Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program

预防慢性术后疼痛和长期使用阿片类药物：围手术期疼痛自我管理计划

• 批准号: 10405475
• 负责人: Katherine E. Hadlandsmyth
• 金额: --
• 依托单位: IOWA CITY VA 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: 2021-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10405475
• 关键词: Acute; Address; Affect; Analgesics; Anxiety; Area; Arthritis; Caring; Chronic; Cities; Clinic; Clinical; Cognitive; Cognitive Therapy; Coping Skills; Data; Development; Disease; Dissemination and Implementation; Distress; General Population; Goals; Guidelines; Healthcare Systems; Human Resources; Hybrids; Incidence; Intervention; Interview; Iowa; Joints; Logistic Regressions; Measures; Methodology; Modeling; Moods; Nurses; Operative Surgical Procedures; Opioid; Orthopedic Surgery; Outcome; Pain; Pain management; Participant; Patients; Perioperative; Pharmaceutical Preparations; Pharmacology; Postoperative Pain; Postoperative Period; Prevention; Procedures; Process; Protocols documentation; Randomized; Randomized Controlled Trials; Records; Relaxation; Replacement Arthroplasty; Reporting; Research; Risk; Risk Factors; Schedule; Self Efficacy; Severities; Single-Blind Study; Site; Substance Use Disorder; Surgeon; Survival Analysis; Telephone; Thinking; Time; Veterans; Work; arm; base; biopsychosocial; chronic pain; chronic pain management; chronic pain patient; comorbidity; cost; cost estimate; design; efficacy evaluation; evidence base; experience; follow-up; future implementation; implementation context; implementation design; implementation outcomes; implementation strategy; improved; improved functioning; innovation; long-term sequelae; member; microcosting; non-opioid analgesic; opioid overuse; opioid use; pain catastrophizing; pain chronification; pain reduction; pain self-management; pilot trial; prescription pain reliever; prevent; preventive intervention; primary endpoint; primary outcome; psychologic; psychological distress; secondary outcome; sedative; self-management program; skills; standard care; surgery outcome; telephone session; treatment arm; treatment effect; trial design; uptake

Background: Surgery can precipitate the development of both chronic pain and long-term opioid use. Preoperative psychological distress is a risk factor for poor post-surgical outcomes. Strategies are needed to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to optimize post-operative outcomes. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. Significance/Impact: This proposal addresses the priority areas of chronic pain and opioid use. This study enhances biopsychosocial pain care during the perioperative period and offers a model to prevent the development of chronic pain and prolonged opioid use following surgery. Innovation: The proposed innovative approach to preventing, rather than managing, chronic postsurgical pain among Veterans could incite a clinical paradigm shift from pain treatment to prevention. Specific Aims: Aim 1: Use a Hybrid Type 1 Randomized Controlled Trial design to examine the efficacy of the Perioperative Pain Self-management (PePS) program versus Standard Care (SC) for preventing chronic postoperative pain and prolonged opioid use. Exploratory analyses will examine whether substance use disorders moderate treatment effects and whether changes in pain catastrophizing and self-efficacy relate to postoperative pain at 6-months post-surgery. Aim 2: Determine the impact of the PePS program on secondary outcomes: mood, functioning, and non-opioid analgesic prescriptions. Aim 3: Evaluate the context of implementation by examining acceptability, feasibility, and appropriateness among Veterans and care team members, and quantifying intervention-specific personnel-related costs. Based on the Implementation Outcomes framework, the current study will use primarily qualitative methodology for aim 3. Methodology: The current study is a hybrid efficacy-implementation design to facilitate a more rapid move toward broad-based dissemination and uptake of the PePS program. For Aim 1 and 2 we will utilize a single- blind, two-arm, parallel, randomized control trial. Participants will include 400 Veterans scheduled at the Iowa City or Minneapolis VAs for unilateral primary total joint arthroplasty. Participants will be randomized to PePS or SC. The PePS program includes 4 telephone sessions: Session one will be preoperative and include an introduction to relaxation and the importance of interpretation in the pain experience. Session two (two weeks postoperative) will include: review of relaxation and the connection between thoughts/interpretation and pain, and introduction to thought records. Session three will include review of thought records and relaxation and introduction to goal-setting and cognitive restructuring. Session four will include: review and creating a plan for continued use of skills. Primary and secondary outcomes will be measured for 6 weeks post-surgery (medications only), and at 3 months, and 6 months post-surgery (all other outcomes). Six-months will be the primary endpoint for pain, mood, and functioning. Multivariate logistic regression will be employed to determine the relationship between treatment arm and the dichotomous outcome: moderate to severe pain at 6-months post-surgery. Survival analyses will be used to determine time to opioid (and other analgesic) cessation. Aim 3 will assess acceptability, appropriateness, feasibility, and estimate costs associated with subsequent implementation. This will include qualitative interviews with both Veteran surgical patients and surgery clinic staff (surgeons, nurses, and clerks) at both sites. We will use micro-costing to quantify work time. Implementation/Next Steps: These findings will be used to inform subsequent implementation work of the PePS program within the VA healthcare system.

背景：手术可以促进慢性疼痛和长期使用阿片类药物的发展。 术前心理困扰是导致术后预后不佳的危险因素。需要战略来实现以下目标 用非药物策略加强围手术期疼痛的药物治疗 优化术后转归。心理干预，如认知行为疗法(CBT)可以 有效减轻慢性疼痛患者的痛苦，改善其功能。而CBT一直是 广泛用于已确诊的慢性疼痛患者，但尚未被用作预防性干预。 目标是从急性到慢性手术后疼痛的过渡。 意义/影响：该提案涉及慢性疼痛和阿片类药物使用的优先领域。本研究 在围手术期加强生物心理社会疼痛护理，并提供一种模式来预防 手术后出现慢性疼痛和长期使用阿片类药物。 创新：建议的预防而不是管理术后慢性疾病的创新方法 退伍军人中的疼痛可能会促使临床范式从疼痛治疗转向预防。 具体目标：目标1：使用混合型1型随机对照试验设计来检查 围术期疼痛自我管理(PEPS)计划与标准护理(SC)预防慢性病的比较 术后疼痛和长期使用阿片类药物。探索性分析将检查物质使用 障碍、中度治疗效果以及疼痛灾难性和自我效能感的变化是否与 术后6个月疼痛情况。目标2：确定PEPS计划对二级市场的影响 结果：情绪、功能和非阿片类止痛药处方。目标3：评估 通过检查退伍军人和护理团队的可接受性、可行性和适当性来实施 成员，并量化与干预有关的人员相关费用。根据实施情况 根据成果框架，本研究将主要使用定性方法来实现目标3。 方法：目前的研究是一种混合的功效实施设计，以促进更快的行动 向广泛传播和采纳PEPS方案迈进。对于目标1和目标2，我们将使用单个- 双臂随机双盲平行对照试验。参与者将包括预定在爱荷华州的400名退伍军人 City或Minneapolis VAS用于单侧初次全关节置换术。参赛者将被随机分配到PEP 或SC。PEPS计划包括4次电话会议：第一次会议将在手术前进行，包括 介绍放松和解释在疼痛体验中的重要性。第二节课(两周 术后)将包括：回顾放松和思想/解释与疼痛之间的联系， 和思想记录导论。第三堂课将包括回顾思想记录和放松，以及 目标设定和认知重建导论。第四堂课将包括：审查和制定计划 持续使用技能。一次和二次结果将在术后6周内进行评估 (仅限药物治疗)，以及术后3个月和6个月(所有其他结果)。六个月将是 疼痛、情绪和功能的主要终点。将使用多变量Logistic回归来确定 治疗臂与两种结果的关系：6个月时中度至重度疼痛 手术后。生存分析将用于确定阿片类药物(和其他止痛剂)停止的时间。 目标3将评估可接受性、适当性、可行性，并估算与以下各项相关的成本 实施。这将包括对资深外科病人和外科诊所的定性访谈。 两个站点的工作人员(外科医生、护士和办事员)。我们将使用微观成本计算来量化工作时间。 执行/下一步：这些调查结果将被用来为后续的执行工作提供信息 退伍军人管理局医疗保健系统内的PEPS计划。