Comparing Three Ways to Prepare Children and Caregivers to Manage Asthma after an Emergency Room Visit – The CHICAGO Trial [Internet]

Excerpt

C.1. Background: Uncontrolled asthma in children is a major contributor to health disparities by race and income in the United States. Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the Emergency Department (ED) are needed.

C.2. Objectives: 1) Complete planning activities, including qualitative interviews with caregivers, clinicians, and community health workers (CHWs), to finalize the study design; 2) Compare the effectiveness of a structured discharge and communication tool vs. this tool plus in-home support vs. enhanced usual care in children presenting to an ED with uncontrolled asthma.

C.3. Methods: We engaged a multi-disciplinary group of stakeholders to complete planning activities for a pragmatic trial. Children were eligible for the pragmatic trial if they were English or Spanish-speaking, ages 5-11 years, presented with uncontrolled asthma to one of 6 EDs, and were likely to be discharged to home after initial therapy. We randomly allocated children and their caregivers in the ED to one of three groups: 1) an ED-only intervention using a culturally-tailored structured discharge and communication tool to support provider- and patient-level implementation of guideline-recommended asthma care on ED discharge (CHICAGO Action Plan after Emergency department discharge, or CAPE); 2) the CAPE together with in-home support by community health workers (CHWs; ED-plus-home) for 6 months, and 3) Enhanced usual care alone (all three groups received teaching about appropriate inhaler technique and spacers for inhalers). We assessed two co-primary outcomes at 1, 3, and 6 months: Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale in children (higher scores indicate worsening asthma) and the PROMIS Satisfaction with Participation in Social Roles in the caregiver (higher scores indicate greater caregiver satisfaction). The minimum important difference for PROMIS measures is estimated to be a T-score of 3 to 5 (0.3 to 0.5 SD, respectively). The primary pre-specified analyses employed multivariate ordinal regression to compare the 6-month change in T-scores between the three groups; a two-tailed p<0.0167 defined a significant difference. Secondary outcomes included indicators of guideline-consistent ED discharge instructions and self-management after ED discharge.

C.4. Results: A total of 373 children (58% of the target 640) were enrolled and randomized to ED-plus-home (n=121), ED-only (n=126), or Enhanced usual care (n=126). Children were mostly boys (67%), black (64%), a third were Latino (31%), and most had public aid health insurance (80%). Retention through the 6-month follow-up visit was low (63%). We did not observe a significant between-group difference in the 6-month change in T-scores in primary outcomes comparing ED-plus-home vs. Enhanced usual care, ED-only vs. Enhanced usual care, and ED-plus-home vs. ED-only groups (adjusted odds ratio [OR] and 98% confidence intervals, CIs, for [1] higher Asthma Impact Scale score in children: OR = 0.68, 0.30 to 1.55, p=0.27; OR = 0.68, 0.31 to 1.45, p=0.22; and OR = 1.01, 0.47 to 2.19, p=0.97, respectively; [2] higher caregiver Satisfaction with Participation in Social Roles: OR = 0.80, 0.35 to 1.80, p=0.50; OR = 0.95, 0.44 to 2.06, p=0.86; and OR = 0.84, 0.39 to 1.83, p=0.60, respectively).

The discharge instructions were significantly more likely to be consistent with guidelines in the ED-plus-home and in the ED-only groups compared with the Enhanced usual care group: 1) use of systemic corticosteroids (98 vs. 61%, p<0.0001; and 99 vs. 61%, p<0.0001, respectively); 2) use of inhaled corticosteroid or other controller (72 vs. 41%, p<0.0001; 63 vs. 41%, p=0.0004, respectively); 3) use of inhaled rescue medications (98 vs. 85%, p=0.0005; and 99 vs. 85%, p<0.0001, respectively); and 4) providing a follow-up appointment within 4 weeks (46 vs. 8%, p<0.0001; and 49 vs. 8%, p<0.0001, respectively); none of the differences between the ED-plus-home and ED-only group were significant. Also, a higher proportion of participants filled prescriptions for inhaled corticosteroids or other controllers within 7 days of ED discharge in the ED-plus-home group (71%) compared to both the ED-only (45%, p=0.0003) and the Enhanced usual care (42%, p<0.0001) groups. We also noted a higher proportion of children attending an outpatient visit with their asthma provider within 4 weeks of ED discharge in the ED-plus-home (51%) compared to the Enhanced usual care (32%, p=0.005) group.

C.5. Conclusions: We did not observe significant benefits of the ED-only and ED-plus-home interventions on primary outcomes in children and in caregivers compared to Enhanced usual care. However, recruitment and retention in the trial proved to be challenging and we were therefore underpowered to exclude the important differences between groups in these primary outcomes. We did observe significant improvements in the quality of ED discharge instructions and participant-self management practices after ED discharge in the ED-only and ED-plus-home groups.

C6. Study limitations: Due to insufficient enrollment (373 [58%] of the target 640 randomizations) and lower than acceptable retention (263 [63%] of 373 participants completed the 6-month follow-up visit), we cannot exclude important effects of the ED-only and ED-plus-home interventions on the pre-specified primary clinical outcomes.