Asthma Navigator Intervention to Improve Health Equity in Children
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
February 12, 2026
February 1, 2026
1.5 years
July 15, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Hospitalization occurrence
Baseline, end of study (average of 52 weeks)
Clinic follow-up
Baseline, end of study (average of 52 weeks)
Study Arms (2)
The Asthma Navigator
EXPERIMENTALThe 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.
Standard of Care
NO INTERVENTIONThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Admitted to the PICU for asthma
You may not qualify if:
- Cystic fibrosis
- Immune deficiency
- Prematurity \<35 weeks
- Gestation and congenital airway deformities
- Non-English speaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Fitzpatrick, PhD, APRN
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study team and participants will not be blinded but statistical analyses will be performed in a blinded fashion using allocations of "Intervention A" and "Intervention B." Randomization will be implemented 2:1, in blocks of 6, via a computer algorithm to minimize unintentional imbalances between groups.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 15, 2024
First Posted
July 22, 2024
Study Start
January 17, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- At the time of study completion on August 2026
- Access Criteria
- Data will be accessed by restricted download once approved.
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.