School-supervised Asthma Therapy is Associated with Improved Long-Term Asthma Outcomes for Underrepresented Minority Children.

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.

Effect of School Integrated Pest Management or Classroom Air Filter Purifiers on Asthma Symptoms in Students With Active Asthma: A Randomized Clinical Trial.

Importance: School and classroom allergens and particles are associated with asthma morbidity, but the benefit of environmental remediation is not known. Objective: To determine whether use of a school-wide integrated pest management (IPM) program or high-efficiency particulate air (HEPA) filter purifiers in the classrooms improve asthma symptoms in students with active asthma. Design, Setting, and Participants: Factorial randomized clinical trial of a school-wide IPM program and HEPA filter purifiers in the classrooms was conducted from 2015 to 2020 (School Inner-City Asthma Intervention Study). There were 236 students with active asthma attending 41 participating urban elementary schools located in the Northeastern US who were randomized to IPM by school and HEPA filter purifiers by classroom. The date of final follow-up was June 20, 2020. Interventions: The school-wide IPM program consisted of application of rodenticide, sealing entry points, trap placement, targeted cleaning, and brief educational handouts for school staff. Infestation was assessed every 3 months, with additional treatments as needed. Control schools received no IPM, cleaning, or education. Classroom portable HEPA filter purifiers were deployed and the filters were changed every 3 months. Control classrooms received sham HEPA filters that looked and sounded like active HEPA filter purifiers. Randomization was done independently (split-plot design), with matching by the number of enrolled students to ensure a nearly exact 1:1 student ratio for each intervention with 118 students randomized to each group. Participants, investigators, and those assessing outcomes were blinded to the interventions. Main Outcomes and Measures: The primary outcome was the number of symptom-days with asthma during a 2-week period. Symptom-days were assessed every 2 months during the 10 months after randomization. Results: Among the 236 students who were randomized (mean age, 8.1 [SD, 2.0] years; 113 [48%] female), all completed the trial. At baseline, the 2-week mean was 2.2 (SD, 3.9) symptom-days with asthma and 98% of the classrooms had detectable levels of mouse allergen. The results were pooled because there was no statistically significant difference between the 2 interventions (P = .18 for interaction). During a 2-week period, the mean was 1.5 symptom-days with asthma after use of the school-wide IPM program vs 1.9 symptom-days after no IPM across the school year (incidence rate ratio, 0.71 [95% CI, 0.38-1.33]), which was not statistically significantly different. During a 2-week period, the mean was 1.6 symptom-days with asthma after use of HEPA filter purifiers in the classrooms vs 1.8 symptom-days after use of sham HEPA filter purifiers across the school year (incidence rate ratio, 1.47 [95% CI, 0.79-2.75]), which was not statistically significantly different. There were no intervention-related adverse events. Conclusions and Relevance: Among children with active asthma, use of a school-wide IPM program or classroom HEPA filter purifiers did not significantly reduce symptom-days with asthma. However, interpretation of the study findings may need to consider allergen levels, particle exposures, and asthma symptoms at baseline. Trial Registration: ClinicalTrials.gov Identifier: NCT02291302.

School nurse asthma program reduces healthcare utilization in children with persistent asthma.

OBJECTIVE: We examined the impact of a novel, school nurse-supervised asthma therapy program on healthcare utilization. METHODS: We retrospectively reviewed charts of 84 children enrolled in this program in central Massachusetts between 2012 and 2015. Physicians identified children with persistent asthma and poor medication adherence. These children were enrolled in the program to receive daily-inhaled corticosteroid at school, supervised by their school nurse, with ongoing communication between physician's office and school nurse through the school year. This program relied on established family, provider and school resources rather than research staff. The primary outcome was change in the number of emergency department (ED) visits in the year before and after enrollment. Secondary outcomes were hospital admissions, school absences, and rescue medication use. RESULTS: The study population was on average 10.5 years old, 63% male, 67% Hispanic, 19% black, 14% white with 95% using Medicaid insurance. Asthma-related ED visits over a 1-year period decreased 37.5%, from a pre-intervention mean of 0.8 visits to a post-intervention mean of 0.3 visits (p < 0.001). Asthma-related hospital admissions decreased from a pre-intervention mean of 0.3 admissions to post-intervention mean of 0 admissions (p < 0.001). Asthma rescue medication refills decreased by 46.3% from the pre- to post-intervention period (p = <.001). There were also non-significant declines in school absences and oral steroid use for children enrolled. CONCLUSIONS: We demonstrate a significant reduction in healthcare utilization for children enrolled in this unique school nurse-supervised asthma program, which utilizes a clinical-school partnership to deliver preventative asthma medication to school-aged children under sustainable conditions.

Racial disparities in family-provider interactions for pediatric asthma care.

OBJECTIVE: Black and Latino children experience significantly worse asthma morbidity than their white peers for multifactorial reasons. This study investigated differences in family-provider interactions for pediatric asthma, based on race/ethnicity. METHODS: This was a cross-sectional study of parent surveys of asthmatic children within the Population-Based Effectiveness in Asthma and Lung Diseases Network. Our study population comprised 647 parents with survey response data. Data on self-reported race/ethnicity of the child were collected from parents of the children with asthma. Outcomes studied were responses to the questions about family-provider interactions in the previous 12 months: (1) number of visits with asthma provider; (2) number of times provider reviewed asthma medications with patient/family; (3) review of a written asthma treatment plan with provider; and (4) preferences about making asthma decisions. RESULTS: In multivariate adjusted analyses controlling for asthma control and other co-morbidities, black children had fewer visits in the previous 12 months for asthma than white children: OR 0.63 (95% CI 0.40, 0.99). Additionally, black children were less likely to have a written asthma treatment plan given/reviewed by a provider than their white peers, OR 0.44 (95% CI 0.26, 0.75). There were no significant differences by race in preferences about asthma decision-making nor in the frequency of asthma medication review. CONCLUSION: Black children with asthma have fewer visits with their providers and are less likely to have a written asthma treatment plan than white children. Asthma providers could focus on improving these specific family-provider interactions in minority children.

Exploring the relationship between school-supervised asthma therapy and social determinants of health in pediatric asthma care.

BACKGROUND: Social 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. METHODS: We 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. RESULTS: Three 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). CONCLUSION: This 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.

Association of Early Childhood Wheeze and Asthma Diagnosis Documentation by Race, Ethnicity, and Language in Children.

OBJECTIVE: To determine whether electronic health record (EHR) documentation of certain early childhood risk factors for asthma, such as wheeze differ by race, ethnicity, and language group, and whether these children have different subsequent asthma prevalences. METHODS: We used EHR data from the Accelerating Data Value Across a National Community Health Center (ADVANCE) Clinical Research Network from children receiving care in US community health centers (n = 71,259 children) across 21 states to examine the presence of ICD-coded documentation of early childhood wheeze and its association with subsequent asthma diagnosis documentation in the EHR by race/ethnicity/language. RESULTS: ICD-coded wheeze was present in 2 to 3% of each race/ethnicity/language group. Among the total sample, 18.5% had asthma diagnosed after age 4. The adjusted prevalence of subsequent asthma diagnosis was greater in children with wheeze than those without. Odds of asthma diagnosis did not differ among children in all race/ethnicity/language groups with early childhood wheeze. Non-Latino Black children without wheeze had higher odds of asthma (OR = 1.19, 95% CI = 1.08-1.32) compared with non-Latino White children without wheeze. DISCUSSION: In US community health centers which serve medically underserved populations, EHR documentation of early childhood wheeze was uncommon and did not differ significantly among race/ethnicity/language groups. Differences in asthma diagnosis in Latinos may not stem from differences in early-life wheeze documentation. However, our findings suggest that there may be opportunities for improvement in early asthma symptom recognition for non-Latino Black children, especially in those without early childhood wheeze.

Participant Perspectives on the Implementation of a School-Linked Text-Message Intervention to Improve Pediatric Asthma Medication Adherence.

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.

A pediatric primary care practice-based obesity intervention to support families: a cluster-randomized clinical trial.

OBJECTIVE: The American Academy of Pediatrics recommends that pediatric practices help families make lifestyle changes to improve BMI, but provider time and access to treatment are limited. This study compared the effectiveness of two pediatric practice-based referral interventions in reducing BMI. METHODS: In this cluster-randomized clinical trial, 20 pediatric primary care practices were randomized to telephonic coaching (Fitline Coaching) or mailed workbook (Fitline Workbook). Parents and their 8- to 12-year-old children with BMI ≥ 85th percentile completed assessments at baseline and at 6 and 12 months post baseline. Primary outcomes were 12-month BMI percentile and z score. RESULTS: A total of 501 children and their parents received Fitline Coaching (n = 243) or Fitline Workbook (n = 258); 26.8% had overweight, 55.4% had obesity, and 17.8% had severe obesity. Mean (SD) age was 10.5 (1.4), and 47.5% were female. BMI percentile improved in both groups; 12-month decline in continuous BMI z score was not statistically significant in either group. However, 20.8% of telephonic coaching participants and 12.4% of workbook participants achieved a clinically significant reduction of at least 0.25 in BMI z score, a significant between-group difference (p = 0.0415). CONCLUSIONS: Both low-intensity interventions were acceptable and produced modest improvements in BMI percentile. One in five children in the telephonic coaching condition achieved clinically meaningful BMI z score improvements. However, more research is needed before such a program could be recommended for pediatric primary care practice.

Updates in school-based asthma management.

PURPOSE OF REVIEW: School-based asthma management is an important component of pediatric asthma care that has the potential to provide more universal evidence-based asthma care to children and mitigate asthma-related health inequities. The purpose of this review is to highlight relevant developments in school-based asthma management over the past 2 years. RECENT FINDINGS: There have been considerable recent scientific advances in school-based asthma management including robust clinical trials of environmental interventions in the classroom setting, school-nurse led interventions, stock albuterol policy changes, school-based telemedicine approaches and innovative methods to engage community stakeholders in research that have pushed the frontiers of school-based asthma care. SUMMARY: Recent scientific work in school-based asthma management demonstrates the potential power of schools in providing access to guideline-based asthma care for all children with asthma and in improving their health outcomes. Future work should focus on the evaluation of methods to promote the adoption of school-based asthma management strategies in real-world practice and support evidence-based policy change and strategic partnerships to improve asthma health outcomes and produce meaningful public health impact for diverse children and families.

Pediatricians' perspectives on COVID-19 and HPV vaccine hesitancy.

Rises in parental vaccine hesitancy, observed during the COVID-19 pandemic, threaten public health. This is especially concerning for vaccines not typically required for school-entry, such as the vaccines for COVID-19 and human papillomavirus (HPV), both of which also have much lower rates of completion compared to other adolescent vaccines. Pediatricians are well-positioned to address vaccine hesitancy and can offer insights into parents' perspectives in this area. There is evidence that pediatricians' sharing their own vaccine stories may help to address parents' concerns; yet we have little information on pediatricians' or their children's COVID-19 vaccine uptake. To address these gaps, we conducted a cross-sectional survey about Massachusetts pediatricians' behaviors and perspectives on vaccines that face significant resistance: HPV and COVID-19 vaccines. A total of 144 people initiated the survey, and 109 participants were eligible and completed the survey. Participants reported high levels of COVID-19 vaccine uptake for themselves (97%) and their children (98%). Similarities in parents' resistance toward both vaccines were identified: fear of side effects; general vaccine resistance. Pediatricians reported a rise in vaccine hesitancy since the beginning of the COVID-19 pandemic. Future research should focus on identifying strategies to build overall vaccine confidence and streamline these efforts for pediatricians.

Quality of Care for Latinx Children with Asthma: Associations with Language Concordance and Continuity of Care.

BACKGROUND: Language concordance between Latinx patients and their clinicians has been shown to affect health outcomes. In addition, there is evidence that consistent continuity of care (COC) can improve health care outcomes. The relationship between language concordance and COC and their association with health equity in chronic disease is less clear. Our aim was to study the moderating effect of clinician and patient language concordance on the association between COC and asthma care quality in Latinx children. METHODS: We utilized an electronic health record dataset from a multistate network of community health centers to compare influenza vaccinations and inhaled steroid prescriptions, by ethnicity and language concordance groups overall and stratified by COC. RESULTS: We analyzed electronic health records for children with asthma (n = 38,442) age 3 to 17 years with ≥2 office visits between 2005 to 2017. Overall, 64% of children had low COC (defined as COC < 0.5) while 21% had high COC (defined as >0.75). All Latinx children had higher rates and odds of receiving influenza vaccination compared with non-Hispanic White children. In addition, Spanish-preferring Latinx children had higher rates and odds of being prescribed inhaled steroids while English-preferring Latinx children had lower odds (OR = 0.85 95%CI = 0.73,0.98) compared with non-Hispanic White children. CONCLUSION: Overall, Latinx children regardless of COC category or language concordance were more likely to receive the influenza vaccine. English-preferring Latinx children with persistent asthma received fewer inhaled steroid prescriptions compared with non-Hispanic White children. Panel chart review and seeing a practice partner might be one way to combat these inequities.

Impact of COVID-19 on childhood obesity: Data from a paediatric weight management trial.

There is growing concern that the coronavirus disease 2019 (COVID-19) pandemic is exacerbating childhood obesity. We sought to examine the effects of the pandemic on weight and weight-related behaviours among children with overweight and obesity participating in an ongoing cluster randomized controlled trial of a paediatric practice-based weight intervention with 2 study arms: nutritionist-delivered coaching telephone calls over 8 weeks with an accompanying workbook on lifestyle changes versus the same workbook in eight mailings without nutritionist coaching calls. In a pooled, secondary analysis of 373 children in central Massachusetts (aged 8-12 years, 29% Latinx, 55% White, 8% Black), the monthly rate of BMI increase more than doubled for those children whose 6-month study visit occurred post-pandemic onset (n = 91) compared to children whose 6-month study visit occurred pre-pandemic onset (n = 282) (0.13 kg/m2 versus 0.05 kg/m2 ; ratio = 2.47, p = 0.02). The post-pandemic onset group also had a significant decrease in activity levels (ß -8.18 MVPA minutes/day, p = 0.01). Caloric intake and screen time did not differ between the pre- and post-pandemic onset groups. These findings show that after the start of the pandemic, children with overweight and obesity experienced an increase in weight and decrease in activity levels. This data can inform public health strategies to address pandemic-related effects on childhood obesity.

Caregiver-perceived neighborhood safety and pediatric asthma severity: 2017-2018 National Survey of Children's Health.

OBJECTIVE: To examine the association between caregiver-perceived neighborhood safety and pediatric asthma severity using a cross-sectional, nationally representative sample. STUDY DESIGN: Using data from the 2017-2018 National Survey of Children's Health, children aged 6-17 years with primary caregiver report of a current asthma diagnosis were included (unweighted N = 3209; weighted N = 3,909,178). Perceived neighborhood safety, asthma severity (mild vs. moderate/severe), demographic, household, and health/behavioral covariate data were collected from primary caregiver report. Poisson regression with robust error variance was used to estimate the association between perceived neighborhood safety and caregiver-reported pediatric asthma severity. RESULTS: Approximately one-third of children studied had moderate/severe asthma. A total of 42% of children with mild asthma and 52% of children with moderate/severe asthma identified as Hispanic or non-Hispanic Black. Nearly 20% of children with mild asthma and 40% of children with moderate/severe asthma were from families living below the federal poverty level (FPL). Children living in neighborhoods perceived by their caregiver to be unsafe had higher prevalence of moderate/severe asthma compared to those in the safest neighborhoods (adjusted prevalence ratio: 1.34; 95% confidence interval: 1.04-1.74). This association was found to be independent of race/ethnicity, household FPL, household smoking, and child's physical activity level after adjusting for covariates. CONCLUSIONS: Children living in neighborhoods perceived by their caregiver to be unsafe have higher prevalence of moderate or severe asthma. Further investigation of geographic context and neighborhood characteristics that influence childhood asthma severity may inform public health strategies to reduce asthma burden and improve disease outcomes.

School Nurse Perspectives on School-Supervised Asthma Therapy: A Qualitative Study.

Background: School-supervised asthma therapy improves asthma outcomes for children, yet this strategy is not widely utilized. School nurses play a vital role in this intervention, yet their perspectives on school-supervised asthma therapy have not been thoroughly examined. Objectives: To examine the perspectives of school nurses participating in school-supervised asthma therapy and identify key facilitators, barriers, and proposed solutions that will facilitate the uptake of this strategy. Methods: We used purposeful sampling to recruit 12 school nurses participating in Asthma Link, a real-world application of school-supervised asthma therapy, between 2017 and 2019. We performed semistructured interviews with school nurses to elicit their perspectives on the facilitators, barriers, and proposed solutions to barriers to Asthma Link implementation. Interview transcripts were analyzed using qualitative descriptive methodology to identify major themes. Results: School nurses identified facilitators for Asthma Link adoption, including the ease of integrating supervised therapy into school nurse routines, recognition of benefits for families with limited resources, and satisfaction participating in preventive care. School nurses identified barriers, including communication challenges with families and providers, families not reliably bringing medication to school, limited nursing staff in schools, and increased school nurse turnover. School nurses proposed specific solutions to these barriers, including appointing Asthma Link liaisons within pediatric practices, incentivizing families to bring medicine to school, and partnering new school nurses with those experienced in delivering Asthma Link to overcome staffing issues and promote program fidelity. Conclusions: School nurse perspectives on the facilitators, barriers, and solutions to barriers are important for understanding how to promote real-world implementation of school-supervised asthma therapy. The themes identified in this study will be utilized to refine our protocol for Asthma Link to facilitate real-world adoption of this evidence-based strategy.

A response to COVID-19 school closures: The feasibility of a school-linked text message intervention as an adaptation to school-supervised asthma therapy.

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.

Social Determinants of Health in Asthma Through the Life Course.

There is strong evidence supporting the influence of social determinants of health (SDOH) on the development and progression of asthma. SDOH are defined as conditions in which people are born, grow up, live, work, and age, which influence their opportunity to be healthy, risk of illness, and life expectancy. The goal of this article was to describe 2 case-based approaches (pediatric and adult) to assessing and addressing SDOH in asthma across the life course and in community settings. As asthma providers and specialists, the role of SDOH is complex in our clinical care; however, it is critical to address social needs identified through clinical care for our patients with asthma. Clinical-community partnerships, through grant and cost-sharing mechanisms with resource agencies, are necessary to ameliorate social needs for patients and their communities and have the potential to improve asthma outcomes. Although this is a unique and exciting time in health care to promote individual and population health, knowledge gaps remain, including best practices to integrate holistic SDOH care into the care of patients with asthma.

CENTER-IT: a novel methodology for adapting multi-level interventions using the Consolidated Framework for Implementation Research-a case example of a school-supervised asthma intervention.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Strategies to improve the recruitment and retention of underserved children and families in clinical trials: A case example of a school-supervised asthma therapy pilot.

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 subsequent 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 workbook). 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.

Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy.

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 school-supervised 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.