Pain Management Strategies, Associated Psychological Variables, and Outcomes in Critical Limb Ischemia

严重肢体缺血的疼痛管理策略、相关心理变量和结果

• 批准号: 10599675
• 负责人: Carlos Mena-Hurtado
• 金额: $ 46.06万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599675
• 关键词: Affect; American; Amputation; Analgesics; Anxiety; Behavior; Behavioral; Blood Vessels; Caring; Cessation of life; Chronic; Clinical; Clinical Data; Clinical Research; Cognition; Cognitive Therapy; Common Data Element; Complex; Data; Data Set; Databases; Dependence; Diabetes Mellitus; Diagnosis; Disease Management; Distress; Equation; Europe; Foundations; Goals; Health Status; Hospitals; Incidence; Individual; Informal Social Control; Intervention; Japan; Leg; Life Style; Limb structure; Link; Longevity; Lower Extremity; Mediating; Medical; Medicare; Mental Depression; Migraine; Modeling; Musculoskeletal Diseases; Norepinephrine; Obesity; Opioid; Outcome; Overdose; Pain; Pain management; Pathway interactions; Patients; Pattern; Perfusion; Peripheral; Peripheral arterial disease; Persistent pain; Personal Satisfaction; Population; Procedures; Proxy; Quality of life; Registries; Regulation; Reporting; Research; Rest; Risk; Risk Management; Self Management; Self-control as a personality trait; Serotonin; Sleep disturbances; Structure; Symptoms; Time; Tissues; Translating; Tricyclic Antidepressive Agents; Ulcer; addiction; base; cardiovascular risk factor; chronic back pain; chronic pain; chronic pain management; control theory; critical limb Ischemia; deconditioning; design; disability; effective intervention; experience; high risk; hospital readmission; improved; inhibitor; innovation; insight; limb ischemia; limb loss; medical specialties; mortality; mortality risk; multimodality; non-healing wounds; opioid use; patient oriented; phenomenological models; prescription opioid; prevent; programs; psychologic; readmission risk; response; reuptake; satisfaction; wound care

PROJECT SUMMARY A growing number of Americans – over 2 million – are affected by critical limb ischemia (CLI), the most severe expression of peripheral artery disease (PAD). CLI is an extremely painful condition characterized by ischemic pain, non-healing wounds or ulcers, or gangrenous tissues. While mortality and amputation burden is substantial, the majority of patients survives the year following diagnosis and more and more emphasis is being placed on shifting the focus of endpoints from avoiding limb loss and mortality to living with CLI and improving patients’ health status and quality of life. The majority of patients with CLI reports chronic pain, which may have a gre at impact on patients’ health status and quality of life. As CLI care is fragmented, with multiple specialties involved, concerted pain management efforts are lacking and amputation is often offered as one of the ways in which chronic pain is currently managed. Supported by insights based on the gate-control theory of pain, both medical and psychological interventions are effective options to manage chronic pain in medical populations. The phenomenology of pain, pain management approaches, and its impact on CLI outcomes, however, is poorly understood. The long-term goal of our program is to create an integrated, patient-centered, and multimodal pain management program for CLI. As a first step, we aim to study the medical pain management approaches of CLI over time, and its association with CLI outcomes across the lifespan. Specifically, we aim to examine the longitudinal patterns of pain medication utilization in CLI and PAD and its association with outcomes (readmission/amputation/depression/anxiety) in national claims-based datasets as well as in a Medicare linked national vascular registry. We hypothesize that the use of pain medications, including opioids, over time is higher in CLI than a control PAD (non-CLI) population; and that patterns of high opioid use differ by CLI intervention strategy (non-invasive, revascularization, or amputation); and that high opioid use in CLI and PAD is associated with a higher risk of readmission, amputation, mortality, and depression/anxiety. In addition, through the patient- centered SCOPE-CLI registry, we will study proxies of the HEAL common data elements through general structured equation models that will help provide insights as to how pain impacts related behavioral domains and functioning and treatment satisfaction. We hypothesize that more severe pain experiences, are associated with higher levels of depression, anxiety, distress, and worse health status and CLI treatment satisfaction. The empirical data generated from this program of research will identify current gaps in pain management strategies and interactions with CLI care, functioning, and outcomes that will further guide the design of future research on care innovations and the integration of holistic CLI pain management strategies.

项目摘要 越来越多的美国人（超过200万）受到严重肢体缺血（CLI）的影响，这是最严重的 外周动脉疾病（PAD）的表达。 CLI是一种极为痛苦的疾病，其特征是缺血 疼痛，非治疗胜利或溃疡或坏疽组织。虽然死亡率和截肢伯恩（Burnen）很大，但 大多数患者在诊断后的一年生存，并且越来越重视 将终点的重点从避免肢体损失和死亡率转移到与CLI生活并改善患者 健康状况和生活质量。大多数CLI患者报告慢性疼痛，可能的灰色 对患者健康状况和生活质量的影响。由于CLI护理是分散的，涉及多个专业， 缺乏一致的疼痛管理工作，并且通常提供截肢作为一种方式之一 慢性疼痛目前已管理。在基于闸门控制理论的洞察力的支持下，两者都有医学 心理干预措施是管理医学人群慢性疼痛的有效选择。 然而，疼痛，疼痛管理方法及其对CLI结局的影响的现象学表现很差 理解。我们计划的长期目标是创建一个集成，以患者为中心和多模式的疼痛 CLI的管理程序。作为第一步，我们旨在研究CLI的医疗疼痛管理方法 随着时间的流逝，及其与整个生命周期的CLI结局的关联。具体来说，我们旨在检查 CLI和PAD中止痛药利用的纵向模式及其与结果的关联 （重新入学/截肢/抑郁/焦虑）在基于国家索赔的数据集中以及在Medicare链接中 国家血管注册中心。我们假设随着时间的流逝，使用包括阿片类药物在内的止痛药的使用更高 在CLI中，比对照组（非CLI）人群；高阿片类药物的这种模式通过CLI干预不同 策略（非侵入性，血运重建或截肢）；在CLI和PAD中使用的高阿片类药物使用是相关的 再入院，截肢，死亡率和抑郁/焦虑症的风险更高。另外，通过患者 - 以范围CLI注册为中心，我们将通过一般研究治疗共同数据元素的代理 结构化方程模型将有助于提供有关疼痛如何影响相关行为领域和 功能和治疗满意度。我们假设更严重的疼痛经历与 更高水平的抑郁，焦虑，困扰以及健康状况较差和CLI治疗满意度。 该研究计划产生的经验数据将确定疼痛管理策略中的当前差距 以及与CLI护理，功能和成果的互动，这将进一步指导未来研究的设计 护理创新和整体CLI疼痛管理策略的整合。