Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 11:58 AM
Study NCT ID:
NCT01043133
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2010-01-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Medical Student Use of Templates to Document Outpatient Asthma Care in Electronic Medical Record
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rgimbel@usuhs.mil', 'phone': '301-295-3077', 'title': 'Ronald W. Gimbel', 'organization': 'USUHS'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'log-binomial', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.97', 'ciLowerLimit': '1.34', 'ciUpperLimit': '11.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.97', 'estimateComment': 'Robust Huber-White standard errors account for clustering', 'statisticalMethod': 'log-binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'immediately after invervention and 30+ days in follow-up', 'description': 'The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Note Completeness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.04', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '17.05', 'spread': '2.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.25', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '-.03', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'immediately after intervention and 30+ days in follow-up', 'description': 'The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'All 3rd year USU medical students rotating through Family Medicine clerkship were invited to participate. The clerkship groups scheduled every 6-8 weeks during the 2009/10 academic year. The study included both male and female participants; ratio based on assignment to rotation group which is predetermined by medical school administrative staff.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the 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': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', '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': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-14', 'studyFirstSubmitDate': '2010-01-05', 'resultsFirstSubmitDate': '2010-12-03', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-14', 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record', 'timeFrame': 'immediately after invervention and 30+ days in follow-up', 'description': 'The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).'}], 'secondaryOutcomes': [{'measure': 'Clinical Note Completeness Score', 'timeFrame': 'immediately after intervention and 30+ days in follow-up', 'description': 'The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electronic medical records', 'documentation templates', 'clinical encounter notes'], 'conditions': ['Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to measure the effectiveness of a social marketing-based medical education intervention on student use of evidence-based templates for documenting outpatient asthma care within an electronic medical record.', 'detailedDescription': 'The purpose of the study was to measure the effectiveness of a physician-educator led clinical documentation workshop, embedded with 7 persuasive social-marketing based messages, on medical student response using a targeted asthma template. Stated differently, whether a physician-educator could "persuade" medical students to use an evidence-based EMR asthma template to document an outpatient mild persistent asthma encounter with a patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Third year medical student completing family medicine clerkship Uniformed Services University\n\nExclusion Criteria:\n\n* All students other than those listed above'}, 'identificationModule': {'nctId': 'NCT01043133', 'briefTitle': 'Study of Medical Student Use of Templates to Document Outpatient Asthma Care in Electronic Medical Record', 'organization': {'class': 'FED', 'fullName': 'Uniformed Services University of the Health Sciences'}, 'officialTitle': 'Social Marketing in Medical Education: Influencing Medical Student Use of Evidence-based Templates in Outpatient Documentation of Asthma Care Using an Electronic Medical Record', 'orgStudyIdInfo': {'id': 'B02930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Behavioral: social marketing-based medical education intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'social marketing-based medical education intervention', 'type': 'BEHAVIORAL', 'otherNames': ['persuasion'], 'description': 'social-marketing based medical education intervention designed to influence medical student use of evidence-based templates. Led by physician instructor.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark B. Stephens, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uniformed Services University of the Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uniformed Services University of the Health Sciences', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Ronald W. Gimbel, PhD', 'oldOrganization': 'Uniformed Services University of the Health Sciences'}}}}