Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT03349567
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Antimicrobial-Prescribing in Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daniel-livorsi@uiowa.edu', 'phone': '319-688-3871', 'title': 'Daniel Livorsi', 'organization': 'Iowa City VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Because the study was not randomized, we cannot exclude temporal confounding or selection bias. By conducting a time-series analysis, we tried to account for confounders that may change over time, and by including a matched-control group, we tried to minimize the possibility of regression to the mean. Second, we cannot exclude the possibility that sites had any other processes in place that could have influenced our outcomes.'}}, 'adverseEventsModule': {'timeFrame': 'Outcomes were tracked for 30 days after each ED patient visit.', 'description': 'Other adverse events consisted of Clostridioides difficile infections', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Seen at Audit-and-feedback ED Sites During Intervention Period', 'description': 'All patients seen in the EDs undergoing the audit-and-feedback intervention will be considered to have been exposed to the intervention. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at intervention sites.\n\nBecause this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper.', 'otherNumAtRisk': 23164, 'deathsNumAtRisk': 23164, 'otherNumAffected': 11, 'seriousNumAtRisk': 23164, 'deathsNumAffected': 141, 'seriousNumAffected': 1593}, {'id': 'EG001', 'title': 'Patients Seen at Control ED Sites During the Intervention Period', 'description': 'All patients seen in the EDs designated as control sites will be considered to have been part of the control group. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at control sites.\n\nBecause this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper.', 'otherNumAtRisk': 28835, 'deathsNumAtRisk': 28835, 'otherNumAffected': 27, 'seriousNumAtRisk': 28835, 'deathsNumAffected': 176, 'seriousNumAffected': 1863}, {'id': 'EG002', 'title': 'Patients Seen at Audit-and-feedback ED Sites During the Baseline Period', 'description': 'For this adverse event reporting section, we are only reporting ED patient-visits at intervention sites during the baseline period.', 'otherNumAtRisk': 28016, 'deathsNumAtRisk': 28016, 'otherNumAffected': 193, 'seriousNumAtRisk': 28016, 'deathsNumAffected': 146, 'seriousNumAffected': 1810}, {'id': 'EG003', 'title': 'Patients Seen at Control EDs During the Baseline Period', 'description': 'For this adverse event reporting section, we are reporting ED patient-visits at control sites during the baseline period.', 'otherNumAtRisk': 33077, 'deathsNumAtRisk': 33077, 'otherNumAffected': 321, 'seriousNumAtRisk': 33077, 'deathsNumAffected': 197, 'seriousNumAffected': 2031}], 'otherEvents': [{'term': 'Clostridioides difficile infection', 'notes': 'This reflects patients who were diagnosed and treated for an infection with Clostridioides difficile.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23164, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 28835, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 28016, 'numEvents': 28016, 'numAffected': 193}, {'groupId': 'EG003', 'numAtRisk': 33077, 'numEvents': 33077, 'numAffected': 321}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization >24 hours after but within 30 days of ED visit', 'notes': 'Any patient hospitalized more than 24 hours after but within 30 days of ED visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23164, 'numEvents': 1452, 'numAffected': 1452}, {'groupId': 'EG001', 'numAtRisk': 28835, 'numEvents': 1687, 'numAffected': 1687}, {'groupId': 'EG002', 'numAtRisk': 28016, 'numEvents': 1664, 'numAffected': 1664}, {'groupId': 'EG003', 'numAtRisk': 33077, 'numEvents': 1834, 'numAffected': 1834}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mortality > 24 hours after ED visit and within 30 days of visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23164, 'numEvents': 141, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 28835, 'numEvents': 176, 'numAffected': 176}, {'groupId': 'EG002', 'numAtRisk': 28016, 'numEvents': 146, 'numAffected': 146}, {'groupId': 'EG003', 'numAtRisk': 33077, 'numEvents': 197, 'numAffected': 197}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51180', 'groupId': 'OG000'}, {'value': '61,912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28016', 'groupId': 'OG000'}, {'value': '33077', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}]}]}, {'title': 'Intervention period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23164', 'groupId': 'OG000'}, {'value': '28835', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incident rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antimicrobial prescription rates.'}], 'paramType': 'NUMBER', 'timeFrame': 'This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.', 'description': 'This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.', 'unitOfMeasure': 'percentage of visits prescribed an abx', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51180', 'groupId': 'OG000'}, {'value': '61912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28016', 'groupId': 'OG000'}, {'value': '33077', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '36.1'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '31.9'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23164', 'groupId': 'OG000'}, {'value': '28835', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '35.8'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '32.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incident rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.35', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.'}], 'paramType': 'MEDIAN', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider more than 24 hours after but within 30 days of the patient's ED visit.", 'unitOfMeasure': 'percentage of visits exposed to late abx', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51180', 'groupId': 'OG000'}, {'value': '61912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28016', 'groupId': 'OG000'}, {'value': '33077', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.5'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '6.1'}]}]}, {'title': 'Intervention period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23164', 'groupId': 'OG000'}, {'value': '28835', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '6.6'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incident rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.27', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.'}], 'paramType': 'MEDIAN', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Hospitalization is defined as the need for hospitalization for any indication at a VA-facility more than 24 hours after but within 30 days of the patient's index visit to the ED.", 'unitOfMeasure': 'percentage of visits hospitalized', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51180', 'groupId': 'OG000'}, {'value': '61912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28016', 'groupId': 'OG000'}, {'value': '33077', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.8'}]}]}, {'title': 'Intervention period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23164', 'groupId': 'OG000'}, {'value': '28835', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.59', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incident rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.34', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.'}], 'paramType': 'MEDIAN', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit.", 'unitOfMeasure': 'percentage of patient-visits who died', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51180', 'groupId': 'OG000'}, {'value': '61912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28016', 'groupId': 'OG000'}, {'value': '33077', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.2'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.2'}]}]}, {'title': 'Intervention period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23164', 'groupId': 'OG000'}, {'value': '28835', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.7'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incident rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.29', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.'}], 'paramType': 'MEDIAN', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered more than 24 hours after but within 30-days of the patient's ED visit.", 'unitOfMeasure': 'percentage of visits tested', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'For the baseline and intervention periods, this outcome will be reported as the percentage of patients who received guideline-concordant management among the sample of qualifying ED visits that were randomly selected for manual chart review.', 'description': 'This outcome was assessed using blinded manual chart reviews in a randomly selected sample of patients that met inclusion criteria, as outlined in our study protocol. For this reason, the denominators for this outcome will not match the patient counts for the other outcomes. If a patient received an antimicrobial when indicated or did not receive an antimicrobial when not indicated, the patient was deemed to have received guideline-concordant management. During the baseline period, 497 charts were randomly selected for review, and 480 ultimately underwent adjudication. During the intervention period, 576 charts were randomly selected for review, and 455 underwent adjudication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods at intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51180', 'groupId': 'OG000'}, {'value': '61912', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.'}, {'id': 'OG001', 'title': 'Patients Seen in the ED at Control Sites', 'description': 'All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '21.8'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '22.2'}]}]}, {'title': 'Intervention', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '19.6'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '21.9'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antibiotic prescription rates.'}], 'paramType': 'MEDIAN', 'timeFrame': 'This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.', 'description': 'This outcomes is defined as the total number of antibacterial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.', 'unitOfMeasure': '% of visits prescribed an antibiotic', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Audit-and-feedback', 'description': 'The experimental arm will consist of 2 Emergency Departments. We will attempt to enroll all ED providers at our 2 intervention sites, and for the analysis, site-level data will be used.\n\nAudit-and-feedback: We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The control arm will consist of 2 ED sites that do not receive the intervention. For the analysis, the control sites will be analyzed at the site-level.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We performed a quasi-experimental study with an interrupted time-series design and a matched-pair non-equivalent control group. There were 2 intervention sites and 2 control sites; 27/31 providers were enrolled at intervention sites. We measured outcomes in the PATIENTS seen at these 4 EDs. In a difference-in-differences analysis, outcomes were compared across intervention and control sites in patients seen before the intervention period (i.e. baseline) to those during the intervention period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23164', 'groupId': 'BG000'}, {'value': '28835', 'groupId': 'BG001'}, {'value': '28016', 'groupId': 'BG002'}, {'value': '33077', 'groupId': 'BG003'}, {'value': '113092', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites During the Intervention Period', 'description': 'These measures reflect patients seen at audit-and-feedback sites during the intervention period.'}, {'id': 'BG001', 'title': 'Patients Seen in the ED at Control Sites During the Intervention Period', 'description': 'These baseline measures reflect patients seen at control sites during the intervention period.'}, {'id': 'BG002', 'title': 'Patients Seen in the ED at Audit-and-feedback Sites During the Baseline Period', 'description': 'These measures reflect patients seen at audit-and-feedback sites before the intervention period, i.e. during the baseline period.'}, {'id': 'BG003', 'title': 'Patients Seen in the ED at Control Sites During the Baseline Period', 'description': 'These measures reflect patients seen at control sites before the intervention period, i.e. during the baseline period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '62'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '61'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '62'}, {'value': '60', 'groupId': 'BG003', 'lowerLimit': '59', 'upperLimit': '60'}, {'value': '60', 'groupId': 'BG004', 'lowerLimit': '59', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2532', 'groupId': 'BG000'}, {'value': '2627', 'groupId': 'BG001'}, {'value': '3014', 'groupId': 'BG002'}, {'value': '3159', 'groupId': 'BG003'}, {'value': '11332', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '20,632', 'groupId': 'BG000'}, {'value': '26208', 'groupId': 'BG001'}, {'value': '25002', 'groupId': 'BG002'}, {'value': '29918', 'groupId': 'BG003'}, {'value': '101760', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '361', 'groupId': 'BG003'}, {'value': '1144', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}, {'value': '517', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}, {'value': '432', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5106', 'groupId': 'BG000'}, {'value': '2720', 'groupId': 'BG001'}, {'value': '5990', 'groupId': 'BG002'}, {'value': '3215', 'groupId': 'BG003'}, {'value': '17031', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '16343', 'groupId': 'BG000'}, {'value': '23832', 'groupId': 'BG001'}, {'value': '19893', 'groupId': 'BG002'}, {'value': '27323', 'groupId': 'BG003'}, {'value': '87391', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '321', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}, {'value': '467', 'groupId': 'BG003'}, {'value': '1580', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1096', 'groupId': 'BG000'}, {'value': '1229', 'groupId': 'BG001'}, {'value': '1337', 'groupId': 'BG002'}, {'value': '1335', 'groupId': 'BG003'}, {'value': '4997', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '% of total visits prescribed an antimicrobial (monthly median)', 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'BG000', 'lowerLimit': '17.8', 'upperLimit': '20.4'}, {'value': '21.6', 'groupId': 'BG001', 'lowerLimit': '19.9', 'upperLimit': '22.4'}, {'value': '21.2', 'groupId': 'BG002', 'lowerLimit': '20.3', 'upperLimit': '23.7'}, {'value': '20.9', 'groupId': 'BG003', 'lowerLimit': '19.4', 'upperLimit': '23.4'}, {'value': '20.7', 'groupId': 'BG004', 'lowerLimit': '19.4', 'upperLimit': '22.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of visits prescribed an abx', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'These numbers reflect patients seen in the 4 participating EDs during the baseline and intervention periods.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-24', 'size': 267194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-01T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2017-11-17', 'resultsFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-02', 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit', 'timeFrame': 'This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.', 'description': 'This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider more than 24 hours after but within 30 days of the patient's ED visit."}, {'measure': 'Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Hospitalization is defined as the need for hospitalization for any indication at a VA-facility more than 24 hours after but within 30 days of the patient's index visit to the ED."}, {'measure': 'Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit."}, {'measure': 'Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit', 'timeFrame': 'For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.', 'description': "Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered more than 24 hours after but within 30-days of the patient's ED visit."}, {'measure': 'Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management', 'timeFrame': 'For the baseline and intervention periods, this outcome will be reported as the percentage of patients who received guideline-concordant management among the sample of qualifying ED visits that were randomly selected for manual chart review.', 'description': 'This outcome was assessed using blinded manual chart reviews in a randomly selected sample of patients that met inclusion criteria, as outlined in our study protocol. For this reason, the denominators for this outcome will not match the patient counts for the other outcomes. If a patient received an antimicrobial when indicated or did not receive an antimicrobial when not indicated, the patient was deemed to have received guideline-concordant management. During the baseline period, 497 charts were randomly selected for review, and 480 ultimately underwent adjudication. During the intervention period, 576 charts were randomly selected for review, and 455 underwent adjudication.'}, {'measure': 'Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit', 'timeFrame': 'This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.', 'description': 'This outcomes is defined as the total number of antibacterial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-Bacterial Agents', 'Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': "Antimicrobial resistance is one of today's most urgent public health problems. One of the most important strategies to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use. There are tremendous opportunities to reduce unnecessary antimicrobial-prescribing, particularly in Emergency Departments (EDs). In this study, the investigators will work collaboratively with ED providers in the Veterans Health Administration (VHA) to reduce unnecessary antimicrobial use. Academic-detailing and an audit-and-feedback intervention will be implemented, and the study will assess how overall antimicrobial-prescribing changes once these interventions are performed. ED providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions. To assess the impact of this intervention, the study will monitor providers' antimicrobial-prescribing behavior through an automated metric, i.e. number of antimicrobial prescriptions per number of patient-visits. To assess changes in the appropriateness of antimicrobial-prescribing, the study team will also perform manual chart reviews and compare prescribing decisions to published guidelines.", 'detailedDescription': "Using a quasi-experimental design, the study team will work collaboratively with ED providers in the Veterans Health Administration (VHA) to improve antimicrobial-prescribing. Academic-detailing and an audit-and-feedback intervention will be implemented. Through audit-and-feedback, providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions.\n\nThe study will use a pretest-posttest design (quasi-experimental design with a non-equivalent control group) to assess the effect of our pilot intervention at 2 participating EDs and 2 control EDs. For each ED, the pretest period will be the 12 months prior to the intervention. The intervention itself will last 12 months.\n\nThere will be an estimated 30 ED providers at the 2 study sites and 30 ED providers at the 2 control sites. Only antimicrobial prescriptions to patients discharged from the ED will be evaluated.\n\nThe primary outcome will be antimicrobial-prescribing volume adjusted for the total number of patient-visits. Secondary outcomes include the frequency of guideline-discordant antimicrobial-prescribing and adverse events.\n\nAt the conclusion of the pilot trial, a quasi-experimental interrupted time-series (ITS) analysis will be performed to assess the change in monthly antimicrobial usage for the 2 intervention sites combined and the 2 control sites combined. The time frame for this ITS analysis will be the one-year prior to the pilot trial's initiation through the trial's 1-year intervention period for a total of 24 months. In addition, a multivariable analysis will be performed to identify predictors of guideline-discordant therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n--An ED provider at one of the intervention or control sites.\n\nExclusion Criteria:\n\n--An ED provider who sees less than 100 patients in the ED per year.'}, 'identificationModule': {'nctId': 'NCT03349567', 'briefTitle': 'Improving Antimicrobial-Prescribing in Emergency Departments', 'organization': {'class': 'FED', 'fullName': 'Iowa City Veterans Affairs Medical Center'}, 'officialTitle': 'The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study', 'orgStudyIdInfo': {'id': '201708772'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Audit-and-feedback', 'description': 'The experimental arm will consist of Emergency Department providers who do receive the intervention.', 'interventionNames': ['Behavioral: Audit-and-feedback']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control arm will consist of providers who do not receive the intervention.'}], 'interventions': [{'name': 'Audit-and-feedback', 'type': 'BEHAVIORAL', 'otherNames': ['Academic detailing'], 'description': 'We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter.', 'armGroupLabels': ['Audit-and-feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard Roudebush VAMC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sioux Falls VA', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iowa City Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-investigator', 'investigatorFullName': 'Daniel Livorsi', 'investigatorAffiliation': 'Iowa City Veterans Affairs Medical Center'}}}}