Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-02-26 @ 12:00 PM
Study NCT ID:
NCT03226366
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2017-07-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C116143', 'term': 'RsbA protein, Proteus mirabilis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'officeofresearch@imail.org', 'phone': '(801) 408-1991', 'title': 'Director, Office of Research', 'organization': 'Intermountain Healthcare'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Intervention effects on hospital mortality and emergency department length of stay were evaluated as study outcomes. Other adverse events were not systematically collected given this was a retrospective study employing review of the electronic clinical record to evaluate a previously-implemented quality improvement initiative reordering of routine emergency department care for patients with sepsis.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016', 'otherNumAtRisk': 911, 'deathsNumAtRisk': 911, 'otherNumAffected': 0, 'seriousNumAtRisk': 911, 'deathsNumAffected': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 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'otherNumAtRisk': 641, 'deathsNumAtRisk': 641, 'otherNumAffected': 0, 'seriousNumAtRisk': 641, 'deathsNumAffected': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From ED Arrival to Administration of First Dose of Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '1183', 'groupId': 'OG002'}, {'value': '641', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016\n\nImmediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate'}, {'id': 'OG002', 'title': 'Pre-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG003', 'title': 'Post-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016'}], 'classes': [{'categories': [{'measurements': [{'value': '173', 'spread': '98', 'groupId': 'OG000'}, {'value': '165', 'spread': '95', 'groupId': 'OG001'}, {'value': '169', 'spread': '90', 'groupId': 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'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '1183', 'groupId': 'OG002'}, {'value': '641', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016\n\nImmediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate'}, {'id': 'OG002', 'title': 'Pre-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG003', 'title': 'Post-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.25', 'ciUpperLimit': '2.61', 'estimateComment': 'Odds ratio for hospital mortality after versus before intervention implementation based on adjusted differences-in-differences analysis', 'groupDescription': "Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \\<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ED Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '1183', 'groupId': 'OG002'}, {'value': '641', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016\n\nImmediate evaluation by multidisciplinary team: Simultaneous initial 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Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-25.9', 'ciUpperLimit': '7.0', 'estimateComment': 'Change in emergency department length of stay (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis', 'groupDescription': "Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \\<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 week', 'description': 'Time (minutes) from ED arrival to ED departure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Door-to-physician Evaluation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}, {'value': '489', 'groupId': 'OG001'}, {'value': '1164', 'groupId': 'OG002'}, {'value': '624', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016\n\nImmediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate'}, {'id': 'OG002', 'title': 'Pre-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'OG003', 'title': 'Post-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '18', 'groupId': 'OG000'}, {'value': '23', 'spread': '15', 'groupId': 'OG001'}, {'value': '22', 'spread': '24', 'groupId': 'OG002'}, {'value': '20', 'spread': '16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '1.8', 'estimateComment': 'Estimated change in emergency department door-to-physician evaluation time (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis', 'groupDescription': "Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \\<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours', 'description': "Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Time of physician initial patient evaluation was missing for a small number of participants in each group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'FG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016\n\nImmediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate'}, {'id': 'FG002', 'title': 'Pre-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'FG003', 'title': 'Post-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '911'}, {'groupId': 'FG001', 'numSubjects': '495'}, {'groupId': 'FG002', 'numSubjects': '1183'}, {'groupId': 'FG003', 'numSubjects': '641'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '911'}, {'groupId': 'FG001', 'numSubjects': '495'}, {'groupId': 'FG002', 'numSubjects': '1183'}, {'groupId': 'FG003', 'numSubjects': '641'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'BG000'}, {'value': '495', 'groupId': 'BG001'}, {'value': '1183', 'groupId': 'BG002'}, {'value': '641', 'groupId': 'BG003'}, {'value': '3230', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'BG001', 'title': 'Post-implementation (Intervention Site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016\n\nImmediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate'}, {'id': 'BG002', 'title': 'Pre-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'id': 'BG003', 'title': 'Post-implementation (Control Site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '19.7', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '19.7', 'groupId': 'BG002'}, {'value': '58.7', 'spread': '20.4', 'groupId': 'BG003'}, {'value': '57.6', 'spread': '19.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '474', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '687', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}, {'value': '1789', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '437', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}, {'value': '1441', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '794', 'groupId': 'BG000'}, {'value': '421', 'groupId': 'BG001'}, {'value': '1114', 'groupId': 'BG002'}, {'value': '596', 'groupId': 'BG003'}, {'value': '2925', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '827', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '1142', 'groupId': 'BG002'}, {'value': '617', 'groupId': 'BG003'}, {'value': '3037', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-11', 'size': 295702, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-11T11:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-01', 'studyFirstSubmitDate': '2017-07-19', 'resultsFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-01', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From ED Arrival to Administration of First Dose of Antibiotics', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Hospital Mortality', 'timeFrame': 'Up to 1 year'}, {'measure': 'ED Length of Stay', 'timeFrame': 'Up to 1 week', 'description': 'Time (minutes) from ED arrival to ED departure'}, {'measure': 'Door-to-physician Evaluation Time', 'timeFrame': 'Up to 24 hours', 'description': "Time (minutes) from subject's arrival in the ED until initial evaluation by a physician."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['door-to-antibiotic time', 'emergency department care', 'antimicrobial', 'care reorganization', 'severe sepsis', 'swarming'], 'conditions': ['Septic Shock', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '32369531', 'type': 'RESULT', 'citation': 'Peltan ID, Bledsoe JR, Brems D, McLean S, Murnin E, Brown SM. Institution of an emergency department "swarming" care model and sepsis door-to-antibiotic time: A quasi-experimental retrospective analysis. PLoS One. 2020 May 5;15(5):e0232794. doi: 10.1371/journal.pone.0232794. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. The potential effect of care reorganization on very early care for sepsis is unknown. This study will investigate whether multidisciplinary coordination of the initial patient evaluation in the emergency department influences door-to-antibiotic time for septic patients.', 'detailedDescription': 'This is a retrospective cohort study of emergency department sepsis care before versus after implementation of a "swarming" model for simultaneous patient evaluation by multidisciplinary care providers. The analysis will use data from similar hospitals that did not change sepsis care organization during the study period to control for changes in sepsis care not resulting from the "swarming" intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients presenting to the ED with sepsis or septic shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Primary inclusion criteria:\n\n* Adult patients age ≥18 years\n* Presented to the ED of study hospital from May 16, 2015 to April 15, 2016 (pre-implementation cohort) or May 16 to November 15, 2016 (post-implementation cohort)\n* Sepsis present in ED (Sequential Organ Failure Assessment \\[SOFA\\] score ≥2 points above baseline while in ED plus antibiotic initiation while in the ED)\n* Triage acuity score 2-5\n\nInclusion criteria for supplemental sensitivity analyses:\n\n* Presented to the ED of study hospital between May 16, 2015 and April 15, 2016 (pre-implementation cohort) or May 16, 2016 and February 15, 2017 (post-implementation cohort).\n* Sepsis on presentation to ED, defined as initial Sequential Organ Failure Assessment (SOFA) score ≥2 points above baseline plus antibiotics initiation within 24 hours of ED arrival.\n\nOverall exclusion criteria:\n\n* Age \\<18 years\n* No antibiotics within 24 hours of ED arrival'}, 'identificationModule': {'nctId': 'NCT03226366', 'briefTitle': 'Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)', 'orgStudyIdInfo': {'id': 'LDS SWARM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-implementation (intervention site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'label': 'Post-implementation (intervention site)', 'description': 'Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017', 'interventionNames': ['Other: Immediate evaluation by multidisciplinary team']}, {'label': 'Pre-implementation (control site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016'}, {'label': 'Post-implementation (control site)', 'description': 'Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017'}], 'interventions': [{'name': 'Immediate evaluation by multidisciplinary team', 'type': 'OTHER', 'otherNames': ['Swarming'], 'description': 'Simultaneous initial evaluation by the ED physician, nurse, and patient care associate', 'armGroupLabels': ['Post-implementation (intervention site)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84065', 'city': 'Riverton', 'state': 'Utah', 'country': 'United States', 'facility': 'Riverton Hospital', 'geoPoint': {'lat': 40.52189, 'lon': -111.9391}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84094', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': 'Alta View Hospital', 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}], 'overallOfficials': [{'name': 'Ithan Peltan, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Intermountain Medical Center', 'investigatorFullName': 'Ithan Peltan', 'investigatorAffiliation': 'Intermountain Health Care, Inc.'}}}}