<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02976623</url>
  </required_header>
  <id_info>
    <org_study_id>ECM 4 (f) 19/01/16</org_study_id>
    <nct_id>NCT02976623</nct_id>
  </id_info>
  <brief_title>Metric-based Feedback Training for the Acquisition of Sonographic Skills</brief_title>
  <official_title>Effects of Metric-based Feedback Training on Acquisition of Sonographic Skills Relevant to Performance of Ultrasound Guided Axillary Brachial Plexus Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Cork</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College Cork</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that feedback based on previously developed and validated&#xD;
      metrics will improve novices' learning of procedural skills.&#xD;
&#xD;
      The objective of this study was to determine the effect of a structured, objective and&#xD;
      terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided&#xD;
      axillary brachial plexus block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of ultrasound guidance during performance of peripheral nerve blocks improves success&#xD;
      rate, shortens performance time and reduces the risk of inadvertent vascular puncture. Safe&#xD;
      and effective procedure performance requires the operator to make a series of real-time, high&#xD;
      stakes decisions relevant to interpretation of sonographic anatomy and subsequent nerve&#xD;
      visualization, needle-to-nerve guidance, needle-to-nerves approximation and local anesthetic&#xD;
      deposition. Teaching novices to perform ultrasound-guided nerve blocks should include&#xD;
      rendering and assessment of its component skills such as interpretation of sonographic&#xD;
      anatomy, consistent needle imaging and correct placement of local anesthetics. Learning and&#xD;
      teaching ultrasound-related motor skills is challenging within the current landscape of&#xD;
      medical and training education. Simulated learning has been advocated as it can facilitate&#xD;
      deliberate practice as opposed to repeated practice. Simulation and e-learning are flexible&#xD;
      training modalities, which facilitate procedural skills rehearsal in a safe environment, free&#xD;
      from risk to patients, and permitting real time feedback. Deliberate practice with feedback&#xD;
      in a simulated environment may accelerate the rate of skill acquisition. Feedback is a&#xD;
      predictor of effective learning and a useful tool for novices learning new skill. However&#xD;
      summative feedback is superior to concurrent feedback for procedural skill acquisition during&#xD;
      simulated but not clinical training and for skill retention. The characteristics of feedback,&#xD;
      which influence its effect on learning, include timing, content, who initiates (elicits) it&#xD;
      and the format and motivation applied to its delivery. Feedback positively influences skill&#xD;
      acquisition by novice learners. How trainees adopt objective versus subjective feedback&#xD;
      remained largely undetermined. The investigators hypothesize that feedback based on&#xD;
      previously developed and validated metrics will improve novices' learning of procedural&#xD;
      skills.&#xD;
&#xD;
      The objective of this study was to determine the effect of a structured, objective and&#xD;
      terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided&#xD;
      axillary brachial plexus block.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      With institutional ethical approval and having obtained written informed consent from each,&#xD;
      12 anesthesia trainees will be invited to participate in this prospective, randomized and&#xD;
      blinded study.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      i. trainees in the Irish national anesthesia training program allocated to Cork teaching&#xD;
      hospital (CUH) ii. have performed no more than 5 ultrasound-guided peripheral nerve blocks at&#xD;
      the time of participation.&#xD;
&#xD;
      Each participant will answer tests to ascertain visuospatial and perceptual abilities (card&#xD;
      rotation, cube comparisons and map planning tests).&#xD;
&#xD;
      Each participant will provide baseline information prior to participation i) age ii) gender&#xD;
      iii) handedness iv) Years since graduating from medical school v) number or estimated number&#xD;
      of previously performed ultrasound-guided interventional procedures including securing&#xD;
      vascular access vi) courses/workshops in ultrasound-guided procedural interventions.&#xD;
&#xD;
      All participants will receive a standard learning in the form of i) a one hour didactic&#xD;
      lecture delivered by a single investigator which outlines basic sonographic anatomy,&#xD;
      ultrasound physics and anatomy relevant to performing ultrasound-guided axillary brachial&#xD;
      plexus block.&#xD;
&#xD;
      Within 24 hours of completing the learning phase, participants will be asked to perform&#xD;
      ultrasonography of left axilla of a volunteer. This will be followed by either feedback A or&#xD;
      feedback B (based on random allocation). Feedback will terminal, summative and commence five&#xD;
      minutes after each participant completed the tasks.&#xD;
&#xD;
      Task description:&#xD;
&#xD;
        1. Participant perform ultrasonography of left axilla and adjacent upper limb as if&#xD;
           preparing to perform ultrasound-guided axillary brachial plexus block&#xD;
&#xD;
        2. Participant identify the four terminal branches of the brachial plexus; identify each on&#xD;
           the screen by using the pointer provided (or freeze image and use arrow on the screen)&#xD;
           and name each verbally.&#xD;
&#xD;
        3. Participant identify the adjacent structures/vessels relevant to the block by indicating&#xD;
           them individually using the pointer provided (or freeze image and use arrow on the&#xD;
           screen) and name each verbally.&#xD;
&#xD;
        4. Once participant have obtained an optimal ultrasound image, participant is requested to&#xD;
           indicate the intended needle insertion point on the skin using the pointer provided.&#xD;
&#xD;
      Participants will be provided with an opportunity to practice performing the tasks for up to&#xD;
      30 minutes. Within one hour of completing the feedback session, participants will be asked to&#xD;
      attempt the same tasks again. Performance before and after feedback delivered will be&#xD;
      video-recorded according to a predefined protocol by a trained investigator. Imaging will be&#xD;
      obtained by an investigator using a handheld camera. Concurrent ultrasound video images will&#xD;
      be recorded using the Digital Video Recorder (DVR) feature of the Ultrasonics Tablet (Sonix&#xD;
      Design Centre, B.K Ultrasound, Richmond, Canada). All video recordings will be edited using a&#xD;
      video editing software (Apple Movie, version 10.0.5, Apple Computer Inc. USA) to present the&#xD;
      procedure together with the ultrasound output on one screen&#xD;
&#xD;
      Types of Feedback:&#xD;
&#xD;
      i. Feedback A: Standard feedback; a consultant anesthetists will be asked to give feedback as&#xD;
      would normally give during performance of such a task in a clinical situation.&#xD;
&#xD;
      ii. Feedback B: Structured feedback; a trained investigator will give feedback according to a&#xD;
      set of metrics and errors previously developed and validated. Trainees will undergo&#xD;
      deliberate practice on the volunteer until they demonstrate adequate and objective&#xD;
      performance as assessed by the set of metrics and errors provided.&#xD;
&#xD;
      Video assessment and scoring:&#xD;
&#xD;
      Two trained, independent and blinded assessors will score the video recordings for a set of&#xD;
      metrics and errors previously developed and validated. The number of steps completed and&#xD;
      errors committed will be compared for i) Group defined by preceding type of feedback, ii) Pre&#xD;
      versus post for each feedback session&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of steps completed and number of errors committed</measure>
    <time_frame>through study completion, an average of one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>scanning time</measure>
    <time_frame>through study completion, an average of one year</time_frame>
    <description>time elapsed from placement of ultrasound probe on volunteer to the time of identification of needle insertion point</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Simulation Training</condition>
  <arm_group>
    <arm_group_label>feedback group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>this group will receive the intervention &quot;metric-based feedback training&quot; 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this control group will receive a standard type feedback on their performance &quot;no intervention&quot;. It will be delivered by a consultant anaesthetist who will be instructed to deliver feedback as they ordinarily do during their clinical practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>metric-based feedback training</intervention_name>
    <description>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.</description>
    <arm_group_label>feedback group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anaesthesia trainees in the first two years of training at Cork University Hospital&#xD;
&#xD;
          -  having performed no more than 5 ultrasound-guided peripheral nerve blocks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to consent&#xD;
&#xD;
          -  have performed more than 5 ultrasound-guided peripheral nerve blocks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cork University Hospital</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 4, 2017</last_update_submitted>
  <last_update_submitted_qc>May 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Cork</investigator_affiliation>
    <investigator_full_name>Brian Declan O'Donnell</investigator_full_name>
    <investigator_title>Consultant Anaesthetist, Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>metrics</keyword>
  <keyword>feedback</keyword>
  <keyword>ultrasound-guided</keyword>
  <keyword>procedural skills</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02976623
org study id: ECM 4 (f) 19/01/16
nct id: NCT02976623
lead sponsor: 
has dmc: No
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.
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:

      i. 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:

        1. Participant perform ultrasonography of left axilla and adjacent upper limb as if
           preparing to perform ultrasound-guided axillary brachial plexus block

        2. 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.

        3. 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.

        4. 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:

      i. 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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: number of steps completed and number of errors committed
time frame: through study completion, an average of one year
measure: scanning time
time frame: through study completion, an average of one year
description: time elapsed from placement of ultrasound probe on volunteer to the time of identification of needle insertion point
arm group label: feedback group
arm group type: Other
description: 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
arm group label: control group
arm group type: No Intervention
description: 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
intervention type: Other
intervention name: metric-based feedback training
description: 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.
arm group label: feedback group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University College Cork
investigator full name: Brian Declan O'Donnell
investigator title: Consultant Anaesthetist, Senior Lecturer
mesh term: Metronidazole
sharing ipd: No