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Completed

NCT Number: NCT02319967

Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

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.

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Key information

Conditions

Asthma Bronchial Diseases Disease Attributes Emergencies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAPE

Behavioral

Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers

CHW home visits

Behavioral

Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.

Primary outcomes

  1. PROMIS Asthma Impact Scale (v1.0, SF8a)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  2. PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)

    Time frame: Baseline and 6 months after index ED discharge

    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.

Secondary outcomes

  1. Childhood Asthma Control Test (cACT)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  2. PROMIS Anxiety (v1.0, SF4a)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  3. PROMIS Depression (v1.0, SF4a)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  4. PROMIS Fatigue (v1.0, SF4a)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  5. PROMIS Sleep Disturbance (v1.0, SF4a)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  6. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

    Time frame: Baseline and 6 months after index ED discharge

    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.

  7. Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits

    Time frame: 6 months post index ED discharge

    Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months

  8. Number of Participants With All-cause Hospitalizations

    Time frame: 6 months post index ED discharge

    Count of participants (children) with at least one all-cause hospitalization at 6 months

  9. Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids

    Time frame: 7 days post index ED discharge

    Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge

  10. Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller

    Time frame: 7 days post index ED discharge

    Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge

  11. Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider

    Time frame: 4 weeks post index ED discharge

    Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge

  12. Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids

    Time frame: At index ED discharge

    Count of participants who were provided documented discharge instructions to use systemic corticosteroids

  13. Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller

    Time frame: At index ED discharge

    Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller

  14. Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication

    Time frame: At index ED discharge

    Count of participants who were provided documented discharge instructions to use an inhaled rescue medication

  15. Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff

    Time frame: At index ED discharge

    Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Chicago Asthma Consortium
  • Chicago Department of Public Health
  • Cook County Health & Hospitals System
  • Illinois Emergency Department Asthma Surveillance Project
  • Illinois Institute of Technology
  • Patient-Centered Outcomes Research Institute
  • Respiratory Health Association
  • Rush University Medical Center
  • Sinai Health System
  • University of Chicago

Registry information

Official study title

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

Acronym: CHICAGO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2014
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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