Asthma causes substantial morbidity among children and much of it is attributable to medication non- adherence. School-based supervision of daily inhaled corticosteroid (ICS) treatment increases medication adherence and reduces episodes of poor asthma control. However, recruiting children from schools enrolls many children with mild asthma and infrequent health care use. Therefore, initiating supervised treatment for these children tends to diminish the program's cost-effectiveness. To address this inefficiency, we propose to target children who are at high risk of poor outcomes by recruiting children who are discharged from the emergency department (ED) following treatment of an asthma attack. While guidelines recommend ED clinicians consider initiating ICS treatment at discharge, <20% of children discharged from the ED following treatment for an asthma attack receive a prescription for controller therapy. Data indicates that patients who use ICS following discharge are half as likely as non-users to experience a repeat ED visit. However, simply providing patients with a prescription does not ensure that they will fill it and use it consistently once discharged. To ensure access and adherence to controller medication, we propose to dispense ICS at discharge and supervise its use at school. We propose to work within the Pediatric Emergency Care Applied Research Network to conduct a pilot clinical trial with the following aims:
Aim 1. Determine the feasibility and acceptability of dispensing inhaled corticosteroids in the emergency department and supervising its use in the school setting. Following ED management of an asthma attack, elementary-age children with mild-to-moderate asthma randomized to the ED-SAMS program will be prescribed once-daily budesonide inhalation power to be supervised as school.
Aim 2. Estimate a range of plausible intervention effect sizes to support the development of a larger multi- center clinical trial. Ninety children from 3 EDs will be randomized to receive an ICS prescription for at-home use (control) or ICS dispensing for at-home and at-school use (intervention). The primary outcome will be 90- day ED recidivism.
Aim 3. Conduct a preliminary cost-effectiveness analysis. We will estimate intervention costs to determine the probability that the intervention could be cost-effective within a range of plausible effect sizes. Successful completion of this pilot trial will support the development of a larger multicenter trial to determine whether the intervention cost-effectively reduces exacerbation risk among elementary-age children with mild-to-moderate asthma.
The proposed project is a pilot clinical trial that seeks to determine the feasibility of dispensing inhaled cortisoteroids in the emergency department and supervising their use in the school setting among children with asthma. The trial will be conducted at three clinical sites of the Pediatric Emergency Care Applied Research Network (PECARN). If this trial is successful, we plan to conduct a larger multicenter trial to determine whether the intervention cost-effectively reduces exacerbation risk among elementary-age children with mild-to-moderate asthma.
