A Prospective Trial of an Endoscopic Quality Improvement Project

NCT02325635 | Completed

• 1 other identifier: 13-002066
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized prospective multi-site validation study.

Conditions

Colon Polyps

Keywords

Adenoma Detection; Adenoma Prediction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Training of Endoscopist

EXPERIMENTAL

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

Other: Educational Training

Deferred Training of Endoscopist

NO INTERVENTION

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

Interventions

Educational Training OTHER

Intervention/Training offered to endoscopists only.

Also known as: Intervention offered to endoscopist only.

Training of Endoscopist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• GI Quality Improvement Consortium: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• 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.

  PMID: 27473182 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Training Support

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Financial Support; Economics; Health Care Economics and Organizations

Study Officials

• Michael Wallace, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 25, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (1)