Administrative Supplement (PA-20-272) to Expand Safe Insulin De-Prescribing (R01 Award) to include Patients with ADRD and Their Caregivers

行政补充文件 (PA-20-272) 将安全胰岛素取消处方（R01 奖）扩大到包括 ADRD 患者及其护理人员

• 批准号: 10492857
• 负责人: RICHARD W GRANT
• 金额: $ 29.78万
• 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/10492857
• 关键词: Address; Administrative Supplement; Adult; Advance Care Planning; Affect; Age; Alzheimer' s Disease; Alzheimer' s disease related dementia; Award; Blood Glucose; Cardiovascular system; Caregivers; Caring; Cessation of life; Chronic Disease; Clinical; Clinical Trials; Clinical trial protocol document; Complex; Data; Dementia; Development; Diabetes Mellitus; Drug Prescriptions; Elderly; Enrollment; Event; Evidence based treatment; Family member; Feedback; Foundations; Fracture; Friends; Funding; Future; Hospitalization; Hypoglycemia; Iatrogenesis; Impaired cognition; Individual; Infrastructure; Insulin; Intervention; Interview; Learning; Measures; Medical; Medicine; Modeling; Modification; Non-Insulin-Dependent Diabetes Mellitus; Online Systems; Outcome; Parents; Patient Self-Report; Patients; Pharmaceutical Preparations; Polypharmacy; Preparation; Procedures; Process; Provider; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Risk; Role; Sulfonylurea Compounds; Time; Treatment Efficacy; Treatment Protocols; Work; acceptability and feasibility; aged; base; decision-making capacity; design; efficacy testing; efficacy trial; evidence base; experience; fall risk; feasibility testing; high risk; high risk population; improved; innovation; mortality; multiple chronic conditions; older patient; preference; prevent; programs; recruit; tool; treatment arm; treatment guidelines; treatment risk; usability

PROJECT SUMMARY Iatrogenic hypoglycemia due to prescribed medications (e.g., insulin and sulfonylureas) is the single greatest management-related problem facing older patients with type 2 diabetes (T2D). These hypoglycemic events are associated with a 1.7-fold increased risk of fall-related fractures, a 2-fold risk of serious cardiovascular events, and a 3-fold increased risk in mortality. Hypoglycemia is an even greater problem for individuals with Alzheimer’s disease and its related dementias (ADRD), which affects nearly 1 in 4 of the nearly 9 million adults with T2D aged ≥ 75 years. Older adults with ADRD have 3-fold increased odds of severe hypoglycemia requiring hospitalization compared to older adults without ADRD. In Aim 1 of the Parent R01 (R01AG068133: Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia; 8/15/2020 - 4/30/2025) we created Prepare for Your Diabetes Care – a patient-facing web-based platform that helps patients prepare for and engage in effective conversations with their provider about their current diabetes medicines. In Aim 2 of the Parent award, we are conducting a randomized clinical trial (RCT) to measure the impact of this intervention on diabetes medication de- prescribing and hypoglycemic events among patients ≥ 75 years with tightly controlled diabetes prescribed insulin and/or sulfonylureas. However, we excluded patients with ADRD. New strategies must engage patients with early ADRD and mild-to-moderate cognitive impairment (MCI) prior to the loss of decision-making capacity. Strategies must also prepare patients’ caregivers. Therefore, in the current Administrative Supplement (PA-20-272), we propose to leverage our existing Prepare for Your Diabetes Care intervention and the Parent clinical trial infrastructure to include high-risk patients with T2D and early ADRD/MCI and their caregivers. In Supplemental Aim 1, we will determine the feasibility and acceptability of the Parent RCT protocol in high-risk older adults with T2D and early ADRD/MCI and their caregivers, and in Aim 2 we will identify barriers and tailoring strategies to enable patients/caregivers to effectively use Prepare for Your Diabetes Care. Based on prior work in patients with early ADRD/MCI and caregivers, we estimate needing to recruit 150 dyads to enroll 30. We will assess standard recruitment and retention metrics (for trial planning), and acceptability and usability metrics and qualitative feedback (for intervention modification). A specific innovative strength of this proposed Supplement is our focus on how to better incorporate the role of caregivers in the process of care planning related to safe diabetes medication de-prescribing in high-risk patients with ADRD and MCI. These Aims are well within the scope of the Parent award and will lead to a future R01-funded RCT of older adults with ADRD/MCI and their caregivers in de-prescribing to prevent hypoglycemia.

项目摘要 处方药物导致的医源性低血糖（例如，胰岛素和磺脲类药物）是唯一的 老年2型糖尿病（T2 D）患者面临的最大管理相关问题。这些 低血糖事件与跌倒相关骨折风险增加1.7倍相关， 严重心血管事件的发生率和死亡率增加3倍的风险。hypothermia是一个偶数 阿尔茨海默病及其相关痴呆症（ADRD）患者面临的更大问题， 在近900万年龄≥ 75岁的T2 D成人患者中，有近1/4的患者受到影响。老年ADRD患者 与老年人相比， 成人无ADRD。在母体R 01的目标1中（R 01 AG 068133：扩展Advance的临床试验 护理计划，以解决方案强度的老年患者在高风险的治疗诱导 低血糖症; 2020年8月15日-2025年4月30日），我们创建了“为您的糖尿病护理做准备”-一个面向患者的 一个基于网络的平台，帮助患者做好准备，并与他们进行有效的对话。 供应商了解他们目前的糖尿病药物。在家长奖的目标2中，我们正在进行一项 随机临床试验（RCT），以衡量这种干预对糖尿病药物治疗的影响， ≥ 75岁的糖尿病严格控制患者中的处方和低血糖事件 处方胰岛素和/或磺脲类药物。然而，我们排除了ADRD患者。新战略 必须让早期ADRD和轻度至中度认知障碍（MCI）的患者参与治疗， 丧失决策能力。战略还必须使患者的护理人员做好准备。因此在 目前的行政补充（PA-20-272），我们建议利用我们现有的准备为您的 糖尿病护理干预和母公司临床试验基础设施，以纳入高风险患者， T2 D和早期ADRD/MCI及其护理人员。在补充目标1中，我们将确定 在高风险老年T2 D患者和早期T2 D患者中实施母RCT方案的可行性和可接受性 ADRD/MCI及其护理人员，在目标2中，我们将确定障碍和定制策略， 患者/护理人员有效地使用为糖尿病护理做好准备。基于先前在患者中的工作 对于早期ADRD/MCI和护理人员，我们估计需要招募150对夫妇才能招募30人。我们将 评估标准招募和保留指标（用于试验计划）以及可接受性和可用性 指标和定性反馈（用于干预措施修改）。一个具体的创新力量， 拟议的补充是我们的重点是如何更好地纳入照顾者在这一过程中的作用 与ADRD高危患者中安全糖尿病药物处方相关的护理计划， MCI。这些目标都在母公司奖的范围内，并将导致未来的R 01资助 老年ADRD/MCI患者及其护理人员取消处方以预防低血糖的RCT。