Learning OutcomeNCT02156921
App-guided Training in eFAST Ultrasound
A study testing App-based training in people with Learning Outcome and Training Efficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Learning Outcome, Training Efficiency
- What is being tested?
- App-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First year medical doctor
- Provided written informed consent
Who cannot join
- Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Academy for Medical Education and Simulation
Copenhagen, Capital Region, DK-2100
About this study
Official title: 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.
- Conditions
- Learning Outcome, Training Efficiency
- Being tested
- App-based training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Self-guided training without app-based training (written hand-outs) |
| Intervention group | Active comparator | Self-guided training with app-based training Receives: Other: App-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video recording of ultrasound skills, rated by consultant radiologists.
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.
Measured: Ratings are to be completed within three months of performance.
Cost-effectiveness of mobile app guided versus textbook guided training
Measured: September 2016
Secondary outcomes (1)
Diagnostic accuracy
Participants are given five videocases, to assess for eFAST verifiable pathology.
Measured: On site via checklist, evaluated on average one day after performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning OutcomeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Academy for Medical Education and Simulation, University of Copenhagen
- Responsible party
- Principal investigator, Philip Mørkeberg Nilsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Philip M Nilsson, Principal investigator, Copenhagen Academy Of Medical Education And Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156921
- Sponsor's protocol ID
- H-3-2014-FSP17
- Status last verified
- Oct 2016
- First submitted
- 27 May 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Mobile App-guided Training in Extended Focused Assessment With Sonography for Trauma (eFAST): A Randomized Trial
- ClinicalTrials.gov ID
- NCT02156921
- Acronym / sponsor ID
- H-3-2014-FSP17
- Conditions
- Learning Outcome, Training Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Academy for Medical Education and Simulation, University of Copenhagen
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Self-guided training without app-based training (written hand-outs) |
| Intervention group | Active comparator | Other: App-based trainingSelf-guided training with app-based training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- First year medical doctor
- Provided written informed consent
Key exclusion criteria (1 listed)
- Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based training | Other | Intervention group |
Primary outcome
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.
Cost-effectiveness of mobile app guided versus textbook guided training
Time frame: September 2016
1 secondary outcome
Diagnostic accuracy
Time frame: On site via checklist, evaluated on average one day after performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip M Nilsson principal investigator
Copenhagen Academy Of Medical Education And Simulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based training in people with Learning Outcome and Training Efficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video recording of ultrasound skills, rated by consultant radiologists. (time frame: Ratings are to be completed within three months of performance.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.