search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Train the leaders course
Audit and feedback
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Train the leaders course

Audit and feedback

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Screening centre's non-polypoid lesion detection rate
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.
Screening centre leader's withdrawal technique
Withdrawal technique assessed by a trained endoscopy nurse

Full Information

First Posted
August 14, 2012
Last Updated
April 15, 2014
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education, Gloucestershire Hospitals NHS Foundation Trust, University of Oslo, Erasmus Medical Center, Ministry of Science and Higher Education, Poland
search

1. Study Identification

Unique Protocol Identification Number
NCT01667198
Brief Title
Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators
Official Title
Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education, Gloucestershire Hospitals NHS Foundation Trust, University of Oslo, Erasmus Medical Center, Ministry of Science and Higher Education, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Tailored training intervention. Audit feedback on colonoscopy quality indicators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Train the leaders course
Arm Type
Experimental
Arm Title
Audit and feedback
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Train the leaders course
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audit and feedback
Intervention Description
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 Outcome Measure Information:
Title
Screening centre leader's adenoma detection rate
Description
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
Time Frame
till the end of calendar year after the training intervention
Secondary Outcome Measure Information:
Title
Screening center's overall adenoma detection rate
Description
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
Time Frame
Till the end of calendar year after the training intervention
Title
Screening centre leader's proximal and distal adenoma detection rate
Description
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
Time Frame
Till the end of calendar year after the training intervention
Title
Screening centre's non-polypoid lesion detection rate
Time Frame
Till the end of calendar year after the training intervention
Title
Overall screening centre's ceacal intubation rate
Description
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.
Time Frame
Till the end of calendar year after the training intervention
Title
Screening centre leader's withdrawal technique
Description
Withdrawal technique assessed by a trained endoscopy nurse
Time Frame
Till the end of calendar year after the training intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal F. Kaminski, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaroslaw Regula, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25670810
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs