Background: Chicago is an epicenter for asthma health disparities in the United States, with African American children 5-11 years old bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. It is unclear how effective guideline recommendations and strategies to reduce environmental triggers of asthma really are, after children are discharged from the ED.
Objectives: Test interventions delivered to the patient/caregiver and to the provider, to improve clinically meaningful outcomes in minority children seeking care in the ED for uncontrolled asthma (Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes [CHICAGO] Trial).
Methods: We will enroll 640 English or Spanish-speaking children ages 5-11 years and their caregivers who present to EDs with uncontrolled asthma. The specific aims are
- complete planning activities, including qualitative interviews with caregivers, clinicians, and community health workers (CHWs), to finalize the study design and protocol, and comply with regulatory requirements from all institutional and community partners for the CHICAGO Trial; and
- conduct a multicenter pragmatic trial comparing effectiveness in three groups: the effectiveness of a provider-level ED-based intervention (Provider-ED) v. Provider-ED combined with a patient-level CHW-led intervention that includes a focus on reducing environmental triggers at home (Provider-ED plus Patient-Home) v. Usual Care.
In additional analyses, we will evaluate the potential for heterogeneity of treatment effects (diversity in responsiveness to treatment). Secondary aim: Identify obstacles and facilitators of successfully implementing the interventions to inform later implementation studies. Patient Outcomes: Caregiver input will be used to identify and prioritize study outcomes. We have provisionally proposed a strategy of two co-primary outcomes, one meaningful to children and one to caregivers/families of children with asthma. Secondary outcomes will examine adherence to self-management skills for use of medications and reduction of asthma triggers in the environment, and acute care use. Partnerships to Facilitate Study: Drawing on collaborations that span nearly two decades, we have assembled a broad-based ED collaborative in Chicago dedicated to eliminating asthma health disparities, including caregivers, patient advocacy groups, the City of Chicago Department of Public Health, and patient-centered outcomes researchers.
Martin MA, Press VG, Erwin K, et al., Engaging end-users in intervention research study design. Journal of Asthma (July 2017).
Krishnan JA, Martin MA, Lohff C, et al., Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan. Contemporary Clinical Trials (June 2017).
Kramer CB, LeRoy L, Donahue S, et al. Enrolling African-American and Latino Patients with Asthma in Comparative Effectiveness Research: Lessons Learned From Eight Patient-Centered Studies. Journal of Allergy and Clinical Immunology (December 2016).
Erwin K, Krishnan JA. Using design methods to provide the care that people want and need. Journal of Comparative Effectiveness Research (June 2016).
Erwin K, Martin MA, Flippin T, et al. Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma. Journal of Comparative Effectiveness Research (June 2016).
Martin MA, Press VG, Nyenhuis SM, et al. Care transition interventions for children with asthma in the emergency department. Journal of Allergy and Clinical Immunology (June 2016).