Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center

范德比尔特-西弗吉尼亚州 (VWV) 合作：HOPE 联盟临床中心

• 批准号: 9902582
• 负责人: Kerri Cavanaugh
• 金额: $ 286.33万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 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/9902582
• 关键词: Academic Medical Centers; Adult; Affect; Agreement; Applications Grants; Area; Award; Behavior Therapy; Bone Diseases; Caregivers; Caring; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Cognitive Therapy; Collaborations; Complex; Data; Diabetes Mellitus; Dialysis patients; Dialysis procedure; Dose; Emotional; End stage renal failure; Etiology; Fostering; Future; Goals; Guidelines; Hemodialysis; Hospitalization; Impairment; Injury; Integrative Medicine; Intervention; Kidney Diseases; Life Experience; Maintenance; Methods; Morbidity - disease rate; Motivation; National Institute of Diabetes and Digestive and Kidney Diseases; Nociception; Opioid; Outcome; Pain; Pain management; Patient Care; Patient Outcomes Assessments; Patients; Peripheral Vascular Diseases; Pharmacology; Pharmacotherapy; Physiological; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Personnel; Schedule; Site; Techniques; Telemedicine; Testing; Therapeutic; Tissues; United States National Institutes of Health; Universities; West Virginia; arm; chronic pain; clinical practice; comparative effectiveness; depressive symptoms; design; efficacy trial; expectation; experience; implementation research; improved; improved outcome; innovation; interest; intervention program; meetings; member; mindfulness; mortality; mortality risk; motivational enhancement therapy; multi-site trial; multidisciplinary; multimodality; multiple chronic conditions; non-cancer chronic pain; novel; opioid use; pain outcome; painful neuropathy; patient oriented; pragmatic trial; prescription opioid; psychologic; randomized trial; recruit; response; safety and feasibility; safety study; shared decision making; treatment strategy

More than 50% of adult in-center hemodialysis patients experience and are treated for non-cancer chronic pain (NCCP). The treatment approach is often complex as the underlying etiology of the pain itself contributes to a combination of physical and psychological impairments. There is a paucity of research evidence specific to hemodialysis to guide the optimal approaches to pharmacotherapy or other innovative strategies to support patient-centered comprehensive pain management to reduce complications of pharmacologic therapy and morbidity overall. As a clinical center member of the Hemodialysis Opioid Prescription Effort (HOPE) Consortium, the overall objective of this proposal is to collaborate with diverse stakeholders to design and conduct a multi-site trial evaluating innovative strategies to reduce opioid dosing, improve quality of life and experience with care specific to pain management among adults receiving in-center hemodialysis. We propose specifically to perform a pragmatic parallel arm trial to test the impact of adding a 12-week interactive video cognitive behavioral therapy (IV-CBT) intervention program, compared to CDC guideline concordant shared decision-making (SDM) for NCCP pharmacotherapy management. The specific aims are: Aim 1 Conduct a multi-site randomized trial to receive IV-CBT and SDM versus SDM alone over 15 months; patients will be assessed at baseline, 12 weeks, 9 months and 15 months; Aim 2 Investigate and describe barriers and facilitators of the implementation of IV-CBT and also SDM among patients, clinicians and dialysis staff; Aim 3 Create a collaborative network of investigators and dialysis facilities for efficient and swift subject recruitment and for dissemination of successful strategies to optimize pain care in dialysis. In Aim 2, applicants will investigate factors related to the interventions applying the Consolidated Framework for Implementation Research (CFIR), and develop recommendations for an implementation toolkit to guide future dissemination of each of the strategies. The research is innovative because: i) it seeks to shift current clinical practice where SDM is consistently integrated into pain management clinical practice; ii) telemedicine is leveraged to support psychological and emotional support strategies to foster motivation and maintenance of multimodal strategies for chronic pain care; and iii) a trial in real-world settings of patients with multi-morbidity, who are regularly excluded from trials, is novel and has greater external validity. The results are expected to have a major positive impact as they will increase clinical understanding and underscore the importance of multidisciplinary chronic pain management strategies in tackling on the significant challenge of improving patient morbidity and quality of life in a highly prevalent and complex area of care.

超过 50% 的成人中心血液透析患者经历过非癌症慢性疼痛并接受治疗 （NCCP）。治疗方法通常很复杂，因为疼痛本身的潜在病因会导致 身体和心理损伤的结合。缺乏具体的研究证据 血液透析指导药物治疗的最佳方法或其他创新策略来支持 以患者为中心的综合疼痛管理，以减少药物治疗的并发症和 总体发病率。作为血液透析阿片类药物处方计划 (HOPE) 的临床中心成员 联盟，该提案的总体目标是与不同的利益相关者合作设计和 进行多中心试验，评估减少阿片类药物剂量、改善生活质量和 对接受中心血液透析的成人进行疼痛管理的护理经验。我们建议 专门进行务实的平行臂试验，以测试添加 12 周互动视频的影响 认知行为治疗 (IV-CBT) 干预计划，与 CDC 指南一致共享 NCCP 药物治疗管理的决策 (SDM)。具体目标是： 目标 1 开展 接受 IV-CBT 和 SDM 对比单独 SDM 超过 15 个月的多中心随机试验；患者将会 在基线、12周、9个月和15个月时进行评估；目标 2 调查并描述障碍和 在患者、临床医生和透析人员中实施 IV-CBT 和 SDM 的促进者；目标 3 创建研究人员和透析设施的协作网络，以实现高效、快速的受试者招募 并传播优化透析疼痛护理的成功策略。在目标 2 中，申请人将 调查与应用综合实施框架的干预措施相关的因素 研究（CFIR），并为实施工具包提出建议，以指导未来的传播 每个策略。这项研究具有创新性，因为： i) 它试图改变当前的临床实践 SDM 始终融入疼痛管理临床实践； ii) 利用远程医疗来支持 心理和情感支持策略，以促进动机和维持多模式策略 用于慢性疼痛护理； iii) 在现实世界中针对患有多种疾病的患者进行的一项试验，这些患者定期接受 被排除在试验之外，是新颖的并且具有更大的外部效度。预计结果将产生重大影响 积极影响，因为它们将增加临床理解并强调多学科的重要性 慢性疼痛管理策略，以应对改善患者发病率和 高度普遍且复杂的护理领域的生活质量。