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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Train the leaders course; Behavioral: Audit and feedback

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-781
    • The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening center's overall 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
Screening centre leader's proximal and distal 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
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	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.	Till the end of calendar year after the training intervention
Screening centre leader's withdrawal technique	Withdrawal technique assessed by a trained endoscopy nurse	Till the end of calendar year after the training intervention

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (ESTIMATE): August 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IP2010016270