The Asthma Action at Erie Trial

 描述(由申请人提供)：伊利试验中的哮喘行动尽管在环境控制和哮喘护理方面取得了重大进展，但儿童哮喘的患病率和发病率在过去30年里一直在上升。哮喘儿童每年的费用在2.0美元到32亿美元之间。哮喘发病率及其相关费用并不是平均承担的；城市、低收入、非裔美国人和波多黎各儿童的发病率最高。社区卫生工作者(CHW)作为对抗这些哮喘差距的潜在干预措施，已经越来越受欢迎。社区卫生工作者是第一线的公共卫生工作者，在卫生、社会服务和社区之间担任联络人，以促进获得服务，并提高提供服务的质量和文化能力。关于CHW哮喘干预效果的证据一直在增加，但仍存在几个关键差距。伊利哮喘行动试验将测试CHW干预的能力，通过三项重要修改在高危儿童中实现哮喘控制：1)CHW将被整合到临床和家庭环境中；2)将提供一个直接解决心理健康和心理社会障碍的系统；3)将只向参与者提供由当前医疗报销系统支持的触发治疗的材料和设备。一项两臂行为随机对照试验(N=220)将与一家联邦合格的健康中心(FQHC)合作进行，该中心为低收入、少数族裔人群提供服务，这些人群是严重哮喘发病率的高风险人群。干预机构将接受针对儿童哮喘教育的综合CHW家庭干预。对照部门将接受以诊所为基础的认证哮喘教育者(AE-C)服务。主要目标1是评估综合CHW家庭哮喘干预的效果，相对于为期12个月的以临床为基础的AE-C教育，如哮喘控制所证明的那样。我们假设，在12个月时，CHW组的活动受限天数将至少比AE-C组少30%。具体目标2是评估干预效果的维持，如随机分组后18个月和24个月的哮喘控制所证明的那样。具体目标3是确定提供CHW和AE-C干预12个月时的成本效益，以及12个月和24个月时与哮喘加重有关的额外成本或节省。具体目标4是评估CHW家庭哮喘综合干预相对于以临床为基础的AE-C教育的效果，如哮喘控制所证明的那样，在那些经历抑郁、压力和/或创伤后应激障碍的人中。这项试验将目前哮喘自我管理教育(AE-C服务)的最佳实践与综合CHW家庭干预进行了比较，在家庭干预中，充分考虑了患者和医疗保健系统的现实挑战。这项试验将为将哮喘CHW纳入临床实践所需的预期效果大小、成本节约和资源提供清晰的信息。。

 DESCRIPTION (provided by applicant): Asthma Action at Erie Trial Asthma prevalence and morbidity has been increasing among children over the last three decades despite significant advances in environmental control and asthma care. The annual costs for children with asthma range between $2.0 and $3.2 billion. Asthma morbidity and its associated costs are not borne equally; they are highest for urban, low income, African American and Puerto Rican children. Community health workers (CHWs) have been growing in popularity as a potential intervention to combat these asthma disparities. CHWs are frontline public health workers who serve as liaisons between health and social services and communities to facilitate access to services and improve the quality and cultural competence of service delivery. The evidence on CHW asthma intervention efficacy has been growing but several critical gaps still exist. The Asthma Action at Erie Trial will test the ability of a CHW intervention with three important modifications to achiev asthma control in high-risk children: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. A two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally- qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. We hypothesize that the CHW arm will have at least 30% fewer days with activity limitation than the AE-C arm at 12-months. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic- based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder. This trial compares the current best practice in asthma self- management education (AE-C services) to an integrated CHW home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity a to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice. .