Clinical trial NCT05744869: SBAT for Health Equity
Official title: School-based Asthma Therapy to Advance Health Equity Among Historically Marginalized Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Michigan State University
name: Virginia Polytechnic Institute and State University
name: University at Buffalo
First posted: 2023-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research trial is to: 1) Solidify a population health SBAT implementation strategy with our longstanding community collaborators, 2) Perform a district-wide hybrid type 3, stepped-wedge, cluster randomized trial, and 3) Assess the supportive resource utilization and essential features of SBAT to extend sustainability and fidelity in a cost-effective manner.

Detailed description: Despite well-established asthma guidelines and availability of effective preventive medications, poor access to guideline-based care is common, especially in historically marginalized communities negatively impacted by social determinants of health (SDOH). There are long-standing inequities in asthma medication use, health care utilization, and outcomes based on race, income, and geography that are rooted in systemic racism and segregation. Many children who should receive daily preventive anti-inflammatory medications do not receive them and follow up care with needed step-ups in asthma treatment does not occur consistently.

Almost 20 years ago, in partnership with the Rochester City School District, an under-resourced urban district with very high poverty rates, the investigators co-developed the paradigm-shifting School-Based Asthma Therapy (SBAT) program to enhance access to guideline-based treatment for children with persistent asthma. SBAT reduces SDOH-related care barriers through the use of: 1) school-based telemedicine visits with primary care providers and asthma specialists facilitating access to asthma assessments for appropriate medication prescription and follow-up, and 2) school-based directly observed therapy (DOT) of preventive asthma medications ensuring access and adherence to these medications. In research studies, SBAT yielded substantial benefit in reducing symptoms and exacerbations, and key stakeholders (caregivers, school district leaders, nurses) express a strong interest in program continuation, since improving asthma outcomes is a top priority for the district and community. Importantly, while this evidence-based program is well accepted in our community and components have been adopted across the country, it has not been implemented broadly in our community nor sustained outside of research trials. SDOH-related barriers have increased over time exacerbating existing health disparities, and children with asthma continue to suffer from morbidity and even mortality. To produce a sustainable public health impact, the investigators must re-imagine school-based asthma care using novel approaches, co-created with our key stakeholders, to define the supports and resources required to extend this evidence-based program's reach and create a resource for national dissemination.

The investigators plan to solidify and test a pioneering SBAT implementation strategy to enhance guideline-based asthma care and reduce disparities. The multilevel SBAT program addresses various SDOH related to healthcare access and quality and social contextual factors that interfere with optimal asthma management. The investigators aim to: 1) Solidify a population health SBAT implementation strategy with our longstanding community collaborators, 2) Perform a district-wide hybrid type 3, stepped-wedge, cluster randomized trial, and 3) Assess the supportive resource utilization and essential features of SBAT to extend sustainability and fidelity in a cost-effective manner.

Upon conclusion, the investigators will have refined and evaluated a stakeholder-driven approach to optimize implementation of SBAT for sustainable improvement in care to ensure health equity for children with asthma.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma, with persistent symptoms or poor control based on NHLBI criteria
* Age \>4 and \<12 years
* Attending school in Rochester City School District
* Caregiver \>18 years, and is able to understand and speak English or Spanish

Exclusion Criteria:

* Caregiver inability to speak and understand English or Spanish. (\*Participants unable to read will be eligible, and all instruments will be given verbally.)
* Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
* In foster care or other situations in which consent cannot be obtained from a guardian.

Based on our prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.

Primary outcomes:
measure: Percentage of children on DOT
timeFrame: 3 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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