Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-05 @ 11:03 AM
Study NCT ID:
NCT05423756
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2022-06-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
INSPIRE Trial for Skin and Soft Tissue Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skgohil@hs.uci.edu', 'phone': '(714) 456-7890', 'title': 'Dr. Shruti Gohil, MD, MPH', 'organization': 'Division of Infectious Diseases, University of California Irvine School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months (baseline), 12 months (intervention)', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.', 'otherNumAtRisk': 60932, 'deathsNumAtRisk': 60932, 'otherNumAffected': 0, 'seriousNumAtRisk': 60932, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.', 'otherNumAtRisk': 57630, 'deathsNumAtRisk': 57630, 'otherNumAffected': 0, 'seriousNumAtRisk': 57630, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60932', 'groupId': 'OG000'}, {'value': '57630', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.'}, {'id': 'OG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.'}], 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'OG000'}, {'value': '28242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43305', 'groupId': 'OG000'}, {'value': '40156', 'groupId': 'OG001'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'OG000'}, {'value': '29388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43927', 'groupId': 'OG000'}, {'value': '30287', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods', 'description': 'Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.\n\nExtended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.\n\nFor example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.', 'unitOfMeasure': 'Extended-Spectrum Days-of-Therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number of participants analyzed reported here is from the baseline and intervention periods'}, {'type': 'SECONDARY', 'title': 'Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60932', 'groupId': 'OG000'}, {'value': '57630', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.'}, {'id': 'OG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.'}], 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'OG000'}, {'value': '28242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43305', 'groupId': 'OG000'}, {'value': '38059', 'groupId': 'OG001'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'OG000'}, {'value': '29388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43927', 'groupId': 'OG000'}, {'value': '30287', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods', 'description': 'Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.\n\nAntipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.\n\nFor example, 2 different antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy.', 'unitOfMeasure': 'Antipseudomonal Days-of-Therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number of participants analyzed reported here is from the baseline and intervention periods'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intensive Care Unit (ICU) Transfer [Safety Outcome 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60932', 'groupId': 'OG000'}, {'value': '57630', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.'}, {'id': 'OG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.'}], 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'OG000'}, {'value': '28242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'OG000'}, {'value': '29388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods', 'description': "Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.", 'unitOfMeasure': 'Days to event', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mean number of days to event here is from the the baseline and intervention periods'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length-of-stay [Safety Outcome 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60932', 'groupId': 'OG000'}, {'value': '57630', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.'}, {'id': 'OG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.'}], 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'OG000'}, {'value': '28242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'OG000'}, {'value': '29388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods', 'description': 'Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.', 'unitOfMeasure': 'Days to event', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mean number of days to event here is from the baseline and intervention periods'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibiotic Treatment After Empiric Period', 'timeFrame': '12 months', 'description': 'The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14.\n\nNote: this outcome is intended for a secondary manuscript', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Empiric and Total Antibiotic Costs', 'timeFrame': '12 months', 'description': 'Empiric and total antibiotic costs for skin and soft tissue infection during hospitalization.\n\nNote: this outcome is intended for a secondary manuscript.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Hospital-Onset C. Difficile', 'timeFrame': '12 months', 'description': 'Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14.\n\nNote: this outcome is intended for a secondary manuscript.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Hospital-Onset MDRO-Positive Cultures', 'timeFrame': '12 months', 'description': 'Newly-detected hospital-onset MDRO-positive cultures on hospital days ≥4 and ≤14. Includes total MDRO and specific MDRO subsets.\n\nNote: this outcome is intended for a secondary manuscript.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.'}, {'id': 'FG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.'}], 'periods': [{'title': 'Baseline (12 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '29595'}, {'groupId': 'FG001', 'numUnits': '46', 'numSubjects': '28242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '29595'}, {'groupId': 'FG001', 'numUnits': '46', 'numSubjects': '28242'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Intervention (12 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '31337'}, {'comment': '2 hospitals were excluded from Arm 2: CPOE Bundle because they divested from HCA Healthcare before the intervention period began', 'groupId': 'FG001', 'numUnits': '44', 'numSubjects': '29388'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '31337'}, {'comment': '2 hospitals were excluded from Arm 2: CPOE Bundle because they divested from HCA Healthcare before the intervention period began', 'groupId': 'FG001', 'numUnits': '44', 'numSubjects': '29388'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Hospitals', 'recruitmentDetails': '92 out of 142 HCA Healthcare hospitals were recruited for this trial. There was a 12-month baseline period (January 1, 2019-December 31, 2019), 5-month phase-in (August 2, 2022-December 31, 2022), and 12-month intervention (January 1, 2023-December 31, 2023). Data from the phase-in period were excluded from all analyses (i.e., Baseline, Intervention, Outcome Measures, and Adverse Events).', 'preAssignmentDetails': '118,562 patients across 92 hospitals were randomized to either the routine stewardship group (Arm 1) or to the CPOE bundle (Arm 2); 2 hospitals were excluded because they divested from HCA Healthcare before the intervention period began.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60932', 'groupId': 'BG000'}, {'value': '57630', 'groupId': 'BG001'}, {'value': '118562', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Routine Stewardship', 'description': 'Continuation of routine antibiotic stewardship strategies.\n\nArm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.'}, {'id': 'BG001', 'title': 'Arm 2: INSPIRE CPOE Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.\n\nArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'BG000'}, {'value': '28242', 'groupId': 'BG001'}, {'value': '57837', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '18', 'groupId': 'BG000'}, {'value': '58', 'spread': '18', 'groupId': 'BG001'}, {'value': '58', 'spread': '18', 'groupId': 'BG002'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'BG000'}, {'value': '29388', 'groupId': 'BG001'}, {'value': '60725', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'spread': '18', 'groupId': 'BG000'}, {'value': '58', 'spread': '17', 'groupId': 'BG001'}, {'value': '59', 'spread': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'BG000'}, {'value': '28242', 'groupId': 'BG001'}, {'value': '57837', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13087', 'groupId': 'BG000'}, {'value': '12377', 'groupId': 'BG001'}, {'value': '25464', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16320', 'groupId': 'BG000'}, {'value': '15719', 'groupId': 'BG001'}, {'value': '32039', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'BG000'}, {'value': '29388', 'groupId': 'BG001'}, {'value': '60725', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13356', 'groupId': 'BG000'}, {'value': '17015', 'groupId': 'BG001'}, {'value': '30371', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17979', 'groupId': 'BG000'}, {'value': '12373', 'groupId': 'BG001'}, {'value': '30352', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Baseline (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29595', 'groupId': 'BG000'}, {'value': '28242', 'groupId': 'BG001'}, {'value': '57837', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black', 'measurements': [{'value': '3052', 'groupId': 'BG000'}, {'value': '3638', 'groupId': 'BG001'}, {'value': '6690', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23153', 'groupId': 'BG000'}, {'value': '20730', 'groupId': 'BG001'}, {'value': '43883', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1246', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '1933', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2144', 'groupId': 'BG000'}, {'value': '3187', 'groupId': 'BG001'}, {'value': '5331', 'groupId': 'BG002'}]}]}, {'title': 'Intervention (12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31337', 'groupId': 'BG000'}, {'value': '29388', 'groupId': 'BG001'}, {'value': '60725', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black', 'measurements': [{'value': '3672', 'groupId': 'BG000'}, {'value': '3989', 'groupId': 'BG001'}, {'value': '7661', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23385', 'groupId': 'BG000'}, {'value': '20885', 'groupId': 'BG001'}, {'value': '44270', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '685', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '1018', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '3595', 'groupId': 'BG000'}, {'value': '4181', 'groupId': 'BG001'}, {'value': '7776', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.'}], 'populationDescription': 'Overall number of participants reflects the total across baseline and intervention periods.\n\n118,562 patients from 92 hospitals were randomized to a study group; Prior to the to start of the intervention period, 2 hospitals divested from the participating healthcare system, and thus were excluded from Arm 2: CPOE Bundle.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-24', 'size': 818759, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-09T12:32', 'hasProtocol': True}, {'date': '2024-03-29', 'size': 592421, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-09T12:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118562}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2022-06-14', 'resultsFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-22', 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intensive Care Unit (ICU) Transfer [Safety Outcome 1]', 'timeFrame': 'Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods', 'description': "Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection."}, {'measure': 'Length-of-stay [Safety Outcome 2]', 'timeFrame': 'Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods', 'description': 'Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.'}, {'measure': 'Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibiotic Treatment After Empiric Period', 'timeFrame': '12 months', 'description': 'The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14.\n\nNote: this outcome is intended for a secondary manuscript'}, {'measure': 'Empiric and Total Antibiotic Costs', 'timeFrame': '12 months', 'description': 'Empiric and total antibiotic costs for skin and soft tissue infection during hospitalization.\n\nNote: this outcome is intended for a secondary manuscript.'}, {'measure': 'Incidence of Hospital-Onset C. Difficile', 'timeFrame': '12 months', 'description': 'Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14.\n\nNote: this outcome is intended for a secondary manuscript.'}, {'measure': 'Incidence of Hospital-Onset MDRO-Positive Cultures', 'timeFrame': '12 months', 'description': 'Newly-detected hospital-onset MDRO-positive cultures on hospital days ≥4 and ≤14. Includes total MDRO and specific MDRO subsets.\n\nNote: this outcome is intended for a secondary manuscript.'}], 'primaryOutcomes': [{'measure': 'Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day', 'timeFrame': 'First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods', 'description': 'Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.\n\nExtended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.\n\nFor example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.'}], 'secondaryOutcomes': [{'measure': 'Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day', 'timeFrame': 'First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods', 'description': 'Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.\n\nAntipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.\n\nFor example, 2 different antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SST', 'CPOE', 'Empiric Therapy'], 'conditions': ['Skin and Soft Tissue (SST) Infection']}, 'referencesModule': {'references': [{'pmid': '40208610', 'type': 'RESULT', 'citation': 'Gohil SK, Septimus E, Kleinman K, Varma N, Sands KE, Avery TR, Mauricio A, Sljivo S, Rahm R, Roemer K, Cooper WS, McLean LE, Nickolay NG, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith KN, Meador B, Froman A, Eibensteiner K, Hayden MK, Kubiak DW, Burks C, Burgess LH, Calderwood MS, Perlin JB, Platt R, Huang SS. Improving Empiric Antibiotic Selection for Patients Hospitalized With Skin and Soft Tissue Infection: The INSPIRE 3 Skin and Soft Tissue Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):680-691. doi: 10.1001/jamainternmed.2025.0887.'}]}, 'descriptionModule': {'briefSummary': 'The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen.\n\nNote: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Facility Inclusion Criteria:\n\n1. HCA Healthcare hospitals admitting adults for skin and soft tissue infection\n2. Facility use of MEDITECH as their electronic health record system\n\nFacility Exclusion Criteria:\n\n\\-\n\nNote: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age \\>=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.'}, 'identificationModule': {'nctId': 'NCT05423756', 'briefTitle': 'INSPIRE Trial for Skin and Soft Tissue Infections', 'organization': {'class': 'OTHER', 'fullName': 'Harvard Pilgrim Health Care'}, 'officialTitle': 'The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections', 'orgStudyIdInfo': {'id': 'PH000763B_SST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Routine Care', 'description': 'Continuation of routine antibiotic stewardship strategies.', 'interventionNames': ['Other: Arm 1: Routine Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: INSPIRE Stewardship Bundle', 'description': 'Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.', 'interventionNames': ['Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection']}], 'interventions': [{'name': 'Arm 1: Routine Care', 'type': 'OTHER', 'description': 'Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.', 'armGroupLabels': ['Arm 1: Routine Care']}, {'name': 'Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection', 'type': 'OTHER', 'description': 'Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.', 'armGroupLabels': ['Arm 2: INSPIRE Stewardship Bundle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Riverside Community hospital', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '95116', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Regional Medical Center of San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Los Robles Hospital & Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'West Hills Hospital & Medical Center', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Medical Center of Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sky Ridge Medical Center', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '80229', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Suburban Medical Center', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Blake Medical Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Brandon Regional Hospital', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Oak Hill Hospital', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '34223', 'city': 'Englewood', 'state': 'Florida', 'country': 'United States', 'facility': 'Englewood Community Hospital', 'geoPoint': {'lat': 26.96201, 'lon': -82.3526}}, {'zip': '32547', 'city': 'Fort Walton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Fort Walton Beach Medical Center', 'geoPoint': {'lat': 30.42059, 'lon': -86.61707}}, {'zip': '34950', 'city': 'Ft. 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