Increasing Serrated Polyp Detection With a Brief Awareness Training

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Completed

CT.gov ID

NCT03902899

Collaborator

National Institute for Public Health and the Environment (RIVM) (Other)

138

Enrollment

Arms

57.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

In this non-randomized controlled trial, a semi-random group of Dutch endoscopist receive an oral training about the significance of serrated polyps. The primary aim of this training is to improve the endoscopist's awareness of the significance of serrated polyps, ultimately leading to increased detection. In addition, a random group of endoscopists that will not receive this training will be used as a reference group.

Data will be collected as part of routine care within the Nationwide Dutch Bowel cancer screening program. The serrated polyp detectionrate of each endoscopist will be extracted from anonymized data that will be prospectively collected as part of routine care within the Dutch Nationwide bowel cancer screening program. Data will be anonymized and provided by Rijksinstituut voor Volksgezondheid en Milieu (RIVM) and ScreenIT.

Condition or Disease	Intervention/Treatment	Phase
Serrated Polyp Colorectal Neoplasms	Other: Educational intervention (oral presentation)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a non-randomized controlled trial with two arms. The intervention-arm consists of all endoscopists employed by 9 semi-randomly chosen Dutch hospitals hospitals who receive an educational training. The control-arm consists of a specific number of randomly chosen endoscopists.This is a non-randomized controlled trial with two arms. The intervention-arm consists of all endoscopists employed by 9 semi-randomly chosen Dutch hospitals hospitals who receive an educational training. The control-arm consists of a specific number of randomly chosen endoscopists.

Masking:

None (Open Label)

Masking Description:

The investigator personally delivers the training and can thus not be blinded for the endoscopists allocated to the intervention-arm.

Primary Purpose:

Health Services Research

Official Title:

The Influence of a Short Training in the Detection Rate of Proximal Serrated Polyps in an Asymptomatic Patient Population

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Oct 26, 2018

Actual Study Completion Date :

Oct 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention-arm All endoscopists employed by 9 semi-randomly chosen hospitals in the Netherlands will be exposed to an educational intervention (oral presentation): an oral awareness training which will be delivered twice, first in 2014 and then in 2016/2017. In total 38 endoscopists are included from these 9 hospitals.	Other: Educational intervention (oral presentation) A brief oral presentation (30-45 minutes) which focused on making endoscopists aware of the significance and characteristics of serrated polyps.
No Intervention: Control arm A random set of 100 endoscopists will be selected ass a reference group. These 100 endoscopists were unaware of the present study, and were thus blinded for their allocation.

Arm

Intervention/Treatment

Experimental: Intervention-arm

All endoscopists employed by 9 semi-randomly chosen hospitals in the Netherlands will be exposed to an educational intervention (oral presentation): an oral awareness training which will be delivered twice, first in 2014 and then in 2016/2017. In total 38 endoscopists are included from these 9 hospitals.

Other: Educational intervention (oral presentation)

A brief oral presentation (30-45 minutes) which focused on making endoscopists aware of the significance and characteristics of serrated polyps.

No Intervention: Control arm

A random set of 100 endoscopists will be selected ass a reference group. These 100 endoscopists were unaware of the present study, and were thus blinded for their allocation.

Outcome Measures

Primary Outcome Measures

Proximal serrated polyp detection rate (PSPDR) [Up to five years (between 2014 and 2018)]
Rate/proportion of an endoscopist's colonoscopies with one or more serrated polyps proximal to or in splenic flexure.

Secondary Outcome Measures

Adenoma detection rate (ADR) [Up to five years (between 2014 and 2018)]
Rate/proportion of an endoscopist's colonoscopies with one or more adenomas

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

Endoscopists accredited to perform colonoscopies within the Dutch Nationwide colorectal cancer screening program

Exclusion criteria:

Absent during both training sessions while employed in one of the trained hospitals

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
National Institute for Public Health and the Environment (RIVM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Evelien Dekker, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT03902899

Other Study ID Numbers:

DW18001

First Posted:

Apr 4, 2019

Last Update Posted:

Apr 4, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Polyps

Study Results

No Results Posted as of Apr 4, 2019