Simulation TrainingNCT02976623
Metric-based Feedback Training for the Acquisition of Sonographic Skills
A study testing metric-based feedback training in people with Simulation Training, run by University College Cork at 1 site in Ireland.
Trial summary
The investigators hypothesized that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills. The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation Training
- What is being tested?
- metric-based feedback training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2016to Feb 2017
- 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
- Anaesthesia trainees in the first two years of training at Cork University Hospital
- having performed no more than 5 ultrasound-guided peripheral nerve blocks
Who cannot join
- refusal to consent
- have performed more than 5 ultrasound-guided peripheral nerve blocks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Metric-based Feedback Training on Acquisition of Sonographic Skills Relevant to Performance of Ultrasound Guided Axillary Brachial Plexus Block
The investigators hypothesized that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills.
The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided axillary brachial plexus block.
Read the detailed description
The use of ultrasound guidance during performance of peripheral nerve blocks improves success rate, shortens performance time and reduces the risk of inadvertent vascular puncture. Safe and effective procedure performance requires the operator to make a series of real-time, high stakes decisions relevant to interpretation of sonographic anatomy and subsequent nerve visualization, needle-to-nerve guidance, needle-to-nerves approximation and local anesthetic deposition. Teaching novices to perform ultrasound-guided nerve blocks should include rendering and assessment of its component skills such as interpretation of sonographic anatomy, consistent needle imaging and correct placement of local anesthetics. Learning and teaching ultrasound-related motor skills is challenging within the current landscape of medical and training education. Simulated learning has been advocated as it can facilitate deliberate practice as opposed to repeated practice. Simulation and e-learning are flexible training modalities, which facilitate procedural skills rehearsal in a safe environment, free from risk to patients, and permitting real time feedback. Deliberate practice with feedback in a simulated environment may accelerate the rate of skill acquisition. Feedback is a predictor of effective learning and a useful tool for novices learning new skill. However summative feedback is superior to concurrent feedback for procedural skill acquisition during simulated but not clinical training and for skill retention. The characteristics of feedback, which influence its effect on learning, include timing, content, who initiates (elicits) it and the format and motivation applied to its delivery. Feedback positively influences skill acquisition by novice learners. How trainees adopt objective versus subjective feedback remained largely undetermined. The investigators hypothesize that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills.
The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided axillary brachial plexus block.
Methods:
With institutional ethical approval and having obtained written informed consent from each, 12 anesthesia trainees will be invited to participate in this prospective, randomized and blinded study.
Inclusion criteria:
- trainees in the Irish national anesthesia training program allocated to Cork teaching hospital (CUH) ii. have performed no more than 5 ultrasound-guided peripheral nerve blocks at the time of participation.
Each participant will answer tests to ascertain visuospatial and perceptual abilities (card rotation, cube comparisons and map planning tests).
Each participant will provide baseline information prior to participation i) age ii) gender iii) handedness iv) Years since graduating from medical school v) number or estimated number of previously performed ultrasound-guided interventional procedures including securing vascular access vi) courses/workshops in ultrasound-guided procedural interventions.
All participants will receive a standard learning in the form of i) a one hour didactic lecture delivered by a single investigator which outlines basic sonographic anatomy, ultrasound physics and anatomy relevant to performing ultrasound-guided axillary brachial plexus block.
Within 24 hours of completing the learning phase, participants will be asked to perform ultrasonography of left axilla of a volunteer. This will be followed by either feedback A or feedback B (based on random allocation). Feedback will terminal, summative and commence five minutes after each participant completed the tasks.
Task description:
- Participant perform ultrasonography of left axilla and adjacent upper limb as if preparing to perform ultrasound-guided axillary brachial plexus block
- Participant identify the four terminal branches of the brachial plexus; identify each on the screen by using the pointer provided (or freeze image and use arrow on the screen) and name each verbally.
- Participant identify the adjacent structures/vessels relevant to the block by indicating them individually using the pointer provided (or freeze image and use arrow on the screen) and name each verbally.
- Once participant have obtained an optimal ultrasound image, participant is requested to indicate the intended needle insertion point on the skin using the pointer provided.
Participants will be provided with an opportunity to practice performing the tasks for up to 30 minutes. Within one hour of completing the feedback session, participants will be asked to attempt the same tasks again. Performance before and after feedback delivered will be video-recorded according to a predefined protocol by a trained investigator. Imaging will be obtained by an investigator using a handheld camera. Concurrent ultrasound video images will be recorded using the Digital Video Recorder (DVR) feature of the Ultrasonics Tablet (Sonix Design Centre, B.K Ultrasound, Richmond, Canada). All video recordings will be edited using a video editing software (Apple Movie, version 10.0.5, Apple Computer Inc. USA) to present the procedure together with the ultrasound output on one screen
Types of Feedback:
- Feedback A: Standard feedback; a consultant anesthetists will be asked to give feedback as would normally give during performance of such a task in a clinical situation. ii. Feedback B: Structured feedback; a trained investigator will give feedback according to a set of metrics and errors previously developed and validated. Trainees will undergo deliberate practice on the volunteer until they demonstrate adequate and objective performance as assessed by the set of metrics and errors provided.
Video assessment and scoring:
Two trained, independent and blinded assessors will score the video recordings for a set of metrics and errors previously developed and validated. The number of steps completed and errors committed will be compared for i) Group defined by preceding type of feedback, ii) Pre versus post for each feedback session
- Conditions
- Simulation Training
- Being tested
- metric-based feedback training
- Keywords
- metrics, feedback, ultrasound-guided, procedural skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metric-based feedback trainingOther
Structured feedback; a trained investigator will give feedback according to a set of metrics and errors previously developed and validated. Trainees will undergo deliberate practice on the volunteer until they demonstrate adequate and objective performance as assessed by the set of metrics and errors provided.
| Study group | Role | What they receive |
|---|---|---|
| feedback group | Other | this group will receive the intervention "metric-based feedback training" on their performance. this will be based on validated metrics and errors, a trained investigator will deliver this feedback. It will be accompanied by deliberate practice Receives: Other: metric-based feedback training |
| control group | No intervention | this control group will receive a standard type feedback on their performance "no intervention". It will be delivered by a consultant anaesthetist who will be instructed to deliver feedback as they ordinarily do during their clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of steps completed and number of errors committed
Measured: through study completion, an average of one year
Secondary outcomes (1)
scanning time
time elapsed from placement of ultrasound probe on volunteer to the time of identification of needle insertion point
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Declan O'Donnell, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976623
- Sponsor's protocol ID
- ECM 4 (f) 19/01/16
- Status last verified
- May 2017
- First submitted
- 11 Nov 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metric-based Feedback Training on Acquisition of Sonographic Skills Relevant to Performance of Ultrasound Guided Axillary Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02976623
- Acronym / sponsor ID
- ECM 4 (f) 19/01/16
- Conditions
- Simulation Training
- Keywords
- metrics, feedback, ultrasound-guided, procedural skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Nov 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 hypothesized that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills.
The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided axillary brachial plexus block.
Detailed description
The use of ultrasound guidance during performance of peripheral nerve blocks improves success rate, shortens performance time and reduces the risk of inadvertent vascular puncture. Safe and effective procedure performance requires the operator to make a series of real-time, high stakes decisions relevant to interpretation of sonographic anatomy and subsequent nerve visualization, needle-to-nerve guidance, needle-to-nerves approximation and local anesthetic deposition. Teaching novices to perform ultrasound-guided nerve blocks should include rendering and assessment of its component skills such as interpretation of sonographic anatomy, consistent needle imaging and correct placement of local anesthetics. Learning and teaching ultrasound-related motor skills is challenging within the current landscape of medical and training education. Simulated learning has been advocated as it can facilitate deliberate practice as opposed to repeated practice. Simulation and e-learning are flexible training modalities, which facilitate procedural skills rehearsal in a safe environment, free from risk to patients, and permitting real time feedback. Deliberate practice with feedback in a simulated environment may accelerate the rate of skill acquisition. Feedback is a predictor of effective learning and a useful tool for novices learning new skill. However summative feedback is superior to concurrent feedback for procedural skill acquisition during simulated but not clinical training and for skill retention. The characteristics of feedback, which influence its effect on learning, include timing, content, who initiates (elicits) it and the format and motivation applied to its delivery. Feedback positively influences skill acquisition by novice learners. How trainees adopt objective versus subjective feedback remained largely undetermined. The investigators hypothesize that feedback based on previously developed and validated metrics will improve novices' learning of procedural skills.
The objective of this study was to determine the effect of a structured, objective and terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided axillary brachial plexus block.
Methods:
With institutional ethical approval and having obtained written informed consent from each, 12 anesthesia trainees will be invited to participate in this prospective, randomized and blinded study.
Inclusion criteria:
- trainees in the Irish national anesthesia training program allocated to Cork teaching hospital (CUH) ii. have performed no more than 5 ultrasound-guided peripheral nerve blocks at the time of participation.
Each participant will answer tests to ascertain visuospatial and perceptual abilities (card rotation, cube comparisons and map planning tests).
Each participant will provide baseline information prior to participation i) age ii) gender iii) handedness iv) Years since graduating from medical school v) number or estimated number of previously performed ultrasound-guided interventional procedures including securing vascular access vi) courses/workshops in ultrasound-guided procedural interventions.
All participants will receive a standard learning in the form of i) a one hour didactic lecture delivered by a single investigator which outlines basic sonographic anatomy, ultrasound physics and anatomy relevant to performing ultrasound-guided axillary brachial plexus block.
Within 24 hours of completing the learning phase, participants will be asked to perform ultrasonography of left axilla of a volunteer. This will be followed by either feedback A or feedback B (based on random allocation). Feedback will terminal, summative and commence five minutes after each participant completed the tasks.
Task description:
- Participant perform ultrasonography of left axilla and adjacent upper limb as if preparing to perform ultrasound-guided axillary brachial plexus block
- Participant identify the four terminal branches of the brachial plexus; identify each on the screen by using the pointer provided (or freeze image and use arrow on the screen) and name each verbally.
- Participant identify the adjacent structures/vessels relevant to the block by indicating them individually using the pointer provided (or freeze image and use arrow on the screen) and name each verbally.
- Once participant have obtained an optimal ultrasound image, participant is requested to indicate the intended needle insertion point on the skin using the pointer provided.
Participants will be provided with an opportunity to practice performing the tasks for up to 30 minutes. Within one hour of completing the feedback session, participants will be asked to attempt the same tasks again. Performance before and after feedback delivered will be video-recorded according to a predefined protocol by a trained investigator. Imaging will be obtained by an investigator using a handheld camera. Concurrent ultrasound video images will be recorded using the Digital Video Recorder (DVR) feature of the Ultrasonics Tablet (Sonix Design Centre, B.K Ultrasound, Richmond, Canada). All video recordings will be edited using a video editing software (Apple Movie, version 10.0.5, Apple Computer Inc. USA) to present the procedure together with the ultrasound output on one screen
Types of Feedback:
- Feedback A: Standard feedback; a consultant anesthetists will be asked to give feedback as would normally give during performance of such a task in a clinical situation. ii. Feedback B: Structured feedback; a trained investigator will give feedback according to a set of metrics and errors previously developed and validated. Trainees will undergo deliberate practice on the volunteer until they demonstrate adequate and objective performance as assessed by the set of metrics and errors provided.
Video assessment and scoring:
Two trained, independent and blinded assessors will score the video recordings for a set of metrics and errors previously developed and validated. The number of steps completed and errors committed will be compared for i) Group defined by preceding type of feedback, ii) Pre versus post for each feedback session
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| feedback group | Other | Other: metric-based feedback trainingthis group will receive the intervention "metric-based feedback training" on their performance. this will be based on validated metrics and errors, a trained investigator will deliver this feedback. It will be accompanied by deliberate practice |
| control group | No intervention | –this control group will receive a standard type feedback on their performance "no intervention". It will be delivered by a consultant anaesthetist who will be instructed to deliver feedback as they ordinarily do during their clinical practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Anaesthesia trainees in the first two years of training at Cork University Hospital
- having performed no more than 5 ultrasound-guided peripheral nerve blocks
Key exclusion criteria (2 listed)
- refusal to consent
- have performed more than 5 ultrasound-guided peripheral nerve blocks
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 |
|---|---|---|
| metric-based feedback trainingStructured feedback; a trained investigator will give feedback according to a set of metrics and errors previously developed and validated. Trainees will undergo deliberate practice on the volunteer until they demonstrate adequate and objective performance as assessed by the set of metrics and errors provided. | Other | feedback group |
Primary outcome
number of steps completed and number of errors committed
Time frame: through study completion, an average of one year
1 secondary outcome
scanning time
Time frame: through study completion, an average of one year
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 9 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metric-based feedback training in people with Simulation Training, run by University College Cork at 1 site in Ireland.
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 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 9 May 2017. 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 Ireland. 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?
number of steps completed and number of errors committed (time frame: through study completion, an average of one year). 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 9 May 2017.