<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/NCT01667198</url>
  </required_header>
  <id_info>
    <org_study_id>IP2010016270</org_study_id>
    <nct_id>NCT01667198</nct_id>
  </id_info>
  <brief_title>Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators</brief_title>
  <official_title>Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Sklodowska-Curie National Research Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre of Postgraduate Medical Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gloucestershire Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Science and Higher Education, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maria Sklodowska-Curie National Research Institute of Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Professional societies recommend that endoscopists measure their ceacal intubation rate,&#xD;
      adenoma detection rate as indicators of the screening colonoscopy quality. However, it is&#xD;
      uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in&#xD;
      the detection of adenomas. The investigators hypothesize that a hands-on-training&#xD;
      intervention tailored to the results of environmental assessment and audit on colonoscopy&#xD;
      quality indicators results in higher adenoma detection rate improvement than simple audit and&#xD;
      feedback. The investigators further hypothesize that by training the leaders of the screening&#xD;
      centres, the effect of the intervention will be further disseminated among other endoscopists&#xD;
      from the participating centers, and will thus result in additional increase in individual&#xD;
      adenoma detection rate.&#xD;
&#xD;
      The primary aim is to compare the impact on adenoma detection rate of two screening&#xD;
      colonoscopy improvement programs:&#xD;
&#xD;
        1. Tailored training intervention.&#xD;
&#xD;
        2. Audit feedback on colonoscopy quality indicators.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Screening centre leader's adenoma detection rate</measure>
    <time_frame>till the end of calendar year after the training intervention</time_frame>
    <description>Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screening center's overall adenoma detection rate</measure>
    <time_frame>Till the end of calendar year after the training intervention</time_frame>
    <description>Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening centre leader's proximal and distal adenoma detection rate</measure>
    <time_frame>Till the end of calendar year after the training intervention</time_frame>
    <description>Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening centre's non-polypoid lesion detection rate</measure>
    <time_frame>Till the end of calendar year after the training intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall screening centre's ceacal intubation rate</measure>
    <time_frame>Till the end of calendar year after the training intervention</time_frame>
    <description>Ceacal intubation is defined as the passage of the colonoscope tip to a point proximal to the ileoceacal valve and visualization of the entire ceacum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening centre leader's withdrawal technique</measure>
    <time_frame>Till the end of calendar year after the training intervention</time_frame>
    <description>Withdrawal technique assessed by a trained endoscopy nurse</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Train the leaders course</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Audit and feedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Train the leaders course</intervention_name>
    <description>Screening centre leaders randomized to the training intervention group will be invited to take part in a train-the-leaders course. The Train-the-leaders course will consist of three phases: (i) pre-training assessment, (ii) hands-on-training and (iii) post-training evaluation and feedback. The Train-the-leaders course will be run in polish by the team from the Maria Sklodowska-Curie Memorial Cancer Center and Institute on Oncology, Warsaw, which was trained in delivering such intervention by experts from the United Kingdom.</description>
    <arm_group_label>Train the leaders course</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Audit and feedback</intervention_name>
    <description>Screening centre leaders randomized to the feedback group will receive (by e-mail and conventional mail) feedback on their individual screening colonoscopy quality indicators (adenoma detection rate and ceacal intubation rate) measured for the 2011 edition of the national screening program. The results will be presented in a league table in order to enable comparison with anonymous results of all endoscopists who performed at least 30 colonoscopies within the screening program. In addition, a link to a webpage containing data on individual and overall colonoscopy quality indicators over the last four years of the screening program will be provided.</description>
    <arm_group_label>Audit and feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  screening center leading colonoscopist&#xD;
&#xD;
          -  at least 30 screening colonoscopies in the 2011 edition of the screening program&#xD;
&#xD;
          -  adenoma detection rate lower than 25%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of participation in the 2012 edition of the screening program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michal F. Kaminski, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaroslaw Regula, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology</name>
      <address>
        <city>Warsaw</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>April 15, 2014</last_update_submitted>
  <last_update_submitted_qc>April 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT01667198
org study id: IP2010016270
nct id: NCT01667198
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Professional societies recommend that endoscopists measure their ceacal intubation rate,
      adenoma detection rate as indicators of the screening colonoscopy quality. However, it is
      uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in
      the detection of adenomas. The investigators hypothesize that a hands-on-training
      intervention tailored to the results of environmental assessment and audit on colonoscopy
      quality indicators results in higher adenoma detection rate improvement than simple audit and
      feedback. The investigators further hypothesize that by training the leaders of the screening
      centres, the effect of the intervention will be further disseminated among other endoscopists
      from the participating centers, and will thus result in additional increase in individual
      adenoma detection rate.

      The primary aim is to compare the impact on adenoma detection rate of two screening
      colonoscopy improvement programs:

        1. Tailored training intervention.

        2. Audit feedback on colonoscopy quality indicators.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Screening centre leader's adenoma detection rate
time frame: till the end of calendar year after the training intervention
description: Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
measure: Screening center's overall adenoma detection rate
time frame: Till the end of calendar year after the training intervention
description: Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
measure: Screening centre leader's proximal and distal adenoma detection rate
time frame: Till the end of calendar year after the training intervention
description: Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
measure: Screening centre's non-polypoid lesion detection rate
time frame: Till the end of calendar year after the training intervention
measure: Overall screening centre's ceacal intubation rate
time frame: Till the end of calendar year after the training intervention
description: Ceacal intubation is defined as the passage of the colonoscope tip to a point proximal to the ileoceacal valve and visualization of the entire ceacum.
measure: Screening centre leader's withdrawal technique
time frame: Till the end of calendar year after the training intervention
description: Withdrawal technique assessed by a trained endoscopy nurse
arm group label: Train the leaders course
arm group type: Experimental
arm group label: Audit and feedback
arm group type: Active Comparator
intervention type: Procedure
intervention name: Train the leaders course
description: Screening centre leaders randomized to the training intervention group will be invited to take part in a train-the-leaders course. The Train-the-leaders course will consist of three phases: (i) pre-training assessment, (ii) hands-on-training and (iii) post-training evaluation and feedback. The Train-the-leaders course will be run in polish by the team from the Maria Sklodowska-Curie Memorial Cancer Center and Institute on Oncology, Warsaw, which was trained in delivering such intervention by experts from the United Kingdom.
arm group label: Train the leaders course
intervention type: Behavioral
intervention name: Audit and feedback
description: Screening centre leaders randomized to the feedback group will receive (by e-mail and conventional mail) feedback on their individual screening colonoscopy quality indicators (adenoma detection rate and ceacal intubation rate) measured for the 2011 edition of the national screening program. The results will be presented in a league table in order to enable comparison with anonymous results of all endoscopists who performed at least 30 colonoscopies within the screening program. In addition, a link to a webpage containing data on individual and overall colonoscopy quality indicators over the last four years of the screening program will be provided.
arm group label: Audit and feedback
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michal F. Kaminski, MD, PhD
role: Principal Investigator
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
last name: Jaroslaw Regula, MD, PhD
role: Study Chair
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Colorectal Neoplasms