Improving Transition Care for Adolescents and Young Adults with Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2

项目总结/摘要 对于患有1型糖尿病（T1 D）的青年人来说，向青年人的过渡是恶化的高风险时期 血糖控制T1 D自我管理是血糖控制的关键驱动因素， 这一发展时期的性质，与多个领域的变化有关（即，生物的，社会的， 环境）。在开始成人治疗之前，需要进行基于证据的过渡准备干预 改善T1 D自我管理和血糖控制并提高过渡准备;然而， 来自严格试验的证据有限。为了解决这一差距，我们开发并进行了一项单臂试验， 多系统过渡准备干预。该试验的初步数据为目前的 申请，建议进行一项基于临床的过渡的随机对照试验（RCT） 准备干预（SHIFT 2）用于T1 D青少年和年轻成人（AYAs）。50名AYA（16-22岁） 父母将被随机分配到：1）6个月的多系统过渡准备计划（SHIFT 2），或 2)常规强化治疗（TAU+）。TAU+包括常规T1 D护理、提供者培训和标准患者 教育，与干预联系时间表相匹配。SHIFT 2将采用混合交付模式， 使用诊所工作人员（注册糖尿病护理和教育专家[CDCES]）和医院进行干预访视- 基于技术平台（例如，虚拟访问、患者门户）。AYAs将收到基于证据的内容， 3个领域：心理教育/技能建设，行为自我管理和提供者沟通。父母 将接受心理教育和培训，在发展适当的育儿策略，以支持他们的 AYA在增加独立的自我管理和准备过渡。供应商将收到一个视频 模块，强调他们的作用，准备AYA过渡，并提供基于证据的实用技巧， 加强与AYA的沟通。为了了解关键利益攸关方在过渡方面的经验， 对过渡到成人护理的AYA及其父母进行定性访谈（n=20 AYA-父母二人组）和提供者（n=10名内分泌提供者和CDCES），以告知 进一步完善方案，以供将来研究使用。该应用具有令人信服的科学和临床意义。 它通过使用严格的随机对照试验设计，循证干预成分， 在多系统框架内，对主要结局（HbA 1c）进行客观评估。发现将 推动科学进步，并为促进独立T1 D的最佳策略提供临床建议 在过渡到成人护理之前，AYAs的自我管理。 .

PROJECT SUMMARY / ABSTRACT For youth with type 1 diabetes (T1D), the transition into young adulthood is a high-risk period for deteriorations in glycemic control. T1D self-management, a key driver of glycemic control, is complicated by the transitional nature of this developmental period, which is associated with changes in multiple domains (i.e., biological, social, and environmental). Evidenced-based transition preparation interventions are needed prior to initiating adult healthcare to improve T1D self-management and glycemic control and increase transition readiness; however, evidence from rigorous trials is limited. To address this gap, we developed and conducted a single-arm pilot of SHIFT, a multisystem transition preparation intervention. Preliminary data from this pilot informed the current application, which proposes to conduct a randomized controlled trial (RCT) of a clinic-based transition preparation intervention (SHIFT2) for adolescents and young adults (AYAs) with T1D. Fifty AYAs (16-22 years) and a parent will be randomized to either: 1) a 6-month multisystem transition preparation program (SHIFT2), or 2) enhanced treatment as usual (TAU+). TAU+ includes usual T1D care, provider training, and standard patient education, matched to the intervention contact schedule. SHIFT2 will employ a hybrid delivery mode for intervention visits using clinic staff (Certified Diabetes Care and Education Specialists [CDCES]) and hospital- based technology platforms (e.g., virtual visits, patient portal). AYAs will receive evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and provider communication. Parents will receive psychoeducation and training in developmentally appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. Providers will receive a video module that highlights their role preparing AYAs for transition and provides evidence-based, practical tips to enhance communication with AYAs. In order to understand key stakeholders’ experiences regarding transitioning to adult care, qualitative interviews with a subset of AYAs who transitioned to adult care and their parents (n=20 AYA-parent dyads) and with providers (n=10 endocrinology providers and CDCES), will be conducted to inform further protocol refinement for future studies. This application has compelling scientific and clinical significance. It improves upon prior research via use of a rigorous RCT design, evidence-based intervention components within a multisystem framework, and objective assessment of the primary outcome (HbA1c). Findings will advance science and inform clinical recommendations regarding optimal strategies to promote independent T1D self-management in AYAs prior to transitioning to adult care. .