NCT02921867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

September 21, 2016

Last Update Submit

March 13, 2018

Conditions

Keywords

ultrasoundradiologysimulationabdominal ultrasoundmedical education

Outcome Measures

Primary Outcomes (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)

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Traditional training

NO INTERVENTION

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

Interventions

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 group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent oral and written Danish or English.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University hospital, Rigshospitalet

Copenhagen, Copenhagen O, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 24509198BACKGROUND
  • 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.

Study Officials

  • Mia L Østergaard, MD

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD researchfellow

Study Record Dates

First Submitted

September 21, 2016

First Posted

October 3, 2016

Study Start

December 1, 2016

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations