Gerald Lynn B, Gerald Joe K, VanBuren John M, Lowe Ashley, Guthrie Cecilia C, Klein Eileen J, Morrison Andrea, Startup Emily, Denninghoff Kurt
University of Arizona, Tucson, AZ, USA.
Asthma and Airway Disease Research Center, 1501 N Campbell Avenue, Tucson, AZ, 85724, USA.
Pilot Feasibility Stud. 2021 Sep 27;7(1):179. doi: 10.1186/s40814-021-00913-0.
While using an inhaled corticosteroid (ICS) in the weeks after an ED visit reduces repeat visits, few children receive a needed prescription. Because a prescription may not be filled or used, dispensing ICS at discharge and supervising its use at school could overcome both barriers until follow-up care is established. To assess the feasibility of such an intervention, we conducted a pilot study among elementary-age school children with persistent asthma who were discharged from the ED following an asthma exacerbation.
Eligible children were randomly assigned to ED-dispensing of ICS with home supervision or ED-dispensing of ICS with home and school supervision. The primary outcomes were ability to recruit and retain participants, ability to initiate school-supervised medication administration within 5 days of discharge, and participant satisfaction.
Despite identifying 437 potentially eligible children, only 13 (3%) were enrolled with 6 being randomized to the intervention group and 7 to the control group. Eleven (85%) randomized participants completed the 90-day interview (primary outcome) and 8 (62%) completed the 120-day interview (safety endpoint). Four (67%) intervention participants started their school regimen within 5 business days and 2 started within 6 business days.
While our pilot study did not meet its recruitment goal, it did achieve its primary purpose of assessing feasibility before undertaking a larger, more intensive study. Several major recruitment barriers need to be mitigated before EDs can successfully partner with schools to establish supervised ICS treatment.
ClinicalTrials.gov , NCT03952286 . Registered 16 May 2019.
虽然在急诊就诊后的几周内使用吸入性糖皮质激素(ICS)可减少再次就诊,但很少有儿童获得所需的处方。由于处方可能未被取药或使用,在出院时发放ICS并在学校监督其使用可以克服这两个障碍,直到建立后续护理。为了评估这种干预措施的可行性,我们对哮喘加重后从急诊出院的小学适龄持续性哮喘儿童进行了一项试点研究。
符合条件的儿童被随机分配至在家中接受监督的急诊发放ICS组或在家中和学校接受监督的急诊发放ICS组。主要结局包括招募和留住参与者的能力、出院后5天内启动学校监督用药管理的能力以及参与者满意度。
尽管确定了437名潜在符合条件的儿童,但仅13名(3%)入组,其中6名被随机分配至干预组,7名被随机分配至对照组。11名(85%)随机分组的参与者完成了90天访谈(主要结局),8名(62%)完成了120天访谈(安全终点)。4名(67%)干预组参与者在5个工作日内开始了学校治疗方案,2名在6个工作日内开始。
虽然我们的试点研究未达到招募目标,但它确实实现了在开展更大规模、更深入研究之前评估可行性的主要目的。在急诊室能够成功与学校合作建立ICS监督治疗之前,需要减轻几个主要的招募障碍。
ClinicalTrials.gov,NCT0********。2019年5月16日注册。