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)
基本信息
- 批准号:10722943
- 负责人:
- 金额:$ 340.66万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AcuteAcute PainAcute pain managementAddressAdoptionAdverse eventAffectAgonistAmericanAnalgesicsAnti-Anxiety AgentsBehavior TherapyBehavioralCaringChronicClinicalDataDoseEvaluationExclusionExhibitsFutureIatrogenesisImpairmentIncidenceInterventionInterviewKansasKnowledgeMediatingMediatorMedication ManagementMethodsMorbidity - disease rateMotivationMuscle relaxantsOperative Surgical ProceduresOpioidOpioid AnalgesicsOutcomeOverdosePainPain managementParticipantPatient CarePatientsPerioperativePharmacological TreatmentPlacebosPostoperative ComplicationsPostoperative PainPostoperative PeriodPrediction of Response to TherapyPrevalenceProtocols documentationQuality of lifeRandomizedRandomized, Controlled TrialsReach, Effectiveness, Adoption, Implementation, and MaintenanceReportingResearchRiskRisk FactorsRisk ReductionSiteSpine surgeryTimeTreatment EfficacyVentilatory DepressionWithdrawal SymptomWorkadverse outcomearmchronic painchronic pain managementdepressive symptomseffectiveness evaluationeffectiveness/implementation hybridefficacy testingforestfuture implementationhealth care settingshigh riskimplementation evaluationimplementation interventionimplementation outcomesinnovationmortalitymotivational enhancement therapynon-opioid analgesicopioid misuseopioid sparingopioid taperingopioid therapyopioid useopioid use disorderopioid withdrawalpharmacologicpoint of careprescription opioidpreventprimary outcomepsychological distressrecruitremote assessmentsecondary outcometizanidinetreatment as usualtreatment effect
项目摘要
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.
摘要
每年有5100万美国人接受手术,其中10%-20%的人长期使用阿片类药物
(LTOU)远远超过全国流行率。这些服用LTOU的患者面临着压倒性的风险增加
术后并发症、发病率、死亡率、疼痛增加、持续的术后LTOU和阿片类药物-
相关伤害。手术是LTOU患者的关键护理要点,因为阿片类药物的处方不管
以前有问题的阿片类药物使用,阿片类药物在长时间内急剧增加,与阿片类药物相关
危害,患者面临着无数负面的术后结果的高风险
影响生活质量。术后阿片类药物逐渐减少与非阿片类急性疼痛处理的研究
通常将这些脆弱的患者排除在外。我们的建议解决了这一严重的知识鸿沟
LTOU患者术后慢性疼痛护理。患者接受疼痛治疗的变化,并
术后阿片类药物逐渐减少,这是一个关键的干预机会。此外,还需要更安全的替代方案来
降低与某些常见非阿片类药物同时使用相关的呼吸抑制的严重风险
以及阿片类止痛药。这项建议建立在PI的研究(K23,R01)术后发展的基础上
激励性访谈和指导阿片类药物逐渐减少支持(MI-阿片类药物逐渐减少)并论证可行性
和最初的经验性支持促进术后阿片类药物的停止,甚至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。替扎尼定具有止痛、肌肉松弛、抗焦虑和阿片类药物-
作为2激动剂,具有节制作用,有可能缓解阿片类药物戒断症状。我们直接针对
通过检测MI-阿片类药物减量(行为)和替扎尼定的联合效应来治疗MIRHIQL主动性
对术前LTOU患者恢复到基线有障碍的(药理学)干预
手术后使用阿片类药物的危害可能超过继续使用的好处。在这个类型1的混合体中
375例术前LTOU脊柱手术患者实施三臂平行RCT的效果
外科手术将在4个地点(斯坦福大学、哈佛大学、维克森林大学、堪萨斯大学)招募,并随机分配到1个
3组(MI-阿片类药物减量和替扎尼定,MI-阿片类药物减量和安慰剂,加强日常护理)并随访
已经12个月了。主要结果是阿片类药物使用基线的时间。次要结果是服用阿片类药物的时间
停止、阿片类药物分配停止、疼痛停止以及术后阿片类药物滥用的风险。我们会
检查改变的动机、改变的谈话和减轻疼痛作为治疗效果和
在预测治疗参与度和参与者属性时,表征治疗交互作用
功效。使用RE-AIM框架的混合方法评估将探索障碍和促进者
未来将更大规模地实施MI-阿片类药物缩减。该项目将解决未得到满足的患者的需求
需要精确的术后疼痛护理以最大限度地减少阿片类药物相关伤害的LTOU。
项目成果
期刊论文数量(0)
专著数量(0)
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会议论文数量(0)
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Jennifer Hah其他文献
Jennifer Hah的其他文献
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{{ truncateString('Jennifer Hah', 18)}}的其他基金
Psychological Risk Factors for Persistent Opioid Use and Prevention of Chronic Opioid Use and Misuse After Surgery: Postoperative Motivational Interviewing and Guided Opioid Weaning
持续使用阿片类药物的心理危险因素以及术后慢性阿片类药物使用和滥用的预防:术后动机访谈和指导阿片类药物戒断
- 批准号:
10206082 - 财政年份:2018
- 资助金额:
$ 340.66万 - 项目类别:
Psychological Risk Factors for Persistent Opioid Use and Prevention of Chronic Opioid Use and Misuse After Surgery: Postoperative Motivational Interviewing and Guided Opioid Weaning
持续使用阿片类药物的心理危险因素以及术后慢性阿片类药物使用和滥用的预防:术后动机访谈和指导阿片类药物戒断
- 批准号:
9763533 - 财政年份:2018
- 资助金额:
$ 340.66万 - 项目类别:
Psychological Risk Factors for Persistent Opioid Use and Prevention of Chronic Opioid Use and Misuse After Surgery: Postoperative Motivational Interviewing and Guided Opioid Weaning
持续使用阿片类药物的心理危险因素以及术后慢性阿片类药物使用和滥用的预防:术后动机访谈和指导阿片类药物戒断
- 批准号:
10425411 - 财政年份:2018
- 资助金额:
$ 340.66万 - 项目类别:
Psychological Factors Contributing to Persistent Opioid Use After Surgery
导致手术后持续使用阿片类药物的心理因素
- 批准号:
8487036 - 财政年份:2013
- 资助金额:
$ 340.66万 - 项目类别:
Psychological Factors Contributing to Persistent Opioid Use After Surgery
导致手术后持续使用阿片类药物的心理因素
- 批准号:
8650810 - 财政年份:2013
- 资助金额:
$ 340.66万 - 项目类别:
Psychological Factors Contributing to Persistent Opioid Use After Surgery
导致手术后持续使用阿片类药物的心理因素
- 批准号:
9039567 - 财政年份:2013
- 资助金额:
$ 340.66万 - 项目类别:
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