Effectiveness of an mHealth psychosocial intervention to prevent transition from acute to chronic postsurgical pain in adolescents

移动医疗社会心理干预对预防青少年术后急性疼痛向慢性疼痛转变的有效性

• 批准号: 10262845
• 负责人: Tonya M Palermo
• 金额: $ 418.25万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10262845
• 关键词: Acute; Acute Pain; Address; Adolescence; Adolescent; Adult; Age; Anxiety; Behavioral; Childhood; Chronic; Clinical; Cognitive Therapy; Country; Data; Deterioration; Distress; Education; Educational process of instructing; Effectiveness; Family; Goals; Health; Healthcare Systems; Home environment; Hospitals; Incidence; Intervention; Longevity; Mediating; Medical; Modeling; Musculoskeletal; Neurobiology; Nonpharmacologic Therapy; Operative Surgical Procedures; Opioid; Outcome; Outcome Study; Pain; Pain intensity; Pain interference; Pain management; Parents; Participant; Pediatric Surgical Procedures; Perioperative; Perioperative Care; Phase; Population; Postoperative Pain; Postoperative Period; Preparation; Prevention; Primary Prevention; Productivity; Psychological Factors; Publishing; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Reporting; Research; Risk; Risk Factors; Schedule; Secondary Prevention; Severities; Site; Sleep disturbances; Spinal Fusion; Technology; Testing; Therapeutic Intervention; Vertebral column; Vulnerable Populations; Work; Youth; addiction; arm; attentional control; base; chronic musculoskeletal pain; chronic pain; clinical practice; coping; cost; daily pain; design; disability; experience; follow-up; four-arm study; health related quality of life; improved; innovation; intense pain; intervention cost; mHealth; opioid exposure; opioid misuse; opioid use; pain outcome; pain reduction; pain self-management; prevent; primary outcome; programs; psychologic; psychosocial; secondary outcome; skills; standard of care; surgical pain; surgical risk; synergism; treatment arm; treatment effect

Acute and chronic postsurgical pain (CPSP) are a major health concern across the lifespan. Adolescents undergoing invasive musculoskeletal surgeries are particularly at risk, with 20% developing CPSP and associated deterioration in health-related quality of life (HRQL). Further, neurobiological and psychosocial changes during adolescence increase vulnerability to addiction, placing these youth at elevated risk for developing persistent opioid use following surgery. Despite research demonstrating the importance of psychological factors in persistence of pain and opioid use following surgery, standard perioperative care in youth relies on opioids to treat pain. Non-pharmacological interventions are not accessible or widely used in this population. Our own studies demonstrate efficacy of mHealth psychosocial interventions to improve chronic pain-related outcomes in youth. Other published data support efficacy of psychosocial interventions to reduce acute postsurgical pain in adolescents. Using stakeholder input, our team adapted our highly successful technology-delivered pain self-management intervention for the perioperative period in a program called SurgeryPal. We developed two distinct interventions to be delivered during 1) the pre-operative phase to target psychosocial risk factors, and 2) the post-operative phase to teach pain self-management skills. The goal of this proposal is to establish the effectiveness of our mHealth perioperative psychosocial intervention to improve clinically meaningful outcomes in adolescents undergoing major musculoskeletal surgery, and to identify the optimal timing of intervention delivery. During the UG3, our team will work cooperatively with the HEAL ERN Program to plan for the efficient implementation of our proposed multi-site randomized clinical trial at 25 collaborating centers and will ready our interventions for deployment. During the UH3 phase, we will conduct a randomized controlled trial in 500 youth age 12-18 years undergoing spinal fusion surgery and their parents. In addition to standard perioperative care, participants will be randomized using a factorial design to receive psychosocial intervention (SurgeryPal) or education (attention control condition) at two treatment phases, each of 4-weeks duration (pre-operative and post-operative) to test timing of intervention delivery. Primary study outcomes are acute pain severity and interference assessed over the first 2 weeks after surgery, and chronic pain intensity and interference at 3-month follow-up. Secondary outcomes include HRQL, psychosocial distress, sleep disturbance, and opioid use and misuse. We will examine synergy of psychosocial intervention during both treatment phases, and explore underlying treatment mechanisms of prevention of transition from acute to CPSP over 6 months. This project represents a significant advance in innovative approaches to deliver non-pharmacological therapies to youth undergoing major musculoskeletal surgeries, which may effect a paradigm shift in clinical practice. This intervention has potential to be integrated into pediatric surgery programs across the country to reduce incidence of CPSP and potential for addiction.

急性和慢性术后疼痛（CPSP）是整个生命周期的主要健康问题。接受侵入性肌肉骨骼手术的青少年面临的风险尤其大，20% 的青少年会患上 CPSP，并导致健康相关生活质量 (HRQL) 恶化。此外，青春期期间的神经生物学和心理社会变化增加了成瘾的可能性，使这些青少年在手术后持续使用阿片类药物的风险更高。尽管研究表明心理因素在手术后持续疼痛和阿片类药物使用中的重要性，但青少年的标准围手术期护理依赖阿片类药物来治疗疼痛。非药物干预措施在该人群中无法获得或广泛使用。我们自己的研究证明了移动健康心理社会干预措施对改善青少年慢性疼痛相关结果的功效。其他已发表的数据支持心理社会干预措施对减少青少年急性术后疼痛的功效。根据利益相关者的意见，我们的团队在一个名为“SurgeryPal”的项目中，采用了我们非常成功的围手术期疼痛自我管理干预技术。我们开发了两种不同的干预措施，在 1) 术前阶段针对心理社会风险因素，2) 术后阶段教授疼痛自我管理技能。该提案的目标是确定我们的 mHealth 围手术期心理社会干预的有效性，以改善接受大型肌肉骨骼手术的青少年的临床有意义的结果，并确定干预实施的最佳时机。在 UG3 期间，我们的团队将与 HEAL ERN 计划合作，规划在 25 个合作中心有效实施我们提议的多地点随机临床试验，并准备好我们的干预措施以供部署。在UH3阶段，我们将对500名12-18岁接受脊柱融合手术的青少年及其父母进行随机对照试验。除了标准的围手术期护理外，参与者将使用因子设计随机化，在两个治疗阶段接受心理社会干预（SurgeryPal）或教育（注意力控制条件），每个阶段持续 4 周（术前和术后），以测试干预实施的时机。主要研究结果是术后前 2 周评估的急性疼痛严重程度和干扰，以及 3 个月随访时评估的慢性疼痛强度和干扰。次要结局包括 HRQL、社会心理困扰、睡眠障碍以及阿片类药物的使用和滥用。我们将检查两个治疗阶段心理社会干预的协同作用，并探索在 6 个月内预防从急性向 CPSP 转变的潜在治疗机制。 该项目代表了为接受大型肌肉骨骼手术的青少年提供非药物治疗的创新方法的重大进步，这可能会影响临床实践的范式转变。这种干预措施有可能被纳入全国的儿科手术计划中，以减少 CPSP 的发生率和成瘾的可能性。