Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT00680368
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2008-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Resident Supervision Index: Assessing Feasibility and Validity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.kashner@va.gov', 'phone': '909 825-7084', 'title': 'T. Michael Kashner, PhD, PI', 'phoneExt': '2853', 'organization': 'Loma Linda VA Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Single site study limiting generalizability of findings'}}, 'adverseEventsModule': {'timeFrame': 'Collected during the 3-months when subjects were interviewed only.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Sample included 75 resident physicians. No adverse events noted.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dissatisfaction with education experience', 'notes': 'Reflects dissatisfaction with education experience', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye strain', 'notes': 'Eye strain attempting to complete a survey', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'quality of care', 'notes': 'There were no adverse health events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental breakdown', 'notes': 'Potential for mental breakdown due to stress of completing a survey in clinic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physician Residents and Attending Physicians', 'description': 'Sample included 112, including 60 physician residents and 37 attending physicians'}], 'classes': [{'categories': [{'measurements': [{'value': '.69', 'groupId': 'OG000', 'lowerLimit': '.57', 'upperLimit': '.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24-hours', 'description': 'Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.', 'unitOfMeasure': 'Intraclass Correlation Coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physician Residents', 'description': 'Includes physician residents who had a supervising attending physician participating in the study, and who received a face to face interview with a research assistant'}], 'classes': [{'categories': [{'measurements': [{'value': '.93', 'groupId': 'OG000', 'lowerLimit': '.91', 'upperLimit': '.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.', 'unitOfMeasure': 'Intraclass Correlation Coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Attending Physicians', 'description': 'Results reported only for the 37 attending physicians in the study sample'}], 'classes': [{'categories': [{'measurements': [{'value': '.88', 'groupId': 'OG000', 'lowerLimit': '.82', 'upperLimit': '.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.', 'unitOfMeasure': 'Intraclass Correlation Coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'The study began with 112 responders: 75 physician residents and 37 attending physicians. Only 60 of the 75 residents had been supervised by one of the 37 participating attending physicians. Thus, 15 residents were dropped from study. Both resident and their attending physician were surveyed to report total supervision time for each of 148 clinical encounters with 143 patients. There were more clinical encounters than patients because some patients had more than one encounter. There were more physician residents than attending physicians because attending physicians may have supervised more than one resident. There were more clinical encounters than residents because a resident may be involved in more than one clinical encounter with a patient.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '15 residents excluded because their attending physician was not participating in the study', 'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'not supervised, not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Physician Residents and Attending Physicians', 'description': 'includes physician residents and attending physicians who were asked to sit through a face to face interview with a research assistant following a clinical encounter with a patient'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Physician residents who consented to participate in the study.'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'The study did not involve a biospecimen. None was collected. None was retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2008-05-16', 'resultsFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2008-05-19', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-15', 'studyFirstPostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.', 'timeFrame': '24-hours', 'description': 'Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.'}], 'secondaryOutcomes': [{'measure': 'Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians', 'timeFrame': '24 hours', 'description': 'Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.'}, {'measure': 'Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians', 'timeFrame': '24 hours', 'description': 'Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Feasibility', 'Supervision', 'Assessing'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '18520472', 'type': 'BACKGROUND', 'citation': "Cannon GW, Keitz SA, Holland GJ, Chang BK, Byrne JM, Tomolo A, Aron DC, Wicker AB, Kashner TM. Factors determining medical students' and residents' satisfaction during VA-based training: findings from the VA Learners' Perceptions Survey. Acad Med. 2008 Jun;83(6):611-20. doi: 10.1097/ACM.0b013e3181722e97."}, {'pmid': '20592508', 'type': 'BACKGROUND', 'citation': "Kashner TM, Henley SS, Golden RM, Byrne JM, Keitz SA, Cannon GW, Chang BK, Holland GJ, Aron DC, Muchmore EA, Wicker A, White H. Studying the effects of ACGME duty hours limits on resident satisfaction: results from VA learners' perceptions survey. Acad Med. 2010 Jul;85(7):1130-9. doi: 10.1097/ACM.0b013e3181e1d7e3."}, {'pmid': '20305532', 'type': 'RESULT', 'citation': 'Byrne JM, Kashner M, Gilman SC, Aron DC, Cannon GW, Chang BK, Godleski L, Golden RM, Henley SS, Holland GJ, Kaminetzky CP, Keitz SA, Kirsh S, Muchmore EA, Wicker AB. Measuring the intensity of resident supervision in the department of veterans affairs: the resident supervision index. Acad Med. 2010 Jul;85(7):1171-81. doi: 10.1097/ACM.0b013e3181d5a954.'}, {'pmid': '21975879', 'type': 'RESULT', 'citation': 'Kashner TM, Byrne JM, Henley SS, Golden RM, Aron DC, Cannon GW, Chang BK, Gilman SC, Holland GJ, Kaminetzky CP, Keitz SA, Muchmore EA, Kashner TK, Wicker AB. Measuring progressive independence with the resident supervision index: theoretical approach. J Grad Med Educ. 2010 Mar;2(1):8-16. doi: 10.4300/JGME-D-09-00083.1.'}, {'pmid': '21975880', 'type': 'RESULT', 'citation': 'Kashner TM, Byrne JM, Chang BK, Henley SS, Golden RM, Aron DC, Cannon GW, Gilman SC, Holland GJ, Kaminetzky CP, Keitz SA, Muchmore EA, Kashner TK, Wicker AB. Measuring progressive independence with the resident supervision index: empirical approach. J Grad Med Educ. 2010 Mar;2(1):17-30. doi: 10.4300/1949-8357-2.1.17.'}]}, 'descriptionModule': {'briefSummary': 'OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter.\n\nRESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for content validity, test-retest reliability, and construct validity.', 'detailedDescription': "OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter.\n\nRESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for test-retest reliability and construct validity.\n\nMETHODOLOGY: Trained interviewers administered the Index during face-to-face and in-clinic interviews with 60 consenting resident physicians and their 37 consenting attending physicians to descsribe the care they provided to 143 patients at the outpatient clinics involving 148 clinical encounters at the Loma Linda VA Medical Center.\n\nFor each encounter, data comes from administering the Resident Supervision Index to the resident and attending. Baseline data describing each subject (attending physicians and resident physicians) came from face-to-face interviews.\n\nTest-retest reliability is assessed by re-administering the Index to residents for within 24 hours of the encounter. Concurrent validity is assessed by re-administering the Index to the attending physician responsible for the patient's care.\n\nCLINICAL RELATIONSHIPS: The study will help our understanding of how residents at VA medical centers receive training and are supervised for the purpose of both education and patient outcomes.\n\nIMPACT/SIGNIFICANCE: The instrument is planned for future studies to assess the association between resident supervision and training outcomes, clinical workload, patient outcomes, quality of care, and care costs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Ages 18 and older\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00680368', 'briefTitle': 'Resident Supervision Index: Assessing Feasibility and Validity', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Resident Supervision Index: Assessing Feasibility and Validity', 'orgStudyIdInfo': {'id': 'SHP 08-164'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Residents and Attending Physicians', 'description': 'This group contains the residents and the attending physicians who consented to participate in the study. They participated in a survey administered by a research assistant. Both physician resident and attending physicians were administered the survey twice within 24-hours and their test-retest responses were compared for reliability. Responses to attending and resident physicians covering the care for the patient and clinical care encounter were compared for accuracy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'VA Loma Linda Healthcare System, Loma Linda, CA', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Terrell Michael Kashner, PhD JD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Loma Linda Healthcare System, Loma Linda, CA'}, {'name': 'Dale S. Cannon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, UT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}