Telehealth Enhancement of Adherence to Medication in Pediatric IBD (TEAM Study)

项目摘要/摘要：对儿童炎症性肠病（IBD）药物依从性的研究表明，不同药物的不依从率在50- 88%之间。这些数据令人担忧，因为1)非依从性IBD患者的复发风险是依从性IBD患者的5.5倍，2)非依从性IBD患者的年度医疗保健费用高出12.5%,3)美国医疗保健的估计年度费用为1000 - 3000亿美元。与不良依从性相关的因素包括对IBD和用于治疗的药物的知识不足，组织障碍以及青少年和/或其家庭的行为问题。因此，不依从性是IBD中一个复杂而重要的卫生保健问题，需要有效的多组分行为干预来改善治疗结果。我们目前的治疗结果研究证明了家庭行为干预治疗不依从的可行性和初步效果。这种干预措施得到了患者和家属的好评，保留率也很高。个体定制的行为治疗是有利的，因为它们能够分析和针对特定的行为，这些行为在功能上维持不依从性，这在不同的患者中是不同的。然而，由于缺乏可用的训练有素的提供者和/或患者家与治疗机构之间的距离，只有有限的患者亚组能够接受这种治疗，这使得参加必要的每周治疗会议变得令人望而却步。远程医疗提供的行为干预已成功地用于儿科人群，但没有针对性的治疗依从性的促进。确定最优的治疗方法，使大多数患者从中受益，是这一研究的下一步关键。因此，本研究旨在通过一项随机对照临床试验，检验一种新型远程医疗行为治疗（TBT）方案在改善IBD儿童和青少年的药物依从性、疾病严重程度、健康相关生活质量和医疗保健利用方面的疗效。TBT条件下的参与者将与仅教育（EO）条件下的参与者进行比较。除了使用一种新颖的远程医疗方法，为服务不足的IBD患者提供量身定制的行为治疗外，本研究还将针对临床相关的患者样本，这些患者表现出严重的不依从性，可能会影响健康结果。拟议的研究可能会对公共卫生产生重大影响，因为它为针对不依从性的个性化行为治疗提供了证据基础，从而减少了获得服务机会有限的家庭的医疗保健差距。194名患者（11-18岁）及其父母将被纳入研究。鉴于IBD中不依从性的流行及其对健康和经济的影响，这项研究是及时和重要的，因为它有可能优化不依从性的行为治疗，积极影响IBD的健康结果，并作为其他儿科人群的遵从性干预的模型。

DESCRIPTION (provided by applicant): Project Summary/Abstract Research on medication adherence in pediatric inflammatory bowel disease (IBD) has demonstrated nonadherence rates ranging from 50-88 percent across medications. These data are alarming given that 1) the risk of relapse in IBD is 5.5 times greater in nonadherent patients than in adherent patients, 2) the annual costs of health care in nonadherent IBD patients are 12.5 percent higher, and 3) the estimated annual cost of nonadherence in US health care is $100-300 billion. Factors related to poor adherence include deficits in knowledge about IBD and medications used for treatment, organizational barriers, and behavioral problems in adolescents and/or their families. Thus, nonadherence is a complex and significant health care issue in IBD, requiring effective multicomponent behavioral intervention to improve treatment outcomes. Our current treatment outcome studies demonstrate the feasibility and preliminary efficacy of family based behavioral intervention for nonadherence. This intervention is viewed favorably by patients and families, and retention is high. Individually-tailored behavioral treatments are advantageous because of their ability to analyze and target specific behaviors that functionally maintain nonadherence, which vary across patients. However, only a limited subgroup of patients is able to receive this type of treatment due to a lack of available trained providers and/or distance between patient homes and their treatment facility, making it prohibitive to attend the necessary weekly treatment sessions. Telehealth delivery of behavioral intervention has been used successfully in pediatric populations, but has not targeted treatment adherence promotion. Determining the most optimal method of treatment delivery to the most patients who would benefit from it is a critical next step in this line of research. Thus, the proposed study aims to test, via a randomized controlled clinical trial, the efficacy of a novel telehealth behavioral treatment (TBT) protocol to improve medication adherence, disease severity, health-related quality of life, and health care utilization in children and adolescents with IBD. Participants in the TBT condition will be compared to those in an education only (EO) condition. In addition to using a novel telehealth approach to delivery of an individually-tailored behavioral treatment for nonadherence in underserved IBD patients, this study will target a clinically relevant sample of patients who demonstrate substantial nonadherence that might affect health outcomes. The proposed study may have a significant impact on public health by providing an evidence base for individually-tailored behavioral treatment of nonadherence delivered in a manner that reduces health care disparities for families that have limited access to services. One hundred ninety-four patients (11-18 years of age) and their parents will be enrolled in the study. Given the prevalence of nonadherence in IBD and its health and economic impact, this study is timely and important, as it has the potential to optimize behavioral treatment of nonadherence, positively impact IBD health outcomes, and serve as a model for adherence intervention in other pediatric populations.