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

NCT01667198 | Completed

• 1 other identifier: IP2010016270
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Tailored training intervention.
2. 2.Audit feedback on colonoscopy quality indicators.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Screening centre leader's adenoma detection rate

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

  till the end of calendar year after the training intervention

Secondary Outcomes (5)

• Screening center's overall adenoma detection rate

  Till the end of calendar year after the training intervention

• Screening centre leader's proximal and distal adenoma detection rate

  Till the end of calendar year after the training intervention

• Screening centre's non-polypoid lesion detection rate

  Till the end of calendar year after the training intervention

• Overall screening centre's ceacal intubation rate

  Till the end of calendar year after the training intervention

• Screening centre leader's withdrawal technique

  Till the end of calendar year after the training intervention

Study Arms (2)

Train the leaders course

EXPERIMENTAL

Procedure: Train the leaders course

Audit and feedback

ACTIVE COMPARATOR

Behavioral: Audit and feedback

Interventions

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.

Train the leaders course

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.

Audit and feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• lack of participation in the 2012 edition of the screening program

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Centre of Postgraduate Medical Education: collaborator
• Gloucestershire Hospitals NHS Foundation Trust: collaborator
• University of Oslo: collaborator
• Erasmus Medical Center: collaborator
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

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

Warsaw, 02-781, Poland

Location

Related Publications (1)

• Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.

  PMID: 25670810 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Michal F. Kaminski, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Jaroslaw Regula, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 17, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

PL (1)