ED-Initiated School-based Asthma Medication Supervision (ED-SAMS)

教育署发起的校本哮喘药物监督 (ED-SAMS)

• 批准号: 9762155
• 负责人: KURT R DENNINGHOFF
• 金额: $ 33.56万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9762155
• 关键词: Academy; Accident and Emergency department; Acute; Address; Adherence; Adrenal Cortex Hormones; Age; American; Applied Research; Asthma; Budesonide; Businesses; Calendar; Caregivers; Child; Childhood; Chronic; Clinical Trials; Communities; Cost Effectiveness Analysis; Data; Development; Education; Effectiveness; Emergency Care; Emergency department visit; Emergency medical service; Enrollment; Ensure; Family; Fill-It; Future; Geography; Guidelines; Healthcare; Home environment; Hospitals; Human Resources; Hypersensitivity; Immunology; Inhalation; Inhalators; Intervention; Low income; Measures; Medical Records; Medicine; Minority; Mission; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multicenter Trials; Outcome; Participant; Patients; Pharmaceutical Preparations; Population; Prevention program; Probability; Provider; Pulmicort; Randomized; Research; Risk; Schools; Students; Supervision; Symptoms; Work; asthma exacerbation; base; clinical research site; cost effective; cost effectiveness; experience; high risk; injured children; intervention cost; intervention effect; medication compliance; medication nonadherence; mortality; pediatric emergency; peer; pilot trial; primary outcome; program costs; programs; recidivism; recruit; satisfaction; secondary outcome; service providers

PROJECT SUMMARY 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.

项目总结 哮喘在儿童中造成相当大的发病率，其中很大一部分可归因于药物治疗 坚持不懈。以学校为基础监督每日吸入性皮质类固醇(ICS)治疗增加用药 坚持并减少哮喘控制不良的发作。然而，从学校招募儿童入学 许多患有轻度哮喘和不经常使用卫生保健的儿童。因此，启动监督治疗 这些孩子往往会降低该计划的成本效益。为了解决这种效率低下的问题，我们建议 针对预后不良的高风险儿童，招募从 哮喘发作治疗后的急诊科(ED)。而指南建议急诊临床医生 考虑在出院时开始ICS治疗，20%的出院儿童在接受治疗后 哮喘发作会收到控制疗法的处方。数据显示，使用ICS的患者如下 出院患者再次就诊的可能性是非患者的一半。然而，简单地为患者提供 处方并不能确保他们在出院后会一直服药和使用。以确保访问和 为了坚持控制性用药，我们建议在出院时分发ICS，并在学校监督其使用。 我们建议在儿科急救应用研究网络内进行试点 临床试验，目的如下：目的1.确定雾化吸入的可行性和可接受性 在急诊科使用皮质类固醇，并在学校环境中监督其使用。跟随边缘 哮喘发作的处理，患有轻中度哮喘的小学儿童随机分为 ED-SAMS计划每天开一次布地奈德吸入剂，作为学校督导。目标 2.估计一系列貌似合理的干预效果大小，以支持更大规模的多 中心临床试验。来自3个急诊室的90名儿童将被随机分配到接受ICS处方的家庭 使用(控制)或家庭和学校使用的ICS分发(干预)。主要结果将是90- 日艾德累犯。目标3.进行初步成本效益分析。我们将估计干预 在一系列看似合理的效果范围内确定干预可能具有成本效益的可能性的成本 大小。成功完成这一试点试验将支持开发更大规模的多中心试验，以 确定干预是否经济有效地降低了小学儿童病情恶化的风险 患有轻中度哮喘。

项目成果

Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS).

• DOI: 10.1186/s40814-021-00913-0
• 发表时间: 2021-09-27
• 期刊: Pilot and feasibility studies
• 影响因子: 1.7
• 作者: Gerald LB;Gerald JK;VanBuren JM;Lowe A;Guthrie CC;Klein EJ;Morrison A;Startup E;Denninghoff K
• 通讯作者: Denninghoff K