title: Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.
abstract: Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design.
authors.affiliation: Population Health Sciences Program, Office of the Vice Chancellor for Health Affairs, University of Illinois at Chicago, United States; Department of Medicine, University of Illinois at Chicago, United States. Electronic address: jakris@uic.edu.
authors.forename: Jerry A
authors.initials: JA
authors.lastname: Krishnan
authors.affiliation: Department of Pediatrics, University of Illinois at Chicago, United States.
authors.forename: Molly A
authors.initials: MA
authors.lastname: Martin
authors.affiliation: Chicago Department of Public Health, United States.
authors.forename: Cortland
authors.initials: C
authors.lastname: Lohff
authors.affiliation: Department of Preventative Medicine, Rush University, United States.
authors.forename: Giselle S
authors.initials: GS
authors.lastname: Mosnaim
authors.affiliation: Sinai Urban Health Institute, Sinai Health System, United States.
authors.forename: Helen
authors.initials: H
authors.lastname: Margellos-Anast
authors.affiliation: Population Health Sciences Program, Office of the Vice Chancellor for Health Affairs, University of Illinois at Chicago, United States; Department of Medicine, University of Illinois at Chicago, United States.
authors.forename: Julie A
authors.initials: JA
authors.lastname: DeLisa
authors.affiliation: Respiratory Health Association, United States.
authors.forename: Kate
authors.initials: K
authors.lastname: McMahon
authors.affiliation: Institute of Design, Illinois Institute of Technology, United States.
authors.forename: Kim
authors.initials: K
authors.lastname: Erwin
authors.affiliation: Department of Emergency Medicine, Sinai Health System, United States.
authors.forename: Leslie S
authors.initials: LS
authors.lastname: Zun
authors.affiliation: Center for Clinical and Translational Science, University of Illinois at Chicago, United States.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Berbaum
authors.affiliation: Illinois Emergency Department Asthma Surveillance Project, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: McDermott
authors.affiliation: Population Health Sciences Program, Office of the Vice Chancellor for Health Affairs, University of Illinois at Chicago, United States; Department of Medicine, University of Illinois at Chicago, United States.
authors.forename: Nina E
authors.initials: NE
authors.lastname: Bracken
authors.affiliation: Department of Pediatrics, Northwestern University, Anne and Robert H. Lurie Children's Hospital of Chicago, United States.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Kumar
authors.affiliation: Department of Pediatrics, University of Chicago, Comer Children's Hospital, United States.
authors.forename: S
authors.initials: S
authors.lastname: Margaret Paik
authors.affiliation: Department of Medicine, University of Illinois at Chicago, United States.
authors.forename: Sharmilee M
authors.initials: SM
authors.lastname: Nyenhuis
authors.affiliation: Chicago Asthma Consortium, United States.
authors.forename: Stacy
authors.initials: S
authors.lastname: Ignoffo
authors.affiliation: Department of Medicine and Pediatrics, University of Chicago, United States.
authors.forename: Valerie G
authors.initials: VG
authors.lastname: Press
authors.affiliation: Department of Pediatrics, Northwestern University, Anne and Robert H. Lurie Children's Hospital of Chicago, United States.
authors.forename: Zachary E
authors.initials: ZE
authors.lastname: Pittsenbarger
authors.affiliation: Department of Emergency Medicine, Cook County Health & Hospitals System, United States; Department of Emergency Medicine, University of Illinois at Chicago, United States.
authors.forename: Trevonne M
authors.initials: TM
authors.lastname: Thompson
mesh_terms: D001741:Black or African American / Q000706:statistics & numerical data; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000517:prevention & control; D002641:Chicago; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D010353:Patient Education as Topic; D058996:Quality Improvement; D000073278:Self-Management
chemical_list: D018927:Anti-Asthmatic Agents
keywords: Community health worker; Health disparities; Pragmatic clinical trial; Quality of asthma care; Stakeholder engagement; Uncontrolled asthma