N/A
N=373
Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02319967 ↗Enrolled (actual)
373
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: PROMIS Asthma Impact Scale (v1.0, SF8a) — -7.8; -9.3; -11.9 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAPE (Behavioral); CHW home visits (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PROMIS Asthma Impact Scale (v1.0, SF8a) |
-7.8; -9.3; -11.9 | — |
| PRIMARY PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) |
0.0; 0.0; 0.0 | — |
| SECONDARY Childhood Asthma Control Test (cACT) |
3.0; 4.0; 5.5 | — |
| SECONDARY PROMIS Anxiety (v1.0, SF4a) |
-3.2; -3.8; -2.5 | — |
| SECONDARY PROMIS Depression (v1.0, SF4a) |
0.0; 0.0; 0.0 | — |
| SECONDARY PROMIS Fatigue (v1.0, SF4a) |
0.0; 0.0; -2.6 | — |
| SECONDARY PROMIS Sleep Disturbance (v1.0, SF4a) |
0.0; 0.0; -1.9 | — |
| SECONDARY Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) |
0.8; 1.1; 1.2 | — |
| SECONDARY Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits |
54; 53; 44 | — |
| SECONDARY Number of Participants With All-cause Hospitalizations |
12; 11; 9 | — |
| SECONDARY Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids |
82; 89; 79 | — |
| SECONDARY Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller |
42; 49; 69 | — |
| SECONDARY Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider |
37; 48; 57 | — |
| SECONDARY Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids |
77; 125; 118 | — |
| SECONDARY Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller |
52; 80; 87 | — |
| SECONDARY Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication |
107; 125; 118 | — |
| SECONDARY Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff |
10; 62; 56 | — |
Summary
Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs 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. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.
Eligibility Criteria
Inclusion criteria (all of the following):
- Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);
- Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health & Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital & Health Sciences System);
- Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
- Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);
- Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
- Diagnosis of asthma exacerbation by treating clinician;
- Treating ED clinician indicates the child is likely to be discharged to home; and
- Caregiver reports that English or Spanish is the preferred language at home.
Exclusion criteria (none of the following):
- Caregiver declines to provide informed consent, or the child declines to provide assent;
- Child is admitted to an intensive care unit or transferred to another healthcare facility;
- Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
- Child is enrolled in another study involving a health-related intervention;
- A CHW is already visiting the home as part of another program;
- Child does not reside in Chicago.
Data sourced from ClinicalTrials.gov (NCT02319967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.