Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-04 @ 6:59 AM
Study NCT ID:
NCT02301793
Status:
COMPLETED
Last Update Posted:
2019-05-17
First Post:
2014-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Educating Nurses About Venous Thromboembolism (VTE) Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ehaut1@jhmi.edu', 'phone': '410-502-3122', 'title': 'Elliott R Haut M.D, PhD, Associate Professor of Surgery, Anesthesiology &Critical Care Medicine', 'organization': 'Johns Hopkins Medical Institutions'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This trial was conducted in a single center potentially limiting the generalizability of our findings. The differences associated with education by specific clinical department in the current study was not explored.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse events were reported at patient visit level', 'eventGroups': [{'id': 'EG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format', 'otherNumAtRisk': 6835, 'deathsNumAtRisk': 6835, 'otherNumAffected': 0, 'seriousNumAtRisk': 6835, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.', 'otherNumAtRisk': 5941, 'deathsNumAtRisk': 5941, 'otherNumAffected': 0, 'seriousNumAtRisk': 5941, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Non Administration of Prescribed VTE Prophylaxis Medication Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4686', 'groupId': 'OG000'}, {'value': '4398', 'groupId': 'OG001'}]}, {'units': 'patient visits', 'counts': [{'value': '6835', 'groupId': 'OG000'}, {'value': '5941', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'OG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}], 'classes': [{'title': 'Pre-Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1925', 'groupId': 'OG000'}, {'value': '2021', 'groupId': 'OG001'}]}, {'units': 'patient visits', 'counts': [{'value': '2722', 'groupId': 'OG000'}, {'value': '2603', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '15.0'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '20.4'}]}]}, {'title': 'Post-Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2761', 'groupId': 'OG000'}, {'value': '2377', 'groupId': 'OG001'}]}, {'units': 'patient visits', 'counts': [{'value': '4113', 'groupId': 'OG000'}, {'value': '3338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '12.8'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '19.1'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'pValueComment': 'The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.', 'groupDescription': 'The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '(Baseline); approximately 3 months later (Post-Education)', 'description': 'This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse', 'unitOfMeasure': 'percentage of nonadministration', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient visits', 'denomUnitsSelected': 'patient visits', 'populationDescription': 'The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.'}, {'type': 'SECONDARY', 'title': 'Rates of All VTE Among Hospitalized Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'OG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}], 'timeFrame': '3-12 months after end of study', 'description': 'Did the intervention decrease rates of VTE among hospitalized patients?', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'OG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}], 'timeFrame': '3-12 months after end of study', 'description': 'Did the intervention decrease rates of DVT among hospitalized patients?', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Rates of Pulmonary Embolism (PE) Among Hospitalized Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'OG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}], 'timeFrame': '3-12 months after end of study', 'description': 'Did the intervention decrease rates of PE among hospitalized patients?', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4686', 'groupId': 'OG000'}, {'value': '4398', 'groupId': 'OG001'}]}, {'units': 'patient visits', 'counts': [{'value': '6835', 'groupId': 'OG000'}, {'value': '5941', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'OG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}], 'classes': [{'title': 'Pre-Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1925', 'groupId': 'OG000'}, {'value': '2021', 'groupId': 'OG001'}]}, {'units': 'patient visits', 'counts': [{'value': '2722', 'groupId': 'OG000'}, {'value': '2603', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '10.0'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '13.2'}]}]}, {'title': 'Post-Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2761', 'groupId': 'OG000'}, {'value': '2377', 'groupId': 'OG001'}]}, {'units': 'patient visits', 'counts': [{'value': '4113', 'groupId': 'OG000'}, {'value': '3338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '9.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '12.6'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'pValueComment': 'The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.', 'groupDescription': 'The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; approximately 3 months later (post education)', 'description': 'Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?', 'unitOfMeasure': 'percentage of patient refused doses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'patient visits', 'denomUnitsSelected': 'patient visits', 'populationDescription': 'The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'FG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}], 'periods': [{'title': 'Pre Education Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Nurses had not been randomized', 'groupId': 'FG000', 'numUnits': '2722', 'numSubjects': 'NA'}, {'comment': 'Nurses had not been randomized', 'groupId': 'FG001', 'numUnits': '2603', 'numSubjects': 'NA'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Nurses had not been randomized', 'groupId': 'FG000', 'numUnits': '2722', 'numSubjects': 'NA'}, {'comment': 'Nurses had not been randomized', 'groupId': 'FG001', 'numUnits': '2603', 'numSubjects': 'NA'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': 'NA'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': 'NA'}]}]}, {'title': 'During and Post Education Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6566', 'numSubjects': '488'}, {'groupId': 'FG001', 'numUnits': '5355', 'numSubjects': '445'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6566', 'numSubjects': '405'}, {'groupId': 'FG001', 'numUnits': '5355', 'numSubjects': '396'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '83'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '49'}]}]}], 'typeUnitsAnalyzed': 'Patient visits', 'recruitmentDetails': 'Nurses were identified using our centralized education directory that associates nurses with their designated departments and hospital floors. On July 23, 2014, nurses were cluster randomized by floor to receive one of two education modules about VTE prevention. Nurses were asked to complete their assigned education module by October 23, 2014.', 'preAssignmentDetails': 'Pre Education Study Period reflects the baseline participants information (patient visits). Post Education Study Period reflects the participants information following the implementation of the nurse education intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1925', 'groupId': 'BG000'}, {'value': '2021', 'groupId': 'BG001'}, {'value': '3946', 'groupId': 'BG002'}]}, {'units': 'Patient Visit', 'counts': [{'value': '2722', 'groupId': 'BG000'}, {'value': '2603', 'groupId': 'BG001'}, {'value': '5325', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format\n\nNurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format'}, {'id': 'BG001', 'title': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format\n\nNurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '56', 'spread': '17.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Patient Visit'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1435', 'groupId': 'BG000'}, {'value': '1186', 'groupId': 'BG001'}, {'value': '2621', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1287', 'groupId': 'BG000'}, {'value': '1417', 'groupId': 'BG001'}, {'value': '2704', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Patient Visit', 'denomUnitsSelected': 'Patient Visit', 'populationDescription': 'The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1106', 'groupId': 'BG000'}, {'value': '980', 'groupId': 'BG001'}, {'value': '2086', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1367', 'groupId': 'BG000'}, {'value': '1396', 'groupId': 'BG001'}, {'value': '2763', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Patient Visit', 'denomUnitsSelected': 'Patient Visit'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2722', 'groupId': 'BG000'}, {'value': '2603', 'groupId': 'BG001'}, {'value': '5325', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Patient Visit', 'denomUnitsSelected': 'Patient Visit'}], 'typeUnitsAnalyzed': 'Patient Visit', 'populationDescription': 'Outcomes assessed were analyzed on patient visit level as each encounter represents a unique participant outcome. Patient A might receive all doses during their first visit and miss doses during a second visit. Patient A might have been in different Arms during different visits. Baseline information was only collected during the pre-education phase'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-16', 'size': 239672, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-15T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Within strata, a coin toss (ERH) was used to randomize floors into either the Dynamic education arm or the Static education arm. Based on the outcome of the coin toss, nurses were then remotely assigned the online education module by an institutional nurse educator (DLS). The assigned educational module then appeared in the nurse's list of education assignments for completion within the institutional Learning Management System. Nurses are required to complete clinically relevant education regularly as part of ongoing professional practice and a waiver of consent was provided by the IRB; therefore nurses were not aware of their participation in a trial nor were they aware that two education modules existed. Additionally, the VTE prophylaxis medication non-administration dataset provided to the biostatistical team (i.e. outcomes assessors) for analysis was blinded by treatment arm and department."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One arm was provided linear static education (Static) using PowerPoint slides with voiceover to cover the concepts. The other arm was provided interactive learner-centric dynamic scenario-based education (Dynamic), where each scenario resulted in either positive reinforcement or corrective feedback with an opportunity to apply knowledge to a new scenario.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 933}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-16', 'studyFirstSubmitDate': '2014-11-22', 'resultsFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-16', 'studyFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non Administration of Prescribed VTE Prophylaxis Medication Doses', 'timeFrame': '(Baseline); approximately 3 months later (Post-Education)', 'description': 'This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse'}], 'secondaryOutcomes': [{'measure': 'Rates of All VTE Among Hospitalized Patients', 'timeFrame': '3-12 months after end of study', 'description': 'Did the intervention decrease rates of VTE among hospitalized patients?'}, {'measure': 'Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients', 'timeFrame': '3-12 months after end of study', 'description': 'Did the intervention decrease rates of DVT among hospitalized patients?'}, {'measure': 'Rates of Pulmonary Embolism (PE) Among Hospitalized Patients', 'timeFrame': '3-12 months after end of study', 'description': 'Did the intervention decrease rates of PE among hospitalized patients?'}, {'measure': 'Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal', 'timeFrame': 'Baseline; approximately 3 months later (post education)', 'description': 'Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Thromboembolism', 'Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '23799091', 'type': 'BACKGROUND', 'citation': 'Shermock KM, Lau BD, Haut ER, Hobson DB, Ganetsky VS, Kraus PS, Efird LE, Lehmann CU, Pinto BL, Ross PA, Streiff MB. Patterns of non-administration of ordered doses of venous thromboembolism prophylaxis: implications for novel intervention strategies. PLoS One. 2013 Jun 14;8(6):e66311. doi: 10.1371/journal.pone.0066311. Print 2013.'}, {'pmid': '24681420', 'type': 'BACKGROUND', 'citation': 'Elder S, Hobson DB, Rand CS, Streiff MB, Haut ER, Efird LE, Kraus PS, Lehmann CU, Shermock KM. Hidden Barriers to Delivery of Pharmacological Venous Thromboembolism Prophylaxis: The Role of Nursing Beliefs and Practices. J Patient Saf. 2016 Jun;12(2):63-8. doi: 10.1097/PTS.0000000000000086.'}, {'pmid': '28813425', 'type': 'DERIVED', 'citation': 'Lau BD, Shaffer DL, Hobson DB, Yenokyan G, Wang J, Sugar EA, Canner JK, Bongiovanni D, Kraus PS, Popoola VO, Shihab HM, Farrow NE, Aboagye JK, Pronovost PJ, Streiff MB, Haut ER. Effectiveness of two distinct web-based education tools for bedside nurses on medication administration practice for venous thromboembolism prevention: A randomized clinical trial. PLoS One. 2017 Aug 16;12(8):e0181664. doi: 10.1371/journal.pone.0181664. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'http://www.pcori.org/research-in-action/improving-patient-nurse-communication-prevent-life-threatening-complication', 'label': 'PCORI Website Page - "Improving Patient-Nurse Communication to Prevent a Life-Threatening Complication"'}, {'url': 'http://www.pcori.org/research-results/2013/preventing-venous-thromboembolism-empowering-patients-and-enabling-patient', 'label': 'PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology"'}, {'url': 'https://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/infections_complications/VTE/strategies.html', 'label': 'Website to take the nurse education module. "Venous Thromboembolism Prevention: The Nurse\'s Perspective"'}]}, 'descriptionModule': {'briefSummary': 'As part of mandatory on-going nursing education, the investigators have incorporated identical information into two distinct web-based learning formats - the traditional linear PowerPoint format (with voice-over) and a new interactive format developed with central nursing education.\n\nThe investigators will cluster randomize nurses by floor to receive either the traditional education or the new interactive education, and evaluate the impact on administration of VTE prophylaxis doses administered by nurses before and after education. All nurses on a floor will receive the same educational format. If one method of education results in statistically significant improvement in VTE prophylaxis administration, the investigators will cross over to deliver the superior education format to all nurses who originally were given the less effective method.', 'detailedDescription': "BACKGROUND\n\n* In an attempt to improve venous thromboembolism (VTE) prophylaxis adherence the investigators carried out qualitative studies to obtain patients' viewpoints on how nurses should be educated about VTE prevention and to assess nurses' beliefs and perceptions about pharmacologic VTE prophylaxis\n* The investigators observed deficiencies in nurses' knowledge and misconceptions about VTE prophylaxis that likely lowers adherence to administration of prescribed VTE prophylaxis doses\n* As a part of our original Patient-Centered Outcomes Research Institute (PCORI) proposal, the investigators planned to educate nurses to address the observed deficiencies and misconceptions and improve their ability to communicate effectively with patients\n\n * Historically, nurse education has been done via a linear, PowerPoint-based platform with voice-over but with no interactive component (TRADITIONAL)\n * A newer platform for nurse education became available for use and includes scenario-based teaching, ongoing assessment, and immediate remediation. Most importantly, it is a highly interactive product (CONTEMPORARY)\n\nSTUDY DESIGN AND ANALYTIC PLAN\n\n* Research hypotheses\n\n * Primary: Nurse participants who receive either of these interventions will improve administration of prescribed VTE prophylaxis evidenced by a decrease in frequency of non-administered doses of VTE prophylaxis, compared with their frequency at baseline.\n * Secondary: Nurse participants who receive the contemporary education format will have a larger decrease in frequency of missed doses of VTE prophylaxis compared with those who participate in the traditional education format.\n* Study Design\n\n * Cluster Randomized Trial 21 floors, block randomized by floor type (medicine \\[n=11\\] vs. surgery \\[n=10\\]) and (ICU \\[n=5\\] vs. non-ICU \\[n=16\\]) All nurses on each floor are assigned the same education type to mitigate issues related to contamination if nurses discuss the education with their colleagues\n* Primary Outcome measure: Proportion of non-administered doses of pharmacological VTE prophylaxis (dose level)\n* Secondary Outcome Measures:\n\n * Proportion of doses documented as missed due to patient refusal (dose level)\n * Proportion of patients with any VTE (patient level)\n * Proportion of patients with Deep Vein Thrombosis (DVT) (patient level)\n * Proportion of patients with Pulmonary Embolism (PE) (patient level)\n* Analytic methods\n\n * Primary analyses - Intention-to-treat (includes all nurses assigned, whether or not they completed the education) Is there a difference between units allocated to either of the interventions comparing their outcome measure to their baseline measure? Is there a difference comparing those who received the contemporary education format vs. the traditional education format?\n * Secondary analysis - Per protocol (includes only nurses who completed the education) Do nurses who receive education perform better (improved administration of prescribed VTE prophylaxis) than those who did not? Do nurses who received the education in the contemporary format perform better than those who received it in the traditional format"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nurses on selected surgical and medical floors at Johns Hopkins Hospital\n\nExclusion Criteria:\n\n* Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study'}, 'identificationModule': {'nctId': 'NCT02301793', 'briefTitle': 'Educating Nurses About Venous Thromboembolism (VTE) Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Educating Nurses About Venous Thromboembolism Prevention', 'orgStudyIdInfo': {'id': 'NA_00043860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contemporary Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.\n\nIntervention: Nurse education in contemporary format', 'interventionNames': ['Behavioral: Nurse education in contemporary format']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Education Format', 'description': 'Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.\n\nIntervention: Nurse education in traditional format', 'interventionNames': ['Behavioral: Nurse education in traditional format']}], 'interventions': [{'name': 'Nurse education in contemporary format', 'type': 'BEHAVIORAL', 'description': 'Education about VTE was delivered through a web-based contemporary interactive format', 'armGroupLabels': ['Contemporary Education Format']}, {'name': 'Nurse education in traditional format', 'type': 'BEHAVIORAL', 'description': 'Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.', 'armGroupLabels': ['Traditional Education Format']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medical Institutions', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Elliott R Haut, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}