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: 10283807
• 负责人: Carrie Elizabeth Brintz
• 金额: $ 12.61万
• 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/10283807
• 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; 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; comparison intervention; 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.

修改后的项目摘要/摘要部分 这一K23奖项将支持候选人迈向独立的临床研究生涯，专注于开发和测试面向心理的心身干预措施，以改善慢性疼痛和手术后疼痛人群的生活质量和治疗结果。在美国，腰椎疼痛影响着5000多万人。美国的脊柱手术率是世界上最高的。然而，多达40%的患者在手术后体验到与疼痛相关的、功能或质量较差的生活结果。尽管长期使用阿片类药物的疗效有限，风险也很高，但多达50%的患者在腰椎手术后服用阿片类药物长达12个月。针对术后不良预后的心理社会危险因素的非药理学方法研究不足，在术后康复过程中也未得到充分利用。拟议的项目旨在1)通过对基于正念的干预(MBI)进行初步测试并使用混合方法收集患者反馈来调整和改进用于一对一远程健康(实时视频会议)的基于正念的干预(MBI)，以用于腰椎手术后康复的患者；2)进行手术后远程健康MBI与教育对照的双臂试点随机对照试验(RCT)，以评估干预和研究程序的可行性和可接受性；以及3)总结与疼痛相关的结果(疼痛干预、阿片类药物的使用)和治疗目标(与疼痛相关的信念、正念、心理物理测量)、干预组内和关键患者亚组内的轨迹(术前负面情绪水平和阿片类药物的使用状况)。该提案针对以下几个领域的职业发展：1)利用混合方法和纵向数据收集和分析开发和测试心身干预措施；2)随机临床试验设计和方法；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使用的内容知识；以及5)赠款撰写技能。候选人的培训目标将在一个由优秀导师和贡献者组成的多学科团队的支持下，通过有针对性的课程工作和研讨会来实现，最终完成拟议的研究项目并传播结果。培训将在一个资源丰富的学术医疗中心进行，该中心拥有一流的手术中心和现有的基础设施，用于对接受腰椎手术的患者进行前瞻性研究。这一发现将有助于为骨科术后人群量身定做远程医疗MBI，并为优化功能强大的RCT提供初步数据。这项K23奖项将促进这位职业生涯早期的候选人建立一个独立的研究计划，专注于优化手术后和疼痛人群中的远程健康正念干预，为个性化疼痛管理实践的科学和交付提供信息。该项目的目标与NCCIH的科学优先事项密切相关，以解决慢性疼痛的普遍负担和持续的阿片类药物流行。