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A Trial on the Effect of Simulation-based Diagnostic Abdominal Ultrasound Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02921867
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Mia Louise Østergaard, Rigshospitalet, Denmark

Brief Summary:
The investigators hypothesise that simulation-based training will have initial educational benefits and in coherence with the traditional apprenticeship model will heighten the educational end-level: That training on the simulator before clinical education will prepare the trainee for practice and thereby support more effective learning.

Condition or disease Intervention/treatment Phase
Pathology Other: Simulation-based training Not Applicable

Detailed Description:

This study will be registered at 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Fluent oral and written Danish or English.

Exclusion Criteria:

  • Clinical ultrasound training or completed ultrasound courses with or without simulation training for more than one week in total prior to enrollment.
  • Failure to complete simulation-based training or pass the simulation-based diagnostic ultrasound test. Failure to complete the logbook.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02921867

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Copenhagen University hospital, Rigshospitalet
Copenhagen, Copenhagen O, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Mia L Østergaard, MD Copenhagen University Hospital at Herlev

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mia Louise Østergaard, MD, PhD researchfellow, Rigshospitalet, Denmark Identifier: NCT02921867     History of Changes
Other Study ID Numbers: Abd.Sim.Training.RT
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mia Louise Østergaard, Rigshospitalet, Denmark:
abdominal ultrasound
medical education