Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia

摘要 随着2型糖尿病(T2D)患者活到老年，在中年时期建立了护理模式 需要根据年龄相关生理和生活环境的变化进行调整。高级护理 规划(ACP)是支持老年人与临床医生一起实时、 在严重疾病的病程中做出复杂的医疗决定，以便他们所接受的医疗护理是一致的 带着他们的目标。虽然经常应用于生命终结决策(例如，关于生命的高级指令- 持续治疗)，ACP范例已经扩展到也为患者做好更有效的准备 参与重新评估目前针对T2D等长期慢性病的治疗目标。的目标是 这项研究将应用扩展的ACP范式(技能培养和为价值启发、决策做准备- 与低血糖相关的不良后果的具体临床问题 易受伤害的老年T2D患者。我们将调整我们现有的、以证据为基础的、面向患者的在线 Prepare Tool(准备工具)用于解决老年T2D患者的治疗强度增加问题 低血糖事件(如开出的胰岛素或磺脲类药物)的风险(目标1)。然后我们将进行一次 在初级保健环境中对600名患者进行随机临床试验，比较这一新的ACP-T2D工具与常规护理 成人≥75岁和低血糖事件风险增加(目标2)。这次干预的目标是 使知情、有准备的患者能够与他们的初级保健提供者接触，重新评估他们的 非典背景下的糖尿病治疗强度和治疗目标。我们假设，对于其中的许多 高危老年人，这些知情的对话将导致药物停药和相应的 较低的临床显著低血糖发生率(主要临床结果，由美国 糖尿病协会低血糖需要另一个人的复苏帮助)相对于通常的护理。 我们还将检查处方更改、急诊/入院情况以及一系列患者报告的结果 与沟通、糖尿病管理和ACP相关。在目标3中，我们将分析 临床和患者层面的背景因素的治疗效果，以告知这种扩大的ACP的未来重复 范例。如果成功，这个相对低成本和可推广的框架可以扩展并应用于 广泛的医疗保健环境和一系列慢性疾病，在这些慢性疾病中，不断变化的风险、好处和 治疗的后果需要随着年龄的增长而重新评估。

Abstract As individuals with type 2 diabetes (T2D) live into older age, patterns of care established during middle age need to be adjusted in response to age-related changes in physiology and life circumstances. Advance care planning (ACP) is a critical tool for supporting older adults to participate with clinicians in making real-time, complex medical decisions over the course of serious illness so that the medical care they receive is aligned with their goals. Although often applied to end-of-life decisions (e.g. advanced directives regarding life- sustaining treatments), the ACP paradigm has been expanded to also prepare patients to more effectively participate in re-assessing current treatment goals for long-term chronic conditions such as T2D. The goal of this study is to apply the expanded ACP paradigm (skill building and preparation for values elicitation, decision- making, and communication) to the specific clinical problem of hypoglycemia-related adverse outcomes in vulnerable older patients with T2D. We will adapt our existing, evidenced-based patient-facing, online PREPARE tool (prepareforyourcare.org) to address treatment intensity in older adults with T2D at increased risk for hypoglycemic events (i.e. prescribed insulin or sulfonylureas) (Aim 1). We will then conduct a randomized clinical trial in the primary care setting comparing this new ACP-T2D tool to usual care among 600 adults ≥ 75 years of age and at increased risk for hypoglycemic events (Aim 2). The goal of this intervention is to enable informed, prepared patients to engage with their primary care providers in re-assessing their diabetes treatment intensity and treatment goals in the context of ACP. We hypothesize that for many of these high-risk older adults, these informed conversations will lead to medication de-prescribing and corresponding lower incidence of clinically-significant hypoglycemia (primary clinical outcome, defined by the American Diabetes Association as hypoglycemia requiring resuscitative help from another person) relative to usual care. We will also examine prescription changes, ED/hospital admissions, and a set of patient-reported outcomes related to communication, diabetes management, and ACP. In Aim 3 we will analyze heterogeneity of treatment effect by clinical and patient-level contextual factors to inform future iterations of this expanded ACP paradigm. If successful, this relatively low-cost and generalizable framework could be scaled and applied in a wide variety of healthcare settings and to a range of chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.