ABSTRACT
Objective: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) Plan is a 3-arm multicenter pragmatic trial to evaluate asthma interventions in high-risk Chicago children presenting to emergency departments (ED) with asthma. A formative evaluation with end-users to provide input into the trial design and outcome instruments was conducted prior to trial initiation. Methods: A multi-level data gathering framework from the field of design and standard qualitative methods was employed. This included one focus group with asthma Community Health Workers (N = 8), two focus groups with caregivers of children with asthma (N = 9), in-home interviews with caregivers (N = 9), key informant interviews at six EDs and outpatient clinical sites (N = 19), and ED tours and observations (N = 6). Data were presented, discussed, and organized into themes. Results: Data indicated that changes to the study design and discharge tool were warranted. A key insight was that ED discharge protocols typically place patient education at a single inopportune time, as families are preparing to leave the ED. At this point in time, families are less receptive to education due to fatigue and a desire to expedite the discharge process. The trial design was modified to reposition the discharge asthma plan to occur at earlier “teachable moments.” Delivery of the asthma discharge plan was assigned to study-employed ED coordinators instead of ED providers and staff. Other potential challenges to study recruitment and implementation were raised and addressed. Conclusions: Engagement of end-users in the design phase of implementation research is critical to improve research feasibility and relevance.
Acknowledgements
We gratefully acknowledge the help of Michael Berbaum, PhD, Nina Bracken, APN, Julie DeLisa, MA, Melissa Gutierrez, MS, Jerry A. Krishnan, MD, PhD, and Sharmilee Nyenhuis, MD, from the University of Illinois at Chicago; Jane Kramer, MD, from Rush University Medical Center; Rajesh Kumar, MD, from Lurie Children's Hospital; Cortland Lohff, MD, from the Chicago Department of Public Health; Tom MacTavish, MA, from the Illinois Institute of Technology Institute of Design; Zack Pittsenbarger, MD, from Lurie Children's Hospital; Trevonne Thompson, MD, from the University of Illinois at Chicago and John H. Stroger Jr. Hospital of Cook County; Les Zun, MD, from the Sinai Health System; and Michael McDermott, MD, from the Illinois Emergency Department Asthma Surveillance Project for their role in the development and implementation of the CHICAGO Plan. We thank the project managers, ED coordinators, CHWs, students, and others that participated for their help in the implementation of the CHICAGO Plan. We also thank the staff, students, and volunteers in the clinical centers and partner organizations who graciously contributed time, effort, and support to the CHICAGO Plan. Finally, we recognize the CHICAGO Plan families that contributed their time and efforts to make this study possible.
Declaration of interest
The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. The statements in this report are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) and its Board of Governors or Methodology Committee.