The Asthma Action at Erie Trial

 描述（由申请人提供）：哮喘行动在伊利试验哮喘的患病率和发病率一直在增加的儿童在过去的三十年中，尽管在环境控制和哮喘护理显着进步。哮喘儿童每年的费用在20亿至32亿美元之间。哮喘发病率及其相关费用的负担并不平等;城市、低收入、非裔美国人和波多黎各儿童的发病率和相关费用最高。社区卫生工作者（CHW）作为对抗这些哮喘差异的潜在干预措施越来越受欢迎。社区卫生工作者是第一线的公共卫生工作者，在卫生和社会服务与社区之间发挥联络作用，以便利获得服务，提高服务质量和提供服务的文化能力。关于CHW哮喘干预有效性的证据一直在增加，但仍存在一些关键差距。伊利哮喘行动试验将测试CHW干预的能力，其中有三个重要的修改，以实现高危儿童的哮喘控制：1）社区卫生工作者将被纳入临床和家庭环境，2）将提供一个直接解决精神健康和心理社会障碍的系统，（3）只向参加者提供由现行医疗报销制度支助的触发补救材料和设备。将与一家联邦合格的健康中心（CIMHC）合作开展一项双臂行为随机对照试验（N=220），该中心为低收入、少数民族人群提供服务，这些人群具有显著哮喘发病率的高风险。干预组将接受儿童哮喘教育的综合CHW家庭干预。对照组将接受基于诊所的认证哮喘教育者（AE-C）服务。主要目的1是评估综合CHW家庭哮喘干预的有效性，相对于12个月以上基于诊所的AE-C教育，如哮喘控制所证明的。我们假设在12个月时，CHW组的活动受限天数比AE-C组至少少30%。具体目标2是评估干预有效性的维持，如随机化后18个月和24个月的哮喘控制所证明的。具体目标3是确定12个月时CHW和AE-C干预措施的成本效益，以及12个月和24个月时与哮喘急性发作相关的额外成本或节省。具体目标4是评估综合CHW家庭哮喘干预相对于基于诊所的AE-C教育的疗效，如哮喘控制所证明的，在经历抑郁、应激和/或创伤后应激障碍的患者中。本试验比较了哮喘自我管理教育（AE-C服务）的当前最佳实践与综合CHW家庭干预，其中充分考虑了患者和医疗保健系统的现实挑战。这项试验将提供清晰的预期效果大小，成本节约，和资源需要整合哮喘CHW到临床实践。.

 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. .