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.

急性和慢性手术后疼痛（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尤其面临风险，20%的人患有CPSP，并伴随健康相关生活质量（HRQL）的恶化。此外，青春期的神经生物学和心理社会变化增加了成瘾的脆弱性，使这些年轻人在手术后持续使用阿片类药物的风险增加。尽管研究表明心理因素在手术后疼痛持续性和阿片类药物使用中的重要性，但青年的标准围手术期护理依赖阿片类药物治疗疼痛。非药物干预在这一人群中无法获得或广泛使用。我们自己的研究证明了mHealth心理社会干预措施在改善青年慢性疼痛相关结果方面的有效性。其他已发表的数据支持社会心理干预在减少青少年术后急性疼痛方面的有效性。利用利益相关者的意见，我们的团队在一个名为Surgerytosis的项目中，将我们非常成功的技术交付的疼痛自我管理干预措施用于围手术期。我们开发了两种不同的干预措施，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，并确定干预提供的最佳时机。在UG 3期间，我们的团队将与HEAL ERN计划合作，计划在25个合作中心有效实施我们提出的多中心随机临床试验，并准备部署我们的干预措施。在UH 3阶段，我们将在500名12-18岁接受脊柱融合手术的青少年及其父母中进行随机对照试验。除标准围手术期护理外，还将使用析因设计将受试者随机分配至两个治疗阶段接受心理社会干预（手术干预）或教育（注意力控制状况），每个治疗阶段持续4周（术前和术后），以测试干预实施的时间。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个月随访时的慢性疼痛强度和干扰。次要结局包括HRQL、心理社会困扰、睡眠障碍和阿片类药物使用和滥用。我们将检查两个治疗阶段的心理干预的协同作用，并探索预防从急性过渡到CPSP超过6个月的潜在治疗机制。 该项目代表了创新方法的重大进步，为接受重大肌肉骨骼手术的青年提供非药物治疗，这可能会影响临床实践的范式转变。这种干预有可能被整合到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。