A Prospective Trial of an Endoscopic Quality Improvement Project

Colon Polyps Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325635
• Other study ID #: 13-002066
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: November 12, 2015
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Randomized prospective multi-site validation study.

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 ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colon Polyps

Intervention

Other:
• Educational Training
Intervention/Training offered to endoscopists only.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	GI Quality Improvement Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No

External Links

•   GIQuIC