Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-03-11 @ 9:26 PM
Study NCT ID:
NCT00856557
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2009-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervening to Prevent Contextual Errors in Medical Decision Making
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Saul.Weiner@va.gov', 'phone': '3125192697', 'title': 'Dr. Saul J. Weiner', 'organization': 'Jesse Brown VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Seminar and Practium', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.\n\nSeminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Intervention', 'description': 'No educational intervention', 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health Outcome Improvement Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Seminar and Practicum', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.\n\nSeminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.'}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'No educational intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Null hypothesis is equal distribution of proportion of successful encounters among groups', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.724', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.346', 'groupDescription': 'Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After 9 months of the recorded visit', 'description': "A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.", 'unitOfMeasure': "proportion of physician's patients", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Contextual Probing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Seminar and Practicum', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.\n\nSeminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.'}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'No educational intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '.26', 'spread': '.25', 'groupId': 'OG000'}, {'value': '.27', 'spread': '.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.99', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During initial patient recordings', 'description': 'Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.', 'unitOfMeasure': "proportion of physician's patients", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Contextual Planning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Seminar and Practicum', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.\n\nSeminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.'}, {'id': 'OG001', 'title': 'No Intervention', 'description': 'No educational intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '.18', 'spread': '.23', 'groupId': 'OG000'}, {'value': '.21', 'spread': '.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.39', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During initial patient recordings', 'description': "Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings", 'unitOfMeasure': "proportion of physician's patients", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Seminar and Practicum', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.\n\nSeminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.'}, {'id': 'FG001', 'title': 'No Intervention', 'description': 'No educational intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Received Intervention/Control', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Tested With Standardized Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'With Patients With Contextual Flags', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'No patients with contextual flags', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Resident physicians were consented and recruited from two clinical training facilities on a rolling basis over 30 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Seminar and Practicum', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.\n\nSeminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.'}, {'id': 'BG001', 'title': 'No Intervention', 'description': 'No educational intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Year in residency', 'classes': [{'title': 'Post Grad Yr (PGY) 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'PGY2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'PGY3', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Resident physicians in primary care.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2009-03-03', 'resultsFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2009-03-04', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-24', 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Outcome Improvement Rate', 'timeFrame': 'After 9 months of the recorded visit', 'description': "A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit."}], 'secondaryOutcomes': [{'measure': 'Rate of Contextual Probing', 'timeFrame': 'During initial patient recordings', 'description': 'Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.'}, {'measure': 'Rate of Contextual Planning', 'timeFrame': 'During initial patient recordings', 'description': "Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with complex psychosocial needs'], 'conditions': ['Psychosocial Circumstances']}, 'referencesModule': {'references': [{'pmid': '23784847', 'type': 'RESULT', 'citation': 'Weiner SJ, Kelly B, Ashley N, Binns-Calvey A, Sharma G, Schwartz A, Weaver FM. Content coding for contextualization of care: evaluating physician performance at patient-centered decision making. Med Decis Making. 2014 Jan;34(1):97-106. doi: 10.1177/0272989X13493146. Epub 2013 Jun 19.'}, {'pmid': '23588745', 'type': 'RESULT', 'citation': 'Weiner SJ, Schwartz A, Sharma G, Binns-Calvey A, Ashley N, Kelly B, Dayal A, Patel S, Weaver FM, Harris I. Patient-centered decision making and health care outcomes: an observational study. Ann Intern Med. 2013 Apr 16;158(8):573-9. doi: 10.7326/0003-4819-158-8-201304160-00001.'}, {'pmid': '20841532', 'type': 'RESULT', 'citation': "Schwartz A, Weiner SJ, Harris IB, Binns-Calvey A. An educational intervention for contextualizing patient care and medical students' abilities to probe for contextual issues in simulated patients. JAMA. 2010 Sep 15;304(11):1191-7. doi: 10.1001/jama.2010.1297."}]}, 'descriptionModule': {'briefSummary': 'This study assessed whether a medical education intervention improves the quality of medical decision making in the care of patients with complex psychosocial -- or contextual -- needs that are essential to address when planning their care. A group of internal medicine residents were randomly assigned to participate in the seminar and practicum and then they, along with a control group that had not participated, were assessed for the quality of their clinical decision making and its impact on patient care. The study also assessed whether contextualization of care is associated with better patient health care outcomes', 'detailedDescription': 'We enrolled 139 internal medicine residents at 2 VA hospitals, Jesse Brown and Hines, in a randomized controlled design. Half participated in a 4 hour seminar series integrated into their ambulatory curriculum. Each month a total of 8 residents participated. Following the intervention there were 3 levels of assessment: (1) All participants, intervention and control, participated in a brief exercise interviewing 4 standardized patients (SPs). Note that we separately enlisted the assistance of 8 attending physicians to assist with case development for these SPs. (2) The research team subsequently enrolled 3 real patients from each physician\'s practice with "red flags" such as poor adherence, or missed visits, suggestive of contextual issues that need to be addressed. Physicians were scored on their performance at identifying the underlying contextual factors that account for these red flags and on formulating an appropriate plan of care. (3) The coders prospectively defined successful vs. unsuccessful outcomes for each case. At the follow up visit data was collected on whether the desired outcome was achieved. The analysis compared the skills, performance and outcomes of the intervention compared with the control group to determine the efficacy of training residents to individualize care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internal Medicine Residency with continuity of care clinics at either Jesse Brown or Hines VA Medical Centers\n\nExclusion Criteria:\n\n* All resident physicians who do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00856557', 'briefTitle': 'Intervening to Prevent Contextual Errors in Medical Decision Making', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Intervening to Prevent Contextual Errors in Medical Decision Making', 'orgStudyIdInfo': {'id': 'EDU 08-430'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seminar and Practicum', 'description': 'Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.', 'interventionNames': ['Behavioral: Seminar and Practicum']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'No educational intervention.'}], 'interventions': [{'name': 'Seminar and Practicum', 'type': 'BEHAVIORAL', 'description': 'A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.', 'armGroupLabels': ['Seminar and Practicum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jesse Brown VA Medical Center, Chicago, IL', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Saul J. Weiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jesse Brown VA Medical Center, Chicago, IL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}