A Trial on the Effect of Simulation-based Diagnostic Abdominal Ultrasound Training
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|ClinicalTrials.gov Identifier: NCT02921867|
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pathology||Other: Simulation-based training||Not Applicable|
This study will be registered at ClincalTrials.gov and reported according to the CONSORT statement.
Setting: Clinical training will forego unaltered as current practice at the department of the individual resident's employment. The simulated training will be held as individual training sessions on the Schallware Ultrasound simulator (station 64; version 010013) placed at the Copenhagen Academy for Education and Simulation (CAMES), Rigshospitalet. Testing will be done on both the simulator at the Simulationcentre at Rigshospitalet, CAMES and on real life patients in the departments of radiology where the residents are employed.
Population: Participants are residents embarking on the first year of their specialized radiological training before any formalized ultrasound training. Enrollment is voluntary and in collaboration with their department of employment.
Intervention and controlled conditions:
A total of 22 residents at the beginning of their specialized radiological education and before their focused ultrasound training are randomised for two educational groups.
The simulation-based training modules will be in a recommend but not mandatory order starting with a general organ-identifying module and continuing with range of pathology modules with headlines: Introduction, Liver I, Liver II, Biliary System, Pancreas and Spleen, Urinary System, Vessels, Other Findings, and Mixed Cases.
The clinical part of training will forego unaltered for both groups for six weeks and all participants will fill out a log of all scans performed and when supervised the supervisor will score their scans using the OSAUS score.
The reviewer scoring the simulation-based test will be blinded. It is not possible to blind the reviewers of the clinical score (OSAUS) as it is the residents' clinical supervisors.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial on the Effect of Simulation-based Diagnostic Abdominal Ultrasound Training|
|Actual Study Start Date :||December 1, 2016|
|Actual Primary Completion Date :||February 15, 2018|
|Actual Study Completion Date :||February 15, 2018|
Experimental: Intervention group
Simulation-based training in nine modules with optional training times and ending with an obligatory certification test before traditional training is started. Traditional training time unaltered: six weeks.
Other: Simulation-based training
The simulation-based training will consist of nine modules that can be trained in random order and training periods within the eight weeks before clinical training starts.
No Intervention: Traditional training
Six weeks focused stay at an ultrasound ward with day to day one-on-one supervision (current practise)
- All participants in both groups will be scored during their clinical ultrasound training by their supervising physicians using Objective Structured Assessment of Ultrasound Skills (OSAUS) [ Time Frame: Enrollment will forego until 22 residents in total has been enrolled; expectantly in 9-12 month.. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921867
|Copenhagen University hospital, Rigshospitalet|
|Copenhagen, Copenhagen O, Denmark, 2100|
|Principal Investigator:||Mia L Østergaard, MD||Copenhagen University Hospital at Herlev|