Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-16 @ 5:15 AM
Study NCT ID:
NCT02325635
Status:
COMPLETED
Last Update Posted:
2015-11-13
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Trial of an Endoscopic Quality Improvement Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014146', 'term': 'Training Support'}], 'ancestors': [{'id': 'D005378', 'term': 'Financial Support'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-12', 'studyFirstSubmitDate': '2014-12-11', 'studyFirstSubmitQcDate': '2014-12-24', 'lastUpdatePostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in adenoma detection rates.', 'timeFrame': '6 months', '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adenoma Detection', 'Adenoma Prediction'], 'conditions': ['Colon Polyps']}, 'referencesModule': {'references': [{'pmid': '27473182', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Randomized prospective multi-site validation study.', 'detailedDescription': '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.\n\nBaseline ADR and polyp/surveillance predication accuracy will be collected for approximately 3 months.\n\nSites randomized to the EQUIP intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback.\n\nControl 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 ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopy centers that are new to GIQuIC and have not yet received training\n* All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate\n\nExclusion Criteria:\n\n* Cases that involve acute indications such as bleeding and active colitis will not be included in data pool\n* Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded\n* Procedures that are deemed incomplete will be excluded\n* 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'}, 'identificationModule': {'nctId': 'NCT02325635', 'acronym': 'Equip 2', 'briefTitle': 'A Prospective Trial of an Endoscopic Quality Improvement Project', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective Randomized Controlled Trial of an Endoscopic Quality Improvement Project-2 (EQUIP-2) to Improve Adenoma Detection in Screening and Surveillance Colonoscopy', 'orgStudyIdInfo': {'id': '13-002066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training of Endoscopist', 'description': 'A series of 1 hour classes with ongoing monitoring and feedback to endoscopist only.', 'interventionNames': ['Other: Educational Training']}, {'type': 'NO_INTERVENTION', 'label': 'Deferred Training of Endoscopist', 'description': 'No intervention during the data collection period. Training will be deferred to end of study.'}], 'interventions': [{'name': 'Educational Training', 'type': 'OTHER', 'otherNames': ['Intervention offered to endoscopist only.'], 'description': 'Intervention/Training offered to endoscopists only.', 'armGroupLabels': ['Training of Endoscopist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Michael Wallace, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'GI Quality Improvement Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Michael Wallace', 'investigatorAffiliation': 'Mayo Clinic'}}}}