Clinical trial NCT02319967: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes
Official title: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: community health worker
emergency
asthma
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Sinai Health System
name: Cook County Health & Hospitals System
name: Rush University Medical Center
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: University of Chicago
name: Chicago Department of Public Health
name: Respiratory Health Association
name: Chicago Asthma Consortium
name: Illinois Institute of Technology
name: Illinois Emergency Department Asthma Surveillance Project
name: Patient-Centered Outcomes Research Institute
First posted: 2014-12-19
Enrollment: 373
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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):

1. Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);
2. 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);
3. Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
4. 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);
5. Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
6. Diagnosis of asthma exacerbation by treating clinician;
7. Treating ED clinician indicates the child is likely to be discharged to home; and
8. Caregiver reports that English or Spanish is the preferred language at home.

Exclusion criteria (none of the following):

1. Caregiver declines to provide informed consent, or the child declines to provide assent;
2. Child is admitted to an intensive care unit or transferred to another healthcare facility;
3. Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
4. Child is enrolled in another study involving a health-related intervention;
5. A CHW is already visiting the home as part of another program;
6. Child does not reside in Chicago.

Primary outcomes:
measure: PROMIS Asthma Impact Scale (v1.0, SF8a)
timeFrame: Baseline and 6 months after index ED discharge
measure: PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)
timeFrame: Baseline and 6 months after index ED discharge
Secondary outcomes:
measure: Childhood Asthma Control Test (cACT)
timeFrame: Baseline and 6 months after index ED discharge
measure: PROMIS Anxiety (v1.0, SF4a)
timeFrame: Baseline and 6 months after index ED discharge
measure: PROMIS Depression (v1.0, SF4a)
timeFrame: Baseline and 6 months after index ED discharge
measure: PROMIS Fatigue (v1.0, SF4a)
timeFrame: Baseline and 6 months after index ED discharge
measure: PROMIS Sleep Disturbance (v1.0, SF4a)
timeFrame: Baseline and 6 months after index ED discharge
measure: Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: Baseline and 6 months after index ED discharge
measure: Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits
timeFrame: 6 months post index ED discharge
measure: Number of Participants With All-cause Hospitalizations
timeFrame: 6 months post index ED discharge
measure: Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids
timeFrame: 7 days post index ED discharge
measure: Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller
timeFrame: 7 days post index ED discharge
measure: Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider
timeFrame: 4 weeks post index ED discharge
measure: Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids
timeFrame: At index ED discharge
measure: Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller
timeFrame: At index ED discharge
measure: Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication
timeFrame: At index ED discharge
measure: Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff
timeFrame: At index ED discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Sinai Health System
state: Illinois
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Cook County Health & Hospitals System
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jerry A Krishnan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krishnan JA, Martin MA, Lohff C, Mosnaim GS, Margellos-Anast H, DeLisa JA, McMahon K, Erwin K, Zun LS, Berbaum ML, McDermott M, Bracken NE, Kumar R, Margaret Paik S, Nyenhuis SM, Ignoffo S, Press VG, Pittsenbarger ZE, Thompson TM; CHICAGO Plan consortium. Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan. Contemp Clin Trials. 2017 Jun;57:10-22. doi: 10.1016/j.cct.2017.03.015. Epub 2017 Mar 31.