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Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators

This study is currently recruiting participants.
Verified August 2012 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Sponsor:
Collaborators:
Medical Centre of Postgraduate Education, Poland
Gloucestershire Hospitals NHS Foundation Trust
University of Oslo
Erasmus Medical Center
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01667198
First received: August 14, 2012
Last updated: November 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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.

Condition Intervention
Colorectal Cancer
 Procedure: Train the leaders course
Behavioral: Audit and feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • Screening centre leader's adenoma detection rate [ Time Frame: till the end of calendar year after the training intervention ] [ Designated as safety issue: No ]
    Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.


Secondary Outcome Measures:
  • Screening center's overall adenoma detection rate [ Time Frame: Till the end of calendar year after the training intervention ] [ Designated as safety issue: No ]
    Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.

  • Screening centre leader's proximal and distal adenoma detection rate [ Time Frame: Till the end of calendar year after the training intervention ] [ Designated as safety issue: No ]
    Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.

  • Screening centre's non-polypoid lesion detection rate [ Time Frame: Till the end of calendar year after the training intervention ] [ Designated as safety issue: No ]
  • Overall screening centre's ceacal intubation rate [ Time Frame: Till the end of calendar year after the training intervention ] [ Designated as safety issue: No ]
    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.

  • Screening centre leader's withdrawal technique [ Time Frame: Till the end of calendar year after the training intervention ] [ Designated as safety issue: No ]
    Withdrawal technique assessed by a trained endoscopy nurse


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Train the leaders course Procedure: Train the leaders course
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.
Active Comparator: Audit and feedback Behavioral: Audit and feedback
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • screening center leading colonoscopist
  • at least 30 screening colonoscopies in the 2011 edition of the screening program
  • adenoma detection rate lower than 25%

Exclusion Criteria:

  • lack of participation in the 2012 edition of the screening program
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667198

Contacts
Contact: Michal F. Kaminski, MD, PhD +48225463058 mfkaminski@coi.waw.pl

Locations
Poland
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Recruiting
Warsaw, Poland, 02-781
Contact: Michal F. Kaminski, MD, PhD     +48225463058     mfkaminski@coi.waw.pl    
Principal Investigator: Michal F. Kaminski, MD, PhD            
Sub-Investigator: Jaroslaw Regula, MD, PhD            
Sub-Investigator: Maciej Rupinski, MD, PhD            
Sub-Investigator: Ewa Wronska, MD, PhD            
Sub-Investigator: Jacek Pachlewski, MD, PhD            
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Medical Centre of Postgraduate Education, Poland
Gloucestershire Hospitals NHS Foundation Trust
University of Oslo
Erasmus Medical Center
Ministry of Science and Higher Education, Poland
Investigators
Principal Investigator: Michal F. Kaminski, MD, PhD The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Study Chair: Jaroslaw Regula, MD, PhD The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01667198     History of Changes
Other Study ID Numbers: IP2010016270
Study First Received: August 14, 2012
Last Updated: November 13, 2012
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013