Purpose To use a process map to evaluate implementation of a community-clinical linked asthma intervention.Design Following the CDC Logic Model, we created a process map that outlined: (1) training community partners, (2) pediatric providers enrolling children and prescribing a second preventive inhaler, (3) families delivering the inhaler to school, (4) children visiting the school health office for daily supervised inhaler administration, and (5) ongoing communication.Setting The trial which the present data comes from was conducted within 4 pediatric primary care practices.Sample The study sample included pediatric providers/staff (n = 14), children (n = 31), parents (n = 31), and school health staff (n = 18).Measures Adherence measures were defined for each process step, using surveys and tracking data.Analysis Descriptive and frequency statistics were calculated.Results All recruited pediatric practices (n = 2) and schools (n = 46) completed training (100%, n = 48). Although delays occurred in sending medication orders from practice staff to schools, all orders were received within 6 weeks of enrollment. Children attended school health offices 92% of scheduled medication days. Providers and families reported high satisfaction with communication, though challenges existed between providers and school health staff.Conclusion Using a process map, we were able to evaluate adherence to intended process steps and inform future adaptations to improve implementation. Process maps can be practical tools for guiding implementation evaluations and intervention adaptations.

Introduction:Children and families from historically marginalized ethnic/racial backgrounds have low participation in clinical trials and pediatric practice staff perspectives on this topic are underexplored. Methods:We conducted interviews (n = 20) with pediatric practice staff and used rapid template analysis to identify themes and sub-themes. Results:We identified several primary themes related to strategies that both research staff and pediatric practice staff can use in order to support the recruitment of historically marginalized populations into research. For example, researchers can facilitate running reports within practices to identify potential trial participants with limited access to care and pediatric providers can offer research opportunities at well visits noting potential benefits of research and directly discuss mistrust in research. Discussion:While the dynamics involved in the recruitment of historically marginalized children and families into trials are inherently complex, we identified several concrete strategies to support this work and increase diversity in pediatric clinical trials.

Background Single maintenance and reliever therapy (SMART) is the guideline-recommended treatment for children with moderate to severe asthma, yet it is underutilized in pediatric practice. Objective To understand barriers and facilitators to SMART adoption within pediatric practice. Methods We interviewed 52 participants (16 pediatricians, 22 parents, and 16 children). Interviews were conducted until theme saturation, recorded, transcribed, coded, and qualitatively analyzed using the Consolidated Framework for Implementation Research. Results We identified barriers, facilitators, and potential solutions to SMART implementation. Participants described barriers at the following levels: (1) the clinic level, which included a lack of clinician training and clinical decision support for SMART; (2) the family level, which included discomfort transitioning away from traditional albuterol and concern about SMART’s effectiveness as a rescue medication; and (3) the school and systems levels, which included poor communication and a lack of aligned care plans across community settings like schools, and challenges navigating insurance coverage. Facilitators to SMART implementation included acceptance of SMART as a simpler treatment that could improve asthma symptoms. Proposed solutions to barriers included the following: (1) clinic-level trainings and integrated clinical decision support; (2) family-level support for reluctant families; and (3) clear communication between clinics and schools, access to SMART-specific medication orders and action plans, and insurance support. Conclusion Most pediatricians and families reported that SMART is a favorable, simple, and acceptable treatment approach for children with asthma. However, pediatricians and families described significant barriers to using guideline-concordant SMART in routine practice. These results could inform targeted efforts to improve the adoption of SMART within pediatric asthma care.

PURPOSE:There has yet to be a comprehensive multi-state study describing the children that use school-based health centers (SBHCs). This study seeks to determine sociodemographics, care utilization patterns, and prevalence of asthma and overweight among children seeking care at SBHCs. METHODS:This retrospective cross-sectional analysis examined electronic health record data of children utilizing SBHCs within a large network of community-based clinics, consisting of 180 SBHCs in 14 U.S. states from 2012-2018. Demographics of exclusive SBHC users (SBHC-only group) were compared to utilizers of SBHCs plus non-SBHC community health centers (SBHC+ group). RESULTS:Of 179,970 children with ≥1 ambulatory visit at a SBHC, 75.6% received care exclusively at SBHCs. Many SBHC-users reported family income <138% of the federal poverty line (48.9%) and self-identified as Hispanic (45.7%). Among SBHC utilizers, the prevalence of asthma (8%) and overweight (30%) were comparable to national statistics. Overall, 33% of children received well-childcare and 24% received influenza vaccinations exclusively at SBHCs. When comparing the two groups within the study, the SBHC-only group were older, and more lacked insurance (13.4%) compared with SBHC+ children (2.6%). The SBHC-only group had fewer total yearly visits, fewer yearly well-child visits, and fewer influenza vaccinations. In age stratified groups, preschool-aged children received the most well-childcare and influenza vaccinations in SBHCs. CONCLUSIONS:SBHCs serve a pediatric population that is disproportionately low-income, uninsured, and Hispanic. Children, particularly preschoolers, receive preventive healthcare at SBHCs. Given the population served, SBHCs have strong potential to address pediatric health inequities if adequately resourced, utilized, and integrated with other facilities including community health centers.

INTRODUCTION:Single maintenance and reliever therapy (SMART) uses a single inhaler for daily maintenance and as-needed relief. Despite evidence that SMART is more effective in reducing exacerbations than traditional therapy, it is not widely implemented. Successful SMART implementation requires participation from school health staff (SHS), who are a critical part of pediatric asthma management. METHODS:Using a descriptive convergent mixed methods design and grounded in the Consolidated Framework for Implementation Research, we conducted surveys and semi-structured interviews with SHS to explore their perspectives on SMART implementation in schools. We calculated descriptive statistics for survey items and used rapid qualitative analysis to synthesize interview data. RESULTS:A total of 11 SHS completed an interview and 22 completed a survey. Nearly all participants were familiar with SMART and 45% reported experience administering SMART. Most participants (59%) believed that SMART would be simpler for their students. In interviews, many participants highlighted that having one inhaler would also be simpler for them to manage. To support SMART implementation, communication with prescribing providers was highlighted as a primary need; 64% wanted a brief phone call with a provider, 59% wanted an email, and 82% wanted to receive a SMART-specific Asthma Action Plan. DISCUSSION:School health staff reported familiarity with SMART and confidence in their ability to administer it. Multilevel needs include clear communication from pediatric providers when children initiate SMART and availability of SMART inhalers. Future research should explore development and implementation of strategies to address these needs while integrating perspectives of providers and families.

Rationale: School-supervised inhaled corticosteroid administration has the potential to improve asthma morbidity for low-income and minoritized children, yet has not been examined in a pragmatic trial. Objective: To assess Asthma Link (AL), a real-world model of school-supervised asthma therapy embedded within pediatric primary care, through a pragmatic trial. Methods: Four pediatric practices were pair-matched and randomized to: 1) AL plus an asthma educational workbook, or 2) Enhanced Usual Care (EUC), the workbook alone. We recruited children aged 6-17 years, prescribed a daily inhaled corticosteroid with poorly controlled asthma symptoms. Parent-child dyads completed surveys at baseline, 3-, 6- and 12-months. Primary outcomes were recruitment, retention, and intervention fidelity. Secondary outcomes were asthma symptoms, medication adherence, emergency room and hospital visits, oral steroid use, and missed schooldays. Results: Of sixty-six children recruited (average age 9 years, 44% female, 65% Hispanic, 23% Black, 62% low-income), retention was 95%, 91%, and 89% at 3-, 6-, and 12-months respectively. All (31/31) AL families brought their child's preventive inhaler into school; children received school health staff-supervised therapy on >95% of schooldays over 12 months. Mean within-child improvement in Asthma Control Test score from baseline was 1.35, 3.90, and 2.80 points higher at 3-, 6-, and 12-months, respectively in the AL group compared to the EUC group. This difference was statistically significant at 6- and 12-months (p=.0003 and p=.007). Children in AL experienced longer time to first asthma exacerbation (defined as oral steroid use, emergency room visit or hospital admission for asthma) within the 12-month period. The median number of days to first exacerbation in AL was 365 days vs. 195 days in the EUC group, (hazard ratio 0.45, p=0.067). In the Asthma Link group, 64.5% went without an asthma exacerbation at 12-months compared with 37.1% without an exacerbation in the EUC group. Children in AL also experienced less school absences and better medication adherence compared with children in the EUC group. Conclusion: School-supervised asthma therapy embedded within pediatric primary care was feasible with high fidelity and improved asthma morbidity for low-income and minoritized children. Future research on school-supervised therapy should focus on the determinants and evaluation of larger scale dissemination, implementation and sustainability even beyond a research context. Such future work could facilitate greater access to this intervention for children suffering from poor medication adherence and asthma morbidity.

Rationale: Social determinants of health (SDoH) significantly impact pediatric asthma outcomes. Children and families from low-income and minority backgrounds experience higher rates of adverse SDoH and suffer disproportionately from asthma-related comorbidities. In efforts to address inequities in pediatric asthma morbidity, there has been a call to measure and report SDoH within asthma clinical trials to understand how social factors influence asthma outcomes and how SDoH may be impacted by asthma interventions. Methods: We are measuring SDoH in a large, ongoing pediatric asthma clinical trial(NCT06388460) examining the impact of school-supervised therapy on asthma outcomes. Children are eligible if ages 5-14 and prescribed daily inhaled corticosteroid with poorly controlled asthma (asthma control test score ≤19 or ≥1 oral steroid course/ED visit/admission/sick visit for asthma in the last year). In a convenience sample of all currently enrolled children, we assessed baseline frequency of SDoH measures. We included asthma-specific and general SDoH measures known to impact asthma outcomes, within the following domains: education access/quality, health care access/quality, home environment, economic stability, and social context. We dichotomized each measure based on whether a response indicated adverse SDoH or not and then created overall scores for each domain; these scores represented whether a parent had endorsed any of the items in that domain. Frequencies and descriptive statistics were calculated for all individual items and domains. Results: In our sample of 136 children, average age was 8.6 (SD:2.7), 63.2% were male, 54.4% identified as White, 12.5% as Black/African American, and 60.5% as Hispanic/Latino. 80.2% of parents reported their child used public insurance in the last year. 11.6% of parents endorsed all five domains, 32.6% endorsed four, 34.9% endorsed three, 16.3% endorsed two and 4.7% endorsed one. In looking at overall frequencies for each domain, education was the highest (90.2%), followed by health care (75.0%), economic stability (69.7%), home environment (64.4%), and social context (31.0%). Conclusions: In our ongoing asthma clinical trial we measured and report SDoH relevant to pediatric asthma care, using a limited number of questions which we will also use at 6- and 12-month follow-up. We observed high levels of adverse SDoH across all domains, reinforcing the importance of measuring SDoH in this context. This work highlights the need for an asthma-specific tool to measure SDoH within clinical trials. The development and validation of such a tool would enhance the ability of asthma trials to meaningfully improve health and social outcomes for children with asthma.

BACKGROUND:Although school-supervised inhaled corticosteroid administration has potential to improve asthma morbidity, there has yet to be an evaluation of the pediatric practice as a setting to identify children with asthma and connect them to school-supervised asthma therapy. OBJECTIVE:Conduct a pragmatic pilot trial of Asthma Link, a model that connects children with asthma seen in pediatric practice to supervised asthma therapy in the school setting. METHODS:Four pediatric practices were pair-matched and randomized to (1) Asthma Link plus an asthma educational workbook or (2) Enhanced Usual Care, the same workbook alone. We recruited children 6 to 17 years old with poorly controlled asthma, prescribed a daily inhaled corticosteroid. Parent-child dyads completed surveys at baseline and 3, 6, and 12 months. PRIMARY OUTCOMES:recruitment/retention of pediatric practices and parent-child dyads and intervention fidelity. SECONDARY OUTCOMES:asthma symptoms, medication adherence, emergency room visits, hospital admissions, oral steroid use, missed schooldays. RESULTS:Four pediatric practices and 66 parent-child dyads were recruited (average child age 9 y, 44% female, 65% Hispanic, 23% Black, 62% low income). All (4 of 4) practices were retained throughout the study and retention of parent-child dyads was 95%, 91%, and 89% at 3, 6, and 12 months, respectively. All (31 of 31) Asthma Link families brought their child's preventive inhaler into school; children received school health staff-supervised therapy on more than 95% of schooldays over 12 months. Children in the Asthma Link group had greater improvement in Asthma Control Test scores, longer time to first asthma exacerbation, less oral steroid use, and better medication adherence compared with the Enhanced Usual Care group. CONCLUSIONS:Extending the reach of pediatric practices to facilitate the delivery of daily asthma prevention medication at school was feasible and improved pediatric asthma morbidity.

Background: Poor adherence to inhaled corticosteroids (ICS) is a significant challenge in pediatric asthma, contributing to health inequities. Text-message reminders for ICS therapy are an evidence-based approach that improves pediatric asthma medication adherence, yet has not been widely adopted into practice, partly due to lack of (1) participant input on design and implementation and (2) use of sustainable community linkages. Remote Asthma Link™ (RAL) seeks to fill this gap as a school-linked text-message intervention wherein parents of children with poorly controlled asthma received daily, 2-way text-message reminders for preventive inhaler use. Responses were shared with school nurses who conducted remote check-ins with families. Enrolled children, largely from underserved backgrounds, experienced improvements in medication adherence and asthma health outcomes. While initial results were promising, we have yet to elicit participant input to refine the protocol for more widespread implementation. Objective: Examine participant perspectives on barriers and facilitators of RAL implementation. Methods: Semistructured interviews were conducted May-June 2022 with intervention participants: 10 parents, 7 school nurses, and 4 pediatric providers (n = 21) until thematic saturation was reached. Interview transcripts were coded using thematic analysis. Results: Several facilitators for RAL implementation were identified, including ease of use and accessibility, personal connection to the school nurse, and receipt of a visual notification for habit formation. Barriers included challenges with school nurses reaching parents, poor understanding of program expectations, and lack of reimbursement structure. Participant-proposed solutions to barriers included utilizing alternate communication methods (eg, social media), educational sessions, and meeting with payors to consider reimbursement models. Conclusion: RAL is a school-linked text-message intervention demonstrating promise in improving outcomes and equity in asthma care. Key implementation facilitators, barriers, and proposed solutions will inform protocol adaptations to promote successful implementation of this and other text-message interventions into clinical practice.

Asthma morbidity disproportionately impacts children from low-income and racial/ethnic minority communities. School-supervised asthma therapy improves asthma outcomes for up to 15 months for underrepresented minority children, but little is known about whether these benefits are sustained over time. We examined the frequency of emergency department (ED) visits and hospital admissions for 83 children enrolled in Asthma Link, a school nurse-supervised asthma therapy program serving predominantly underrepresented minority children. We compared outcomes between the year preceding enrollment and years one-four post-enrollment. Compared with the year prior to enrollment, asthma-related ED visits decreased by 67.9% at one year, 59.5% at two years, 70.2% at three years, and 50% at four years post-enrollment (all p-values< 0.005). There were also significant declines in mean numbers of total ED visits, asthma-related hospital admissions, and total hospital admissions. Our results indicate that school nurse-supervised asthma therapy could potentially mitigate racial/ethnic and socioeconomic inequities in childhood asthma.

BackgroundSocial determinants of health (SDoH), including access to care, economic stability, neighborhood factors, and social context, strongly influence pediatric asthma outcomes. School-supervised asthma therapy (SST) is an evidence-based strategy that improves asthma outcomes, particularly for historically marginalized children, by providing support for daily medication adherence in school. However, little is known about the relationship between these programs and the adverse SDoH commonly affecting underrepresented minority and marginalized children with asthma.MethodsWe examined qualitative data from interviews (n = 52) conducted between 2017 and 2020 with diverse multi-level partners involved in Asthma Link, a SST intervention. Participants included end-users (children and their parents), deliverers (school nurses and pediatric providers), and systems-level partners (e.g., insurers, legislators, and state officials). We used inductive coding to determine themes and subthemes and deductive coding using the Healthy People 2030 SDoH framework.ResultsThree themes emerged: (1) SST mitigates adverse SDoH (improves access to preventive healthcare and asthma health literacy), (2) SST benefits children experiencing specific adverse SDoH (provides a consistent medication routine to children with unstable family/housing situations) and (3) specific adverse SDoH impede SST implementation (economic instability, culture and language barriers).ConclusionThis study suggests an important relationship between SDoH and SST that warrants further evaluation in our future work on this community-based asthma intervention. Moreover, our findings underscore the importance of measuring SDoH in the implementation and evaluation of pediatric asthma interventions, particularly given the strong influence of these social factors on child health outcomes.

Background: Due to underrepresentation of racial/ethnic minority and low-income groups in clinical studies, there is a call to improve the recruitment and retention of these populations in research. Pilot studies can test recruitment and retention practices for better inclusion of medically underserved children and families in sub-sequent clinical trials. We examined this using a school-based asthma intervention, in preparation for a larger clinical trial in which our goal is to include an underserved study population.Methods: We recruited children with poorly controlled asthma in a two-site pilot cluster randomized controlled trial of school-supervised asthma therapy versus enhanced usual care (receipt of an educational asthma work-book). We sought a study population with a high percentage of children and families from racial/ethnic minority and low-income groups. The primary outcome of the pilot trial was recruitment/retention over 12 months. Strategies used to facilitate recruitment/retention of this study population included engaging pre-trial multi-level stakeholders, selecting trial sites with high percentages of underserved children and families, training diverse medical providers to recruit participants, conducting remote trial assessments, and providing multi-lingual study materials.Results: Twenty-six children [42.3% female, 11.5% Black, 30.8% Multiracial (Black & other), 76.9% Hispanic, and 92.3% with family income below $40,000] and their caregivers were enrolled in the study, which represents 55.3% of those initially referred by their provider, with 96.2%, 92.3%, and 96.2% retention at 3-, 6-, and 12 -month follow-up, respectively.Conclusion: Targeted strategies facilitated the inclusion of a medically underserved population of children and families in our pilot study, prior to expanding to a larger trial.

Implementation science frameworks advise the engagement of multi-level partners (at the patient, provider, and systems level) to adapt and increase the uptake of evidence-based practices (EBPs). However, there is little guidance to ensure that systems-level adaptations reflect the voices of providers who deliver and patients/caregivers who receive EBPs. We present a novel methodology, grounded in the Consolidated Framework for Implementation Research (CFIR), which anchors the engagement of multi-level partners to the voices of individuals who deliver and receive EBPs. Using the CFIR domains: intervention adaptation, individuals involved, inner/outer setting, and process, we illustrate our 4-step methodology through a case example of Asthma Link, a school-supervised asthma management intervention. In step 1, we interviewed “individuals involved” in the intervention (providers/caregivers/patients of Asthma Link) to identify implementation barriers. In step 2, we selected systems-level partners in the “inner and outer setting” that could assist with addressing these barriers. In step 3, we presented the barriers to these systems-level partners and conducted semi-structured interviews to elicit their recommended solutions (process). Interviews were audio-recorded, transcribed, and open-coded. A theoretical sampling model and deductive reasoning were used to identify solutions to implementation barriers. In step 4, we utilized multi-level input to adapt the Asthma Link intervention. Identified barriers included inability to obtain two inhalers for home and school use, inconsistent delivery of the inhaler to school by families, and challenges when schools did not have a nurse. Interviews conducted with school/clinic leaders, pharmacists, payors, legislators, and policymakers (n=22) elicited solutions to address provider and patient/caregiver-identified barriers, including (1) establishing a Medicaid-specific pharmacy policy to allow dispensation of two inhalers, (2) utilizing pharmacy-school delivery services to ensure medication reaches schools, and (3) identifying alternate (non-nurse) officials to supervise medication administration. The iterative process of engaging multi-level partners helped to create an adapted Asthma Link intervention, primed for effective implementation. This novel methodology, grounded in the CFIR, ensures that systems-level changes that require the engagement of multi-level partners reflect the voices of individuals who deliver and receive EBPs. This methodology demonstrates the dynamic interplay of CFIR domains to advance the field of implementation science.

Background School-supervised asthma therapy improves asthma medication adherence and morbidity, particularly among low-income and underrepresented minority (URM) children. However, COVID-19-related school closures abruptly suspended this therapy. In response, we developed a school-linked text message intervention. Objective The purpose of the study is to investigate the feasibility and acceptability of a school-linked text message intervention. Methods In December 2020, children previously enrolled in school-supervised asthma therapy in Central Massachusetts were recruited into this school-linked text message intervention. We sent two-way, automated, daily text reminders in English or Spanish to caregivers of these children, asking if they had given their child their daily preventive asthma medicine. Our study team notified the school nurse if the caregiver did not consistently respond to text messages. School nurses performed weekly remote check-ins with all families. The primary outcome of the study was feasibility: recruitment, retention, and intervention fidelity. Secondarily we examined intervention acceptability and asthma health outcomes. Results Twenty-six children (54% male, 69% Hispanic, 8% Black, 23% White, 93% Medicaid insured) and their caregivers were enrolled in the intervention with 96% participant retention at 6 months. Caregiver response rate to daily text messages was 81% over the study period. Children experienced significant improvements in asthma health outcomes. The intervention was well accepted by nurses and caregivers. Conclusion A school-linked text messaging intervention for pediatric asthma is feasible and acceptable. This simple, accessible intervention may improve health outcomes for low-income and URM children with asthma. It merits further study as a potential strategy to advance health equity.

Rationale: Few evidence-based public health interventions are adopted in practice, in part due to a disconnect between the outcomes measured in clinical trials and the outcomes important to stakeholders that determine implementation in real-world practice. AsthmaLink is a school-supervised asthma therapy program which partners pediatric providers, school nurses, and families. To inform the design of a cluster randomized controlled trial of AsthmaLink, we elicited systems-level stakeholder input. Methods: Maximum variation sampling was used to recruit 18 stakeholders to participate in semi-structured interviews that were recorded, transcribed, and open coded: Department of Public Health officials (n = 4), school officials (n = 4), pediatric practice managers (n = 3), health insurance officials (n = 4), and legislators (n = 3). Thematic analysis was used to identify common themes related to stakeholder priorities for clinical trial design and perceived barriers to AsthmaLink adoption. Results: Stakeholder groups identified common priorities for the clinical trial design, including examination of the extent to which AsthmaLink (1) reduces health care utilization, (2) is cost effective (2) addresses health disparities, (3) reduces school absenteeism, and (4) educates families about asthma. Stakeholder groups reported potential barriers to AsthmaLink adoption, including challenges pertaining to (1) securing resources, staffing, and reimbursement, (2) variability across school districts, and (3) standing out amidst multiple programs vying for resources. Conclusions: Systems-level stakeholder input informed refinements to the clinical trial design of a schoolsupervised therapy program including outcome and implementation measures and choice of study population. Incorporating systems-level stakeholder perspectives into clinical trial design is critical to achieve adoption of evidence-based interventions into practice.