Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes

NCT02319967 | Completed Results DMC

• 2 other identifiers: 2014-1214AS-1307-05420
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma

Keywords

community health worker; emergency; asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Childhood Asthma Control Test (cACT)

  Baseline and 6 months after index ED discharge

• PROMIS Anxiety (v1.0, SF4a)

  Baseline and 6 months after index ED discharge

• PROMIS Depression (v1.0, SF4a)

  Baseline and 6 months after index ED discharge

• PROMIS Fatigue (v1.0, SF4a)

  Baseline and 6 months after index ED discharge

• PROMIS Sleep Disturbance (v1.0, SF4a)

  Baseline and 6 months after index ED discharge

Study Arms (3)

Enhanced usual care

NO INTERVENTION

Inhaler technique education and distribution of spacers to all participants.

ED-only

EXPERIMENTAL

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

ED-plus-home

EXPERIMENTAL

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; Behavioral: CHW home visits

Interventions

CAPE BEHAVIORAL

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

ED-only; ED-plus-home

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.

ED-plus-home

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (6)

Sinai Health System

Chicago, Illinois, 60608, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Cook County Health & Hospitals System

Chicago, Illinois, 60612, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 28366780 DERIVED

Related Links

• Patient-Centered Outcomes Research Institute (PCORI): Funding award details

MeSH Terms

Conditions

Asthma; Emergencies

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jerry A. Krishnan, MD, PhD
• Organization: University of Illinois at Chicago

chicagotrial@uic.edu

312-413-3291

Study Officials

• Jerry A Krishnan, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice Chancellor for Population Health Sciences, Professor of Medicine and Public Health

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 19, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 19, 2019
• Results First Posted: April 22, 2019

Record last verified: 2019-06

Locations

US (6)