Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05744869 |
Other study ID # |
00008016 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.