A Prospective Trial of an Endoscopic Quality Improvement Project

NCT ID: NCT02325635

Last Updated: 2015-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-09-30

Brief Summary

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Randomized prospective multi-site validation study.

Detailed Description

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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 ).

Conditions

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Colon Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Training of Endoscopist

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

Group Type EXPERIMENTAL

Educational Training

Intervention Type OTHER

Intervention/Training offered to endoscopists only.

Deferred Training of Endoscopist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Training

Intervention/Training offered to endoscopists only.

Intervention Type OTHER

Other Intervention Names

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Intervention offered to endoscopist only.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GI Quality Improvement Consortium

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Michael Wallace

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Wallace, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27473182 (View on PubMed)

Other Identifiers

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13-002066

Identifier Type: -

Identifier Source: org_study_id

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