PathologyNCT02921867
A Trial on the Effect of Simulation-based Diagnostic Abdominal Ultrasound Training
A study testing Simulation-based training in people with Pathology, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pathology
- What is being tested?
- Simulation-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2016to 15 Feb 2018
- 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
- Fluent oral and written Danish or English.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University hospital, Rigshospitalet
Copenhagen, Copenhagen O, 2100
About this study
Official title: A Randomized Trial on the Effect of Simulation-based Diagnostic Abdominal Ultrasound Training
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.
Read the detailed 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.
- Conditions
- Pathology
- Being tested
- Simulation-based training
- Keywords
- ultrasound, radiology, simulation, abdominal ultrasound, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Enrollment will forego until 22 residents in total has been enrolled; expectantly in 9-12 month..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PathologyStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Louise Østergaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mia L Østergaard, MD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921867
- Sponsor's protocol ID
- Abd.Sim.Training.RT
- Status last verified
- Mar 2018
- First submitted
- 21 Sep 2016
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24509198Ostergaard 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.
PubMed 30617476
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on the Effect of Simulation-based Diagnostic Abdominal Ultrasound Training
- ClinicalTrials.gov ID
- NCT02921867
- Acronym / sponsor ID
- Abd.Sim.Training.RT
- Conditions
- Pathology
- Keywords
- ultrasound, radiology, simulation, abdominal ultrasound, medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 3 Oct 2016 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Simulation-based trainingSimulation-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. |
| Traditional training | No intervention | –Six weeks focused stay at an ultrasound ward with day to day one-on-one supervision (current practise) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fluent oral and written Danish or English.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Simulation-based trainingThe 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. | Other | Intervention group |
Primary outcome
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)
Time frame: Enrollment will forego until 22 residents in total has been enrolled; expectantly in 9-12 month..
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 15 Mar 2018.
- Background: PubMed 24509198Todsen 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.
- Derived from this study: PubMed 30617476Ostergaard 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.
- Individual participant dataSharing planned: No
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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.
Mia L Østergaard, MD principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based training in people with Pathology, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 1 inclusion and 2 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 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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) (time frame: Enrollment will forego until 22 residents in total has been enrolled; expectantly in 9-12 month..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921867, which also lists 2 linked publications.
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 15 Mar 2018.