Integrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Spine Surgery (MIRHIQL)

为脊柱手术中长期使用阿片类药物的患者整合定制的术后阿片类药物逐渐减量和疼痛管理支持 (MIRHIQL)

• 批准号: 10722943
• 负责人: Jennifer Hah
• 金额: $ 340.66万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722943
• 关键词: Acute; Acute Pain; Acute pain management; Address; Adoption; Adverse event; Affect; Agonist; American; Analgesics; Anti-Anxiety Agents; Behavior Therapy; Behavioral; Caring; Chronic; Clinical; Data; Dose; Evaluation; Exclusion; Exhibits; Future; Iatrogenesis; Impairment; Incidence; Intervention; Interview; Kansas; Knowledge; Mediating; Mediator; Medication Management; Methods; Morbidity - disease rate; Motivation; Muscle relaxants; Operative Surgical Procedures; Opioid; Opioid Analgesics; Outcome; Overdose; Pain; Pain management; Participant; Patient Care; Patients; Perioperative; Pharmacological Treatment; Placebos; Postoperative Complications; Postoperative Pain; Postoperative Period; Prediction of Response to Therapy; Prevalence; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Risk; Risk Factors; Risk Reduction; Site; Spine surgery; Time; Treatment Efficacy; Ventilatory Depression; Withdrawal Symptom; Work; adverse outcome; arm; chronic pain; chronic pain management; depressive symptoms; effectiveness evaluation; effectiveness/implementation hybrid; efficacy testing; forest; future implementation; health care settings; high risk; implementation evaluation; implementation intervention; implementation outcomes; innovation; mortality; motivational enhancement therapy; non-opioid analgesic; opioid misuse; opioid sparing; opioid tapering; opioid therapy; opioid use; opioid use disorder; opioid withdrawal; pharmacologic; point of care; prescription opioid; prevent; primary outcome; psychological distress; recruit; remote assessment; secondary outcome; tizanidine; treatment as usual; treatment effect

Abstract 51 million Americans undergo surgery annually and 10-20% present for surgery with long-term opioid use (LTOU) far exceeding the national prevalence. These patients on LTOU are at overwhelmingly increased risk of postoperative complications, morbidity, mortality, increased pain, persistent postoperative LTOU, and opioid- related harms. Surgery is a critical point-of-care for patients with LTOU as opioids are prescribed regardless of prior problematic opioid use, opioids are acutely escalated for prolonged durations compounded opioid-related harms, and patients are at heightened risk for a myriad of negative postoperative outcomes adversely impacting QOL. Research examining postoperative opioid tapering and non-opioid acute pain management often excludes these vulnerable patients. Our proposal addresses this critical knowledge gap in acute to chronic postoperative pain care for patients with LTOU. Patients are receptive to changes in pain therapy and opioid tapering after surgery, representing a key intervention opportunity. Also, safer alternatives are needed to reduce serious risks of respiratory depression associated with concomitant use of certain common non-opioid and opioid pain medications. This proposal builds off the PI’s research (K23, R01) developing postoperative Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) and demonstrating feasibility and initial empiric support in promoting postoperative opioid cessation without adversely affecting pain even among patients with preoperative opioid use. Tizanidine has analgesic, muscle relaxant, anxiolytic and opioid- sparing effects, and potential to relieve opioid withdrawal symptoms as an 2-agonist. We directly address the HEAL MIRHIQL initiative by examining the combined effects of MI-Opioid Taper (behavioral) and tizanidine (pharmacologic) interventions among patients with preoperative LTOU exhibiting impaired return to baseline opioid use after surgery where harms may outweigh benefits of continued use. In this Type 1 hybrid effectiveness-implementation three-arm parallel RCT, 375 patients with preoperative LTOU undergoing spine surgery will be recruited across 4 sites (Stanford, Harvard, Wake Forest, U. of Kansas) and randomized to 1 of 3 groups (MI-Opioid Taper and tizanidine, MI-Opioid Taper and placebo, enhanced usual care) and followed for 12 months. The primary outcome is time to baseline opioid use. Secondary outcomes are time to opioid cessation, opioid dispensing cessation, pain cessation, and risk of postoperative opioid misuse. We will examine motivation for change, change talk, and reduction in pain as mediators of treatment effects and characterize treatment interactions with participant attributes in predicting both treatment engagement and efficacy. A mixed-methods evaluation using the RE-AIM framework will explore barriers and facilitators to future larger-scale implementation of MI-Opioid Taper. The project will address the unmet needs of patients on LTOU presenting for surgery in need of precision postoperative pain care to minimize opioid-related harms.

抽象的 每年有5100万美国人接受手术，而长期使用阿片类药物的手术为10-20％ （LTOU）远远超过了全国患病率。这些在LTOU上的患者的风险绝大多数增加 术后并发症，发病率，死亡率，疼痛增加，持续性术后LTOU和OOID- 相关危害。对于LTOU患者而言，手术是一个关键的护理点 事先有问题的Ooid使用，OOIDS在长时间的持续时间内急剧升级 危害，患者面临着无数负面术后结果的风险 影响QOL。研究检查术后阿片类药物锥度和非阿片类药物急性疼痛管理 通常不包括这些脆弱的患者。我们的提议解决了急性的关键知识差距 LTOU患者的慢性术后疼痛护理。患者接受疼痛治疗的变化和 手术后的骨细胞逐渐减少，代表关键的干预机会。另外，需要安全的替代方案 减少与使用某些常见非阿片类药物有关的严重呼吸抑郁症风险 和阿片类止痛药。该建议建立在PI的研究（K23，R01）的基础上，开发术后 动机访谈和指导的阿片类药物逐渐锥度支持（Mi-Apioid锥度）并证明可行性 以及在促进术后阿片类药物停止方面的最初经验支持，也不会对疼痛产生不利影响 在术前使用阿片类药物的患者中。 tizanidine具有镇痛，肌肉松弛剂，抗焦虑和阿片类药物 保留效果，并有可能作为2激动剂挽救阿片类药物戒断符号。我们直接解决 通过检查Mi-Apioid锥度（行为）和tizanidine的综合作用来治愈MIRHIQL倡议 （药理）术前LTO的患者的干预措施表现出受损返回基线 手术后的绿木药物可能会超过持续使用的益处。在这种类型的1杂种中 有效性实施三臂并联RCT，375例术前LTOU患者接受脊柱 手术将在四个地点（斯坦福大学，哈佛，堪萨斯州的威克森林）中招募，并随机分为1 3组（Mi-Apoid Taper和Tizanidine，Mi-Apioid Taper and Altbo，增强了通常的护理），然后 12个月。主要结果是是使用基线卵巢剂使用的时候了。次要结果是时候到达绿o中的 停止，OID分配停止，停止疼痛和术后阿片类药物滥用的风险。我们将 研究改变，改变谈话和减轻疼痛的动机，作为治疗效果的介体和 在预测治疗参与和 使用RE-AIM框架进行的混合方法评估将探索障碍和促进者 Mi-Apioid锥度的未来大规模实施。该项目将满足患者未满足的需求 ltou进行手术，需要精确的术后疼痛护理，以最大程度地减少阿片类药物相关的危害。