Reducing Chronic Pain and Opioid Use in Hemodialysis Patients

减少血液透析患者的慢性疼痛和阿片类药物的使用

基本信息

批准号：
9902131
负责人：
Sahir Kalim
金额：
$ 241.1万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-24 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9902131
关键词：
Address Adult Affective Analgesics Anxiety Behavior Behavior Therapy Behavioral Blinded Blood Vessels Brief Pain Inventory Buprenorphine Centers for Disease Control and Prevention (U.S.)Chronic Client satisfaction Clinical Clinical Trials Cognitive Cognitive Therapy Comorbidity Cues Data Dialysis procedure Dose Educational Materials Enrollment Etiology Exercise Fracture Future General Population Group Processes Group Therapy Health Hemodialysis High Prevalence Hospitalization Hour Individual International Interview Kidney Diseases Medical Research Medicine Mental Depression Metabolic Mindfulness Training Mission Mood Disorders Morbidity - disease rate Musculoskeletal Diseases National Institute of Diabetes and Digestive and Kidney Diseases Needles Nonpharmacologic Therapy Opioid Outcome Outpatients Pain Pain Research Pain management Pathway interactions Patients Population Problem Sets Procedures Psychological Factors Psychopathology Public Health Quality of life Randomized Randomized Controlled Trials Recovery Renal Osteodystrophy Research Screening procedure Severities Social Workers Stress Surveys Therapeutic Time Training Vascular Diseases addiction arm buprenorphine dependence buprenorphine treatment chronic pain chronic pain patient clinical care cognitive reappraisal common symptom coping falls hospitalization rates improved innovation mental state mindfulness mindfulness meditation misuse of prescription only drugs mortality multidisciplinary neuropsychiatry novel open label opioid use opioid use disorder pain perception prescription opioid primary endpoint programs psychoeducation psychological distress psychosocial recruit response reward processing satisfaction secondary endpoint social social health determinants targeted treatment

项目摘要

Project Summary/ Abstract Despite the high prevalence of chronic pain and opioid use in hemodialysis patients, and compelling data associating chronic pain and opioid prescriptions with poor outcomes, evidence from clinical trials to address these problems in hemodialysis patients is lacking and signifies a pressing unmet clinical need. This proposal is to participate as a Clinical Center in the Hemodialysis Opioid Prescription Effort (HOPE) Consortium. Because pain is a multidimensional phenomenon with physical and psychosocial components, a unidimensional approach to pain management relying solely on analgesics is unlikely to be efficacious. Nonpharmacologic therapies for co-occurring chronic pain and opioid use in hemodialysis patients should target and alter cognitive-affective circuits that govern responses elicited by pain, stress, mood disorders, and opioid-related cues. These domains are directly addressed through the behavioral therapy program known as MORE (Mindfulness-Oriented Recovery Enhancement)—a multi-pronged mindfulness-oriented individualized group therapy that integrates mindfulness training, cognitive reappraisal, and enhancement of natural reward processing. The central hypothesis for this proposal is that MORE therapy will alter the dysfunctional cognitive, affective, and behavioral pathways that influence chronic pain perception and opioid use, resulting in significant reductions in pain severity and opioid use among hemodialysis patients, and that for patients with opioid use disorder, engagement in the MORE program will increase the likelihood of starting buprenorphine treatment. Guided by MORE's demonstrated efficacy in the general population, the specific aims are: 1) Determine the impact of MORE on chronic pain and opioid use in hemodialysis patients; and 2) Determine predictors of chronic pain, opioid use, and response to MORE. The approach to Aim 1 is an open-label, assessor-blinded, randomized superiority trial (1:1 randomization) comparing assignments to MORE therapy versus control conditions among adult hemodialysis patients with chronic pain treated with a ≥90-day prescription of opioids (120 patients per Clinical Center). The Aim 2 approach will assess which comorbidities, psychological factors, and social determinants of health predict baseline pain and opioid dose (cross-sectional) as well as response to MORE (longitudinal) using data from patients enrolled in the clinical trial outlined in Aim 1. The proposed study will be critical to establish new avenues of research and clinical care that directly impact chronic pain management and opioid use in dialysis and general populations. The expected outcome is a comprehensive understanding of the impact of the MORE program on co-occurring chronic pain and opioid use in hemodialysis patients, and identification of future therapy targets. The proposed research is significant as it stands to improve quality of life, satisfaction, morbidity, and mortality in hemodialysis patients.

项目摘要/摘要尽管血液透析患者慢性疼痛和阿片类药物的使用率很高，并且令人信服的数据将慢性疼痛和阿片类药物处方与结果不佳相关联，临床试验的证据以解决血液透析患者中的这些问题缺乏并表明迫切的未满足的临床需求。这个建议是作为临床中心参加血液透析阿片类药物处方（HOPE）财团的参与。因为疼痛是具有身体和社会心理成分的多维现象，所以仅依靠镇痛药的一维疼痛管理方法不太可能是有效的。血液透析患者的慢性疼痛和阿片类药物使用的非药物治疗应应靶向和改变认知情感圈子，这些圈子由疼痛，压力，情绪障碍引起的反应和阿片类药物相关的提示。这些领域是通过称为行为疗法的计划直接解决的更多（以正念为导向的恢复增强） - 多管齐下的正念个性化的集成正念训练，认知重新评估和增强自然奖励的小组疗法加工。该提议的中心假设是，更多的治疗将改变功能失调的认知，情感和影响慢性疼痛感知和OID的行为途径，导致显着血液透析患者的疼痛严重程度和阿片类药物使用的减少，对于使用阿片类药物的患者疾病，参与更多程序将增加开始丁丙诺啡治疗的可能性。在More在一般人群中表现出的效率的指导下，具体目的是：1）确定更多对血液透析患者慢性疼痛和阿片类药物使用的影响； 2）确定预测指标慢性疼痛，阿片类药物使用以及对更多的反应。 AIM 1的方法是一个开放标签，评估者盲目的，随机优势试验（1：1随机化）将分配与更多治疗与对照进行比较成人血液透析患者的慢性疼痛患者的病情≥90天的阿片类药物处方治疗（每个临床中心120名患者）。 AIM 2方法将评估哪些合并症，心理因素，和健康的社会决定者预测基线疼痛和阿片类药物剂量（横断面）以及反应使用AIM 1中概述的临床试验的患者的数据进行更多（纵向）。研究对于建立直接影响慢性疼痛的研究和临床护理的新途径至关重要透析和一般人群中的管理和阿片类药物使用。预期的结果是一个全面的了解更多计划对同时发生的慢性疼痛和阿片类药物的影响血液透析患者以及未来治疗靶点的鉴定。拟议的研究很重要可以改善血液透析患者的生活质量，满意度，发病率和死亡率。