Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

NCT ID: NCT02319967

Last Updated: 2019-06-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced usual care

Inhaler technique education and distribution of spacers to all participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

CAPE

Intervention Type BEHAVIORAL

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

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).

Group Type EXPERIMENTAL

CAPE

Intervention Type BEHAVIORAL

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

CHW home visits

Intervention Type BEHAVIORAL

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

Interventions

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CAPE

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinai Health System

OTHER

Sponsor Role collaborator

Cook County Health & Hospitals System

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

Chicago Department of Public Health

OTHER_GOV

Sponsor Role collaborator

Respiratory Health Association

UNKNOWN

Sponsor Role collaborator

Chicago Asthma Consortium

UNKNOWN

Sponsor Role collaborator

Illinois Institute of Technology

OTHER

Sponsor Role collaborator

Illinois Emergency Department Asthma Surveillance Project

UNKNOWN

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Jerry Krishnan

Associate Vice Chancellor for Population Health Sciences, Professor of Medicine and Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry A Krishnan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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Sinai Health System

Chicago, Illinois, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Cook County Health & Hospitals System

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28366780 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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AS-1307-05420

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2014-1214

Identifier Type: -

Identifier Source: org_study_id

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