Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-19 @ 2:56 AM
Study NCT ID:
NCT02753751
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimizing Electronic Alerts for Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'francis.p.wilson@yale.edu', 'phone': '2037376095', 'title': 'Francis P. Wilson', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Randomization occurred at the patient level, potentially biasing the results towards the null hypothesis.\n\nThe alert was largely informational with no patient-specific recommendations.\n\nThe alert was only sent to certain care providers, notably excluding nurses and pharmacists, who might specifically benefit from receipt of the alert.\n\nThe alert was conducted across six hospitals within a single large health system in the Northeastern United States, limiting generalizability.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study (22 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'No alert will be fired.', 'otherNumAtRisk': 2971, 'deathsNumAtRisk': 2971, 'otherNumAffected': 0, 'seriousNumAtRisk': 2971, 'deathsNumAffected': 265, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.', 'otherNumAtRisk': 3059, 'deathsNumAtRisk': 3059, 'otherNumAffected': 0, 'seriousNumAtRisk': 3059, 'deathsNumAffected': 272, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'categories': [{'measurements': [{'value': '622', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.13', 'pValueComment': 'A p-value of \\<=0.04 was considered statistically significant to account for the interim analysis.', 'groupDescription': 'In our retrospective analysis of patients with AKI at 3 potential study hospitals, the composite outcome was 24.5%. A clinically meaningful relative reduction in this risk would be 20%. 5,024 patients (2,512 in each group) would have 90% power to detect a difference in outcome at least this extreme at a two-sided alpha of 0.05 as calculated using the Cochran-Mantel-Haenszel test. We have elected to increase this number by 20% to account for potential contamination.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The Mantel-Haenszel test was used, accounting for each hospital as an individual stratum, and to obtain the pooled relative risks across hospitals without adjusting for other baseline factors. (Alert arm is the numerator, control arm is the denominator.) Patients discharged prior to 14 days without an outcome of interest were assumed to be free of that outcome at 14 days. A p-value of \\<=0.04 was considered statistically significant to account for the interim analysis.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days from randomization', 'description': 'Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization.\n\nDialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.\n\nMortality will be determined from hospital administrative records.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days from randomization', 'description': '14-day or inpatient mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days from randomization', 'description': '14-day, inpatient, or discharged on dialysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AKI Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days from randomization', 'description': 'Percent of patients who progress to stage 2 AKI and to stage 3 AKI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AKI Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'title': '<2 days', 'categories': [{'measurements': [{'value': '2108', 'groupId': 'OG000'}, {'value': '2239', 'groupId': 'OG001'}]}]}, {'title': '2-<7 days', 'categories': [{'measurements': [{'value': '722', 'groupId': 'OG000'}, {'value': '700', 'groupId': 'OG001'}]}]}, {'title': '7+ days', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days from randomization', 'description': 'Number of participants with AKI duration of \\<2 days, 2-\\<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Readmission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'timeFrame': '30 days from randomization', 'description': '30 day readmission rate', 'reportingStatus': 'POSTED', 'populationDescription': 'Data have not yet been collected.'}, {'type': 'SECONDARY', 'title': 'Index Hospitalization Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'title': 'Direct Costs', 'categories': [{'measurements': [{'value': '10300', 'groupId': 'OG000', 'lowerLimit': '5400', 'upperLimit': '21900'}, {'value': '10600', 'groupId': 'OG001', 'lowerLimit': '5400', 'upperLimit': '22800'}]}]}, {'title': 'Total Costs', 'categories': [{'measurements': [{'value': '19100', 'groupId': 'OG000', 'lowerLimit': '9900', 'upperLimit': '42500'}, {'value': '20100', 'groupId': 'OG001', 'lowerLimit': '10200', 'upperLimit': '43600'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Index hospitalization through discharge, up to one year', 'description': 'Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.', 'unitOfMeasure': 'dollars', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'title': 'IV fluid drip order', 'categories': [{'measurements': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1174', 'groupId': 'OG001'}]}]}, {'title': 'IV fluid bolus order', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '444', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}]}, {'title': 'Urine Output Measurement', 'categories': [{'measurements': [{'value': '2130', 'groupId': 'OG000'}, {'value': '2242', 'groupId': 'OG001'}]}]}, {'title': 'Subsequent Creatinine Measurement (28 hours)', 'categories': [{'measurements': [{'value': '2532', 'groupId': 'OG000'}, {'value': '2666', 'groupId': 'OG001'}]}]}, {'title': 'Renal Consult (within 14 days)', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}]}, {'title': 'Contrast exposure', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Aminoglycoside exposure', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Aminoglycoside exposure among those already receiving aminoglycoside', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'NSAID exposure', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'NSAID exposure among those already receiving NSAIDs', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'ACE/ARB exposure', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}]}, {'title': 'ACE/ARB exposure among those already receiving ACE/ARB', 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}]}, {'title': 'AKI documentation (at end of encounter)', 'categories': [{'measurements': [{'value': '1871', 'groupId': 'OG000'}, {'value': '2141', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours from randomization to discharge, up to one year', 'description': 'Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization.\n\nEach metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Chart Documentation of AKI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'OG000'}, {'value': '3059', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'OG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'classes': [{'categories': [{'measurements': [{'value': '1871', 'groupId': 'OG000'}, {'value': '2141', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Index hospitalization', 'description': 'Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Chart documentation via ICD-10 codes (code N17) have been collected. Documentation via chart adjudication has not yet been collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'FG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2971'}, {'groupId': 'FG001', 'numSubjects': '3059'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2971'}, {'groupId': 'FG001', 'numSubjects': '3059'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From 3/29/2018 to 12/14/2019, 6,030 individuals met enrollment criteria and were randomized across 6 hospitals of a single healthcare system.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2971', 'groupId': 'BG000'}, {'value': '3059', 'groupId': 'BG001'}, {'value': '6030', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'No alert will be fired.'}, {'id': 'BG001', 'title': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.\n\nAKI Alert: Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'groupId': 'BG000', 'lowerLimit': '59.4', 'upperLimit': '81.6'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '81.7'}, {'value': '71.2', 'groupId': 'BG002', 'lowerLimit': '59.2', 'upperLimit': '81.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1440', 'groupId': 'BG000'}, {'value': '1442', 'groupId': 'BG001'}, {'value': '2882', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1531', 'groupId': 'BG000'}, {'value': '1617', 'groupId': 'BG001'}, {'value': '3148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '331', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2664', 'groupId': 'BG000'}, {'value': '2712', 'groupId': 'BG001'}, {'value': '5376', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '462', 'groupId': 'BG000'}, {'value': '484', 'groupId': 'BG001'}, {'value': '946', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2208', 'groupId': 'BG000'}, {'value': '2234', 'groupId': 'BG001'}, {'value': '4442', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': 'NA', 'comment': 'Was not collected. Collected primary race only.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Was not collected. Collected primary race only.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2971', 'groupId': 'BG000'}, {'value': '3059', 'groupId': 'BG001'}, {'value': '6030', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medical Admission', 'classes': [{'categories': [{'measurements': [{'value': '2280', 'groupId': 'BG000'}, {'value': '2284', 'groupId': 'BG001'}, {'value': '4564', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ICU Patient', 'classes': [{'categories': [{'measurements': [{'value': '961', 'groupId': 'BG000'}, {'value': '962', 'groupId': 'BG001'}, {'value': '1923', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ER Patient', 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ward Patient', 'classes': [{'categories': [{'measurements': [{'value': '1902', 'groupId': 'BG000'}, {'value': '2004', 'groupId': 'BG001'}, {'value': '3906', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital 1 (Urban, teaching)', 'classes': [{'categories': [{'measurements': [{'value': '1238', 'groupId': 'BG000'}, {'value': '1277', 'groupId': 'BG001'}, {'value': '2515', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital 2 (Urban, teaching)', 'classes': [{'categories': [{'measurements': [{'value': '599', 'groupId': 'BG000'}, {'value': '649', 'groupId': 'BG001'}, {'value': '1248', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital 3 (Urban, teaching)', 'classes': [{'categories': [{'measurements': [{'value': '456', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '935', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital 4 (Suburban, teaching)', 'classes': [{'categories': [{'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '567', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital 5 (Suburban, non-teaching)', 'classes': [{'categories': [{'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital 6 (Suburban, non-teaching)', 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Kidney Disease', 'classes': [{'categories': [{'measurements': [{'value': '1127', 'groupId': 'BG000'}, {'value': '1163', 'groupId': 'BG001'}, {'value': '2290', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive Heart Failure', 'classes': [{'categories': [{'measurements': [{'value': '1307', 'groupId': 'BG000'}, {'value': '1351', 'groupId': 'BG001'}, {'value': '2658', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COPD', 'classes': [{'categories': [{'measurements': [{'value': '1015', 'groupId': 'BG000'}, {'value': '1049', 'groupId': 'BG001'}, {'value': '2064', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Mellitus', 'classes': [{'categories': [{'measurements': [{'value': '1197', 'groupId': 'BG000'}, {'value': '1287', 'groupId': 'BG001'}, {'value': '2484', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '2434', 'groupId': 'BG000'}, {'value': '2510', 'groupId': 'BG001'}, {'value': '4944', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Malignancy', 'classes': [{'categories': [{'measurements': [{'value': '471', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '931', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Depression', 'classes': [{'categories': [{'measurements': [{'value': '687', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '1342', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Liver Disease', 'classes': [{'categories': [{'measurements': [{'value': '397', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '855', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'eGFR at admission (ml/min/1.73m2)', 'classes': [{'categories': [{'measurements': [{'value': '55.1', 'groupId': 'BG000', 'lowerLimit': '34.2', 'upperLimit': '84.4'}, {'value': '55.8', 'groupId': 'BG001', 'lowerLimit': '36.6', 'upperLimit': '83.5'}, {'value': '55.4', 'groupId': 'BG002', 'lowerLimit': '35.3', 'upperLimit': '83.9'}]}]}], 'paramType': 'MEDIAN', 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[{'measurements': [{'value': '138', 'groupId': 'BG000', 'lowerLimit': '135', 'upperLimit': '141'}, {'value': '138', 'groupId': 'BG001', 'lowerLimit': '135', 'upperLimit': '141'}, {'value': '138', 'groupId': 'BG002', 'lowerLimit': '135', 'upperLimit': '141'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Potassium, meq/L', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'BG000', 'lowerLimit': '3.8', 'upperLimit': '4.6'}, {'value': '4.2', 'groupId': 'BG001', 'lowerLimit': '3.8', 'upperLimit': '4.6'}, {'value': '4.2', 'groupId': 'BG002', 'lowerLimit': '3.8', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Chloride, meq/L', 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000', 'lowerLimit': '98', 'upperLimit': '106'}, {'value': '102', 'groupId': 'BG001', 'lowerLimit': '98', 'upperLimit': '106'}, {'value': '102', 'groupId': 'BG002', 'lowerLimit': '98', 'upperLimit': '106'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Bicarbonate, meq/L', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '27'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '27'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Anion Gap, meq/L', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '14'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '15'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Blood Urea Nitrogen, mg/dL', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '42'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '40'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'White Blood Cell Count, (cells*1000/ul)', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'BG000', 'lowerLimit': '7.2', 'upperLimit': '13.5'}, {'value': '9.8', 'groupId': 'BG001', 'lowerLimit': '7.2', 'upperLimit': '13.8'}, {'value': '9.8', 'groupId': 'BG002', 'lowerLimit': '7.2', 'upperLimit': '13.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells*1000/uL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hemoglobin, g/dL', 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '12.3'}, {'value': '10.5', 'groupId': 'BG001', 'lowerLimit': '8.9', 'upperLimit': '12.3'}, {'value': '10.6', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '12.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Platelet Count, (cells*1000/ul)', 'classes': [{'categories': [{'measurements': [{'value': '202.5', 'groupId': 'BG000', 'lowerLimit': '149', 'upperLimit': '266'}, {'value': '200', 'groupId': 'BG001', 'lowerLimit': '144', 'upperLimit': '266'}, {'value': '201', 'groupId': 'BG002', 'lowerLimit': '146', 'upperLimit': '266'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells*1000/ul', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Contrast in prior 72 hours', 'classes': [{'categories': [{'measurements': [{'value': '586', 'groupId': 'BG000'}, {'value': '623', 'groupId': 'BG001'}, {'value': '1209', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiothoracic surgery in prior 72 hours', 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ACE inhibitor/ARB in prior 72 hours', 'classes': [{'categories': [{'measurements': [{'value': '626', 'groupId': 'BG000'}, {'value': '670', 'groupId': 'BG001'}, {'value': '1296', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NSAID in prior 72 hours', 'classes': [{'categories': [{'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '791', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PPI in prior 72 hours', 'classes': [{'categories': [{'measurements': [{'value': '684', 'groupId': 'BG000'}, {'value': '677', 'groupId': 'BG001'}, {'value': '1361', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from admission to randomization, hours', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'BG000', 'lowerLimit': '28.8', 'upperLimit': '104.3'}, {'value': '50.1', 'groupId': 'BG001', 'lowerLimit': '29.8', 'upperLimit': '101.0'}, {'value': '50.3', 'groupId': 'BG002', 'lowerLimit': '29.3', 'upperLimit': '103.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Time from AKI to randomization, hours', 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'BG000', 'lowerLimit': '0.2', 'upperLimit': '1.3'}, {'value': '0.5', 'groupId': 'BG001', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0.2', 'upperLimit': '1.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Unique providers reached', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '13'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '13'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Providers', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-24', 'size': 296846, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-17T17:50', 'hasProtocol': True}, {'date': '2020-08-21', 'size': 222584, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-17T17:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6030}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2016-04-25', 'resultsFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-18', 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Progression of AKI, Inpatient Dialysis, or Inpatient Death', 'timeFrame': '14 days from randomization', 'description': 'Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization.\n\nDialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.\n\nMortality will be determined from hospital administrative records.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '14 days from randomization', 'description': '14-day or inpatient mortality'}, {'measure': 'Dialysis', 'timeFrame': '14 days from randomization', 'description': '14-day, inpatient, or discharged on dialysis'}, {'measure': 'AKI Progression', 'timeFrame': '14 days from randomization', 'description': 'Percent of patients who progress to stage 2 AKI and to stage 3 AKI'}, {'measure': 'AKI Duration', 'timeFrame': '14 days from randomization', 'description': 'Number of participants with AKI duration of \\<2 days, 2-\\<days, and 7+ days (Aki duration defined as time in days between AKI onset and AKI cessation during index hospitalization)'}, {'measure': 'Readmission Rate', 'timeFrame': '30 days from randomization', 'description': '30 day readmission rate'}, {'measure': 'Index Hospitalization Cost', 'timeFrame': 'Index hospitalization through discharge, up to one year', 'description': 'Cost of index hospitalization, measured in direct and total costs. Direct costs reflect those associated with direct patient contact involving billable services (for example lab, nursing costs, and supplies). Total costs also include non-billable support services such as medical records, human resources, accounting, support staff, utilities and dietary costs.'}, {'measure': 'Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization', 'timeFrame': '24 hours from randomization to discharge, up to one year', 'description': 'Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV contrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization.\n\nEach metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.'}, {'measure': 'Number of Subjects With Chart Documentation of AKI', 'timeFrame': 'Index hospitalization', 'description': 'Proportion of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '25726515', 'type': 'BACKGROUND', 'citation': 'Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.'}, {'pmid': '40832403', 'type': 'DERIVED', 'citation': 'Wissel BD, Percy Z, Zachem TJ, Beaulieu-Jones B, Kohane IS, Goldstein SL, Gecili E, Dexheimer JW. Heterogeneous Effect of Automated Alerts on Mortality. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333302. doi: 10.1101/2025.08.11.25333302.'}, {'pmid': '33461986', 'type': 'DERIVED', 'citation': 'Wilson FP, Martin M, Yamamoto Y, Partridge C, Moreira E, Arora T, Biswas A, Feldman H, Garg AX, Greenberg JH, Hinchcliff M, Latham S, Li F, Lin H, Mansour SG, Moledina DG, Palevsky PM, Parikh CR, Simonov M, Testani J, Ugwuowo U. Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. BMJ. 2021 Jan 18;372:m4786. doi: 10.1136/bmj.m4786.'}, {'pmid': '31154298', 'type': 'DERIVED', 'citation': 'Mutter M, Martin M, Yamamoto Y, Biswas A, Etropolski B, Feldman H, Garg A, Gourlie N, Latham S, Lin H, Palevsky PM, Parikh C, Moreira E, Ugwuowo U, Wilson FP. Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale. BMJ Open. 2019 Jun 1;9(5):e025117. doi: 10.1136/bmjopen-2018-025117.'}], 'seeAlsoLinks': [{'url': 'http://akistudy.org', 'label': 'This link is displayed on the alert and is our clinical trial study website. It contains information about the trial, describes AKI best practices, and provides contact information.'}]}, 'descriptionModule': {'briefSummary': 'This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.', 'detailedDescription': 'Acute kidney injury (AKI) carries a significant, independent risk of mortality among hospitalized patients. Recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. International guidelines for the treatment of AKI focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. Early nephrologist involvement may also improve outcomes in AKI. Without appropriate provider recognition of AKI, however, none of these measures can be taken, and patient outcomes may suffer. AKI is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden.\n\nThe investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. The trial, which randomized 2400 patients with AKI as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of AKI did not improve the course of acute kidney injury, reduce dialysis or death rates. However this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. In the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness.\n\nThis study will be a randomized, controlled trial of an electronic AKI alert system. Using the Kidney Disease: Improve Global Outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. The primary outcome will be a composite of progression of acute kidney injury, dialysis and death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 18 years admitted to a participating study hospital\n* Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).\n\nExclusion Criteria:\n\n* ESKD diagnosis code\n* Dialysis order prior to AKI onset\n* Initial creatinine \\>=4.0mg/dl\n* Prior admission in which patient was randomized.\n* Admission to hospice service or comfort measures only order\n* Kidney transplant within 6 months'}, 'identificationModule': {'nctId': 'NCT02753751', 'briefTitle': 'Optimizing Electronic Alerts for Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Optimizing Electronic Alerts for Acute Kidney Injury', 'orgStudyIdInfo': {'id': '1604017596'}, 'secondaryIdInfos': [{'id': 'YALEAKIALERT', 'type': 'OTHER', 'domain': 'former unique ID'}, {'id': '1R01DK113191-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK113191-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'No alert will be fired.'}, {'type': 'EXPERIMENTAL', 'label': 'Electronic AKI Alert', 'description': 'A pop-up alert will fire when a provider opens the electronic health record of a patient with AKI until such time as AKI is documented in the problem list, or AKI resolves.', 'interventionNames': ['Other: AKI Alert']}], 'interventions': [{'name': 'AKI Alert', 'type': 'OTHER', 'description': 'Provider\'s will receive a "pop-up" alert in the electronic health record until AKI is documented in the problem list or AKI resolves.', 'armGroupLabels': ['Electronic AKI Alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Francis P Wilson, MD MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available within one year of completion.', 'ipdSharing': 'YES', 'description': 'De-identified aggregate data for the primary and secondary outcomes will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}