Asthma Navigator Intervention to Improve Health Equity in Children

NCT ID: NCT06513832

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2026-08-31

Brief Summary

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.

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

The asthma navigator

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia Clinical & Translational Science Alliance (CTSA)

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Anne M Fitzpatrick

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Fitzpatrick, PhD, APRN

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne Fitzpatrick, PhD, APRN

Role: CONTACT

anne.fitzpatrick@emory.edu

404-727-9112

Facility Contacts

Anne Fitzpatrick

Role: primary

anne.fitzpatrick@emory.edu

404-727-9112

Other Identifiers

STUDY00007482

Identifier Type: -

Identifier Source: org_study_id