Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes
NCT ID: NCT02319967
Last Updated: 2019-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
373 participants
INTERVENTIONAL
2015-03-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced usual care
Inhaler technique education and distribution of spacers to all participants.
No interventions assigned to this group
ED-only
Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.
CAPE
Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
ED-plus-home
Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.
Home visits by a community health worker (CHW).
CAPE
Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
CHW home visits
Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
Interventions
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CAPE
Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
CHW home visits
Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
Eligibility Criteria
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Inclusion Criteria
2. Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health \& Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital \& Health Sciences System);
3. Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
4. Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);
5. Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
6. Diagnosis of asthma exacerbation by treating clinician;
7. Treating ED clinician indicates the child is likely to be discharged to home; and
8. Caregiver reports that English or Spanish is the preferred language at home.
Exclusion Criteria
2. Child is admitted to an intensive care unit or transferred to another healthcare facility;
3. Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
4. Child is enrolled in another study involving a health-related intervention;
5. A CHW is already visiting the home as part of another program;
6. Child does not reside in Chicago.
5 Years
11 Years
ALL
No
Sponsors
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Sinai Health System
OTHER
Cook County Health & Hospitals System
OTHER
Rush University Medical Center
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
University of Chicago
OTHER
Chicago Department of Public Health
OTHER_GOV
Respiratory Health Association
UNKNOWN
Chicago Asthma Consortium
UNKNOWN
Illinois Institute of Technology
OTHER
Illinois Emergency Department Asthma Surveillance Project
UNKNOWN
Patient-Centered Outcomes Research Institute
OTHER
University of Illinois at Chicago
OTHER
Responsible Party
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Jerry Krishnan
Associate Vice Chancellor for Population Health Sciences, Professor of Medicine and Public Health
Principal Investigators
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Jerry A Krishnan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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Sinai Health System
Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Cook County Health & Hospitals System
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Countries
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References
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Krishnan JA, Martin MA, Lohff C, Mosnaim GS, Margellos-Anast H, DeLisa JA, McMahon K, Erwin K, Zun LS, Berbaum ML, McDermott M, Bracken NE, Kumar R, Margaret Paik S, Nyenhuis SM, Ignoffo S, Press VG, Pittsenbarger ZE, Thompson TM; CHICAGO Plan consortium. Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan. Contemp Clin Trials. 2017 Jun;57:10-22. doi: 10.1016/j.cct.2017.03.015. Epub 2017 Mar 31.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Patient-Centered Outcomes Research Institute (PCORI): Funding award details
Other Identifiers
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AS-1307-05420
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2014-1214
Identifier Type: -
Identifier Source: org_study_id
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