Reducing asthma attacks in disadvantaged school children with asthma: study protocol for a type 2 hybrid implementation-effectiveness trial (Better Asthma Control for Kids, BACK)

Abstract

Background: Asthma is a leading cause of children's hospitalizations, emergency department visits, and missed school days. Our school-based asthma intervention has reduced asthma exacerbations for children experiencing health disparities in the Denver Metropolitan Area, due partly to addressing care coordination for asthma and social determinants of health (SDOH), such as access to healthcare and medications. Limited dissemination of school-based asthma programs has occurred in other metropolitan and rural areas of Colorado. We formed and engaged community advisory boards in socioeconomically diverse regions of Colorado to develop two implementation strategy packages for delivering our school-based asthma intervention - now termed "Better Asthma Control for Kids (BACK)" - with tailoring to regional priorities, needs and resources.

Methods: In this proposed type 2 hybrid implementation-effectiveness trial, where the primary goal is equitable reach to families to reduce asthma disparities, we will compare two different packages of implementation strategies to deliver BACK across four Colorado regions. The two implementation packages to be compared are: 1) standard set of implementation strategies including Tailor and Adapt to context, Facilitation and Training termed, BACK-Standard (BACK-S); 2) BACK-S plus an enhanced implementation strategy, that incorporates network weaving with community partners and consumer engagement with school families, termed BACK-Enhanced (BACK-E). Our evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, including its Pragmatic Robust Implementation Sustainability Model (PRISM) determinants of implementation outcomes. Our central hypothesis is that our BACK-E implementation strategy will have significantly greater reach to eligible children/families than BACK-S (primary outcome) and that both BACK-E and BACK-S groups will have significantly reduced asthma exacerbation rates ("attacks") and improved asthma control as compared to usual care.

Discussion: We expect both the BACK-S and BACK-E strategy packages will accelerate dissemination of our BACK program across the state - the comparative impact of BACK-S vs. BACK-E on reach and other RE-AIM outcomes may inform strategy selection for scaling BACK and other effective school-based programs to address chronic illness disparities.

Trial registration: Clinicaltrials.gov identifier: NCT06003569, registered on August 22, 2023, https://classic.

Clinicaltrials: gov/ct2/show/NCT06003569 .

Keywords: Asthma; Child health; Health equity; Implementation science; School health services; Social determinants of health.

Fig. 1

Key roles in our patient-centered BACK program. Our BACK program puts the child and family at the center of everything we do. The role of the ANav is to support the school nurse-led team to deliver the core functions of BACK. This includes the ANav assisting the school nurse-led team with asthma education for the child/family, and asthma case management and care coordination between the child/family, health provider team, and community resources for SDOH. The ANav links families to community resources for SDOH to address financial constraints of asthma care, such as inadequate insurance coverage, lack of affordable transportation, and difficulty affording medications

Fig. 2

Implementation Research Logic Model. Abbreviations – PRISM (Pragmatic Robust Implementation Sustainability Model), RN (School Nurse), ANav (Asthma Navigator), BACK (Better Asthma Control for Kids), SDOH (Social Determinants of Health), CAB (Community Advisory Board)

Fig. 3

Study design for DECIPHeR Colorado program. In this diagram, there are two groupings of schools, those in GROUP A that had organizational readiness to implement either BACK-S or BACK-E in Year 1 of the funded trial, and those in GROUP B needed an additional year to prepare for implementation. The rows in each group represent the study arms for randomization. The columns are the study years, where the first column is the final year of the UG3-funded planning phase that included baseline data collection for the schools/school nurses in GROUP A, and Years 1–4 are the UH3-funded hybrid implementation-effectiveness trial period. BACK-S indicates the standard Better Asthma Control for Kids (BACK) package of implementation strategies of Tailor and adapt to context, Facilitation and Training, and BACK-E represents the enhanced strategy package of BACK-S strategies plus network weaving and consumer engagement. After 2 years of implementation, schools transition into the Maintenance phase where we will assess if they sustain either BACK-S or BACK-E, designated as MBACK-S or MBACK-E; for Arms 1 and 2 in Group B those are MBACK-S and MBACK-E, respectively

Fig. 4

Annual Timeline for Mixed Methods data collection and analysis. This figure depicts the timing of qualitative and quantitative data collection and analysis over the course of each study year, and the planned use of these data. Abbreviations: AIF (Asthma Intake Form), Qual (qualitative), Quant (quantitative), BACK (Better Asthma Control for Kids intervention), NPS (net promoter score – level of recommendation of BACK), SDOH (social determinants of health)