Importance of Engaging End-Users in Intervention Research Study Design: Lessons Learned from the CHICAGO Trial

Objective:

The Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Trial) was funded to conduct a 3-arm multicenter pragmatic trial to evaluate interventions to improve asthma control in high risk Chicago children. In preparation for the trial, the study team conducted a formative evaluation with end-users.

Methods:

In the summer of 2014, we engaged caregivers of children with asthma through focus groups (2 groups, N=9) and user-centered interviews (N=9), and conducted a focus group with asthma CHWs (N=8), to collect their experience.  Additional stakeholder input was obtained through key informant interviews at each of the six emergency department (ED) clinical sites with ED-based providers, administrators, nurses, and ambulatory providers. ED tours and observations were also conducted at each site.

Results:

The primary intervention in EDs is delivery of a redesigned discharge asthma action plan. Input from the caregivers, CHWs, and providers suggested multiple design modifications to this instrument to improve its utility to caregivers and providers. The results also revealed that ED discharge protocols typically include patient education at a single point in time, usually just as families are preparing to leave the ED and are least ready to take full advantage of interactions with ED staff.  The CHICAGO Trial study design was therefore modified to reposition self-management education so that it occurs at various “teachable moments” during the treatment and observation period.

Conclusions:

Engagement of end-users in the design phase of implementation research is a critical step to ensure research feasibility and relevance.