Simulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills Transfer Clinical Trial
Official title:
Learning From Errors During Simulation-based Ultrasound Training
| Verified date | October 2015 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Videnskabsetiske Komitesystem |
| Study type | Interventional |
During the past decades, simulation-based training has become essential for making trainees
fit for clinical practice. Traditionally, trainees are instructed to practice with as few
errors as possible during simulation-based training. However, recent evidence from the field
of psychology suggests that transfer of learning may improve if trainees are encouraged to
commit errors during training. The aim of this study is to assess on performances with real
patients the effect of error-management instructions compared to error-avoidance
instructions during simulation-based virtual reality ultrasound training.
This study is planned as a randomized controlled trial. Participants include medical
students with no prior simulation practice at the fifth or sixth year of medical school. All
participants receive 3 hours simulation-based ultrasound training focusing on fetal weight
estimation. The participants (N=60) are randomized into two groups: Participants in group 1
are instructed to follow the simulator program step-by-step to achieve the highest possible
simulator metric scores by making as few errors as possible. Participants in group 2 are
instructed to experiment and explore and to deliberately make errors during training. A
simulation-based pre- and post-test is administered before and after training.
Participants are scheduled to perform a transfer test seven to ten days after simulation
training. The transfer test consists of fetal weight estimation on a real patient. The
primary outcome is weight deviation of participant measurements compared to expert findings.
Secondary outcomes include performance assessments of pre-, post- and transfer test
performances by blinded ultrasound experts using the Objective Structured Assessment of
Ultrasound Skills (OSAUS) scale. Using an alpha level of 0.05, an effect size of 0.80, and a
power of 0.80, 25 participants are needed in the two study groups. Loss to follow-up of up
to 20% of study participants is anticipated, resulting in 30 participants in each study
group.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - are enrolled during the fifth or sixth year of medical school - provide written informed consent Exclusion Criteria: - have clinical or simulator ultrasound experience |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Juliane Marie Center, Copenhagen University Hospital Rigshospitalet | Copenhagen | |
| Denmark | Dept. of Fetal Medicine, Juliane Marie Centre | Copenhagen O |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | diagnostic accuracy | The primary outcome is diagnostic accuracy during the transfer test performances. Diagnostic accuracy is determined as the percentage deviation from the fetal weight estimation performed by an experienced sonographer (i.e. an ultrasound expert). | 7-10 days later in a tranfer test | No |
| Secondary | performance scores based on the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale | Secondary outcome measures include performance scores based on the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. | 7-10 days in a tranfer test | No |