Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO)

Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: CAPE; Behavioral: CHW home visits

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60612
      • Cook County Health & Hospitals System
    • Chicago, Illinois, United States, 60608
      • Sinai Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Enhanced usual care; Inhaler technique education and distribution of spacers to all participants.
Experimental: ED-only; Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator.	Behavioral: CAPE; Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
Experimental: ED-plus-home; Inhaler technique education and distribution of spacers to all participants. Structured patient-centered ED discharge template (CAPE) to be completed by ED coordinator. Home visits by a community health worker (CHW).	Behavioral: CAPE; Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers; Behavioral: CHW home visits; Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Asthma Impact Scale (v1.0, SF8a)	Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma. PROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is [-44.7 to 44.7] PROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is [-48 to 48] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers. PROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is [-35.1 to 35.1] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.	Baseline and 6 months after index ED discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Asthma Control Test (cACT)	The scores of each item were summed for a total score (0-27) to measure change from index to 6-month primary endpoint. Low scores indicate worse asthma; high scores indicate better asthma. Childhood Asthma Control Test (cACT): Min possible score: 0; Max possible score: 27 Possible range for change in score is [-27 to 27] The reported value represents a change in score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
PROMIS Anxiety (v1.0, SF4a)	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less anxiety; high scores indicate more anxiety. PROMIS Anxiety: Min possible T-score: 40.3; Max possible T-score: 81.6 Possible range for change in T-score is [-41.3 to 41.3] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in anxiety. A positive change in score indicates worsening of anxiety. A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
PROMIS Depression (v1.0, SF4a)	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less depression; high scores indicate more depression. PROMIS Depression: Min possible T-score: 41.0; Max possible T-score: 79.4 Possible range for change in T-score is [-38.4 to 38.4] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in depression. A positive change in score indicates worsening of depression. A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
PROMIS Fatigue (v1.0, SF4a)	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less fatigue; high scores indicate more fatigue. PROMIS Fatigue: Min possible T-score: 33.7; Max possible T-score: 75.8 Possible range for change in T-score is [-42.1 to 42.1] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in fatigue (i.e., less fatigue). A positive change in score indicates worsening of fatigue (i.e., more fatigue). A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
PROMIS Sleep Disturbance (v1.0, SF4a)	Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less sleep disturbance; high scores indicate more sleep disturbance. PROMIS Sleep Disturbance (v1.0, SF4a): Min possible T-score: 32.0; Max possible T-score: 73.3 Possible range for change in T-score is [-41.3 to 41.3] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in sleep disturbance (i.e., less sleep disturbance). A positive change in score indicates worsening of sleep disturbance (i.e., more sleep disturbance). A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)	The overall score is the mean score across all 13 items. Each item is scored on a 7-point Likert scale with 1 indicating severe impairment and 7 indicating no impairment. Higher scores indicate better quality of life; lower scores indicate worse quality of life. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ): Min possible score: 1; Max possible score: 7 Possible range for change in score is [-6 to 6] The reported value represents a change in overall score from baseline to 6 months after index ED discharge. A negative change in score indicates worsening quality of life. A positive change in score indicates improvement in quality of life. A score of 0 indicates no change.	Baseline and 6 months after index ED discharge
Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits	Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months	6 months post index ED discharge
Number of Participants With All-cause Hospitalizations	Count of participants (children) with at least one all-cause hospitalization at 6 months	6 months post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids	Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge	7 days post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller	Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge	7 days post index ED discharge
Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider	Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge	4 weeks post index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids	Count of participants who were provided documented discharge instructions to use systemic corticosteroids	At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller	Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller	At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication	Count of participants who were provided documented discharge instructions to use an inhaled rescue medication	At index ED discharge
Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff	Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge	At index ED discharge

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Patient-Centered Outcomes Research Institute; University of Chicago; Rush University Medical Center; Ann & Robert H Lurie Children's Hospital of Chicago; Sinai Health System; Cook County Health & Hospitals System; Illinois Institute of Technology; Respiratory Health Association; Chicago Department of Public Health; Chicago Asthma Consortium; Illinois Emergency Department Asthma Surveillance Project
• Investigators: Principal Investigator: Jerry A Krishnan, MD, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.

Helpful Links

• Patient-Centered Outcomes Research Institute (PCORI): Funding award details

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: asthma; emergency; community health worker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2014-1214; AS-1307-05420 (Other Grant/Funding Number: PCORI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No