Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT01522560
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Multiscore Feedback in Professionalism for Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-07', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validate Multiscore Feedback (MSF)', 'timeFrame': 'up to 60 days', 'description': 'To evaluate content validity, copies of the questionnaires will be sent to experts in education in the Anesthesia Institute and Graduate Medical Education at The Cleveland Clinic; they will be asked if the new questionnaires are a good tool to measure professionalism for anesthesia residents'}], 'secondaryOutcomes': [{'measure': 'secondary goal is to test a Multiscore Feedback (MSF) as a method of evaluation in professionalism for anesthesia residents.', 'timeFrame': 'up to 18 months', 'description': 'We will assess the impact of feedback using the MSF (versus no feedback) on the professional behavior of anesthesia residents as measured by the MSF. The randomized groups of residents with and without feedback will be compared on mean MSF score after the first and second months of the rotation using a linear mixed effects model to account for the correlation between measurements on the same resident and to adjust for baseline score as a covariate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CA2 and CA3 residents', 'Pediatric Anesthesia'], 'conditions': ['CA2 and CA3 Residents Doing a Two Month Rotation in', 'Pediatric Anesthesia Department']}, 'descriptionModule': {'briefSummary': "Professionalism is one of the six competences required by The Accreditation for Graduate Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia residents are faced with unique communication challenges in their practice including brief contact time with their patients, operating room efficiency pressure, etc. To assess professionalism in Anesthesiology residents is important to obtain evaluations from people with whom they interact including patients, surgeons, colleagues and members of the support team. The Multisource feedback (MSF) approach has been used to evaluate communication skills and professionalism among practicing physicians and residents in a variety of settings. This evaluation model has never been used previously to evaluate anesthesia residents. The investigators propose a randomized controlled trial to validate and evaluate a MSF in professionalism for anesthesia residents. Participants include eighty residents doing two months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using face and content validity methods and comparing them with the current system of evaluation. Residents will be randomly assigned to a feedback group or to the control group. Both groups will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group assigned to feedback is going to have a 'coaching meeting' every month to identify strengths and weaknesses and create strategies for improvement. The investigators are planning to compare the mean values of the baseline evaluations with the mean values obtained after the first and second months from the MSF."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CA2 and CA3 residents doing a two month rotation in Pediatric Anesthesia Department\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01522560', 'briefTitle': 'Evaluation of Multiscore Feedback in Professionalism for Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'orgStudyIdInfo': {'id': '11-473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': "Residents will be randomly assigned to a feedback group or to the control group. Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a MSF evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. Only the group assigned to feedback is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the MSF.", 'interventionNames': ['Other: Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Feedback group', 'description': "Residents will be randomly assigned to a feedback group or to the control group. Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a MSF evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. Only the group assigned to feedback is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the MSF.", 'interventionNames': ['Other: Feedback group']}], 'interventions': [{'name': 'Feedback group', 'type': 'OTHER', 'description': "Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation.\n\nThis group is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the Multiscore Feedback (MSF).", 'armGroupLabels': ['Feedback group']}, {'name': 'Control group', 'type': 'OTHER', 'description': "Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation.", 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Nelson Riveros, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}