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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
373
Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
Sinai Health System
Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Cook County Health & Hospitals System
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
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.
Time frame: 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.
Time frame: Baseline and 6 months after index ED discharge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At index ED discharge
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