Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT02633735
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elyse.o.kharbanda@healthpartners.com', 'phone': '952-967-5038', 'title': 'Elyse Kharbanda', 'organization': 'HealthPartners Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Within 7 days of index ED visit.', 'description': 'The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Appy CDS Intervention', 'description': 'The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The Appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.\n\nPost Appy Clinical Decision Support: The Appy CDS is a point of care clinical decision support system that provides the provider with 1) risk for appendicitis based on EHR data, 2) recommendations on actions to take based on risk, 3) advises on imaging use.', 'otherNumAtRisk': 3161, 'deathsNumAtRisk': 3161, 'otherNumAffected': 222, 'seriousNumAtRisk': 3161, 'deathsNumAffected': 0, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'Control', 'description': 'People in the control arm receive usual care.', 'otherNumAtRisk': 2779, 'deathsNumAtRisk': 2779, 'otherNumAffected': 224, 'seriousNumAtRisk': 2779, 'deathsNumAffected': 0, 'seriousNumAffected': 109}], 'otherEvents': [{'term': 'Return to ED within 7 days of index', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3161, 'numAffected': 222}, {'groupId': 'EG001', 'numAtRisk': 2779, 'numAffected': 224}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Appendiceal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Negative appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 365, 'numAffected': 27}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Missed appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3161, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2779, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre to Post Ratio of Image Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '3161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Usual care'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.\n\nappy-cds: See description under arm/group section'}], 'classes': [{'title': 'CT Use', 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '.92', 'upperLimit': '1.4'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '.97', 'upperLimit': '1.17'}]}]}, {'title': 'US Use', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '.92', 'upperLimit': '1.16'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '.91', 'upperLimit': '1.12'}]}]}, {'title': 'All Imaging Use', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '.98', 'upperLimit': '1.14'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '.94', 'upperLimit': '1.11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-intervention of 8 months (average), and post intervention of 23 months', 'description': 'First, we evaluated whether patient characteristics (age, sex, race/ethnicity) differed by study arm and phase using frequency distributions, means and standard deviations. Second, we estimated use of imaging for CT, US and CT or US by study arm and phase. We evaluated the effectiveness of AppyCDS by estimating the ratio of ratios (ROR) and 95% confidence intervals (CI) of intervention arm, from pre-intervention phase to intervention phase as compared to UC arm over the two study phases, for all imaging outcomes.', 'unitOfMeasure': 'ratio of pre-post use', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers are sum of subjects in pre-implementation and implementation phases.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Usual care'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.\n\nappy-cds: See description under arm/group section'}], 'periods': [{'title': 'Pre-implementation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '788'}, {'groupId': 'FG001', 'numSubjects': '1011'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '788'}, {'groupId': 'FG001', 'numSubjects': '1011'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Implementation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1991'}, {'groupId': 'FG001', 'numSubjects': '2150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1991'}, {'groupId': 'FG001', 'numSubjects': '2150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'ED Sites were randomized to the AppyCDS intervention or usual care (UC). Sites were stratified by health system and then grouped on patterns of pediatric referral and provider cross coverage. EDs or groups of EDs were sorted into pairs by estimated pediatric patient volume. Study phases were consistent but date ranges varied by health system.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'BG000'}, {'value': '3161', 'groupId': 'BG001'}, {'value': '5940', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Usual care'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.\n\nappy-cds: See description under arm/group section'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '11.9', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '11.8', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1512', 'groupId': 'BG000'}, {'value': '1780', 'groupId': 'BG001'}, {'value': '3292', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1267', 'groupId': 'BG000'}, {'value': '1381', 'groupId': 'BG001'}, {'value': '2648', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '788', 'groupId': 'BG000'}, {'value': '1104', 'groupId': 'BG001'}, {'value': '1892', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1991', 'groupId': 'BG000'}, {'value': '2057', 'groupId': 'BG001'}, {'value': '4048', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '875', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2000', 'groupId': 'BG000'}, {'value': '2059', 'groupId': 'BG001'}, {'value': '4059', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline characteristics reflect the sum of participants who completed the pre-implementation and implementation phase in both study arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-06', 'size': 2641055, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-13T12:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel cluster-randomized clinical trial at 14 general EDs in two large care system to evaluate the impact of appy-CDS intervention with a pre and post intervention phases'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5940}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2015-11-24', 'resultsFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-26', 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre to Post Ratio of Image Use', 'timeFrame': 'pre-intervention of 8 months (average), and post intervention of 23 months', 'description': 'First, we evaluated whether patient characteristics (age, sex, race/ethnicity) differed by study arm and phase using frequency distributions, means and standard deviations. Second, we estimated use of imaging for CT, US and CT or US by study arm and phase. We evaluated the effectiveness of AppyCDS by estimating the ratio of ratios (ROR) and 95% confidence intervals (CI) of intervention arm, from pre-intervention phase to intervention phase as compared to UC arm over the two study phases, for all imaging outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support'], 'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '33560426', 'type': 'DERIVED', 'citation': "Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Dehmer SP, Ekstrom H, Rauchwerger AS, McMichael B, Cotton DM, Kene MV, Simon LE, Zhu J, Warton EM, O'Connor PJ, Kharbanda EO; Clinical Research on Emergency Services and Treatments Network (CREST) and the Critical Care Research Center, HealthPartners Institute. Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036344. doi: 10.1001/jamanetworkopen.2020.36344."}, {'pmid': '31229394', 'type': 'DERIVED', 'citation': 'Cotton DM, Vinson DR, Vazquez-Benitez G, Margaret Warton E, Reed ME, Chettipally UK, Kene MV, Lin JS, Mark DG, Sax DR, McLachlan ID, Rauchwerger AS, Simon LE, Kharbanda AB, Kharbanda EO, Ballard DW; Clinical Research on Emergency Services and Treatments (CREST) Network. Validation of the Pediatric Appendicitis Risk Calculator (pARC) in a Community Emergency Department Setting. Ann Emerg Med. 2019 Oct;74(4):471-480. doi: 10.1016/j.annemergmed.2019.04.023. Epub 2019 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes.\n\nThe proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.', 'detailedDescription': 'Abdominal pain is one of the most common reasons for children and adolescents to seek care in the emergency department (ED). Computed tomography (CT) has been promoted as a method to improve diagnostic accuracy when evaluating patients with acute abdominal pain. In the past 20 years, CT use has increased dramatically, especially for children receiving care in general ED settings. Although in some adult cohorts, increased CT use has been associated with decreased rates of negative appendectomies, similar improvements in health outcomes among children with acute abdominal pain have not occurred. Negative consequences of CT include increased costs and substantial exposure to ionizing radiation.\n\nAlthough appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered.\n\nThe proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. This cluster randomized trial builds on more than 10 years of work on derivation and validation of ED-based clinical decision rules, previous successful outpatient and emergency department clinical decision support interventions, and complex economic and statistical analyses of risk assessment and ED resource use. In this project, the investigators aim to extend the benefits of previous efforts by developing and implementing an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain. The results of this project will extend the understanding of how to maximize the clinical return on massive public and private sector investments being made in sophisticated EHR systems. If successful, this flexible decision support tool could be adapted and implemented broadly in a range of acute care settings to both standardize and personalize care delivered to pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children and adolescents ages 5-20 years with abdominal pain\n* internal med, family med, or emergency med trained providers at participating EDs\n\nExclusion Criteria:\n\n* select comorbid conditions\n* previous abdominal surgery\n* treated for select comorbid conditions'}, 'identificationModule': {'nctId': 'NCT02633735', 'acronym': 'Appy-CDS', 'briefTitle': 'EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care', 'orgStudyIdInfo': {'id': '14-025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Appy CDS', 'description': 'The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The intervention is administered to providers in this arm.', 'interventionNames': ['Other: Appy CDS']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Appy CDS', 'type': 'OTHER', 'description': 'See description under arm/group section', 'armGroupLabels': ['Appy CDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '55440', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Medical Group', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Elyse O Kharbanda, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}, {'name': 'Anupam B Kharbanda, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and Clinics of Minnesota"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': "Children's Hospitals and Clinics of Minnesota", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}