Clinical trial NCT06796387: Implementation of the School-based Asthma Therapy Program
Official title: Implementation of the School-Based Asthma Therapy Program to Optimize Adherence and Improve Child Health
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: 2025-01-28
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 an enhanced implementation (EI) strategy for SBAT with longstanding community collaborators, 2) Perform a district-wide hybrid type 3, stepped-wedge, cluster randomized trial of usual care / basic implementation (BI) vs. enhanced implementation (EI), and 3) Assess the supportive resource utilization and essential features of SBAT implementation to extend sustainability and fidelity in a cost-effective manner.

Detailed description: Despite well-established asthma guidelines and availability of effective preventive medications, poor adherence to guideline-based care is common. 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. In partnership with the Rochester City School District, the investigators previously co-developed the paradigm-shifting School-Based Asthma Therapy (SBAT) program to enhance adherence to guideline-based treatment for children with persistent asthma. The investigators demonstrated that SBAT reduces barriers to adherence through the use of: 1) School-based telemedicine visits with primary care providers and asthma specialists to facilitate access to asthma assessments for appropriate preventive medication prescription and follow-up, and 2) School-based directly observed therapy (DOT) of preventive asthma medications to support medication adherence. In research studies, SBAT yielded substantial benefit in reducing symptoms and asthma exacerbations, and key stakeholders (caregivers, school district leaders, nurses, healthcare providers) expressed strong support for program continuation and scale-up, since improving asthma outcomes is a top priority for the district and community. However, despite positive effects and cost-effectiveness demonstrated in research studies, SBAT has not been implemented broadly in the community nor sustained outside of research trials. Healthcare barriers have increased over time and children with asthma continue to suffer from morbidity and even mortality. To now produce sustainable impact, school-based asthma care must be re-imagined using novel approaches, co-created with key stakeholders, to provide the supports and resources required to extend this evidence-based program's fidelity and reach and to create a resource for national dissemination. The investigators plan to solidify and test a co-developed, sustainable SBAT enhanced implementation strategy to optimize guideline-based asthma care and prevent asthma morbidity. The goal of this research trial is to: 1) Solidify an enhanced implementation strategy for SBAT with longstanding community collaborators, 2) Perform a district-wide hybrid type-3, stepped-wedge, cluster randomized trial of usual care / basic implementation (BI) vs. enhanced implementation (EI) of SBAT, and 3) Assess the supportive resource utilization and essential features of SBAT implementation to extend sustainability and fidelity in a cost-effective manner. Upon conclusion, the investigators will have developed and tested an implementation approach for SBAT that will have broad implications for enhancing adherence to effective treatments for children with asthma, preventing morbidity, and improving child health.

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

Primary outcomes:
measure: Percentage of children on directly observed therapy (DOT) of their controller asthma medication
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Mean number of symptom-free days in prior 14 days
timeFrame: 12-month follow-ups
measure: Number of acute health care visits due to asthma
timeFrame: 12 months
measure: Absenteeism due to asthma
timeFrame: 12 months
measure: Quality of Life Score
timeFrame: 12 months
measure: Medication Adherence
timeFrame: 12 months
measure: Program Reach
timeFrame: 12 months
measure: Program Adoption
timeFrame: 12 months
measure: Program Maintenance
timeFrame: 12 months
measure: Program Cost Effectiveness
timeFrame: 12 months
Other outcomes:
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