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.

Background:E-cigarette use remains prevalent among US adolescents, with many reporting daily use and high nicotine dependence. Few evidence-based mobile health interventions focus specifically on adolescents. Objective:This study aimed to evaluate the feasibility, engagement, and preliminary efficacy of vaper-to-vaper (V2V)-a multicomponent, peer-driven texting intervention supporting adolescent e-cigarette cessation. Methods:A cluster randomized pilot study was conducted in 5 Massachusetts high schools, with schools randomized to either the V2V texting intervention (n=3) or a control group (n=2) that received a link to the National Cancer Institute's Smokefree.gov Quit Vaping website. The V2V intervention included four components: (1) peer-written messages provided motivation, tips, and strategies to support adolescents in quitting vaping, sent daily in the first 30 days; (2) peer videos featuring adolescents sharing their experiences with e-cigarettes and motivations to quit, sent regularly as links aligned with related peer message topics; (3) peer coaches-university students aged younger than 22 years who had successfully quit vaping-trained to provide support, encouragement and answers to participants' questions through the texting platform; and (4) a fictional, gamified mystery story integrated into the texting platform to promote engagement. Each gamified message included a short story segment and a question, with the next segment unlocked after a response or automatically after 3 days. The intervention was mainly delivered over 30 days, but adolescents could message the peer coach over the 3 months. Eligible participants (grades 9-12, current e-cigarette users) were followed for 3 months. We assessed the feasibility of recruitment and retention (target: 80 participants, ≥85% retention), engagement with intervention components, and participant satisfaction. The secondary outcomes included improvements from baseline in confidence to quit, self-efficacy to resist vaping in specific high-risk situations, and fewer days vaped. E-cigarette cessation was biochemically verified using the Abbott iScreen cotinine test. Results:Seventy-one adolescents enrolled (intervention: 39/71, 55% ; control: 32/71, 45%), with a 96% follow-up rate at 3 months. Among intervention participants who responded to engagement items (N=37), high engagement-defined as self-reported use always, usually, or about half the time-was highest for peer messaging (n=29, 78%), followed by gamification (n=18, 49%), peer coaching (n=18, 49%), and peer video (n=13, 35%). The intervention group showed nonsignificant improvements in confidence to quit (n=17, 46%, vs n=9, 24%, moved from not at all, somewhat, or moderately confident to very or extremely confident) and in the number of days vaped in the past 30 days (-3.6 vs -2.9), while self-efficacy scores (adapted smoking self-efficacy scale range 12-60) were slightly lower compared to the control group (mean -0.21, SD 1.14, vs mean 0.06, SD 1.39). Cotinine-validated 7-day point prevalence abstinence was similar between groups (intervention: 21.6% vs control: 22.6%). Conclusions:The V2V intervention demonstrated feasibility and acceptability, with strong engagement and high satisfaction. Although differences between groups were not statistically significant, findings suggest that peer-driven mobile interventions are a promising approach to support adolescent e-cigarette cessation.

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.

Fitline is a pediatric practice-based, family-centered weight management intervention in which families with children aged 8-12 with overweight/obesity receive a brief pediatrician-delivered intervention and 4 hours of telephonic nutrition and lifestyle coaching accompanied by a workbook. We analyzed study tracking records and satisfaction survey data from 243 families, of which 31% (n = 75) identified as Latino. Latino families completed fewer coaching sessions. Only 70% of Latino families completed all 8 coaching sessions, compared to 89% of non-Latino families (p < 0.001). Significantly fewer Latino families completed study tracking assessments of dietary recalls (p < 0.01) and actigraph measurements at 12 months (p < 0.01). More Latino families reported that the coaching sessions (p = 0.04) and workbook (p = 0.01) were very helpful, compared to non-Latino families. Given higher rates of overweight/obesity among Latino children, it is imperative to understand how best to ensure Latino families can participate in and experience the full effect of weight management interventions.

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.

PurposeWe sought to explore perceived barriers to engaging in weight-related health behavior change among parent child dyads.DesignThis is a secondary analysis of data from a cluster-randomized controlled trial investigating the effectiveness of Fitline telephonic coaching vs Fitline workbook at improving weight-related health behaviors and body mass index for children 8-12 years old with overweight and obesity.SettingThe trial which the present data comes from was conducted within 20 pediatric primary care practices in Central Massachusetts.SampleData from 499 parent-child dyads were included.MeasuresBarriers to weight-related health behavior changes were assessed via 10 survey items answered by parents and the enrolled child at baseline, 6- and 12-month.AnalysisWe used frequencies to describe the distribution of parent and child reported behavior-change barriers as well as McNemar's and Bowker's tests to compare distributions of behavior-change barriers at baseline and change in report of behavior-change barriers at 6-month.ResultsWe found that barriers to weight-related health behavior change varied within parent child dyads with up to 30% of dyads disagreeing on behavior-change barrier perception at baseline. Additionally, up to 37% of dyads were not aligned on reported change in barriers to health behavior change at 6-month.ConclusionOur findings support the potential benefit of integrating behavior-change barrier assessment from both the parent and child perspectives into intervention delivery when developing and tailoring family-centered interventions.

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.

BACKGROUND:Youth vaping is a serious public health concern, being more prevalent than any other tobacco use. To inform cessation interventions, we explored what adolescents perceive as their reasons for quitting and strategies to help them quit.METHOD:Semi-structured interviews were conducted with a convenience sample of 11 adolescents reporting vaping in the past 90 days and recruited from a high school in Massachusetts. Interviews were transcribed and dual-coded. Inductive thematic analysis was employed, and thematic summaries were prepared.RESULTS:Reasons adolescents reported for quitting included cost, experiencing "nic-sick" from nicotine withdrawal or excess intake, negative impacts on mood, concentration, or health, and experiencing symptoms of nicotine dependence. Nearly all tried to quit multiple times. Barriers to quitting included exposure to vaping, access to vape products, stress, and "cool" new products or flavors. Quit strategies included avoiding others vaping, seeking social support to quit, addressing peer pressure to continue vaping, learning successful quit strategies from peers, and using distraction strategies or alternatives to vaping.CONCLUSION:Many adolescents who vape want to quit, and most have tried multiple times. Interventions need to engage adolescents with varying reasons to quit, barriers, and quit strategy preferences.CLINICAL TRIAL REGISTRATION:This study is registered through ClinicalTrials.gov. The trial registration number is NCT05140915. The trial registration date is 11/18/2021.

Abstract Objective Digital interventions have been widely implemented to promote tobacco cessation. However, implementations of these interventions have not yet considered how participants’ e-cigarette use may influence their quitting outcomes. We explored the association of e-cigarette use and quitting smoking within the context of a study testing a digital tobacco cessation intervention among individuals in the United States who were 18 years and older, smoked combustible cigarettes, and enrolled in the intervention between August 2017 and March 2019. Results We identified four e-cigarette user groups (n = 990) based on the participants’ baseline and six-month e-cigarette use (non-users, n = 621; recently started users, n = 60; sustained users, n = 187; recently stopped users, n = 122). A multiple logistic regression was used to estimate the adjusted odds ratios (AOR) of six-month quit outcome and the e-cigarette user groups. Compared to e-cigarette non-users, the odds of quitting smoking were significantly higher among recently stopped users (AOR = 1.68, 95% CI [1.06, 2.67], p = 0.03). Participants who were most successful at quitting combustible cigarettes also stopped using e-cigarettes at follow-up, although many sustained using both products. Findings suggest that digital tobacco cessation interventions may carefully consider how to promote e-cigarette use cessation among participants who successfully quit smoking. Trial registration ClinicalTrials.gov identifier NCT03224520 (July 21, 2017).

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.

ObjectiveThe 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.MethodsIn 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.ResultsA 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).ConclusionsBoth 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.