Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Conditions

• Asthma in Children

Eligibility Criteria

Sex

ALL

Age

5 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• BACK-S — BEHAVIORAL
  BACK = Better Asthma Control for Kids: The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).
• BACK-E — BEHAVIORAL
  The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.

Study Details

Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.

Key Dates

Start date

Sep 21, 2023

Status verified

Apr 2026

Primary completion

May 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• No Intervention: Usual care
  School nurses/schools randomized to usual care will continue to receive their usual care from school nurses and then subsequently provide the intervention given their asthma remains poorly controlled at the start of the next school year following enrollment.
• Experimental: BACK-S
  The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).
• Experimental: BACK-E
  The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.

Primary Outcome Measure

Reach [ Time Frame: Up to 48 months ]

Central Contacts

• Michaela Brtnikova, PhD
  303-724-2643
  [email protected]

Locations (13)

Find similar trials in Ault, CO

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