Implementation of the School-based Asthma Therapy Program

Not Applicable

Not yet recruiting

• Conditions: Asthma in Children

• Registration Number: NCT06796387
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study First Submitted: 2024-05-22
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-29
• Study Start: 2025-12
• Primary Completion: 2030-07
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of children on directly observed therapy (DOT) of their controller asthma medication	3 month follow-up	The percentage of eligible children in schools initiated on guideline-based DOT at the 3 month follow-up.

Secondary Outcome Measures

Name	Time	Method
Mean number of symptom-free days in prior 14 days	12-month follow-ups	Mean number of symptom-free days (24 hours without symptoms) in prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).
Number of acute health care visits due to asthma	12 months	Number of acute health care visits (emergency, hospitalization, urgent care) for asthma over 12 months.
Quality of Life Score	12 months	Pediatric Asthma Caregiver Quality of Life score at each follow-up. Scores range from1-7, higher scores indicate better quality of life.
Program Reach	12 months	Proportion of Eligible Participants Enrolled into SBAT each school year
Program Adoption	12 months	Proportion of students enrolled into SBAT including at least one telemedicine visit and 1 month of directly observed therapy.
Program Maintenance	12 months	Proportion of students enrolled into SBAT that continue with directly observed therapy (DOT) of medications past 3 months
Program Cost Effectiveness	12 months	Evaluation of cost of program per student/participant
Absenteeism due to asthma	12 months	Number of days participant misses school due to asthma
Medication Adherence	12 months	Score on the Medication Adherence Report Scale at each follow-up. Scores range from 5-25, with higher scores indicating a higher level of adherence.