervention Group A Images
Group 1 will report image bank A, receive the educational intervention and then report image bank B with the checklist.
|
The three groups will report 2 image banks of 15 CT images each. Image bank A will contain 15 CT images each with a brief history including the mechanism of injury. Image bank B will contain 10 new CT images and 5 CT images contained within image bank A, but with an altered but compatible mechanism of injury. Group 1 will report image bank A, receive the educational intervention and then report image bank B with the checklist. Group 2 will report image bank B, receive the educational intervention and then report image bank A. Group 3 will report image bank A and B without any intervention. |
|
Experimental: Group 2 Intervention Group B Images
Group 2 will report image bank B, receive the educational intervention and then report image bank A.
|
The three groups will report 2 image banks of 15 CT images each. Image bank A will contain 15 CT images each with a brief history including the mechanism of injury. Image bank B will contain 10 new CT images and 5 CT images contained within image bank A, but with an altered but compatible mechanism of injury. Group 1 will report image bank A, receive the educational intervention and then report image bank B with the checklist. Group 2 will report image bank B, receive the educational intervention and then report image bank A. Group 3 will report image bank A and B without any intervention. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of detection and error of a hot CT report.
Time Frame: 1 year
|
Measure using percentage difference in hot report accuracy rates between those who receive the educational package and those who did not.
Participants will submit their answers onto the platform and these will be evaluated by Radiologists familiar with the trauma scans the participants have reviewed.
The primary analysis will be comparative between the pickup rate between the first and second imaging set within groups 1 and 2. Group 3 will act a control group to determine the effect of repetition on skill development rather than the education package.
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25/RAD/176
- 361877 (Other Identifier: Integrated Research Application System)
- 70122 (Other Identifier: Central Portfolio Management System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Requests for data sharing can be made after publication of the primary results paper. Requests should be made to the Chief Investigator in the first instance. Requesters will be asked to complete an application form detailing specific requirements, rationale, and proposed usage. The CI and study sponsor (including the sponsor's Research Governance Manager (or deputy), the Information Governance Team, Calidcott Guardian, IM&T Security Officer and the researcher funder, as appropriate) will review all requests.
Consideration will be given to:
- The viability and suitability of the request
- Appropriate steps have been taken to minimise the risk of identifying participants
- Data security policies and procedures of recipient organisation (including country if abroad) and other regulatory requirements are applicable
- The credentials of the requestor
Where access to requested data is granted, requesters organisation must sign a data sharing agreement before they can access any
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma Abdomen
-
Children's Hospital of PhiladelphiaMayo ClinicRecruiting
-
Centre Hospitalier Departemental VendeeActive, not recruiting
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingWounds and Injuries | Abdomen, Acute | Abdominal Injury | Blunt Trauma to Abdomen | Abdomen InjuryUnited States
-
Denver Health and Hospital AuthorityCompleted
-
Azienda Usl di BolognaCompletedTrauma Abdomen | Liver Injury | Trauma SplenicItaly
-
New York Medical CollegeRecruitingIntestinal Obstruction | Trauma Abdomen | Intestinal PerforationUnited States
-
Tianjin Medical UniversityTianjin HospitalRecruitingAcute Abdomen | Abdominal Trauma | Emergency SurgeryChina
-
Assiut UniversityCompletedNon Enhanced MSCT Abdomen in Diagnosis of Acute AbdomenEgypt
-
KCI USA, IncCompleted
-
A.O. Ospedale Papa Giovanni XXIIIUnknown
Clinical Trials on Education
-
Erzincan UniversityCompletedQuality of Life | Nursing Caries | Breastfeeding | Postpartum | Nursing Model | Levine Conservation Model
-
Oregon Health and Science UniversityEnrolling by invitation
-
Mexican National Institute of Public HealthUniversity of North Carolina, Chapel Hill; Danone ResearchCompleted
-
Mclean HospitalCompleted
-
University of South FloridaNational Cancer Institute (NCI)WithdrawnPediatric CancerUnited States
-
University of TartuRecruiting
-
Jen-Ai Hospital Institutional Review BoardEnrolling by invitation
-
US Department of Veterans AffairsThe American Legion Department of WisconsinCompletedCoronary Artery Disease | Hypertension | Diabetes Mellitus | HyperlipidemiaUnited States
-
Simon Fraser UniversityNatural Sciences and Engineering Research Council, CanadaNot yet recruiting
-
University of Social Sciences and Humanities, WarsawNational Science Centre, PolandRecruiting