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

NCT ID: NCT02921867

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Simulation-based training

Intervention Type OTHER

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.

Traditional training

Six weeks focused stay at an ultrasound ward with day to day one-on-one supervision (current practise)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mia Louise Østergaard

MD, PhD researchfellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mia L Østergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Locations

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Copenhagen University hospital, Rigshospitalet

Copenhagen, Copenhagen O, Denmark

Site Status

Countries

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Denmark

References

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Todsen T, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Jensen ML, Ringsted C. Reliable and valid assessment of point-of-care ultrasonography. Ann Surg. 2015 Feb;261(2):309-15. doi: 10.1097/SLA.0000000000000552.

Reference Type BACKGROUND
PMID: 24509198 (View on PubMed)

Ostergaard ML, Rue Nielsen K, Albrecht-Beste E, Kjaer Ersboll A, Konge L, Bachmann Nielsen M. Simulator training improves ultrasound scanning performance on patients: a randomized controlled trial. Eur Radiol. 2019 Jun;29(6):3210-3218. doi: 10.1007/s00330-018-5923-z. Epub 2019 Jan 7.

Reference Type DERIVED
PMID: 30617476 (View on PubMed)

Other Identifiers

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Abd.Sim.Training.RT

Identifier Type: -

Identifier Source: org_study_id

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