Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Summary

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.

Conditions

• Asthma in Children

Interventions

BEHAVIORAL

BACK-S

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).

BEHAVIORAL

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Amy G Huebschmann, MD · Childrens Hospital Colorado

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-21

Primary Completion

2027-05-31

Completion

2027-08-31

Countries

• United States

Study Locations