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

项目摘要/摘要 对于患有1型糖尿病(T1D)的年轻人来说，进入青年成年期是病情恶化的高危时期 在血糖控制方面。T1D自我管理是血糖控制的关键驱动因素，过渡时期的 这一发展阶段的性质，与多个领域的变化有关(即，生物、社会、 和环境)。在开始成年之前，需要循证的过渡准备干预措施 医疗保健，以改善T1D自我管理和血糖控制，并增加过渡准备；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 Shift，一种多系统过渡准备干预。来自这一试点的初步数据通知了当前 应用程序，该应用程序建议进行基于临床的过渡的随机对照试验(RCT) T1D青少年和青壮年(AYA)的准备干预(Shift 2)。50个年龄段(16-22岁) 父母将被随机分配到：1)为期6个月的多系统过渡准备计划(Shift2)，或者 2)加强常规治疗(TAU+)。TAU+包括通常的T1D护理、提供者培训和标准患者 教育，与干预接触时间表相匹配。Shift2将采用混合交付模式 使用诊所工作人员(认证糖尿病护理和教育专家[CDCES])和医院进行干预访问- 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 三个领域：心理教育/技能培养、行为自我管理和提供者沟通。家长 将接受心理教育和适合发展的育儿策略培训，以支持他们的 阿亚在加强独立自我管理和准备过渡方面发挥了重要作用。提供商将收到一段视频 该模块突出了他们在为AYA过渡做准备方面的作用，并提供了基于证据的实用提示，以 加强与AYAS的沟通。为了了解关键利益相关者在转型方面的经验 对于成人护理，对过渡到成人护理的AYA及其父母(n=20)进行了定性访谈 AYA-父母二人组)和与提供者(n=10个内分泌提供者和CDCES)，将进行 为今后的研究进一步完善方案。这一应用具有重要的科学意义和临床意义。 它通过使用严格的随机对照试验设计、基于证据的干预组件来改进先前的研究 在多系统框架内，对主要结果进行客观评估(糖化血红蛋白1c)。调查结果将 推动科学进步，并提供有关促进独立T1D的最佳策略的临床建议 AYAS在过渡到成人护理之前的自我管理。 。

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. .