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：手术可以加速慢性疼痛和长期阿片类药物使用的发展。 术前心理压力是术后不良结局的危险因素。需要制定战略， 用非药物策略加强围手术期疼痛的药物治疗， 优化术后结果。心理干预，如认知行为疗法（CBT）， 有效减轻慢性疼痛患者的痛苦并改善其功能。虽然CBT已经 广泛用于已确定慢性疼痛的患者，但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：该提案涉及慢性疼痛和类阿片使用的优先领域。本研究 加强了围手术期的生物心理社会疼痛护理，并提供了一个预防 手术后出现慢性疼痛和长期使用阿片类药物。 创新：提出的预防而不是管理慢性手术后 退伍军人的疼痛可能会引发从疼痛治疗到预防的临床范式转变。 具体目的：目的1：使用混合1型随机对照试验设计检查 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 疾病的中度治疗效果，以及疼痛灾难化和自我效能的变化是否与 术后6个月时的术后疼痛。目标2：确定PePS计划对中学教育的影响 结果：情绪、功能和非阿片类镇痛药处方。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，并量化具体干预措施的人事相关费用。实际执行 结果框架，目前的研究将主要使用定性方法的目标3。 方法：目前的研究是一个混合的效率-执行设计，以促进更快的移动 促进PePS计划的广泛传播和吸收。对于目标1和2，我们将使用一个单一的- 双盲、双组、平行、随机对照试验。参加者将包括400名退伍军人计划在爱荷华州 城市或明尼阿波利斯VA用于单侧初次全关节置换术。受试者将被随机分配至PePS组 PePS计划包括4次电话会议：第一次会议将在术前进行，包括 介绍放松和解释在疼痛体验中的重要性。第二次会议（两周 术后）将包括：放松的回顾以及思想/解释和疼痛之间的联系， 以及思想记录的介绍。第三次会议将包括审查思想记录和放松， 目标设定和认知重构的介绍。第四次会议将包括：审查和制定计划， 继续使用技能。将在术后6周内测量主要和次要结局 （仅药物），以及术后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。将采用多变量logistic回归来确定 治疗组与二分结局之间的关系：6个月时的中度至重度疼痛 手术后生存分析将用于确定至阿片类药物（和其他镇痛药）停药的时间。 目标3将评估可接受性、适当性、可行性，并估算与后续行动相关的成本。 实施.这将包括与退伍军人外科患者和外科诊所的定性访谈 两个研究中心的工作人员（外科医生、护士和办事员）。我们将使用微成本来量化工作时间。 执行/下一步：这些调查结果将用于为《行动纲领》的后续执行工作提供信息。 在VA医疗保健系统内的PePS计划。