Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-25 @ 12:54 AM
Study NCT ID:
NCT02354820
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'webjr@iu.edu', 'phone': '3172786928', 'title': 'William E. Bennett, Jr. Principal Investigator', 'organization': 'Indiana University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management.', 'otherNumAtRisk': 9667, 'otherNumAffected': 0, 'seriousNumAtRisk': 9667, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management.\n\nEvidence Based Constipation Reminders', 'otherNumAtRisk': 6597, 'otherNumAffected': 0, 'seriousNumAtRisk': 6597, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Persistent Constipation Within 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4324', 'groupId': 'OG000'}, {'value': '3153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management.\n\nEvidence Based Constipation Reminders'}], 'classes': [{'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'All visits within 6 months of initial constipation complaint.', 'description': 'Parents are asked if constipation is still present at a subsequent visit within 6 months.', 'unitOfMeasure': 'participants with persistent symptoms', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management.'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management.\n\nEvidence Based Constipation Reminders'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9667'}, {'groupId': 'FG001', 'numSubjects': '6597'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9667'}, {'groupId': 'FG001', 'numSubjects': '6597'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9667', 'groupId': 'BG000'}, {'value': '6597', 'groupId': 'BG001'}, {'value': '16264', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management.'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management.\n\nEvidence Based Constipation Reminders'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9667', 'groupId': 'BG000'}, {'value': '6597', 'groupId': 'BG001'}, {'value': '16264', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '9'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '9'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4752', 'groupId': 'BG000'}, {'value': '3283', 'groupId': 'BG001'}, {'value': '8035', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4915', 'groupId': 'BG000'}, {'value': '3314', 'groupId': 'BG001'}, {'value': '8229', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '4431', 'groupId': 'BG000'}, {'value': '3447', 'groupId': 'BG001'}, {'value': '7878', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '907', 'groupId': 'BG000'}, {'value': '683', 'groupId': 'BG001'}, {'value': '1590', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4329', 'groupId': 'BG000'}, {'value': '2467', 'groupId': 'BG001'}, {'value': '6796', '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': 'Symptoms of constipation', 'classes': [{'categories': [{'measurements': [{'value': '612', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '1044', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2015-01-26', 'resultsFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-19', 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Persistent Constipation Within 6 Months', 'timeFrame': 'All visits within 6 months of initial constipation complaint.', 'description': 'Parents are asked if constipation is still present at a subsequent visit within 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Constipation', 'Encopresis']}, 'descriptionModule': {'briefSummary': 'This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN.\n* Patients given a pre-screener form as part of the existing CHICA decision support system.\n* Age between 2 years and 12 years, inclusive.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT02354820', 'acronym': 'CHICA-GI', 'briefTitle': 'Child Health Improvement Through Computer Automation of Constipation Management in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Child Health Improvement Through Computer Automation of Constipation Management in Primary Care', 'orgStudyIdInfo': {'id': 'CHICA-GI Constipation'}, 'secondaryIdInfos': [{'id': 'K23DK098235', 'link': 'https://reporter.nih.gov/quickSearch/K23DK098235', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management.', 'interventionNames': ['Other: Evidence Based Constipation Reminders']}], 'interventions': [{'name': 'Evidence Based Constipation Reminders', 'type': 'OTHER', 'armGroupLabels': ['Experimental']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William E. Bennett, Jr.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'William E. Bennett, Jr.', 'investigatorAffiliation': 'Indiana University School of Medicine'}}}}