Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT03736603
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing Pathways to Improve Pediatric Asthma 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital/Inpatient: Mean length of hospital stay', 'timeFrame': '1 year'}, {'measure': 'Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization', 'timeFrame': '1 year'}, {'measure': 'Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure', 'timeFrame': '1 year'}, {'measure': 'Hospital/Inpatient: Proportion of children who screen positive for secondhand tobacco smoke exposure whose caregivers are referred to smoking cessation resources', 'timeFrame': '1 year'}, {'measure': 'Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge', 'timeFrame': '1 year'}, {'measure': 'Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days', 'timeFrame': '1 year'}, {'measure': 'Hospital/Inpatient: Proportion of children transferred to a higher level of care', 'timeFrame': '1 year'}, {'measure': 'Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage', 'timeFrame': '1 year'}, {'measure': 'Emergency Department: Proportion of children who have chest radiographs performed', 'timeFrame': '1 year'}, {'measure': 'Emergency Department: Proportion of children admitted to the hospital', 'timeFrame': '1 year'}, {'measure': 'Emergency Department: Proportion of children transferred to a higher level of care', 'timeFrame': '1 year'}, {'measure': 'Emergency Department: Mean length of emergency department stay', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Background:\n\nAsthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Single-site studies of pediatric asthma pathways have shown significant improvements in quality of care.\n\nPrimary Objective:\n\nTo evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ED) and hospital settings.\n\nPrimary Endpoints:\n\n1. Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival\n2. Inpatient/Hospital: Mean length of hospital stay\n\nStudy Design:\n\nThis project will be implemented through an established quality improvement collaborative of hospitals across the United States, the Value in Inpatient Pediatrics Network (part of the American Academy of Pediatrics). A cluster randomized design will be employed. Group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ED and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). Group 2 will receive the same intervention with the addition of a mobile app pathway tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participant/Local champion Eligibility Criteria:\n\nInclusion Criteria:\n\n* Working as a physician at the study site\n\nExclusion Criteria:\n\n* None\n\nPatient/child eligibility criteria:\n\nInclusion Criteria:\n\n* Age 2-17 years\n* Primary diagnosis of asthma\n\nExclusion Criteria:\n\n* Transferred in from another inpatient facility\n* Presence of a chronic medical condition that precludes pathway use'}, 'identificationModule': {'nctId': 'NCT03736603', 'acronym': 'PIPA', 'briefTitle': 'Implementing Pathways to Improve Pediatric Asthma Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The PIPA Study (Pathways for Improving Pediatric Asthma Care): A Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '17 KA 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pathway Intervention 1', 'description': 'Hospitals randomized to group 1 receive PIPA Intervention Bundle 1.', 'interventionNames': ['Behavioral: PIPA Intervention Bundle 1']}, {'type': 'EXPERIMENTAL', 'label': 'Pathway Intervention 2', 'description': 'Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app.', 'interventionNames': ['Behavioral: PIPA Intervention Bundle 2']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Hospitals are in the control arm (usual care) after January 2017 until active implementation begins, which includes 3-6 months of implementation preparation (identifying local multidisciplinary champions, educational sessions/webinars for local champions, one teleconference with an external practice facilitator).'}], 'interventions': [{'name': 'PIPA Intervention Bundle 1', 'type': 'BEHAVIORAL', 'description': 'The PIPA intervention bundle 1 includes:\n\n1. Pathway Implementation Toolkit\n2. Local Multidisciplinary Champions\n3. Audit and Feedback\n4. Educational Seminars/Webinars\n5. Practice Facilitation', 'armGroupLabels': ['Pathway Intervention 1']}, {'name': 'PIPA Intervention Bundle 2', 'type': 'BEHAVIORAL', 'description': 'The PIPA intervention bundle 2 includes:\n\n1. Pathway Implementation Toolkit\n2. Local Multidisciplinary Champions\n3. Audit and Feedback\n4. Educational Seminars/Webinars\n5. Practice Facilitation\n6. Mobile App', 'armGroupLabels': ['Pathway Intervention 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Sunitha V Kaiser, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Pediatrics', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}