Simulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills TransferNCT02369640
Learning From Errors During Simulation-based Ultrasound Training
A study testing Error-management training vs error-avoidance training. Defined by training instructions. in people with Simulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills Transfer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills Transfer
- What is being tested?
- Error-management training vs error-avoidance training. Defined by training instructions.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- are enrolled during the fifth or sixth year of medical school
- provide written informed consent
Who cannot join
- have clinical or simulator ultrasound experience
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Juliane Marie Center, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Dept. of Fetal Medicine, Juliane Marie Centre
Copenhagen O, 2100
About this study
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.
- Being tested
- Error-management training vs error-avoidance training. Defined by training instructions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error-management training vs error-avoidance training. Defined by training instructions.Procedure or surgery
. Error-avoidance training: The participants 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, and only to follow the task required in the training program.
Study group 2. Error-management training: The participants are required to complete the same training program as study group 1. The participants are instructed to experiment and explore on their own and to deliberately make errors during the task that they are instructed to perform. Participants are instructed to reflect on their errors based on the simulator metrics that they do not pass. Errors are framed as positive events and instructor comments may include statements such as "the more errors you make, the more you learn!" or "you have made an error? Great! Because now you can learn something new!"
| Study group | Role | What they receive |
|---|---|---|
| Error-avoidance training | Experimental | Study group 1: Error-avoidance training (Focusing on achieving the highest possible metrics score by avoiding errors). Receives: Procedure: Error-management training vs error-avoidance training. Defined by training instructions. |
| Error-management training | Experimental | Study group 2: Error-management training (Focusing on making errors and thinking of them in a positive way). Receives: Procedure: Error-management training vs error-avoidance training. Defined by training instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7-10 days later in a tranfer test
Secondary outcomes (1)
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.
Measured: 7-10 days in a tranfer test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills TransferStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin G. Tolsgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369640
- Sponsor's protocol ID
- H-4-2015-FSP
- Status last verified
- Oct 2015
- First submitted
- 17 Feb 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning From Errors During Simulation-based Ultrasound Training
- ClinicalTrials.gov ID
- NCT02369640
- Acronym / sponsor ID
- H-4-2015-FSP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Error-avoidance training | Experimental | Procedure: Error-management training vs error-avoidance training. Defined by training instructions.Study group 1: Error-avoidance training (Focusing on achieving the highest possible metrics score by avoiding errors). |
| Error-management training | Experimental | Procedure: Error-management training vs error-avoidance training. Defined by training instructions.Study group 2: Error-management training (Focusing on making errors and thinking of them in a positive way). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- are enrolled during the fifth or sixth year of medical school
- provide written informed consent
Key exclusion criteria (1 listed)
- have clinical or simulator ultrasound experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Error-management training vs error-avoidance training. Defined by training instructions.. Error-avoidance training: The participants 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, and only to follow the task required in the training program. Study group 2. Error-management training: The participants are required to complete the same training program as study group 1. The participants are instructed to experiment and explore on their own and to deliberately make errors during the task that they are instructed to perform. Participants are instructed to reflect on their errors based on the simulator metrics that they do not pass. Errors are framed as positive events and instructor comments may include statements such as "the more errors you make, the more you learn!" or "you have made an error? Great! Because now you can learn something new!" | Procedure or surgery | Error-avoidance training, Error-management training |
Primary outcome
diagnostic accuracy
Time frame: 7-10 days later in a tranfer test
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).
1 secondary outcome
performance scores based on the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale
Time frame: 7-10 days in a tranfer test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error-management training vs error-avoidance training. Defined by training instructions. in people with Simulation-based Ultrasound Training, Error-management Training, Training With Errors, Skills Transfer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: 7-10 days later in a tranfer test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.