SBAT for Health Equity

Asthma in Children Clinical Trial

Official title:

School-based Asthma Therapy to Advance Health Equity Among Historically Marginalized Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05744869
• Other study ID #: 00008016
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2025
• Est. completion date: August 31, 2029

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: Jill S Halterman, MD, MPH
• Phone: 5852755798
• Email: Jill_halterman[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 31, 2029
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Behavioral:
• SBAT Implementation
Implementation of the SBAT Program
• Usual Care
Usual Care for children with asthma

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	Michigan State University, University at Buffalo, Virginia Polytechnic Institute and State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children on DOT	The percentage of eligible children in schools initiated on guideline-based DOT at the 3 month follow-up.	3 month follow-up