Paul Tremblay

Randomized Controlled Trial to Improve Care for Urban Children With Asthma: Results of the School-Based Asthma Therapy Trial

OBJECTIVE To evaluate the impact of the School-Based Asthma Therapy trial on asthma symptoms among urban children with persistent asthma. DESIGN Randomized trial, with children stratified by smoke exposure in the home and randomized to a school-based care group or a usual care control group. SETTING Rochester, New York. PARTICIPANTS Children aged 3 to 10 years with persistent asthma. INTERVENTIONS Directly observed administration of daily preventive asthma medications by school nurses (with dose adjustments according to National Heart, Lung, and Blood Institute Expert Panel guidelines) and a home-based environmental tobacco smoke reduction program for smoke-exposed children, using motivational interviewing. MAIN OUTCOME MEASURE Mean number of symptom-free days per 2 weeks during the peak winter season (November-February), assessed by blinded interviews. RESULTS We enrolled 530 children (74% participation rate). During the peak winter season, children receiving preventive medications through school had significantly more symptom-free days compared with children in the control group (adjusted difference = 0.92 days per 2 weeks; 95% confidence interval, 0.50-1.33) and also had fewer nighttime symptoms, less rescue medication use, and fewer days with limited activity (all P < .01). Children in the treatment group also were less likely than those in the control group to have an exacerbation requiring treatment with prednisone (12% vs 18%, respectively; relative risk = 0.64; 95% confidence interval, 0.41-1.00). Stratified analyses showed positive intervention effects even for children with smoke exposure (n = 285; mean symptom-free days per 2 weeks: 11.6 for children in the treatment group vs 10.9 for those in the control group; difference = 0.96 days per 2 weeks; 95% confidence interval, 0.39-1.52). CONCLUSIONS The School-Based Asthma Therapy intervention significantly improved symptoms among urban children with persistent asthma. This program could serve as a model for improved asthma care in urban communities.

Screening for Environmental Tobacco Smoke Exposure among Inner City Children with Asthma

OBJECTIVES. The goals were (1) to develop an index measure of environmental tobacco smoke based on parent self-report of smoking behaviors and (2) to determine whether the index score was associated with childrens present and future cotinine levels. METHODS. Data were drawn from a community intervention for inner-city children with persistent asthma (N = 226; response rate: 72%). Measures of child salivary cotinine levels and parent self-reported environmental tobacco smoke-related behaviors were obtained at baseline and 7 to 9 months later. To develop the index score, we used a 15-fold cross-validation method, with 70% of our data, that considered combinations of smoke exposure variables and controlled for demographic features. We chose the most parsimonious model that minimized the mean square predictive error. The resulting index score included primary caregiver smoking and home smoking ban status. We validated our model with the remaining 30% of the data. Analysis of variance and multivariate analyses were used to determine the association of the index score with childrens cotinine levels. RESULTS. Fifty-four percent of children with asthma lived with ≥1 smoker, and 51% of caregivers reported a complete home smoking ban. The childrens mean baseline cotinine level was 1.55 ng/mL (range: 0.0–21.3 ng/mL). Childrens baseline and follow-up cotinine levels increased as scores on the index measure increased. In a linear regression, the index score was significantly positively associated with childrens cotinine measurements at baseline and 7 to 9 months later. CONCLUSION. An index measure with combined information regarding primary caregiver smoking and household smoking restrictions helped to identify children with asthma with the greatest exposure to environmental tobacco smoke and could predict which children would have elevated cotinine levels 7 to 9 months later.

A Pilot Study to Enhance Preventive Asthma Care among Urban Adolescents with Asthma

Background. Low-income, minority teens have disproportionately high rates of asthma morbidity and are at high risk for nonadherence to preventive medications. Objective. To assess the feasibility and preliminary effectiveness of an innovative school-based asthma program to enhance the delivery of preventive care for 12–15 year olds with persistent asthma. We hypothesized that this intervention would (1) be feasible and acceptable among this population and (2) yield reduced asthma morbidity. Design/methods. Subjects/setting: Teens with persistent asthma and a current preventive medication prescription in Rochester, NY. Design: Single group pre-post pilot study during the 2009–2010 school year. Intervention: Teens visited the school nurse daily for 6–8 weeks at the start of the school year to receive directly observed therapy (DOT) of preventive asthma medications; 2–4 weeks following DOT initiation, they received three counseling sessions (one in-home and two via telephone) using motivational interviewing (MI) to explore attitudes about asthma management, build motivation for medication adherence, and support transition to independent preventive medication use. Primary outcome: Number of symptom-free days (SFDs)/2 weeks; outcome data were collected 2 months after baseline and at the end of school year. Results. We enrolled 30 teens; 28 participated in the intervention. All teens initiated a trial of school-based DOT. All in-home MI visits were completed successfully, and 89% completed both follow-up sessions. Teens experienced an overall reduction of symptoms with more SFDs/2 weeks from baseline to 2-month and final (end of school year) assessments (8.71 vs. 10.79 vs. 12.89, respectively, p = .046 and p = .004). Teens also reported fewer days with symptoms, less activity limitation, and less rescue medication use (all p < .05). Exhaled nitric oxide levels decreased (p = .012), suggesting less airway inflammation. At the final assessment, teens reported significantly higher motivation to take their preventive medication every day (p = .043). At the end of the study, 79% of teens stated that they were better at managing asthma on their own, and 93% said they would participate in a similar program again. Conclusions. This pilot study provides preliminary evidence of the feasibility and effectiveness of a novel school-based intervention to promote independence in asthma management and improve asthma outcomes in urban teens.

The school-based preventive asthma care trial: results of a pilot study

OBJECTIVE To test the feasibility and preliminary effectiveness of the School-Based Preventive Asthma Care Technology (SB-PACT) program, which includes directly observed therapy of preventive asthma medications in school facilitated by Web-based technology for systematic symptom screening, electronic report generation, and medication authorization from providers. STUDY DESIGN We conducted a pilot randomized trial of SB-PACT versus usual care with 100 children (aged 3-10 years) from 19 inner-city schools in Rochester, New York. Outcomes were assessed longitudinally by blinded interviewers. Analyses included bivariate statistics and linear regression models, adjusting for baseline symptoms. RESULTS There were data for 99 subjects for analysis. We screened all children using the Web-based system, and 44 of 49 treatment group children received directly observed therapy as authorized by their providers. Treatment group children received preventive medications 98% of the time they were in school. Over the school year, children in the treatment group experienced nearly 1 additional symptom-free day over 2 weeks versus the usual care group (11.33 vs 10.40, P = .13). Treatment children also experienced fewer nights with symptoms (1.68 vs 2.20, P = .02), days requiring rescue medications (1.66 vs 2.44, P = .01), and days absent from school due to asthma (0.37 vs 0.85, P = .03) compared with usual care. Further, treatment children had a greater decrease in exhaled nitric oxide (-9.62 vs -0.39, P = .03), suggesting reduction in airway inflammation. CONCLUSION The SB-PACT intervention demonstrated feasibility and improved outcomes across multiple measures in this pilot study. Future work will focus on further integration of preventive care delivery across community and primary care systems.

Working Toward a Sustainable System of Asthma Care: Development of the School-Based Preventive Asthma Care Technology (SB-PACT) Trial

Objective. We previously conducted the School-Based Asthma Therapy trial to improve adherence to national asthma guidelines for urban children through directly observed administration of preventive asthma medications in school. The trial successfully improved outcomes among these children; however, several factors limit its potential for dissemination. To enhance sustainability, we subsequently developed a new model of care using web-based guides for efficient communications and integration within school and community systems. This article describes the development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial. Method. We developed the SB-PACT web-based system based on stakeholder feedback, and conducted a pilot randomized trial with 100 children to establish its feasibility in facilitating preventive asthma care for high-risk children. The SB-PACT system represents a new model of care using web-based guides for asthma symptom screening, follow-up control assessments, and electronic communications with providers. Result. We enrolled and successfully screened all children using the web-based system. Most providers used the electronic communication system without difficulty, and the majority of children in the intervention group received preventive medications through school as planned and dose adjustments as needed. Several challenges to implementation also were encountered. Conclusions. This program is designed to promote sustainability of school-based asthma care, reduce program costs, and ultimately succeed in a real-world setting. With further refinements, it has the potential to be implemented nationally in schools.

Implementation of a community-based secondhand smoke reduction intervention for caregivers of urban children with asthma: process evaluation, successes and challenges

Many children, including those with asthma, remain exposed to secondhand smoke. This manuscript evaluates the process of implementing a secondhand smoke reduction counseling intervention using motivational interviewing (MI) for caregivers of urban children with asthma, including reach, dose delivered, dose received and fidelity. Challenges, strategies and successes in applying MI are highlighted. Data for 140 children (3-10 years) enrolled in the School Based Asthma Therapy trial, randomized to the treatment condition and living with one or more smoker, were analyzed. Summary statistics describe the sample, process measures related to intervention implementation, and primary caregiver (PCG) satisfaction with the intervention. The full intervention was completed by 79% of PCGs, but only 17% of other smoking caregivers. Nearly all (98%) PCGs were satisfied with the care study nurses provided and felt the program might be helpful to others. Despite challenges, this intervention was feasible and well received reaching caregivers who were not actively seeking treatment for smoking cessation or secondhand smoke reduction. Anticipating the strategies required to implement such an intervention may help promote participant engagement and retention to enhance the programs ultimate success.

Effect of the school-based telemedicine enhanced asthma management (SB-TEAM) program on asthma morbidity: A randomized clinical trial

Importance Poor adherence to recommended preventive asthma medications is common, leading to preventable morbidity. We developed the School-Based Telemedicine Enhanced Asthma Management (SB-TEAM) program to build on school-based supervised therapy programs by incorporating telemedicine at school to overcome barriers to preventive asthma care. Objective To evaluate the effect of the SB-TEAM program on asthma morbidity among urban children with persistent asthma. Design, Setting, and Participants In this randomized clinical trial, children with persistent asthma aged 3 to 10 years in the Rochester City School District in Rochester, New York, were stratified by preventive medication use at baseline and randomly assigned to the SB-TEAM program or enhanced usual care for 1 school year. Participants were enrolled at the beginning of the school year (2012-2016), and outcomes were assessed through the end of the school year. Data were analyzed between May 2017 and November 2017 using multivariable modified intention-to-treat analyses. Interventions Supervised administration of preventive asthma medication at school as well as 3 school-based telemedicine visits to ensure appropriate assessment, preventive medication prescription, and follow-up care. The school site component of the telemedicine visit was completed by telemedicine assistants, who obtained history and examination data. These data were stored in a secure virtual waiting room and then viewed by the primary care clinician, who completed the assessment and communicated with caregivers via videoconference or telephone. Preventive medication prescriptions were sent to pharmacies that deliver to schools for supervised daily administration. Main Outcomes and Measures The primary outcome was the mean number of symptom-free days per 2 weeks, assessed by bimonthly blinded interviews. Results Of the 400 enrolled children, 247 (61.8%) were male and 230 (57.5%) were African American, and the mean (SD) age was 7.8 (1.7) years. Demographic characteristics and asthma severity in the 2 groups were similar at baseline. Among children in the SB-TEAM group, 196 (98.0%) had 1 or more telemedicine visits, and 165 (82.5%) received supervised therapy through school. We found that children in the SB-TEAM group had more symptom-free days per 2 weeks postintervention compared with children in the enhanced usual care group (11.6 vs 10.97; difference, 0.69; 95% CI, 0.15-1.22; P = .01), with the largest difference observed at the final follow-up (difference, 0.85; 95% CI, 0.10-1.59). In addition, children in the SB-TEAM group were less likely to have an emergency department visit or hospitalization for asthma (7% vs 15%; odds ratio, 0.52; 95% CI, 0.32-0.84). Conclusions and Relevance The SB-TEAM intervention significantly improved symptoms and reduced health care utilization among urban children with persistent asthma. This program could serve as a model for sustainable asthma care among school-aged children. Trial Registration clinicaltrials.gov Identifier: NCT01650844

Prompting Asthma Intervention in Rochester-Uniting Parents and Providers (PAIR-UP) A Randomized Trial

IMPORTANCE A disproportionate number of impoverished and minority children have asthma and receive suboptimal preventive care. OBJECTIVE To evaluate whether the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers (PAIR-UP) intervention, administered in primary care offices, improves the delivery of preventive care and reduces morbidity for urban children with asthma. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized trial in which 12 urban primary care practices were matched based on size and type and randomly allocated to the PAIR-UP intervention or usual care (UC). We enrolled 638 children aged 2 to 12 years with persistent or poorly controlled asthma in the waiting room prior to a visit with a clinician for any reason from October 2009 to January 2013. Blinded interviewers called caregivers within 2 weeks to inquire about preventive measures taken at the visit and called them 2 and 6 months later to assess symptoms. INTERVENTIONS Children enrolled at PAIR-UP practices received prompts for the caregiver and clinician at the time of the visit that outlined the childs asthma severity or control as well as specific guideline-based recommendations to enhance preventive care. These practices also received educational resources and periodic feedback on their asthma care performance. The UC practices received copies of the asthma guidelines. MAIN OUTCOMES AND MEASURES The primary outcome was symptom-free days (SFDs) per 2 weeks at the 2-month follow-up. RESULTS We enrolled 638 children (participation rate of 80%; 36% were black, 36% were Hispanic, and 68% had Medicaid insurance). Groups were similar in demographic characteristics and asthma severity at baseline. At the index visit, more children in the PAIR-UP group received a preventive medication action (new medication, increased dose, recommendation to restart preventive medication) than in the UC group (58% vs 33%; odds ratio [OR] = 2.8; 95% CI, 1.9 to 3.9). More children in the PAIR-UP group than in the UC group received an asthma action plan (61% vs 23%; OR = 8.3; 95% CI, 3.7 to 18.7), discussions regarding asthma (93% vs 78%; OR = 4.5; 95% CI, 2.8 to 7.2), and secondhand smoke counseling (80% vs 63%; OR = 2.6; 95% CI, 1.2 to 5.5). At the 2-month follow-up, children in the PAIR-UP group had more SFDs per 2 weeks than those in the UC group (mean difference, 0.78 days; 95% CI, 0.29 to 1.27). At 6 months, the improvement in SFDs was no longer statistically significant (mean difference, 0.56; 95% CI, -0.14 to 1.25). CONCLUSIONS AND RELEVANCE The PAIR-UP intervention improved the delivery of preventive asthma care and reduced asthma morbidity for high-risk urban children with persistent asthma at 2 months, but the improvement in SFDs was no longer significant at 6 months. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01105754.