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: 10186447
• 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/10186447
• 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; Future; 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 patient; comorbidity; control trial; cost; cost estimate; design; efficacy evaluation; evidence base; experience; follow-up; implementation design; implementation outcomes; implementation strategy; improved; improved functioning; innovation; member; microcosting; non-opioid analgesic; opioid overuse; opioid use; pain catastrophizing; 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; 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：手术会导致慢性疼痛和长期使用阿片类药物的发展。 术前心理困扰是手术后结果不良的危险因素。需要策略 通过非药物策略的疼痛围手术期药物治疗管理 优化术后结果。心理干预措施，例如认知行为疗法（CBT）可以 有效地减少慢性疼痛患者的痛苦并改善功能。而CBT一直 广泛用于已建立慢性疼痛的患者，尚未用作预防性干预 针对从急性到慢性术后疼痛的过渡。 意义/影响：该提案解决了慢性疼痛和阿片类药物使用的优先领域。这项研究 在围手术期间增强生物心理社会疼痛护理，并提供一个模型来防止 手术后的慢性疼痛和长期使用阿片类药物的使用。 创新：拟议的创新方法来预防而不是管理慢性术后术 退伍军人的疼痛可能会促进从疼痛治疗到预防的临床范式转变。 具体目的：目标1：使用混合类型1随机对照试验设计来检查 围手术期疼痛自我管理（PEPS）计划与标准护理（SC）防止慢性 术后疼痛和长期使用阿片类药物。探索性分析将检查是否使用物质 疾病中度治疗效果以及疼痛的变化是否灾难性和自我效能感与 术后6个月的术后疼痛。目标2：确定PEPS计划对次要的影响 结果：情绪，功能和非阿片类镇痛处方。目标3：评估背景 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，并量化特定于干预的人员相关费用。基于实施 结果框架，当前的研究将主要使用定性方法来实现目标3。 方法学：当前的研究是一种混合功效 - 实现设计，以促进更快的移动 朝基于广泛的传播和对PEPS计划的吸收。对于目标1和2，我们将使用一个 盲，两臂，平行，随机对照试验。参加者将包括安排在爱荷华州的400名退伍军人 单侧原发性总关节置换术的城市或明尼阿波利斯VA。参与者将被随机分配给PEPS 或sc。 PEPS计划包括4个电话会议：会议第一将是术前的，并包括一个 放松简介和解释在痛苦体验中的重要性。第二节（两个星期） 术后）将包括：放松的审查以及思想/解释与痛苦之间的联系， 和思想记录介绍。第三节将包括审查思想记录和放松以及 介绍目标和认知重组。第四节将包括：审核和制定计划 继续使用技能。手术后6周将测量初级和次要结果 （仅用药物），在手术后3个月和6个月（所有其他结局）。六个月将是 疼痛，情绪和功能的主要终点。将采用多元逻辑回归来确定 治疗臂与二分法结果之间的关系：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（和其他镇痛）停止的时间。 AIM 3将评估可接受性，适当性，可行性以及随后相关的成本 执行。这将包括对资深外科患者和手术诊所的定性访谈 两个站点的员工（外科医生，护士和文员）。我们将使用微型成本来量化工作时间。 实施/下一步：这些发现将用于告知随后的实施工作 VA医疗保健系统中的PEPS计划。