- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156921
App-guided Training in eFAST Ultrasound
October 26, 2016 updated by: Philip Mørkeberg Nilsson, Rigshospitalet, Denmark
Cost-effectiveness of Mobile App-guided Training in Extended Focused Assessment With Sonography for Trauma (eFAST): A Randomized Trial
This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound training compared to self-directed training with written handouts on subsequent performance on simulated patient cases and theoretical cases.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Capital Region
-
Copenhagen, Capital Region, Denmark, DK-2100
- Copenhagen Academy for Medical Education and Simulation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First year medical doctor
- Provided written informed consent
Exclusion Criteria:
- Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Self-guided training without app-based training (written hand-outs)
|
|
Active Comparator: Intervention group
Self-guided training with app-based training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Video recording of ultrasound skills, rated by consultant radiologists.
Time Frame: Ratings are to be completed within three months of performance.
|
The video-recordings of the technical performances are merged with the ultrasonography screen-recordings to one anonymized video-clip.
These combined video-clips are rated with the OSAUS rating by two raters.
The OSAUS scale (Objective Structured Assessment of Ultrasound Skills) is used for all performance assessments.
The raters are consultant radiologists.
|
Ratings are to be completed within three months of performance.
|
Cost-effectiveness of mobile app guided versus textbook guided training
Time Frame: September 2016
|
September 2016
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: On site via checklist, evaluated on average one day after performance.
|
Participants are given five videocases, to assess for eFAST verifiable pathology.
|
On site via checklist, evaluated on average one day after performance.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philip M Nilsson, Copenhagen Academy of Medical Education and Simulation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 27, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- H-3-2014-FSP17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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