Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

students with poor asthma control (or indicators of excess burden on school Asthma Intake Form)

age 5-12 years of age

attending one of participating schools in rural Colorado (school selection criteria: high rates of socioeconomic need based on high rates of free-and-reduced lunch or rural status)

Disqualifiers

age < 5 years or > 12 years

students with no or controlled asthma

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: BACK-SExperimental treatment 1 intervention
Group C: BACK-EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reach

% of eligible students enrolled Numerator of Reach = number students consented with confirmed Asthma Intake Form (AIF) eligibility Denominator of Reach = number of eligible students o This denominator includes all students presumed eligible based on AIF at school registration, minus any students determined to NOT be eligible by AIF once the navigator called to confirm eligibility.

Time frame
Up to 48 months

Secondary outcomes

1

Number of episode requiring systemic steroid therapy

A reported number of episodes of systemic steroid therapy due to asthma, either orally or parenterally per year.

Time frame
Up to 48 months
2

Number of ED/UC visits

A reported number of Emergency Department (ED) and Urgent Care (UC) visits due to asthma per year.

Time frame
Up to 48 months
3

Number of hospitalizations

A reported number of hospitalizations due to asthma per year.

Time frame
Up to 48 months

Other outcomes

1

Effectiveness based on asthma exacerbations

Number of asthma exacerbations per year - defined as the number of asthma exacerbations requiring systemic steroid therapy, either orally or parenterally, following an ED visit, urgent care visit, hospitalization, or as directed by their clinician

Time frame
Up to 48 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator