Long-terms Effects of Simulation-based Ultrasound Training: A Randomized Trial

NCT01895868 | Completed

• 1 other identifier: H-3-2012-154
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical effects of simulation-based ultrasound training has not yet been explored. To examine the long-term effects of training, we plan to conduct a trial, where half of all new residents are randomized to simulation-based training and the other half to traditional clinical training only. The effects are assessed after two months of practice by evaluating two ultrasound scans performed by the residents. These scans are subsequently evaluated by a blinded consultant gynecologist and rated using the Objective Structured Assessment of Ultrasound Skills, which has been validated in previous studies.

Conditions

Ultrasound Training; Ultrasound Simulation; Ultrasound Assessment; Technology-enhanced Learning; Virtual Reality Simulation

Keywords

Ultrasound training; Ultrasound simulation; Ultrasound assessment; Technology-enhanced learning; virtual reality simulation

Outcome Measures

Primary Outcomes (1)

• Technical ultrasound performances

  The main outcome measure is the technical proficiency after two months of practice. Two scans from the emergency department are recorded and subsequently assessed by a blinded clinician, who also had access to the ultrasound descriptions that corresponded to each scan. The assessments were performed using the Objective Structured Assessment of Ultrasound Skills (Tolsgaard et al. 2013), which has been validated in a construct validity study including 30 clinicians with different levels of experience prior to this trial.

  2 months

Secondary Outcomes (1)

• Diagnostic accuracy

  Two months

Other Outcomes (1)

• Number of completed scans

  2 months

Study Arms (2)

Simulation-based training

ACTIVE COMPARATOR

Participants in the intervention group receive simulation training using two types of ultrasound simulators: The Scantrainer (Medaphor) and the BluePhantom (CAE). All participants are training to pre-established proficiency-criteria.

Other: Simulation-based ultrasound training

Control

NO INTERVENTION

Clinical training alone.

Interventions

Simulation-based ultrasound training OTHER

Also known as: Scantrainer, Medaphor, BluePhantom, CAE

Simulation-based training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) proficiency in written and oral Danish, 2) informed written consent.

You may not qualify if:

• \) prior employment at an OB/GYN department in a clinical position, 2) any formal ultrasound training with or without hands-on practice and (3) prior experience with virtual reality simulation.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Dept. Gynecology, Rigshospitalet.

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Tolsgaard MG, Ringsted C, Dreisler E, Norgaard LN, Petersen JH, Madsen ME, Freiesleben NL, Sorensen JL, Tabor A. Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial. Ultrasound Obstet Gynecol. 2015 Sep;46(3):312-8. doi: 10.1002/uog.14780. Epub 2015 Aug 6.

  PMID: 25580809 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 7, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

DK (1)