Implementation of the SBAT Program

Study Overview
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Brief Summary
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The goal of this research trial is to develop and evaluate a stakeholder-driven approach to optimize implementation of the School-based Asthma Therapy (SBAT) program for sustainable improvement in adherence to guideline-based care and reduce health disparities for children with asthma. We will compare basic implementation (BI) to enhanced implementation (EI) based on stakeholder-informed strategies. The EI strategies will include support to school-health staff to facilitate the following components: 1) telemedicine asthma visits through school with primary care and/or specialist providers to prescribe initial preventive medications and step-ups, 2) school-based directly-observed-therapy (DOT) of preventive asthma medications, 3) follow-up telemedicine asthma control assessments, and 4) centralized case management as needed.

Detailed Description
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Asthma is one of the most common chronic conditions of childhood, affecting more than 4 million children in the US and leading to significant morbidity and cost. While well-established guidelines recommend effective, daily preventive medications for children with persistent asthma, under-treatment is very common, especially in historically marginalized communities. More than a decade ago, we developed the School-Based Asthma Therapy (SBAT) program to enhance adherence to guideline-based treatment for children with persistent asthma in the Rochester City School District, through school-based directly observed therapy (DOT) of preventive asthma medications. SBAT led to improved symptoms and fewer exacerbations, and we now have ample data to support clinical and cost effectiveness of school-based DOT in randomized trials. We subsequently adapted our SBAT program to include a basic implementation support strategy to promote adoption and maintenance with less research team involvement, using protocols, simple screening tools, and telemedicine visits with prompting to facilitate asthma assessments and medication prescription for DOT. These programs include school-based telemedicine visits with both primary care and asthma specialist providers to ensure optimal assessments of asthma severity and control, prompting for appropriate prescription of guideline-based medications to be delivered via DOT at school, and follow-up visits for potential medication adjustments for children with continued poor control These iterations of SBAT also yielded substantial benefit when implemented in our research trials, and key stakeholders expressed a strong interest in program continuation. However, even with protocols and strategies for delivery available, outside of research trials and without additional staff support, the program has been implemented for <10% of eligible children. We now plan to develop and test financially sustainable enhanced implementation strategies to support uptake of the SBAT program throughout the school district. We include all core elements from our prior trials: 1) systematic school-based asthma screening, 2) telemedicine asthma visits through school with primary care and/or specialist clinicians for guideline-based assessment and prescription of needed medications, and 3) school-based DOT of preventive asthma medications. We will conduct a prospective cluster randomized Hybrid Type 3 study to compare the 2 levels of implementation support, for 4-12 year old children with persistent or poorly controlled asthma in all schools in the district. Our overarching goal is to determine the supports and resources required for effective and sustained implementation of SBAT, tailored to the unique challenges and limited resources in the city school district, to improve adherence to guideline-based asthma care and promote health equity. Aim 1: Develop an enhanced implementation strategy with key stakeholders to address facilitators / barriers and needed implementation resources for SBAT. Guided by the Practical, Robust Implementation & Sustainability Model (PRISM), we will use qualitative interviews and surveys with caregivers, school nurses, administrators, providers, and health plan leaders to inform enhanced, sustainable implementation strategies. We will develop an implementation strategy matched to identified barriers and available resources. We will then use content mapping to result in a tailored, enhanced implementation (EI) strategy. Aim 2: Conduct a hybrid type 3 cluster randomized effectiveness-implementation study throughout the city school district. We will employ mixed methods to compare our basic implementation approach (BI) to an enhanced implementation approach (EI = BI + additional stakeholder informed implementation supports) for SBAT. We will evaluate and compare RE-AIM outcomes between these two strategies to ensure; 1) Broad and equitable Reach to eligible students, 2) Effectiveness in enhancing adherence and reducing morbidity, 3) Adoption in schools, 4) Implementation of and fidelity to core program components, and 5) Maintenance at the individual and setting level. Our primary hypothesis is that schools with EI strategies for SBAT will have greater implementation fidelity, with DOT of guideline-based controller medications initiated for a higher percentage of eligible children by 3 months, compared to schools with BI strategies. Aim 3: Assess the supportive resource utilization and cost-effectiveness of EI compared to BI to support financial sustainability of SBAT. We will assess programmatic, productivity, and medical costs to evaluate the cost of implementation and how successful implementation could affect patient healthcare and other costs. Upon study completion, we will have developed and evaluated a stakeholder-driven, scalable approach to optimize implementation of the SBAT program for sustainable improvement in adherence to guideline-based care and reduced health disparities for children with asthma.

Official Title
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Optimizing Adherence to Asthma Guidelines - Implementation of the School-Based Asthma Therapy Program

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: Enhanced Implementation (EI)
* Behavioral: Basic Implementation (BI)


Participation Criteria
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Eligibility Criteria
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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, we anticipate <10% of subjects to be excluded based on these criteria.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Implementation (EI)<br>For schools randomized to the Enhanced Implementation (EI) of SBAT, the program will include all the same components of the Basic Implementation (brief symptom screen, access to telemedicine visits, and protocol for initiating DOT), as well as the following elements that will be facilitated with the support of an implementation team: telemedicine asthma visits through school with primary care and/or specialist providers to prescribe needed initial medication as well as medication step-ups for DOT school-based DOT of preventive asthma medications follow-up telemedicine asthma control assessments centralized case management support and care coordination | Behavioral: Enhanced Implementation (EI)<br>* Enhanced Implementation (EI) of the SBAT Program<br>|
| Active Comparator: Basic Implementation (BI)<br>During student health services orientation, the SBAT team will recommend school-based DOT for children with persistent or poorly controlled asthma, and will provide a simple asthma screening survey to assess symptoms and a written protocol for initiating DOT. Telemedicine visits and DOT are available for all children in the school district, but the implementation team will not help to facilitate these components within the BI schools. | Behavioral: Basic Implementation (BI)<br>* Basic Implementation (BI) of the SBAT Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |