Asthma Navigator Intervention to Improve Health Equity in Children

The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:

• To identify the factors related to differential experiences of asthma self-management
• To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: The asthma navigator

Detailed Description

Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.

At Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted to the PICU for asthma

Exclusion Criteria:

• Cystic fibrosis
• Immune deficiency
• Prematurity <35 weeks
• Gestation and congenital airway deformities
• Non-English speaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Asthma Navigator; The Children's electronic medical record (EMR) of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end.	Behavioral: The asthma navigator; The asthma navigator is a Registered Respiratory Therapist and Certified Asthma Educator who will review the care plan at discharge and provide asthma education; assist with follow-up clinic appointment scheduling, medication access, and transportation; and daily as-needed telephone support.
No Intervention: Standard of Care; This arm will not have access to the Asthma Navigator. The Children's EMR of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Future unscheduled healthcare utilization for asthma exacerbation	The occurrence of unscheduled healthcare utilization and the date and time of occurrence will be assessed through weekly screenings of each child's EMR at Children's (Epic system).	Baseline, end of study (average of 52 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization occurrence	Number of hospitalizations would be measured.	Baseline, end of study (average of 52 weeks)
Clinic follow-up	Number of clinic follow ups would be measured.	Baseline, end of study (average of 52 weeks)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Georgia Clinical & Translational Science Alliance
• Investigators: Principal Investigator: Anne Fitzpatrick, PhD, APRN, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Asthma in Children; Asthma self-management
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00007482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All subject-level clinical data at enrollment will be preserved and shared during study completion on 7/31/26. Shared data will be deidentified and original data maintained at the Principal Investigator's institution. Recruitment progress and final study results will be documented at clinicaltrials.gov. Protocols, informed consent forms to participate in the trial and the data dictionary will be shared with the data. Data will be shared with qualified investigators with an appropriate research and approved data use agreement (DUA). Data will be accessed by restricted download once approved.
• IPD Sharing Time Frame: At the time of study completion on August 2026
• IPD Sharing Access Criteria: Data will be accessed by restricted download once approved.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No