Engaging end-users in intervention research study design.

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.

Care transition interventions for children with asthma in the emergency department.

The emergency department (ED) is a critical point of identification and treatment for some of the most high-risk children with asthma. This review summarizes the evidence regarding care transition interventions originating in the ED for children with uncontrolled asthma, with a focus on care coordination and self-management education. Although many interventions on care transition for pediatric asthma have been tested, only a few were actually conducted in the ED setting. Most of these targeted both care coordination and self-management education but ultimately did not improve attendance at follow-up appointments with primary care providers, improve asthma control, or reduce health care utilization. Conducting any ED-based intervention in the current environment is challenging because of the many demands on ED providers and staff, poor communication within and outside of the medical sector, and caregiver/patient burden. The evidence to date suggests that ED care transition interventions should consider expanding beyond the ED to bridge the multiple sectors children with asthma navigate, including health care settings, homes, schools, and community spaces. Patient-centered approaches may also be important to ensure adequate intervention design, enrollment, retention, and evaluation of outcomes important to children and their families.

Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan.

Background: Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the emergency department (ED) are needed. Objectives: This multicenter pragmatic clinical trial was designed to compare an ED-only intervention (decision support tool), an ED-only intervention and home visits by community health workers for 6 months (ED-plus-home), and enhanced usual care (UC). Methods: Children aged 5 to 11 years with uncontrolled asthma were enrolled. The change over 6 months in the Patient-Reported Outcomes Measurement Information System Asthma Impact Scale score in children and Satisfaction with Participation in Social Roles score in caregivers were the primary outcomes. The secondary outcomes included guideline-recommended ED discharge care and self-management. Results: Recruitment was significantly lower than expected (373 vs 640 expected). Of the 373 children (64% Black and 31% Latino children), only 63% completed the 6-month follow-up visit. In multivariable analyses that accounted for missing data, the adjusted odds ratios and 98% CIs for differences in Asthma Impact Scores or caregivers' Satisfaction with Participation in Social Roles scores were not significant. However, guideline-recommended ED discharge care was significantly improved in the intervention groups versus in the UC group, and self-management behaviors were significantly improved in the ED-plus-home group versus in the ED-only and UC groups. Conclusions: The ED-based interventions did not significantly improve the primary clinical outcomes, although the study was likely underpowered. Although guideline-recommended ED discharge care and self-management did improve, their effect on clinical outcomes needs further study.