Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00355069
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2006-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Better Pediatric Asthma Outcomes Through Chronic Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 548}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2006-07-19', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'asthma control', 'timeFrame': 'assessed at all 5 study visits'}, {'measure': 'guideline appropriate medicating by providers', 'timeFrame': 'assessed at all 5 study visits'}, {'measure': 'patient knowledge', 'timeFrame': 'assessed at all 5 study visits'}], 'secondaryOutcomes': [{'measure': 'self efficacy', 'timeFrame': 'assessed at all 5 study visits'}, {'measure': 'social support', 'timeFrame': 'assessed at all 5 study visits'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatric', 'asthma', 'translational research', 'health information technology'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '15669584', 'type': 'BACKGROUND', 'citation': 'Twiggs JE, Fifield J, Jackson E, Cushman R, Apter A. Treating asthma by the guidelines: developing a medication management information system for use in primary care. Dis Manag. 2004 Fall;7(3):244-60. doi: 10.1089/dis.2004.7.244.'}, {'pmid': '12393083', 'type': 'BACKGROUND', 'citation': 'Twiggs JE, Fifield J, Apter AJ, Jackson EA, Cushman RA. Stratifying medical and pharmaceutical administrative claims as a method to identify pediatric asthma patients in a Medicaid managed care organization. J Clin Epidemiol. 2002 Sep;55(9):938-44. doi: 10.1016/s0895-4356(02)00428-6.'}, {'pmid': '20812783', 'type': 'RESULT', 'citation': 'Fifield J, McQuillan J, Martin-Peele M, Nazarov V, Apter AJ, Babor T, Burleson J, Cushman R, Hepworth J, Jackson E, Reisine S, Sheehan J, Twiggs J. Improving pediatric asthma control among minority children participating in medicaid: providing practice redesign support to deliver a chronic care model. J Asthma. 2010 Sep;47(7):718-27. doi: 10.3109/02770903.2010.486846.'}]}, 'descriptionModule': {'briefSummary': 'This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a chronic care model to the care of poor, minority, inner-city children with asthma, at risk of the worst outcomes for the leading chronic disease of children.\n\nThe specific aims are to:\n\n1. Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology;\n2. Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and\n3. Evaluate the added effect on outcomes of family-focused, supportive education delivered by a community health worker.\n\nThe key product of the computer support system is a guideline prompt that serves as the mechanism for integrating patient specific data with standards of care. 548 children, ages 5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in CT, and receiving care at one of four Federally Qualified Community Health Centers will be recruited. All sites will have access to the computer support system and the to-be-developed, Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of prompts delivered at the point of care on patient outcomes will be compared to the effect of no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education will be assessed in combination with prompted care compared to no-prompt care and compared to no education. All patients will receive standard screening and outreach to keep appointments. Data will be obtained from medical records, medical and pharmacy claims data as well as patient and parent interviews at baseline and quarterly for 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* determined by provider to be asthmatic\n* member of Medical Managed Care Organization partner group\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00355069', 'briefTitle': 'Better Pediatric Asthma Outcomes Through Chronic Care', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Better Pediatric Asthma Outcomes Through Chronic Care', 'orgStudyIdInfo': {'id': '1U18HS011068-01', 'link': 'https://reporter.nih.gov/quickSearch/1U18HS011068-01', 'type': 'AHRQ'}, 'secondaryIdInfos': [{'id': 'U18HS011068', 'link': 'https://reporter.nih.gov/quickSearch/U18HS011068', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education', 'interventionNames': ['Behavioral: electronic (computer based) provider feedback tool']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education', 'interventionNames': ['Behavioral: electronic (computer based) provider feedback tool']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Received the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt', 'interventionNames': ['Behavioral: electronic (computer based) provider feedback tool']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Received the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education)', 'interventionNames': ['Behavioral: electronic (computer based) provider feedback tool']}], 'interventions': [{'name': 'electronic (computer based) provider feedback tool', 'type': 'BEHAVIORAL', 'otherNames': ['UCAN Control Asthma Program', 'Medication Assessment Prompt (MAP)'], 'description': 'All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Judith Fifield, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Director, Ethel Donaghue TRIPP Center', 'investigatorFullName': 'Judith Fifield', 'investigatorAffiliation': 'UConn Health'}}}}