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是一种极其痛苦的疾病，其特征是缺血性 疼痛、不愈合的伤口或溃疡、或坏疽组织。虽然死亡率和截肢负担很大， 大多数患者在诊断后存活一年，越来越多的重点放在 将终点的重点从避免肢体丧失和死亡转移到患有CLI并改善患者的生活质量， 健康状况和生活质量。大多数CLI患者报告慢性疼痛，可能有一个等级， 影响患者的健康状况和生活质量。由于CLI护理是分散的，涉及多个专业， 缺乏协调一致的疼痛管理努力，截肢往往是提供的方式之一， 目前，慢性疼痛已得到控制。在基于疼痛的门控理论的见解的支持下， 心理干预是治疗医学人群慢性疼痛的有效选择。的 然而，疼痛的现象学，疼痛管理方法及其对CLI结果的影响， 明白我们项目的长期目标是创造一个综合的、以病人为中心的、多模式的疼痛治疗方法。 CLI的管理程序。作为第一步，我们的目标是研究CLI的医疗疼痛管理方法 随着时间的推移，以及它与整个生命周期的CLI结果的关联。具体来说，我们的目标是研究 CLI和PAD中止痛药使用的纵向模式及其与结局的相关性 （再入院/截肢/抑郁/焦虑）在国家索赔为基础的数据集，以及在医疗保险相关联的 国家血管登记处。我们假设，随着时间的推移，包括阿片类药物在内的止痛药的使用率更高， 在CLI中，PAD（非CLI）对照人群中阿片类药物使用率较高; CLI干预的阿片类药物使用率较高的模式不同 策略（非侵入性、血运重建或截肢）; CLI和PAD中阿片类药物的高使用与 具有更高的再入院、截肢、死亡和抑郁/焦虑的风险。此外，通过患者- 中心SCOPE-CLI注册表，我们将研究代理的HEAL通用数据元素，通过一般 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的见解， 功能和治疗满意度。我们假设，更严重的疼痛经验，与 更高水平的抑郁、焦虑、痛苦，以及更差的健康状况和CLI治疗满意度。的 从这项研究计划产生的经验数据将确定目前的差距，疼痛管理策略 以及与CLI护理、功能和结果的相互作用，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。