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 11 years 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 6 months 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.

Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan

“…A more detailed description of the study design is presented in the Supplementary Methods (available in the Online Repository at www.jaci-global.org ) and was previously published. 12 In brief, children with uncontrolled asthma presenting to the ED and their caregivers were enrolled in a randomized clinical effectiveness trial before discharge to home. Participants were randomly allocated to 1 of 3 study groups ( Fig 1 ).…”

“…The CHICAGO plan, which is funded by the Patient-Centered Outcomes Research Institute (contract no. AS-1307-05420), 12 included a 1-year stakeholder engagement period to finalize the study design and a 3-year randomized clinical effectiveness trial in 6 EDs affiliated with public or private hospitals that serve a high proportion of Black or Latino children in Chicago. The goal of the CHICAGO plan was to compare (1) an ED-only intervention using a culturally tailored, literacy-appropriate, paper-based, decision support and communication tool (CHICAGO Action Plan after Emergency Department Discharge [CAPE] 13 ) to improve the quality of care on discharge to home; (2) the same ED-only intervention combined with in-home support by community health workers (CHWs) for 6 months (ED-plus-home); and (3) enhanced usual care (UC) (spacers and education for appropriate inhaler technique).…”

Childhood Asthma Disparities in Chicago

“…Multiple initiatives evolved from these partnerships, including the Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) Plan, a multi-center comparative effectiveness trial funded by the Patient-Centered Outcomes Research Institute (PCORI). 9 This trial tested an emergency department (ED) discharge tool called the C HICAGO A ction P lan after E D discharge (CAPE) 10 and community health worker (CHW) home intervention. The PCORI-funded study focused on the ED to home transition but the investigators and partners had a broader vision about opportunities to improve asthma care, which was realized with the receipt of one of the nine U34 awards in September of 2015 (CHICAGO Plan II).…”

Obstructive Airway Disease: Rational, Evidence-Based Bronchodilator Therapy

“…This could minimize the likelihood of future exacerbations and instruct them in the use of the VHC or VHC with an appropriate mask in small children. 9 Ideally and most cost-effectively, patients should be sent home with the relatively inexpensive VHC and aerosol devices that they need and with written instructions to minimize the likelihood that they will require early readmission. This message should appeal to the insurance industry in the United States (or to the taxpayer/health ministry in national health-care systems), who are certainly aware that the cost of asthma exacerbations requiring hospitalization far exceeds the cost of providing patients with the intellectual and physical tools to keep them well and out of hospital!…”