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

March 13, 2018 updated by: Mia Louise Østergaard, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

20

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

  • Denmark
    • Copenhagen O
      • Copenhagen, Copenhagen O, Denmark, 2100
        • Copenhagen University Hospital, Rigshospitalet

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:

  • 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.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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..
Enrollment will forego until 22 residents in total has been enrolled; expectantly in 9-12 month..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Mia L Østergaard, MD, Copenhagen University Hospital at Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2016

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Abd.Sim.Training.RT

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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