Asthma disproportionately affects children living in disadvantaged communities. The
well-documented disparities in asthma outcomes for minorities, including death, worse
asthma control, greater likelihood of emergency room visits, and higher rates of school
absenteeism are partly related to unmet SDOH for low-income families. Many SDOH
contribute to uncontrolled asthma for low-income families, such as lack of insurance and
transportation. For the child with asthma, this leads to reduced preventive care visits
leading to more emergency visits and hospitalizations. Poor asthma control contributes to
lower school performance due to missed school days and/fatigue and poorer concentration
due to poor sleep quality. As a result, asthma is one of seven educationally relevant
health disparities that school leaders seek to address to bend the widening achievement
gap between low-income and higher income students. While some measures of health equity
improved in the last decade, socio-economic disparities in asthma care have been
stubbornly persistent.
A recent Cochrane review along with other reports identify key benefits of school-based
asthma management programs, including reduced acute/urgent care health care use and days
of restricted activity for students. Additionally, our work in this area for more than 15
years demonstrates improvements in self-management behaviors, quality of life, and school
absenteeism. Core elements of our existing Colorado school-based asthma program
(Col-SBAP) are concordant with those identified as effective in a Cochrane review,
including education and counseling strategies to improve asthma knowledge and
self-management skills to successfully control asthma. To date, these core Col-SBAP
elements have been implemented in six school districts by school nurses and project
funded asthma navigators (ANavs) - each ANav serves 40-65 children with uncontrolled
asthma across one or more schools. A lesson learned during Col-SBAP implementation from
our CABs is that the investigators need to address families' SDOH. Thus, the
investigators developed a two-step intervention program, Col-SBAP combined with SDOH
assessment/referral, termed Better Asthma Control for Kids (BACK). Our ANavs have had
great success in identifying and addressing SDOH that directly impact asthma care,
including inadequate insurance coverage, transportation, and difficulty affording
medications. The core components of BACK are highly pragmatic and acceptable, as
evidenced by the Denver Public School system sustaining Col-SBAP for 3 years with no
external funding.
The investigators have developed, refined and piloted a program that is feasible to
implement, and that has been sustained without external funding in one school district,
but requires ongoing funding in other school districts. Support has largely come from
public health agencies with limited engagement of Medicaid and other funders. To date,
ours and others' work in school-based asthma care is also limited by the lack of
generalizability to rural and smaller urban areas, and by the fact that our
implementation guide does not help schools tailor implementation strategies to their
community/site needs, resources, and priorities. Thus, the key next step to scale out
BACK more broadly to use tools from the D&I field to prepare us for primetime
dissemination and scalability. The UG3 award has allowed us to: 1) work purposively with
multi-sectoral partners (including public health funders and insurers) in regions across
Colorado where the investigators have not yet implemented our program to identify local
needs, priorities and resources for BACK, and 2) tailor BACK implementation strategies to
local factors. In the UH3 trial, the investigators will evaluate the effects of
implementing BACK in diverse areas of Colorado, including rural regions with two
different implementation packages, and will also identify different contextual factors
that predict RE-AIM outcomes. Briefly, the investigators will identify how and why
implementation strategies critical for local uptake and sustainability vary in their
impact. Lessons learned will support the co-development of our BACK dissemination
playbook with our partners so diverse and disadvantaged communities across the nation can
feasibly implement BACK in a way that addresses local factors critical for success and
sustainability.
Multi-sectoral engagement, including funders: The EPIS framework encourages the
involvement of partners across multiple socioecological levels to support implementation.
For BACK this includes patients/families, school health staff, primary care clinics, and
community SDOH representatives that are part of our CABs. The investigators have also
worked to engage health insurers and public health departments to ensure our
implementation strategies consider payer perspectives and state public health
integration.
Development Process for our Dissemination Playbook: The principles of "Designing for
Dissemination" hold that it is critical to design evidence-based programs (EBPs) as a
"product" that specifies not just core components, but details how to deliver the
"product" within a site's usual way of practice. EPIS has been used previously to engage
stakeholders to effectively package EBPs to tailor how implementation to address local
needs and priorities. A key next step for future BACK dissemination is an innovative
playbook to assist potential adopters to pick the types of "plays" needed to deliver the
program with fidelity to core components but in a way that permits localized
sustainability.
The investigators anticipate that typologies of context exist for each school site, such
as the number of children eligible for BACK, needs and priorities for BACK, or the size
of the school health team, that will influence implementation. Thus, the investigators
propose to use our Aim 3a mixed methods evaluation to co-create a dissemination playbook
prototype for implementation with our multi-sectoral partners, to help future adopters
select implementation strategies tailored to their contextual typologies.
Innovative design of our playbook: Our dissemination playbook is innovative and extends
the work of others by being interactive and allowing for site-specific tailoring through
site self-evaluation assessments with immediate feedback identifying and suggesting
relevant implementation strategies. It will permit tailoring to site to consider the
general RE-AIM outcomes of BACK, including Reach to students and implementation costs. In
addition, the playbook will allow school leaders to consider any significant variability
of impact of BACK for different typologies of schools/communities (e.g., rural vs. urban,
school nurse on-site yes/no). It will also highlight opportunities for reimbursement,
including a bill to support community health worker reimbursement that was drafted by the
Colorado House/Senate legislature in 2023.
Our specific aims for the UH3 trial phase are:
Aim 1: Among n=60 school nurses, their schools and students with poorly controlled asthma
randomized to BACK-S vs. BACK-E in 4 regions of Colorado compare the reach (primary
outcome), student retention, adoption, costs to future adopters, and sustainment.
Hypothesis 1a (Primary): Reach will be significantly greater among students with poorly
controlled asthma when delivered using the BACK -E implementation package as compared to
BACK-S package.
Aim 2: Determine and compare annual asthma exacerbation rates (i.e., exacerbations/year)
in children with uncontrolled asthma randomized to either usual care (control) or the
BACK intervention (using either the BACK-S or BACK-E implementation package).
Hypothesis 2: BACK will be more effective than usual care at reducing annual asthma
exacerbations.
Aim 3a: Identify factors that predict student reach and retention, school-level adoption,
costs to future adopters (schools), and sustainment for BACK-S or BACK-E.
Aim 3b: Based on the evaluation of Aims 1, 2 and 3a, adapt the current Denver based
Col-SBAP, Asthma COMP implementation guide into a multi-media BACK dissemination playbook
to guide the future dissemination of BACK (EPIS phase 4) Engagement of Multi-sectoral
partners for Aims 1-3 Table 3 details the organization and membership in our partner
groups. Drs. Szefler, Cicutto, Huebschmann, McFarlane and De Camp and Ms. Gleason formed
community advisory boards (CAB) in 5 Colorado regions that met 3-4 times yearly in the
UG3 phase and will continue to meet semi-annually in the UH3 phase. Our team will
continue to work closely with the non-investigator elected chair to maintain engagement
and effective group processes.
SCHOOL SITE RECRUITMENT:
Among the 5 school regions the investigators engaged with in the UG3 Phase, the
investigators have successfully identified school nurses from four of the 5 regions for
UH3 study participation. The 4 participating regions for the UH3 phase are the Lower
Arkansas Valley (LAV), Delta/Mesa, Greeley/Weld/Fort Morgan, and Pikes Peak regions. The
Montezuma/La Plata region was unable to engage with school districts to participate in
the UH3 trial, but the investigators are maintaining the CAB in this region in
anticipation of future BACK implementation.
School sites recruited serve socioeconomically diverse communities in rural and mid-size
urban areas, representing ethnically/racially diverse populations that have SDOH
characteristics placing them at higher risk of asthma burden. These include rural
populations (e.g., the Lower Arkansas Valley, Morgan and Delta counties) and
small-to-mid-size urban populations (e.g., Mesa County, Greeley), and large urban
populations (Colorado Springs/Pikes Peak). The schools the investigators selected within
each of the regions have >32% rates of free and reduced lunch, have a large proportion of
minority children, and higher risk SDOH characteristics. The investigators will provide
services in English and Spanish and employ bilingual ANavs.
APPROACH FOR AIMS 1-2 (UH3) Overarching objective: This research is guided by the Reach,
Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and its emphasis
on equity and representativeness. The investigators will study diverse and rural schools
across four regions of Colorado and students with poor asthma control. In Aim 1, the
investigators will compare reach and other implementation outcomes among schools and
students with randomization at the school nurse level (n=~60) to deliver either the
BACK-standard vs. BACK-enhanced implementation package. Separately, in Aim 2, the
investigators will compare the effectiveness of the BACK intervention when delivered as
either BACK-standard or BACK-enhanced, as compared to usual care. See Section 3D for
specific aims.
PRAGMATIC UH3 STUDY DESIGN The investigators will conduct a pragmatic type 2 hybrid
implementation-effectiveness trial; randomized at the level of school nurses, involving
an open cohort, parallel cluster randomized trial where intervention conditions are
phased in over two years. The investigators will compare the implementation outcomes of
BACK-S and BACK-E with each other and will also compare the effectiveness outcomes
(asthma exacerbations) of BACK-S/BACK-E with control arm.
