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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667198
• Other study ID #: IP2010016270
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: April 15, 2014
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2014
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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. Tailored training intervention.

2. Audit feedback on colonoscopy quality indicators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Poland	The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw

Sponsors (6)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Erasmus Medical Center, Gloucestershire Hospitals NHS Foundation Trust, Medical Centre of Postgraduate Education, Poland, Ministry of Science and Higher Education, Poland, University of Oslo

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Screening centre's non-polypoid lesion detection rate		Till the end of calendar year after the training intervention	No
Secondary	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	No
Secondary	Screening centre leader's withdrawal technique	Withdrawal technique assessed by a trained endoscopy nurse	Till the end of calendar year after the training intervention	No