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, Nyenhuis SM, Krishnan JA, Erwin K, Mosnaim G, Margellos-Anast H, Paik SM, Ignoffo S, McDermott M; CHICAGO Plan Consortium. Care transition interventions for children with asthma in the emergency department. J Allergy Clin Immunol. 2016 Dec;138(6):1518-1525. doi: 10.1016/j.jaci.2016.10.012. Review. PubMed PMID: 27931533. (Abstract only available)
Kramer CB, LeRoy L, Donahue S, Apter AJ, Bryant-Stephens T, Elder J, Hamilton W, Krishnan JA, Shelef DQ, Stout JW, Sumino K, Teach S, Federman AD. Enrolling African-American and Latino Patients with Asthma in Comparative Effectiveness Research: Lessons Learned From Eight Patient-Centered Studies. J Allergy Clin Immunol. 2016 Dec;138(6):1600-1607. doi: 10.1016/j.jaci.2016.10.011. Review. PubMed PMID: 27789250. (Abstract only available).
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Erwin K, Martin MA, Flippin T, Norell S, Shadlyn A, Yang J, Falco P, Rivera J, Ignoffo S, Kumar R, Margellos-Anast H, McDermott M, McMahon K, Mosnaim G, Nyenhuis SM, Press VG, Ramsay JE, Soyemi K, Thompson TM, Krishnan JA. Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma. J Comp Eff Res. 2016 Jan;5(1):17-30. doi: 10.2217/cer.15.52. Epub 2015 Dec 21. PubMed PMID: 26690579.