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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319967
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : April 22, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Sinai Health System
Cook County Health & Hospitals System
Rush University Medical Center
Ann & Robert H Lurie Children's Hospital of Chicago
University of Chicago
Chicago Department of Public Health
Respiratory Health Association
Chicago Asthma Consortium
Illinois Institute of Technology
Illinois Emergency Department Asthma Surveillance Project
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jerry Krishnan, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: CAPE Behavioral: CHW home visits Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)
Study Start Date : March 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319967


Locations
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United States, Illinois
Sinai Health System
Chicago, Illinois, United States, 60608
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Cook County Health & Hospitals System
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Illinois at Chicago
Sinai Health System
Cook County Health & Hospitals System
Rush University Medical Center
Ann & Robert H Lurie Children's Hospital of Chicago
University of Chicago
Chicago Department of Public Health
Respiratory Health Association
Chicago Asthma Consortium
Illinois Institute of Technology
Illinois Emergency Department Asthma Surveillance Project
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jerry A Krishnan, MD, PhD University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Jerry Krishnan, University of Illinois at Chicago:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jerry Krishnan, Associate Vice Chancellor for Population Health Sciences, Professor of Medicine and Public Health, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02319967    
Other Study ID Numbers: 2014-1214
AS-1307-05420 ( Other Grant/Funding Number: PCORI )
First Posted: December 19, 2014    Key Record Dates
Results First Posted: April 22, 2019
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jerry Krishnan, University of Illinois at Chicago:
community health worker
emergency
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases