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：手术可加速慢性疼痛和长期使用阿片类药物的发展。 术前心理困扰是术后效果不佳的危险因素。需要采取策略 通过非药物策略加强围手术期疼痛的药物治疗管理 优化术后效果。认知行为疗法（CBT）等心理干预可以 有效减轻慢性疼痛患者的痛苦并改善其功能。虽然 CBT 已 广泛用于患有慢性疼痛的患者，但尚未用作预防性干预措施 针对从急性到慢性术后疼痛的转变。 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。这项研究 加强围手术期的生物心理社会疼痛护理，并提供一个模型来预防 手术后出现慢性疼痛和长期使用阿片类药物。 创新：拟议的预防而非管理慢性术后慢性并发症的创新方法 退伍军人的疼痛可能会引发临床范式从疼痛治疗转向预防。 具体目标： 目标 1：使用混合 1 型随机对照试验设计来检验以下药物的功效： 围手术期疼痛自我管理 (PePS) 计划与标准护理 (SC) 预防慢性疼痛的比较 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是否 疾病调节治疗效果以及疼痛灾难性和自我效能的变化是否与 术后6个月的术后疼痛。目标 2：确定 PePS 计划对中学的影响 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，并量化与特定干预措施相关的人员成本。基于实施 在成果框架中，当前研究将主要使用定性方法来实现目标 3。 方法：当前的研究是一种混合功效实施设计，以促进更快速的行动 实现 PePS 计划的广泛传播和采用。对于目标 1 和 2，我们将利用单 盲法、双臂、平行、随机对照试验。参与者将包括计划在爱荷华州举行的 400 名退伍军人 城市或明尼阿波利斯 VA 进行单侧初次全关节置换术。参与者将被随机分配到 PePS 或SC。 PePS 计划包括 4 次电话会议： 第一场会议将在术前进行，包括 介绍放松以及解释疼痛体验的重要性。第二节（两周 术后）将包括：回顾放松以及想法/解释和疼痛之间的联系， 以及思想记录的介绍。第三节将包括回顾思想记录和放松 介绍目标设定和认知重建。第四节会议将包括：审查并制定计划 持续使用技能。主要和次要结果将在术后 6 周内进行测量 （仅药物）以及术后 3 个月和 6 个月（所有其他结果）。六个月将是 主要终点为疼痛、情绪和功能。将采用多元逻辑回归来确定 治疗组与二分结果之间的关系：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（和其他镇痛药）停止的时间。 目标 3 将评估可接受性、适当性、可行性，并估算与后续相关的成本 执行。这将包括对经验丰富的外科患者和外科诊所的定性访谈 两个站点的工作人员（外科医生、护士和文员）。我们将使用微观成本来量化工作时间。 实施/后续步骤：这些发现将用于为后续的实施工作提供信息 VA 医疗保健系统内的 PePS 计划。