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| Name | Class |
|---|---|
| Georgia Clinical & Translational Science Alliance | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Asthma Navigator | Experimental | 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. |
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| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The asthma navigator | 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. |
| 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) |
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| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Fitzpatrick, PhD, APRN | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
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.
At the time of study completion on August 2026
Data will be accessed by restricted download once approved.
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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.
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| Baseline, end of study (average of 52 weeks) |