Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-06-26 @ 4:13 AM
Study NCT ID:
NCT01775033
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2013-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regionalized Pediatric Emergency Care in Rural Pennsylvania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average distance from home to the nearest facility with specialized pediatric emergency care capabilities', 'timeFrame': 'One-year', 'description': 'This population-based outcome will act as a measure of access and relates to HRSA Maternal Child Health Bureau performance measure AHS-8 and AHS-9 (access to pre-hospital EMS and wait times)'}], 'secondaryOutcomes': [{'measure': 'Incidence of emergency transfers to CHP after an index community ED visit', 'timeFrame': '90 days'}, {'measure': 'Incidence of emergency transfers to CHP that do not result in a hospital admission', 'timeFrame': '90 days'}, {'measure': 'Total health care encounters outside the county within three months after an index community ED visit', 'timeFrame': '90 days'}, {'measure': 'Mortality after an index community ED visit for specified high-risk conditions (trauma, sepsis, and in the chronic disease population)', 'timeFrame': '90 days', 'description': 'These outcomes will address our goal to increase child health and related to the HRSA Maternal Child Health Bureau performance measures MICH-1,2 and 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatrics', 'Emergency medical services', 'Emergency Treatment', 'Telemedicine'], 'conditions': ['Emergencies']}, 'referencesModule': {'references': [{'pmid': '21041285', 'type': 'BACKGROUND', 'citation': 'Lorch SA, Myers S, Carr B. The regionalization of pediatric health care. Pediatrics. 2010 Dec;126(6):1182-90. doi: 10.1542/peds.2010-1119. Epub 2010 Nov 1.'}, {'pmid': '16953527', 'type': 'BACKGROUND', 'citation': 'Berger E. Growing pains: Report notes pediatric emergencies need greater emphasis. Ann Emerg Med. 2006 Aug;48(2):143-4. doi: 10.1016/j.annemergmed.2006.06.024. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to develop and evaluate an organized, regional system of pediatric emergency care in rural western Pennsylvania.', 'detailedDescription': 'The OUTREACH project will develop, implement and evaluate an organized system of regional pediatric emergency care in rural western Pennsylvania. Toward that end the investigators have developed three broad goals: (1) to define the key barriers and potential solutions to regionalized pediatric emergency care through community stakeholder engagement; (2) to implement a regionalized system of pediatric emergency care using education, community outreach and telemedicine; and (3) evaluate the impact of the system on health care access and outcomes for rural children. The investigators will implement the intervention in a sample of rural hospitals in Pennsylvania using a staggered roll-out design, and compare outcomes of children seen in these hospitals to similar matched hospitals in the state, using Pennsylvania state Medicaid data to evaluate the impact of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pennsylvania\n* Medicaid beneficiary\n* Less than or equal to 18 years of age\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01775033', 'acronym': 'OUTREACH', 'briefTitle': 'Regionalized Pediatric Emergency Care in Rural Pennsylvania', 'nctIdAliases': ['NCT02306408'], 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Regionalized Pediatric Emergency Care in Rural Pennsylvania: the Optimizing Utilization and Rural Emergency Access for Children Study', 'orgStudyIdInfo': {'id': 'H3AMC24076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multicomponent intervention', 'description': 'Hospitals in the experimental arm will receive a four-component intervention that integrates local education, community outreach, telemedicine and protocolized triage and transport', 'interventionNames': ['Other: Multicomponent intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Hospitals in the control arm will receive usual care.'}], 'interventions': [{'name': 'Multicomponent intervention', 'type': 'OTHER', 'description': 'Develop, implement and evaluate an organized system of regional pediatric emergency care in rural Western Pennsylvania using four pillars: education, community, protocolized triage and transport, and telemedicine.', 'armGroupLabels': ['Multicomponent intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jeremy M Kahn, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Critical Care, Medicine and Health Policy & Management', 'investigatorFullName': 'Jeremy Kahn', 'investigatorAffiliation': 'University of Pittsburgh'}}}}