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

This study has been completed.
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: April 15, 2014
Last verified: April 2014

August 14, 2012
April 15, 2014
July 2012
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01667198 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators
Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Colorectal Cancer
  • 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.
  • 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.
  • Experimental: Train the leaders course
    Intervention: Procedure: Train the leaders course
  • Active Comparator: Audit and feedback
    Intervention: Behavioral: Audit and feedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01667198
IP2010016270
No
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
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
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
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP