<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/NCT02986217</url>
  </required_header>
  <id_info>
    <org_study_id>101614</org_study_id>
    <nct_id>NCT02986217</nct_id>
  </id_info>
  <brief_title>The Effect of Structured Feedback on Live Surgical Performance</brief_title>
  <acronym>CSATS</acronym>
  <official_title>The Effect of Structured Feedback on Live Surgical Performance: A Single-Blind Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to establish the effect of regular structured feedback on surgical&#xD;
      performance using crowd sourced video assessments with validated objective performance scores&#xD;
      and time to complete a specific surgical procedure through a randomized controlled trial. The&#xD;
      working hypothesis is that regular structured assessment will lead to a greater measurable&#xD;
      improvement in performance, as defined by objective performance scores, than will traditional&#xD;
      feedback methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The American Association of Gynecologic Laparoscopists (AAGL) and Accreditation Council of&#xD;
      Graduate Medical Education (ACGME) have endeavored to implement structure and standardization&#xD;
      for the fellowship in minimally invasive gynecologic surgical programs (FMIGS) and obstetric&#xD;
      and gynecology residency programs respectively. Educational objectives are explicitly&#xD;
      delineated. Though the fellowship and residency educational objectives are well rounded, and&#xD;
      include the development of skills to become leaders and educators in the field of minimally&#xD;
      invasive gynecologic surgery (MIGS) and general obstetrics and gynecology, one of the main&#xD;
      objective of the fellowship and residency training is the attainment of surgical skill. This&#xD;
      is ensured by a requirement for a breadth of surgical exposure including vaginal surgery,&#xD;
      hysteroscopy, traditional laparoscopy, management of surgical complications, minimally&#xD;
      invasive hysterectomy, urogynecologic procedures, gastrointestinal surgery, urinary tract&#xD;
      surgery, reproductive surgery, and the surgical management of common gynecologic conditions&#xD;
      such as endometriosis. Minimum case requirements have been implemented to provide guidance&#xD;
      for FMIGS and residency programs. In addition, trainees are required to log surgical cases&#xD;
      and this information is utilized for FMIGS and residency program site inspections as well as&#xD;
      for feedback of surgical competency. Despite standardization efforts by the AAGL and ACGME,&#xD;
      the FMIGS and obstetric and gynecology residency curriculums are still in evolution. There is&#xD;
      likely still great variation in surgical exposure between programs. In addition, though&#xD;
      regular feedback is a requirement of training programs, the process is likely unstructured&#xD;
      and subjective; based on case logs, self-assessments, and feedback by faculty surgeons. There&#xD;
      is thus a critical need to develop a standardized, objective, timely, and actionable feedback&#xD;
      methodology to facilitate program oversight and ensure FMIGS fellows and obstetrics and&#xD;
      gynecology residents are achieving surgical competency throughout their training. In the&#xD;
      absence of such structured feedback models, it will remain difficult to optimize FMIGS&#xD;
      fellowship and obstetrics and gynecology resident training, and provide objective&#xD;
      measurements of the impact of such training on surgical performance and patient outcomes. .&#xD;
&#xD;
      The long-term goal of this study is to assist in developing methods for surgical assessment&#xD;
      that facilitate program oversight, allow fellows, residents, and program directors to&#xD;
      identify specific skill sets in need of improvement, monitor progress in skill acquisition,&#xD;
      and clearly and objectively document achievement of milestones throughout training. The&#xD;
      study's overall objective is to determine how consistent structured feedback using crowd&#xD;
      sourcing impacts time to complete a task as well as surgical performance as measured by GOALS&#xD;
      and GEARS scores. The central hypothesis is that fellows and residents who receive consistent&#xD;
      structured feedback over a sustained period of time will have shorter task times, overall&#xD;
      improved performance, and greater satisfaction than fellows and residents receiving&#xD;
      traditional feedback. The rationale for this work is that it will provide focus and&#xD;
      supportive data for large-scale studies of surgical skill acquisition and development.&#xD;
&#xD;
      This study seeks to establish the effect of regular structured feedback on surgical&#xD;
      performance using crowd sourced video assessments with GOALS and GEARS through a randomized&#xD;
      controlled trial. The study hypothesizes regular structured assessment will lead to a greater&#xD;
      measurable improvement in performance, as defined by change and GOALS and GEARS scores, than&#xD;
      will traditional feedback methods as well as time to complete a specific procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI Left institution and did not transfer study to another PI&#xD;
  </why_stopped>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>difference in mean time needed to perform cuff closure during hysterectomy</measure>
    <time_frame>6 weeks post study enrollment</time_frame>
    <description>The difference in mean time (measured in minutes) needed to perform vaginal cuff closure during hysterectomy between subjects in the control versus experimental groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>difference in mean surgical performance score</measure>
    <time_frame>6 weeks post study enrollment</time_frame>
    <description>The difference in mean surgical performance score of a vaginal cuff closure at the time of hysterectomy between participants in the control versus experimental groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>difference in trainee satisfaction with feedback method</measure>
    <time_frame>6 weeks post study enrollment</time_frame>
    <description>the difference in mean satisfaction score between participants in the control versus experimental groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Surgical Education</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the Control Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the control group will receive traditional feedback methods as determined by each participant's training program. Subjects in the control group will repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the Experimental Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the experimental group will then receive feedback within 5 business days of video submission and repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regular structured assessment of surgical performance</intervention_name>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current position as a resident in obstetrics and gynecology in a year of training&#xD;
             where laparoscopic or robotic hysterectomy is regularly performed -- OR -- FMIGS&#xD;
             Fellow regularly performing laparoscopic or robotic hysterectomy&#xD;
&#xD;
          -  participants must be between 18 and 60 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persons not in a position as a resident in obstetrics and gynecology in a year of&#xD;
             training where laparoscopic or robotic hysterectomy is regularly performed -- OR --&#xD;
             persons not a FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy&#xD;
&#xD;
          -  participants younger than 18 and older than 60 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02986217
org study id: 101614
nct id: NCT02986217
lead sponsor: 
has dmc: No
This study seeks to establish the effect of regular structured feedback on surgical
      performance using crowd sourced video assessments with validated objective performance scores
      and time to complete a specific surgical procedure through a randomized controlled trial. The
      working hypothesis is that regular structured assessment will lead to a greater measurable
      improvement in performance, as defined by objective performance scores, than will traditional
      feedback methods.
The American Association of Gynecologic Laparoscopists (AAGL) and Accreditation Council of
      Graduate Medical Education (ACGME) have endeavored to implement structure and standardization
      for the fellowship in minimally invasive gynecologic surgical programs (FMIGS) and obstetric
      and gynecology residency programs respectively. Educational objectives are explicitly
      delineated. Though the fellowship and residency educational objectives are well rounded, and
      include the development of skills to become leaders and educators in the field of minimally
      invasive gynecologic surgery (MIGS) and general obstetrics and gynecology, one of the main
      objective of the fellowship and residency training is the attainment of surgical skill. This
      is ensured by a requirement for a breadth of surgical exposure including vaginal surgery,
      hysteroscopy, traditional laparoscopy, management of surgical complications, minimally
      invasive hysterectomy, urogynecologic procedures, gastrointestinal surgery, urinary tract
      surgery, reproductive surgery, and the surgical management of common gynecologic conditions
      such as endometriosis. Minimum case requirements have been implemented to provide guidance
      for FMIGS and residency programs. In addition, trainees are required to log surgical cases
      and this information is utilized for FMIGS and residency program site inspections as well as
      for feedback of surgical competency. Despite standardization efforts by the AAGL and ACGME,
      the FMIGS and obstetric and gynecology residency curriculums are still in evolution. There is
      likely still great variation in surgical exposure between programs. In addition, though
      regular feedback is a requirement of training programs, the process is likely unstructured
      and subjective; based on case logs, self-assessments, and feedback by faculty surgeons. There
      is thus a critical need to develop a standardized, objective, timely, and actionable feedback
      methodology to facilitate program oversight and ensure FMIGS fellows and obstetrics and
      gynecology residents are achieving surgical competency throughout their training. In the
      absence of such structured feedback models, it will remain difficult to optimize FMIGS
      fellowship and obstetrics and gynecology resident training, and provide objective
      measurements of the impact of such training on surgical performance and patient outcomes. .

      The long-term goal of this study is to assist in developing methods for surgical assessment
      that facilitate program oversight, allow fellows, residents, and program directors to
      identify specific skill sets in need of improvement, monitor progress in skill acquisition,
      and clearly and objectively document achievement of milestones throughout training. The
      study's overall objective is to determine how consistent structured feedback using crowd
      sourcing impacts time to complete a task as well as surgical performance as measured by GOALS
      and GEARS scores. The central hypothesis is that fellows and residents who receive consistent
      structured feedback over a sustained period of time will have shorter task times, overall
      improved performance, and greater satisfaction than fellows and residents receiving
      traditional feedback. The rationale for this work is that it will provide focus and
      supportive data for large-scale studies of surgical skill acquisition and development.

      This study seeks to establish the effect of regular structured feedback on surgical
      performance using crowd sourced video assessments with GOALS and GEARS through a randomized
      controlled trial. The study hypothesizes regular structured assessment will lead to a greater
      measurable improvement in performance, as defined by change and GOALS and GEARS scores, than
      will traditional feedback methods as well as time to complete a specific procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: difference in mean time needed to perform cuff closure during hysterectomy
time frame: 6 weeks post study enrollment
description: The difference in mean time (measured in minutes) needed to perform vaginal cuff closure during hysterectomy between subjects in the control versus experimental groups.
measure: difference in mean surgical performance score
time frame: 6 weeks post study enrollment
description: The difference in mean surgical performance score of a vaginal cuff closure at the time of hysterectomy between participants in the control versus experimental groups.
measure: difference in trainee satisfaction with feedback method
time frame: 6 weeks post study enrollment
description: the difference in mean satisfaction score between participants in the control versus experimental groups
arm group label: Control Group
arm group type: No Intervention
description: Participants randomized to the Control Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the control group will receive traditional feedback methods as determined by each participant's training program. Subjects in the control group will repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
arm group label: Experimental Group
arm group type: Experimental
description: Participants randomized to the Experimental Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy. Subjects in the experimental group will then receive feedback within 5 business days of video submission and repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles. At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
intervention type: Other
intervention name: regular structured assessment of surgical performance
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: Undecided