Clinical trial NCT01667198: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
name: Gloucestershire Hospitals NHS Foundation Trust
name: University of Oslo
name: Erasmus Medical Center
name: Ministry of Science and Higher Education, Poland
First posted: 2012-08-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


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

Primary outcomes:
measure: Screening centre leader's adenoma detection rate
timeFrame: till the end of calendar year after the training intervention
Secondary outcomes:
measure: Screening center's overall adenoma detection rate
timeFrame: Till the end of calendar year after the training intervention
measure: Screening centre leader's proximal and distal adenoma detection rate
timeFrame: Till the end of calendar year after the training intervention
measure: Screening centre's non-polypoid lesion detection rate
timeFrame: Till the end of calendar year after the training intervention
measure: Overall screening centre's ceacal intubation rate
timeFrame: Till the end of calendar year after the training intervention
measure: Screening centre leader's withdrawal technique
timeFrame: Till the end of calendar year after the training intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Study officials:
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
name: Michal F. Kaminski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Jaroslaw Regula, MD, PhD
role: STUDY_CHAIR
References:
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.