Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: CAPE
* Behavioral: CHW home visits


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced usual care<br>Inhaler technique education and distribution of spacers to all participants. | |
| Experimental: ED-only<br>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<br>* Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers<br>|
| Experimental: ED-plus-home<br>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<br>* Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers<br>Behavioral: CHW home visits<br>* Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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community health worker, emergency, asthma