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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.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

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,CHI

doi

10.1016/j.cct.2017.03.015

subject

Has Abstract

pub_date

2017-06-01 00:00:00

pages

10-22

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(16)30342-1

journal_volume

pub_type

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Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.