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NCT Number: NCT05744869

SBAT for Health Equity

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.

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Key information

Conditions

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SBAT Implementation

Behavioral

Implementation of the SBAT Program

Usual Care

Behavioral

Usual Care for children with asthma

Primary outcomes

  1. Percentage of children on DOT

    Time frame: 3 month follow-up

    The percentage of eligible children in schools initiated on guideline-based DOT at the 3 month follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Jill S Halterman, MD, MPH

CONTACT

[email protected]

5852755798

Maria Fagnano, MPH, MS

CONTACT

[email protected]

5852758220

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Michigan State University
  • University at Buffalo
  • Virginia Polytechnic Institute and State University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 27, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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