Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT01312805
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2011-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aaecarro@iu.edu', 'phone': '3172789616', 'title': 'Aaron E. Carroll, MD, MS', 'organization': 'Indiana University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CHICA Control', 'description': 'This arm received CHICA without the asthma module\n\nCHICA Control: This is CHICA without the asthma module, and was used as a control', 'otherNumAtRisk': 1016, 'otherNumAffected': 0, 'seriousNumAtRisk': 1016, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CHICA Asthma Module', 'description': 'This arm received the CHICA asthma module\n\nCHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma', 'otherNumAtRisk': 1082, 'otherNumAffected': 0, 'seriousNumAtRisk': 1082, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnosis Rate of Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1010', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CHICA Control', 'description': 'This arm received CHICA without the asthma module\n\nCHICA Control: This is CHICA without the asthma module, and was used as a control'}, {'id': 'OG001', 'title': 'CHICA Asthma Module', 'description': 'This arm received the CHICA asthma module\n\nCHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We excluded those participants who had a previous diagnosis of asthma in the 14 months before the start of the study. This left the numbers seen above.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHICA Control', 'description': 'This arm received CHICA without the asthma module\n\nCHICA Control: This is CHICA without the asthma module, and was used as a control'}, {'id': 'FG001', 'title': 'CHICA Asthma Module', 'description': 'This arm received the CHICA asthma module\n\nCHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1016'}, {'groupId': 'FG001', 'numSubjects': '1082'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1016'}, {'groupId': 'FG001', 'numSubjects': '1082'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1016', 'groupId': 'BG000'}, {'value': '1082', 'groupId': 'BG001'}, {'value': '2098', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CHICA Control', 'description': 'This arm received CHICA without the asthma module\n\nCHICA Control: This is CHICA without the asthma module, and was used as a control'}, {'id': 'BG001', 'title': 'CHICA Asthma Module', 'description': 'This arm received the CHICA asthma module\n\nCHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1016', 'groupId': 'BG000'}, {'value': '1082', 'groupId': 'BG001'}, {'value': '2098', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '515', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1045', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '501', 'groupId': 'BG000'}, {'value': '552', 'groupId': 'BG001'}, {'value': '1053', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2098}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2011-03-09', 'resultsFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-08', 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis Rate of Asthma', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'clinical decision support', 'CHICA'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study seeks to improve physician adherence to four recommendations of the NHLBI asthma treatment guidelines:\n\n1. Improve case detection of asthma among patients with pulmonary symptoms,\n2. Grade all asthma patients asthma, identifying those with persistent versus intermittent asthma,\n3. Improve rates of use of controller medications - particularly inhaled steroids - among patients with persistent asthma,\n4. Provide an asthma treatment plan for all asthma patients.', 'detailedDescription': 'Objectives: Improve physician adherence to four recommendations of the NHLBI asthma treatment guidelines:\n\n1. Improve case detection of asthma among patients with pulmonary symptoms,\n2. Grade all asthma patients asthma, identifying those with persistent versus intermittent asthma,\n3. Improve rates of use of controller medications - particularly inhaled steroids - among patients with persistent asthma,\n4. Provide an asthma treatment plan for all asthma patients.\n\nDesign: This will be a randomized controlled trial. Patients registering for appointments at the PCC Pediatric clinic will be randomized to an intervention or control arm. Patients in the intervention arm, and the physicians who see them, will receive the full intervention. Patients in the control arm will receive usual care.\n\nIntervention: The CHICA computer system has been in regular use at the PCC Pediatrics clinic since November 4, 2004. At patient check-in, CHICA produces a health survey that parents complete in the weighting room. The survey is scanned into CHICA before the physician encounter. CHICA produces a worksheet for the physician that includes prompts and reminders based date from the health survey and the electronic medical record. The completer worksheet is scanned back into CHICA. Intervention and control groups will continue to use this system\n\nIn the intervention group, CHICA will include a question asking for the presence of asthma or asthma symptoms on the health survey. If the family responds that asthma or symptoms of asthma are present, CHICA will:\n\n1. Alert the physician and ask him or her to confirm or deny the presence of asthma and to rate the asthma as persistent or intermittent,\n2. Generate a chart showing the criteria for each asthma grade,\n3. Recommend controller medications if the patient has persistent asthma and ask the physician to document if controllers were prescribed,\n4. Generate a partially completed treatment plan for the physician to complete and give to the patient.\n\nFor patients confirmed to have asthma, CHICA will place a question on the health survey at subsequent visits that assesses symptoms. For patients who have been prescribed controller medications, CHICA will put a question on the health survey asking about patient adherence to the medication. The physician worksheet will alert the physician to changes in the patient\'s symptom status or to non-adherence to controller medication, in compliance with NHLBI guidelines.\n\nOutcome Measures: To determine the rates of asthma case finding in the intervention and control groups, we will pull the RMRS electronic records of all patients seen during the first 6 months of the trial and determine the prevalence of diagnoses for asthma (ICD-9 code equal to 493.\\*).\n\nAfter 6 months of running the trial, we will randomly select from those patients in the trial who have an ICD-9 diagnosis of asthma (493.\\*), 75 patients from the intervention group and 75 patients from the control group. The paper "shadow" charts for these patients will be pulled from the chart room at the PCC Pediatrics clinic. Trained chart reviewers will document the following:\n\n1. Has the patient\'s asthma been graded as intermittent or persistent?\n2. Is there documentation of an asthma treatment plan?\n3. Has the patient been prescribed a controller medication?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Families who visit the Wishard/IUMG Primary Care Center (PCC) pediatric clinic are eligible for our study. Families are randomly assigned to either the control or intervention group, where they will remain for the study's duration. No blocking or other methods of stratification are used. There are no additional exclusion criteria. Data collection will occur for a minimum of 6 months and not to exceed two years\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT01312805', 'briefTitle': 'Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting', 'orgStudyIdInfo': {'id': 'CHICA_Asthma_Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHICA Control', 'description': 'This arm received CHICA without the asthma module', 'interventionNames': ['Other: CHICA Control']}, {'type': 'EXPERIMENTAL', 'label': 'CHICA Asthma Module', 'description': 'This arm received the CHICA asthma module', 'interventionNames': ['Other: CHICA Asthma Module']}], 'interventions': [{'name': 'CHICA Asthma Module', 'type': 'OTHER', 'description': 'This module was added to CHICA to help diagnose and manage asthma', 'armGroupLabels': ['CHICA Asthma Module']}, {'name': 'CHICA Control', 'type': 'OTHER', 'description': 'This is CHICA without the asthma module, and was used as a control', 'armGroupLabels': ['CHICA Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Wishard Primary Care Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Aaron E Carroll, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Aaron Carroll', 'investigatorAffiliation': 'Indiana University'}}}}