<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/NCT02185079</url>
  </required_header>
  <id_info>
    <org_study_id>ECM4(i)06/05/2014</org_study_id>
    <nct_id>NCT02185079</nct_id>
  </id_info>
  <brief_title>The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia</brief_title>
  <official_title>The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia on Clinical Performance and Clinical Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cork University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cork University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Procedural skills are an important determinant of clinical outcomes for certain patient&#xD;
      groups. Training for procedural skills in the medical profession is still largely based on an&#xD;
      apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by&#xD;
      &quot;practicing&quot; on patients under direct supervision by seniors (consultants or senior&#xD;
      registrars/residents). Learning a complex and high risk procedural skill on patients is not&#xD;
      ideal.&#xD;
&#xD;
      As medical training moves from apprentice based to competency based training along and as for&#xD;
      the number of clinical learning opportunities for trainees is less, it is necessary to&#xD;
      develop a comprehensive training programme which enables effective and efficient learning&#xD;
      without compromising on patient safety. Metrics-based performance based progression has shown&#xD;
      to improve clinical performance not only in novices but also in experts.&#xD;
&#xD;
      We envisage a standard methodology which could address the deficiencies in procedural&#xD;
      training currently. This would entail development and validation of a set of metrics for a&#xD;
      particular procedure, evaluation of a proficiency based progression training programme based&#xD;
      on those metrics to and demonstration of improved clinical performance and clinical outcome&#xD;
      associated with that programme. Although elements of this &quot;end -end&quot; approach have been&#xD;
      demonstrated previously for various procedures, we propose to apply this methodology in its&#xD;
      entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To&#xD;
      date we have developed and are validating a set of metrics for this procedure. Proficiency&#xD;
      based training leading to better procedural skills leading to better patient outcomes has not&#xD;
      been studied so far. Epidural analgesia during labor lends itself as an excellent model for&#xD;
      evaluating the whole process. It has a specific procedural skill which is closely linked to&#xD;
      patient outcome which is measurable and occurs in finite time interval.&#xD;
&#xD;
      The hypothesis of the study is that in novice anaesthetic trainees, training with metrics&#xD;
      based performance based progression in addition to improving the clinical performance will&#xD;
      also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved&#xD;
      by conventional training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, randomized, double blind control study. Ethical committee&#xD;
      approval and consent from both participating anaesthetist and patients will be obtained.&#xD;
&#xD;
      Trainees will be recruited from Cork University Hospital. Anaesthetic trainees with less than&#xD;
      2 years of experience in anaesthesia and who has performed less than 50 epidurals in the&#xD;
      preceding 2 years (not limited to labor epidurals) will be requested to participate in the&#xD;
      study.&#xD;
&#xD;
      The trainees will be randomized in to group 1 and group 2. In group 1, standardized&#xD;
      conventional teaching and training for labor epidural analgesia will be used. In group 2,&#xD;
      they will be trained by metrics based simulation to predetermined level of proficiency. Each&#xD;
      trainee will then perform 10 labor epidural catheter insertions and the procedures will be&#xD;
      video recorded with patients consent.&#xD;
&#xD;
      Observers blinded to the groups will be used for the data collection, outcome assessment and&#xD;
      analysis. Failure rate of epidural will be assessed based on the occurrence of one or more of&#xD;
      the following events,&#xD;
&#xD;
        1. Inadequate analgesia at 45 minutes from start of epidural needle placement.&#xD;
&#xD;
        2. Resiting epidural or abandoning the procedure.&#xD;
&#xD;
        3. Accidental Dural puncture.&#xD;
&#xD;
        4. Supervisor take over. The primary end point of the study is to compare difference in&#xD;
           epidural failure rates between the two groups. Secondary end point will include&#xD;
           assessment of clinical performance using metrics based assessment by two blinded&#xD;
           reviewers based on video recordings and patient satisfaction with epidural analgesia. In&#xD;
           addition to demographic data of the patients, duration of labor, cervical dilation at&#xD;
           the time of insertion of the catheter, length of catheter inserted, time of insertion of&#xD;
           catheter, experience of the operator and position of the patient during epidural&#xD;
           placement will be noted. Age, sex and anaesthesia experience of the trainees will also&#xD;
           be collected.&#xD;
&#xD;
      The estimated labor epidural failure rates for year 1 trainees is 25%.6 We hope to reduce the&#xD;
      failure rate in interventional group to 5%. 48 procedures per group will be sufficient to&#xD;
      show a statistically significant difference between the groups with p value of 0.05% and&#xD;
      power of 80%. To allow for dropouts, 8 trainees per group will be recruited and each will&#xD;
      perform 10 procedures making it a total of 80 procedures per group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Epidural failure rate</measure>
    <time_frame>within 48 hours after completion of epidural</time_frame>
    <description>Failure rate of epidural will be assessed based on the occurrence of one or more of the following events,&#xD;
Inadequate analgesia at 45 minutes from start of epidural needle placement.&#xD;
Resiting epidural or abandoning the procedure.&#xD;
Accidental Dural puncture.&#xD;
Supervisor take over.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>assessment of clinical performance using metrics based assessment</measure>
    <time_frame>within 36 months after aquiring the video of epidrual catheter insertion procedure</time_frame>
    <description>assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction with epidural analgesia</measure>
    <time_frame>within 48 hours of completion of insertion of labor epidural catheter</time_frame>
    <description>Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be subjected to training to proficiency based on the metrics developed for labor epidural catheter placement in a epidural simulator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training to proficiency</intervention_name>
    <description>Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be trained to proficience based on the metrics developed for labor epidural catheter placement in a epidural simulator.</description>
    <arm_group_label>Group M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional training</intervention_name>
    <description>Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has&#xD;
             performed less than 50 epidurals in the preceding 2 years (not limited to labor&#xD;
             epidurals) will be requested to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No tmeeting inclusion criteria&#xD;
&#xD;
          -  Not consenting for study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cork University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cork University Hospital</name>
      <address>
        <city>Cork,Ireland</city>
        <state>Cork</state>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cork University Hospital</investigator_affiliation>
    <investigator_full_name>Karthikeyan Kallidaikurichi Srinivasan</investigator_full_name>
    <investigator_title>Specialist Registrar,Anaesthetics,Cork University Hospital</investigator_title>
  </responsible_party>
  <keyword>labor</keyword>
  <keyword>epidural</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02185079
org study id: ECM4(i)06/05/2014
nct id: NCT02185079
lead sponsor: 
has dmc: No
Procedural skills are an important determinant of clinical outcomes for certain patient
      groups. Training for procedural skills in the medical profession is still largely based on an
      apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by
      "practicing" on patients under direct supervision by seniors (consultants or senior
      registrars/residents). Learning a complex and high risk procedural skill on patients is not
      ideal.

      As medical training moves from apprentice based to competency based training along and as for
      the number of clinical learning opportunities for trainees is less, it is necessary to
      develop a comprehensive training programme which enables effective and efficient learning
      without compromising on patient safety. Metrics-based performance based progression has shown
      to improve clinical performance not only in novices but also in experts.

      We envisage a standard methodology which could address the deficiencies in procedural
      training currently. This would entail development and validation of a set of metrics for a
      particular procedure, evaluation of a proficiency based progression training programme based
      on those metrics to and demonstration of improved clinical performance and clinical outcome
      associated with that programme. Although elements of this "end -end" approach have been
      demonstrated previously for various procedures, we propose to apply this methodology in its
      entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To
      date we have developed and are validating a set of metrics for this procedure. Proficiency
      based training leading to better procedural skills leading to better patient outcomes has not
      been studied so far. Epidural analgesia during labor lends itself as an excellent model for
      evaluating the whole process. It has a specific procedural skill which is closely linked to
      patient outcome which is measurable and occurs in finite time interval.

      The hypothesis of the study is that in novice anaesthetic trainees, training with metrics
      based performance based progression in addition to improving the clinical performance will
      also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved
      by conventional training.
This will be a prospective, randomized, double blind control study. Ethical committee
      approval and consent from both participating anaesthetist and patients will be obtained.

      Trainees will be recruited from Cork University Hospital. Anaesthetic trainees with less than
      2 years of experience in anaesthesia and who has performed less than 50 epidurals in the
      preceding 2 years (not limited to labor epidurals) will be requested to participate in the
      study.

      The trainees will be randomized in to group 1 and group 2. In group 1, standardized
      conventional teaching and training for labor epidural analgesia will be used. In group 2,
      they will be trained by metrics based simulation to predetermined level of proficiency. Each
      trainee will then perform 10 labor epidural catheter insertions and the procedures will be
      video recorded with patients consent.

      Observers blinded to the groups will be used for the data collection, outcome assessment and
      analysis. Failure rate of epidural will be assessed based on the occurrence of one or more of
      the following events,

        1. Inadequate analgesia at 45 minutes from start of epidural needle placement.

        2. Resiting epidural or abandoning the procedure.

        3. Accidental Dural puncture.

        4. Supervisor take over. The primary end point of the study is to compare difference in
           epidural failure rates between the two groups. Secondary end point will include
           assessment of clinical performance using metrics based assessment by two blinded
           reviewers based on video recordings and patient satisfaction with epidural analgesia. In
           addition to demographic data of the patients, duration of labor, cervical dilation at
           the time of insertion of the catheter, length of catheter inserted, time of insertion of
           catheter, experience of the operator and position of the patient during epidural
           placement will be noted. Age, sex and anaesthesia experience of the trainees will also
           be collected.

      The estimated labor epidural failure rates for year 1 trainees is 25%.6 We hope to reduce the
      failure rate in interventional group to 5%. 48 procedures per group will be sufficient to
      show a statistically significant difference between the groups with p value of 0.05% and
      power of 80%. To allow for dropouts, 8 trainees per group will be recruited and each will
      perform 10 procedures making it a total of 80 procedures per group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Epidural failure rate
time frame: within 48 hours after completion of epidural
description: Failure rate of epidural will be assessed based on the occurrence of one or more of the following events,
Inadequate analgesia at 45 minutes from start of epidural needle placement.
Resiting epidural or abandoning the procedure.
Accidental Dural puncture.
Supervisor take over.
measure: assessment of clinical performance using metrics based assessment
time frame: within 36 months after aquiring the video of epidrual catheter insertion procedure
description: assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings
measure: patient satisfaction with epidural analgesia
time frame: within 48 hours of completion of insertion of labor epidural catheter
description: Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text
arm group label: Group C
arm group type: Active Comparator
description: Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
arm group label: Group M
arm group type: Experimental
description: Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be subjected to training to proficiency based on the metrics developed for labor epidural catheter placement in a epidural simulator.
intervention type: Behavioral
intervention name: Training to proficiency
description: Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be trained to proficience based on the metrics developed for labor epidural catheter placement in a epidural simulator.
arm group label: Group M
intervention type: Behavioral
intervention name: Conventional training
description: Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
arm group label: Group C
criteria: 
gender: All
minimum age: 23 Years
maximum age: 60 Years
healthy volunteers: No
last name: Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD
role: Principal Investigator
affiliation: Cork University Hospital
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Cork University Hospital
investigator full name: Karthikeyan Kallidaikurichi Srinivasan
investigator title: Specialist Registrar,Anaesthetics,Cork University Hospital
mesh term: Labor Pain