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（T2 D）患者进入老年， 需要根据生理和生活环境中与年龄相关的变化进行调整。预先护理 计划（ACP）是支持老年人与临床医生一起参与实时， 在严重疾病的过程中做出复杂的医疗决定，以便他们接受的医疗护理是一致的 他们的目标。虽然经常应用于生命终结的决定（例如，关于生命的高级指令）， 持续治疗），ACP范式已经扩展到也准备患者更有效地 参与重新评估长期慢性疾病（如T2 D）的当前治疗目标。的目标 本研究是应用扩展的ACP范式（技能建设和价值观的启发，决策， 制定和沟通）的具体临床问题的低血糖相关的不良后果， 易受伤害的老年T2 D患者我们将调整现有的、基于证据的、面向患者的、在线的 用于解决T2 D老年人治疗强度增加的T2 D治疗工具（T2 D reforyourcare.org） 低血糖事件风险（即处方胰岛素或磺脲类药物）（目的1）。然后我们将进行一次 在初级保健环境中进行的一项随机临床试验，在600名受试者中比较了这种新的ACP-T2 D工具与常规护理 年龄≥ 75岁且低血糖事件风险增加的成人（目的2）。这次干预的目的是 使知情的、准备好的患者能够与他们的初级保健提供者一起重新评估他们的 ACP背景下的糖尿病治疗强度和治疗目标。我们假设，对于其中的许多人来说， 高风险的老年人，这些知情的谈话将导致药物取消处方和相应的 具有临床意义的低血糖发生率较低（主要临床结局，由美国 糖尿病协会认为低血糖需要另一个人的复苏帮助）相对于常规护理。 我们还将检查处方变更、艾德/住院和一组患者报告的结果 与沟通、糖尿病管理和ACP有关。在目标3中，我们将分析 临床和患者水平背景因素的治疗效果，以告知该扩展ACP的未来迭代 范例如果成功，这一成本相对较低且可推广的框架可在 广泛的各种医疗保健环境和一系列慢性疾病，其中不断变化的风险，利益， 治疗的结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.