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A Prospective Trial of an Endoscopic Quality Improvement Project (Equip 2)

Primary Purpose

Colon Polyps

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Training
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colon Polyps focused on measuring Adenoma Detection, Adenoma Prediction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Endoscopy centers that are new to GIQuIC and have not yet received training
  • All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate

Exclusion Criteria:

  • Cases that involve acute indications such as bleeding and active colitis will not be included in data pool
  • Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded
  • Procedures that are deemed incomplete will be excluded
  • Patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (Boston bowel preparation score <5, or inadequate to exclude polyps >5mm) will be excluded

Sites / Locations

  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training of Endoscopist

Deferred Training of Endoscopist

Arm Description

A series of 1 hour classes with ongoing monitoring and feedback to endoscopist only.

No intervention during the data collection period. Training will be deferred to end of study.

Outcomes

Primary Outcome Measures

Change in adenoma detection rates.
The primary outcome will be the change in adenoma detection rates between baseline and the intervention. Validate the effect of a quality improvement training program on the proportion of patients among whom at least one adenoma is detected

Secondary Outcome Measures

Full Information

First Posted
December 11, 2014
Last Updated
November 12, 2015
Sponsor
Mayo Clinic
Collaborators
GI Quality Improvement Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT02325635
Brief Title
A Prospective Trial of an Endoscopic Quality Improvement Project
Acronym
Equip 2
Official Title
A Prospective Randomized Controlled Trial of an Endoscopic Quality Improvement Project-2 (EQUIP-2) to Improve Adenoma Detection in Screening and Surveillance Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
GI Quality Improvement Consortium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized prospective multi-site validation study.
Detailed Description
GI practice sites that have recently agreed to participate in the GIQuIC program will be randomized on a site-basis, to the EQUIP intervention or control. Baseline ADR and polyp/surveillance predication accuracy will be collected for approximately 3 months. Sites randomized to the EQUIP intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback. Control sites will not receive supplemental training and will be monitored by with no feedback. After completion of the study all sites will be offered the intervention (as is standard feedback in GIQuIC ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyps
Keywords
Adenoma Detection, Adenoma Prediction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training of Endoscopist
Arm Type
Experimental
Arm Description
A series of 1 hour classes with ongoing monitoring and feedback to endoscopist only.
Arm Title
Deferred Training of Endoscopist
Arm Type
No Intervention
Arm Description
No intervention during the data collection period. Training will be deferred to end of study.
Intervention Type
Other
Intervention Name(s)
Educational Training
Other Intervention Name(s)
Intervention offered to endoscopist only.
Intervention Description
Intervention/Training offered to endoscopists only.
Primary Outcome Measure Information:
Title
Change in adenoma detection rates.
Description
The primary outcome will be the change in adenoma detection rates between baseline and the intervention. Validate the effect of a quality improvement training program on the proportion of patients among whom at least one adenoma is detected
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Endoscopy centers that are new to GIQuIC and have not yet received training All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate Exclusion Criteria: Cases that involve acute indications such as bleeding and active colitis will not be included in data pool Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded Procedures that are deemed incomplete will be excluded Patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (Boston bowel preparation score <5, or inadequate to exclude polyps >5mm) will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wallace, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27473182
Citation
Wallace MB, Crook JE, Thomas CS, Staggs E, Parker L, Rex DK. Effect of an endoscopic quality improvement program on adenoma detection rates: a multicenter cluster-randomized controlled trial in a clinical practice setting (EQUIP-3). Gastrointest Endosc. 2017 Mar;85(3):538-545.e4. doi: 10.1016/j.gie.2016.07.042. Epub 2016 Jul 26.
Results Reference
derived
Links:
URL
http://giquic.gi.org/
Description
GIQuIC

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A Prospective Trial of an Endoscopic Quality Improvement Project

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