医疗技术的实用性试验能提高哮喘患儿治疗的依从性：一项随机临床试验
2015/04/27
摘要
意义：大多数哮喘患者只服用低于一半剂量的哮喘控制药物。对于提高依从性的干预多是昂贵的、不切实际的，也只有少数能成功。
目的：本研究旨在检测语音识别（SR）干预能否提高哮喘儿童服用哮喘控制药物的依从性。
试验设计、设置和受试者：TBWS(the breathe well study)研究是一项为期24个月的真实世界的随机临床试验。本研究在凯泽科罗拉多的一个大型模型医疗保健组织进行。1187位3～12岁被诊断为持续性哮喘,使用吸入性糖皮质激素治疗的儿童被随机分为计算机SR干预组或常规护理组，2009年10月～2013年2月对这些儿童进行为期24月的随访。
干预：在干预组，当吸入性糖皮质激素需要重新配置或过期时，语音识别电话会打给患儿的父母进行干预。电话是根据电子健康记录和父母在电话问询中表示愿意接受帮助所提供的医疗和人口统计信息自动定制的，通过电话随访可以让家长学习更多哮喘控制知识或与哮喘护士或药师通话等。
主要终点事件和指标:检测随访24个月内哮喘患儿对哮喘控制药物持有率，以确定小儿哮喘控制药物的依从性。
结果：按照意向治疗分析，干预组的吸入性糖皮质激素依从性高于常规护理组25.4%（24个月平均[标准误SE] 依从性为44.5%[1.2%] vs 35.5% [1.1%]，P＜0.001＝。两组的哮喘相关急诊事件发生率无显著差异。以年龄、性别、种族、体重指数和疾病相关特征分层的亚组，干预效果一致。
结论：干预对依从性的重要影响表明低成本的语音识别依从性程序与电子健康记录结合的强大潜在可能性。两组的急诊事件发生率无差异可能是因为凯泽科罗拉多的哮喘急诊医疗事件发生率本来就很低。在控制不良的哮喘患者中使用电子健康记录-语音识别干预可能降低医疗服务的使用。
（杨冬 审校）
JAMA Pediatr. 2015 Feb 9. doi: 10.1001/jamapediatrics.2014.3280. [Epub ahead of print]
Pragmatic Trial of Health Care Technologies to Improve Adherence to Pediatric Asthma Treatment: A Randomized Clinical Trial.
Bender BG1, Cvietusa PJ2, Goodrich GK2, Lowe R2, Nuanes HA2, Rand C3, Shetterly S2, Tacinas C2, Vollmer WM4, Wagner N2, Wamboldt FS1, Xu S2, Magid DJ5.
ABSTRACT
IMPORTANCE:Most patients with asthma take fewer than half of prescribed doses of controller medication. Interventions to improve adherence have typically been costly, impractical, and at best only minimally successful.
OBJECTIVE:To test a speech recognition (SR) intervention to improve adherence to pediatric asthma controller medication.
DESIGN, SETTING, AND PARTICIPANTS:The Breathe Well study was a 24-month pragmatic randomized clinical trial. The study was conducted within Kaiser Permanente Colorado, a large, group-model health maintenance organization. A total of 1187 children aged 3 to 12 years with a persistent asthma diagnosis and prescription for an inhaled corticosteroid were randomized to the computerized SR intervention or usual care condition and followed up for 24 months between October 2009 and February 2013.
INTERVENTIONS:Speech recognition telephone calls to parents in the intervention condition were triggered when an inhaled corticosteroid refill was due or overdue. Calls were automatically tailored with medical and demographic information from the electronic health record and from parent answers to questions in the call regarding recent refills or a desire to receive help refilling, learn more about asthma control, or speak with an asthma nurse or pharmacy staff member.
MAIN OUTCOMES AND MEASURES:Adherence to pediatric asthma controller medication, measured as the medication possession ratio over 24 months.
RESULTS:In the intention-to-treat analysis, inhaled corticosteroid adherence was 25.4% higher in the intervention group than in the usual care group (24-month mean [SE] adherence, 44.5% [1.2%] vs 35.5% [1.1%], respectively; P < .001). Asthma-related urgent care events did not differ between the 2 groups. The intervention effect was consistent in subgroups stratified by age, sex, race/ethnicity, body mass index, and disease-related characteristics.
CONCLUSIONS AND RELEVANCE:The intervention's significant impact on adherence demonstrates strong potential for low-cost SR adherence programs integrated with an electronic health record. The absence of change in urgent care visits may be attributable to the already low number of asthma urgent care visits within Kaiser Permanente Colorado. Application of electronic health record-leveraged SR interventions may reduce health care utilization when applied in a population with less-controlled asthma.
JAMA Pediatr. 2015 Feb 9. doi: 10.1001/jamapediatrics.2014.3280. [Epub ahead of print]
