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NCT Number: NCT01667198

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Train the leaders course

Procedure

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.

Audit and Feedback

Behavioral

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.

Primary outcomes

  1. Screening centre leader's adenoma detection rate

    Time frame: till the end of calendar year after the training intervention

    Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.

Secondary outcomes

  1. Screening center's overall adenoma detection rate

    Time frame: Till the end of calendar year after the training intervention

    Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.

  2. Screening centre leader's proximal and distal adenoma detection rate

    Time frame: Till the end of calendar year after the training intervention

    Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.

  3. Screening centre's non-polypoid lesion detection rate

    Time frame: Till the end of calendar year after the training intervention

  4. Overall screening centre's ceacal intubation rate

    Time frame: Till the end of calendar year after the training intervention

    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.

  5. Screening centre leader's withdrawal technique

    Time frame: Till the end of calendar year after the training intervention

    Withdrawal technique assessed by a trained endoscopy nurse

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Centre of Postgraduate Medical Education
  • Erasmus Medical Center
  • Gloucestershire Hospitals NHS Foundation Trust
  • Ministry of Science and Higher Education, Poland
  • University of Oslo

Registry information

Official study title

Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2012
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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