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

扩大预先护理计划的临床试验，以解决治疗引起的低血糖高风险的老年患者的治疗强度

• 批准号: 10237364
• 负责人: RICHARD W GRANT
• 金额: $ 67.41万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10237364
• 关键词: Address; Adult; Advance Care Planning; Advance Directives; Adverse event; Age; Age-Years; American; California; Cardiovascular system; Caring; Cessation of life; Chronic; Clinical; Clinical Trials; Communication; Complex; Complication; Decision Making; Diabetes Mellitus; Documentation; Elderly; Ensure; Epidemic; Event; Evidence based treatment; Fracture; Future; Glucose; Glycosylated hemoglobin A; Goals; Grant; Health; Healthcare; Heterogeneity; Hospitalization; Hypoglycemia; Impaired cognition; Incidence; Individual; Insulin; Intervention; Kidney Failure; Life; Medical; Medical center; Medicine; Methods; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Patient Outcomes Assessments; Patient Participation; Patient Preferences; Patient Self-Report; Patients; Patterns of Care; Persons; Pharmaceutical Preparations; Physiology; Population; Preparation; Primary Health Care; Provider; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Resuscitation; Risk; Safety; Self Efficacy; Specific qualifier value; Sulfonylurea Compounds; Testing; Time; Treatment Efficacy; Treatment Protocols; Visit; Voice; adverse outcome; age related; aged; base; care providers; clinical effect; clinically significant; comorbidity; contextual factors; cost; diabetes distress; diabetes management; end of life; evidence base; experience; falls; health care settings; health literacy; high risk; improved; innovation; middle age; mortality; older patient; pragmatic trial; preference; primary care setting; randomized trial; response; skills; success; support tools; tool; treatment as usual; treatment effect; treatment guidelines; treatment risk; usability

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.

抽象的 随着患有2型糖尿病（T2D）的个体生活到老年时代，在中年建立的护理模式 需要根据与年龄相关的生理和生活环境变化进行调整。预先护理 计划（ACP）是支持老年人与临床医生进行实时参与的关键工具 在严重疾病的过程中，复杂的医疗决定，以使他们接受的医疗服务保持一致 尽管经常适用于临终决定（例如，有关生活的高级指令 - 维持治疗）ACP范式已扩展，以便更有效地准备患者 参与重新评估长期慢性病（例如T2D）的当前治疗目标。目标 这项研究是应用扩展的ACP范式（技能构建和价值启发的准备，决策 - 与低血糖相关的不良后果的特定临床问题进行交流） T2D脆弱的老年患者。我们将适应我们现有的，基于证据的患者，在线 准备工具（preparforyourcare.org）以解决T2D时老年人的治疗强度 降血糖事件的风险（即规定的胰岛素或磺酰尿菌）（AIM 1）。然后，我们将进行 初级保健环境中的随机临床试验，将这种新的ACP-T2D工具与600的常规护理进行了比较 成年人≥75岁，降血糖事件的风险增加（AIM 2）。这种干预的目的是 为了使知情，准备好患者与他们的初级保健提供者互动，以重新评估他们的 ACP背景下的糖尿病治疗强度和治疗目标。我们假设许多 高风险的老年人，这些知情的对话将导致药物脱离处方和相应 临床上严重低血糖症的发病率较低（由美国定义的主要临床结果 相对于通常的护理，糖尿病关联是低血糖，需要从另一个人那里获得复苏的帮助。 我们还将检查处方更改，ED/医院入院以及一组患者报告的结果 与沟通，糖尿病管理和ACP有关。在AIM 3中，我们将分析异质性 通过临床和患者级的上下文因素的治疗效果，以告知这种扩展的ACP的未来迭代 范例。如果成功，则可以将这个相对低成本和可推广的框架缩放和应用 各种各样的医疗机构以及各种慢性病，在这些状态下，不断发展的风险，福利和 治疗的后果需要随着年龄的增长而重新评估。