SB-CAP: School-Based Community Asthma Program
Study Details
Study Description
Brief Summary
To refine and assess a comprehensive, feasible implementation strategy of a school-based asthma research program to allow for full integration within schools. The comprehensive School-Based Community Asthma Program (SB-CAP) includes the following core elements: 1) systematic asthma assessment, 2) telemedicine asthma visits through school with primary care and/or specialist providers to prescribe initial preventive medications and step-ups, 3) school-based DOT of preventive asthma medications, and 4) centralized case management as needed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Despite well-established asthma guidelines and the availability of effective preventive medications, under-treatment is common, especially in historically marginalized communities. Many children who should receive daily preventive anti-inflammatory medications are not receiving them, and follow up care with needed step-ups in asthma treatment does not occur consistently. The investigators now have evidence from several randomized trials (RCTs) that school-based directly observed therapy (DOT) of preventive asthma medications can improve outcomes for children with persistent asthma. The investigators have also found that school-based telemedicine can address additional gaps in implementing asthma care by facilitating assessments for initial preventive medication prescriptions for DOT as well as follow-up care for needed medication step-ups for children who continue to have poor control. While these programs have yielded significant benefit, all of our prior studies were conducted as RCTs with substantial involvement from the research team, and they have not been sustained in the community without this additional support.
To now produce a sustainable public health impact, the investigators must adapt the delivery model further to allow for full integration within schools. The comprehensive School-Based Community Asthma Program (SB-CAP) includes the core elements from our RCTs: 1) systematic asthma assessment, 2) telemedicine asthma visits through school with primary care and/or specialist providers to prescribe initial preventive medications and step-ups, 3) school-based DOT of preventive asthma medications, and 4) centralized case management as needed.
Aim 1: Refine an implementation plan, including the selection of needed implementation strategies, for the SB-CAP program in conjunction with key stakeholders. The investigators will co-develop a plan for pragmatic implementation of our successful school-based asthma program, including needed delivery model adaptations, with feedback from key stakeholders. Guided by the PRISM (Practical, Robust Implementation & Sustainability Model) framework, the investigators will use surveys and qualitative interviews with caregivers, school nurses and administrators, primary care and specialist providers, insurers, and health plan leaders, to develop a plan for sustainable implementation of the core elements from our RCTs, with a menu of strategies to support schools.
Aim 2: Perform a stepped-wedge, cluster randomized trial of real-world implementation of the SB-CAP program in Rochester city schools. The investigators will use identified strategies to implement the intervention in randomly assigned clusters of schools throughout the district in 3 waves. The investigators will evaluate RE-AIM (reach, effectiveness, adoption, implementation, maintenance) outcomes and iteratively adapt implementation to ensure; 1) Broad and equitable reach to eligible students (primary outcome), 2) Effectiveness in reducing asthma attacks and absenteeism, 3) Adoption in eligible schools, 4) Implementation of core program components, and 5) Maintenance of the program beyond the implementation period. Our primary hypothesis is that 'program reach' will be equivalent or better than response rates/study reach in our randomized trials.
Aim 3: Conduct an evaluation of SB-CAP implementation processes. The investigators will assess for equitable outcomes across RE-AIM domains and identify contextual factors at the patient and community / school levels that may impact RE-AIM outcomes. The investigators will also evaluate whether equity-focused variables (race, ethnicity, insurance) moderate the intervention effect across RE-AIM outcomes. The investigators will evaluate the implementation and sustainability infrastructure to identify resources to support equitable implementation and sustained program delivery, and will assess costs associated with both delivery of the intervention and implementation strategies.
Upon study completion, the investigators will have established a strategy for implementing SB-CAP as an integrated, sustainable, and equitable program to improve guideline-based care and reduce disparities for children with asthma, and will have key information regarding resources needed for pragmatic implementation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SB-CAP For schools randomized to the SB-CAP program, the following core elements will be implemented: systematic asthma assessment 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 centralized case management support as needed |
Behavioral: SB-CAP
SB-CAP
|
| No Intervention: Control Comparison While all schools in the district have the opportunity to utilize telemedicine visits and a protocol for initiating DOT of medications, these strategies will not be implemented for the control comparison schools. |
Outcome Measures
Primary Outcome Measures
- Program Reach [End of Intervention (5 years)]
The number of eligible participants enrolled divided by the number exposed to recruitment efforts.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Child attending a participating Rochester City School District school
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Child age: 4-12 years
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Child has physician diagnosed asthma with persistent or poor control based on NHLBI criteria
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Caregiver age 18 years or older
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Caregiver speaks and understands either English or Spanish
Exclusion Criteria:
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Children in foster care or other situations where consent can not be obtained
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Children with complicating illnesses (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Rochester
- University of Rhode Island
- Virginia Polytechnic Institute and State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00008016