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

Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921867
• Other study ID #: Abd.Sim.Training.RT
• Status: Completed
• Phase: N/A
• First received: September 21, 2016
• Last updated: March 13, 2018
• Start date: December 1, 2016
• Est. completion date: February 15, 2018

Study information

• Verified date: March 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pathology

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University hospital, Rigshospitalet	Copenhagen	Copenhagen O

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Todsen T, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingsø 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..