Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use after Lumbar Spine Surgery

术后远程医疗正念干预可改善腰椎手术后疼痛相关的结果并减少阿片类药物的使用

• 批准号: 10462694
• 负责人: Carrie Elizabeth Brintz
• 金额: $ 12.66万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10462694
• 关键词: 3-Dimensional; Academic Medical Centers; Address; Adult; Affect; Age; Anxiety; Area; Award; Behavior Therapy; Belief; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Complex; Data; Data Analyses; Data Collection; Development; Education; Enrollment; Feedback; Future; Goals; Grant; Growth; Home; Hour; Individual; Information Dissemination; Infrastructure; Intervention; Intervention Studies; Intervention Trial; Interview; Knowledge; Measures; Mental Depression; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methodology; Methods; Mind-Body Intervention; National Center for Complementary and Integrative Health; Neuronal Plasticity; Operative Surgical Procedures; Opioid; Orthopedic Surgery; Orthopedics; Outcome; Pain; Pain Measurement; Pain intensity; Pain interference; Pain management; Participant; Patient Outcomes Assessments; Patients; Persistent pain; Persons; Physical Function; Population; Postoperative Pain; Postoperative Period; Practice Management; Prediction of Response to Therapy; Procedures; Prospective Studies; Protocols documentation; Psychophysics; Psychosocial Factor; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Reporting; Research; Research Project Grants; Research Training; Resources; Risk Factors; Science; Self Efficacy; Spine pain; Spine surgery; Structure; Surveys; System; Testing; Time; Training; Treatment outcome; United States; Vertebral column; Work; Writing; acceptability and feasibility; arm; base; biopsychosocial; career; career development; central sensitization; chronic pain; clinically relevant; design; disability; emotional distress; experience; group intervention; high risk; improved; improved functioning; intervention participants; learning strategy; meetings; mindfulness; mindfulness intervention; multidisciplinary; negative affect; online delivery; opioid epidemic; opioid use; pain outcome; pain processing; pain sensitivity; patient oriented; patient population; patient subsets; post intervention; prescription opioid; programs; psychological distress; psychosocial; satisfaction; skills; surgery outcome; telehealth

Modified Project Summary/Abstract Section This K23 award will support the candidate’s growth toward an independent clinical research career focused on developing and testing psychosocially-oriented mind-body interventions to improve the quality-of-life and treatment outcomes of chronic pain and postsurgical pain populations. Lumbar spine pain affects over 50 million individuals in the United States (US). The rate of spine surgeries performed in the US is the highest in the world. Yet, up to 40% of patients experience poor pain-related, functional, or quality of life outcomes after surgery. Despite the limited efficacy and high risks associated with long term opioid use, up to 50% of patients are prescribed opioids for up to 12 months following lumbar spine surgery. Nonpharmacological approaches addressing psychosocial risk factors for poor post-surgical outcomes are understudied and underutilized during postsurgical recovery. The proposed project aims to 1) adapt and refine a mindfulness-based intervention (MBI) for one-on-one telehealth delivery (live videoconference) to patients recovering from lumbar spine surgery by conducting a preliminary test of the MBI and collecting patient feedback using mixed methods; 2) conduct a two-arm pilot randomized controlled trial (RCT) of the postsurgical telehealth MBI vs. an education control to evaluate the feasibility and acceptability of the interventions and research procedures; and 3) summarize trajectories of pain-related outcomes (pain interference, opioid usage) and treatment targets (pain-related beliefs, mindfulness, psychophysical measures), within intervention groups and within key patient subgroups (levels of preoperative negative affect and opioid use status). The proposal targets career development in several areas: 1) developing and testing mind-body interventions utilizing mixed methods and longitudinal data collection and analysis; 2) randomized clinical trial design and methodology; 3) psychophysical testing of pain modulatory systems; 4) content knowledge in postoperative orthopaedic pain and opioid use; and 5) grant-writing skills. The candidate’s training goals will be achieved with the support of a multidisciplinary team of accomplished mentors and contributors, through targeted course work and seminars, culminating in completion of the proposed research project and dissemination of results. Training will take place in a resource-rich academic medical center with a top-performing surgical center and existing infrastructure for the prospective study of patients undergoing lumbar spine surgery. The findings will help tailor a telehealth MBI for an orthopaedic postsurgical population and provide preliminary data to optimize a well-powered RCT. This K23 award will promote the early career candidate in establishing an independent research program focused on optimizing telehealth mindfulness interventions in postsurgical and pain populations to inform the science and delivery of personalized pain management practices. The goals of this project are strongly aligned with NCCIH scientific priorities to address the widespread burden of chronic pain and the ongoing opioid epidemic.

修改的项目摘要/摘要部分 这项K23奖将支持候选人的成长，致力于独立的临床研究职业，重点是开发和测试以心理为导向的思维身心干预措施，以改善慢性疼痛和术后疼痛群体的生活质量和治疗结果。在美国，腰椎疼痛会影响超过5000万人（美国）。在美国进行的脊柱手术率是世界上最高的。然而，多达40％的患者在手术后经历了与疼痛相关，功能或生活质量质量的差异。尽管长期使用阿片类药物的效率有限和高风险，但在腰椎手术后长达12个月，多达50％的患者被开处方。在手术后恢复期间，了解和不足的情况下，针对较差的术后结局的心理心理风险因素的非药理学方法被理解为不足。拟议的项目的目的是1）适应和完善基于正念的干预措施（MBI），以一对一的远程医疗服务（实时视频会议）通过对MBI进行初步测试并使用混合方法收集患者反馈，以从腰椎手术中恢复过来。 2）进行术后远程医疗MBI与教育控制的两臂飞行员随机对照试验（RCT），以评估干预措施和研究程序的可行性和可接受性； 3）与疼痛相关结局（疼痛干扰，阿片类药物使用率）和治疗靶（与疼痛相关的信念，正念，心理物理测量值），干预组和关键患者亚组（术前负面影响和阿片类药物使用状态的水平）内的摘要轨迹。该提案针对多个领域的职业发展：1）使用混合方法和纵向数据收集和分析来开发和测试思维体干预措施； 2）随机临床试验设计和方法论； 3）疼痛调节系统的心理物理测试； 4）术后骨科疼痛和阿片类药物的内容知识； 5）赠款技巧。候选人的培训目标将通过有针对性的课程工作和半手级的多学科团队的支持，并在完成拟议的研究项目的完成和结果传播方面实现。培训将在资源丰富的学术医疗中心进行，该中心具有最佳的外科手术中心和现有的基础设施，以对接受腰椎手术的患者进行前瞻性研究。这些发现将有助于为骨科术后人群定制远程医疗MBI，并提供初步数据以优化功能良好的RCT。该K23奖将促进早期职业候选人建立一个独立的研究计划，该计划旨在优化术后和疼痛人群中的远程医疗正念干预措施，以告知科学和提供个性化疼痛管理实践。该项目的目标与NCCIH的科学优先事项密切相符，以解决慢性疼痛和正在进行的阿片类药物流行的宽度伯恩。