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.

Trial registration: ClinicalTrials.gov NCT02319967.

Keywords: Community health worker; Health disparities; Pragmatic clinical trial; Quality of asthma care; Stakeholder engagement; Uncontrolled asthma.

Published by Elsevier Inc.

Figures

Figure 1. CHICAGO Plan study schema

640 children age 5 to 11 years presenting with uncontrolled asthma to the emergency department (ED) will be randomized to one of three groups to evaluate ED-based interventions vs. ED plus home-based interventions to promote asthma self-management skills vs. enhanced usual care. All children, including those in enhanced usual care, receive education in the ED about the appropriate use of MDI devices and two MDI spacers free-of-charge. The ED-based intervention consists of a paper-based decision support and communication tool (“C”, CAPE or Chicago Action Plan after Emergency department discharge). The five CHW-led home visits (“H”) take place over 6 months (2–3 days, 2 weeks, 1 month, 3 months, and 6 months after ED discharge). The assessment of outcomes will be performed at baseline (in-person on the day of ED discharge); 1 month (via phone), 3 months (via phone), and 6 months (in-person) after ED discharge. Participants enrolled in the first half of the 15-month recruitment period are invited to participate in a 12-month follow-up phone assessment to assess the durability of effects after the end of the 6-month intervention in the ED plus home-based intervention group.

Figure 2. Setting for the CHICAGO Plan

Data from the Chicago Department of Public Health indicate that emergency department visit rates are highest (dark red) in west and south sides of Chicago (Figure 2A), areas enriched with black (African-American) children (Figure 2B). The CHICAGO Plan will recruit from EDs in six Clinical centers, : Ann 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 Comer Children’s Hospital, and the University of Illinois Hospital & Health Sciences System. Locations of 911 ambulance calls for children 5 to 14 years with asthma who were transported to the six Clinical centers in 2011 are illustrated as yellow dots (Figure 2A).

Figure 3. Organizational structure for the CHICAGO Plan

The CHICAGO Plan consortium includes six Clinical center emergency departments that serve children living in the west and south sides of Chicago (see Figure 2 for list of Clinical centers), the Illinois Institute of Technology’s Institute of Design, two non-profit community-based organizations with established asthma programs (Chicago Asthma Consortium, Respiratory Health Association), a research organization with expertise in community health worker programs (CHW; Sinai Urban Health Institute), a representative of the Illinois Emergency Department Asthma Surveillance Project, and a representative of the Chicago Department of Public Health. Investigators and staff from these organizations collaborated in five workgroups (Regulatory, Patient/stakeholder, Asthma guidelines, Emergency medicine, and Publications and presentations), a CHW coordinating center, a Data coordinating center, and a Steering Committee; see 3.1 “Study team organizational structure,” for more information. Each Clinical center underwent initial and ongoing review of human subjects research activities by institution-specific institutional review boards. The CHICAGO Plan included an independent Data Safety Monitoring Board (see 3.6, Data safety monitoring”), and administrative oversight from a Program Officer at the Patient-Centered Outcomes Research Institute.