Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study

急诊科针灸治疗疼痛：BraveNet 多中心可行性研究

• 批准号: 10267175
• 负责人: Jeffery A Dusek
• 金额: $ 65.82万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-22 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10267175
• 关键词: Academic Medical Centers; Accident and Emergency department; Accreditation; Acupuncture Therapy; Acute Pain; Adoption; Adverse effects; American; Analgesics; Anxiety; California; Caring; Clinic; Consensus; Data; Data Collection; Emergency Department patient; Feasibility Studies; Future; Goals; Health system; Healthcare Systems; Hospitals; Integrative Medicine; Intervention; Interview; Joints; Measures; Medical; Methods; Numeric Rating Scale; Opioid; Pain; Pain intensity; Pain management; Palpation; Patient Recruitments; Patients; Pharmaceutical Preparations; Preparation; Probability; Procedures; Process; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Records; Reporting; Risk; Screening procedure; Site; Staging; Standardization; Structure; Surveys; Treatment outcome; Universities; University Hospitals; Visit; addiction; clinically significant; data quality; electronic data; feasibility research; feasibility testing; follow-up; implementation evaluation; implementation intervention; implementation outcomes; implementation process; improved; insight; opioid exposure; opioid use; pain relief; pain score; participant retention; pilot trial; practice-based research network; pragmatic trial; prescription opioid; primary outcome; randomized trial; recruit; response; secondary outcome; systematic review; treatment as usual

Pain accounts for up to 78% of Emergency Department (ED) patient visits and acute pain in the ED continues to be under or improperly managed by current treatments (e.g. opioids). The Joint Commission (TJC) has urged caution regarding use of opioids in hospitals and, effective Jan. 1 2018, TJC required their accredited hospitals/facilities to provide non-pharmacologic options for pain, with acupuncture as one option. Low-risk and effective approaches to improve pain management, such as acupuncture, are needed in the ED. In our recent preliminary, randomized controlled trial (RCT), ED patients presenting with pain >4 on the 0-10 numeric rating scale (NRS) were randomized to either Acupuncture (n=23) or Usual Care (n=23). Patients reported pain intensity change scores (baseline to 60 min) of -3.0 units for Acupuncture and -1.56 units for Usual Care. Decreases in the range of -1.3 to -2.0 units on the NRS are considered clinically significant. Results from this pilot RCT are promising. However, to standardize an intervention in preparation for a future, multi-site pragmatic, definitive RCT, further steps are needed. In this U01 pragmatic trial proposal, we propose to: 1) develop a ‘responsive manualization’ of an acupuncture intervention; and 2) conduct an implementation evaluation, evaluating (a) feasibility of participant recruitment and data collection in an RCT; b) the implementation of the acupuncture intervention, including implementation outcomes, processes, barriers and facilitators. Several systematic reviews have concluded that the evidence for pain relief from acupuncture in the ED is promising, but next steps require future, multi-site RCTs. Accordingly, we propose to test the feasibility of our refined study procedures in the BraveNet Practice Based Research Network, which is a group of 15 active US integrative medicine clinics. Our U01 includes the BraveNet Coordinating Center at Einstein and BraveNet clinic-affiliated ED sites: University Hospitals/Case Western Reserve University; Vanderbilt University Medical Center; and University of California-San Diego. A total of 150 subjects (50 per site) will be randomized to either Acupuncture or Usual Care (1:1 allocation). In addition, RCT participating patients and ED providers at each site will participate in structured interviews to support implementation of a future, multi-site, definitive RCT. Our Specific Aims are: AIM 1. Develop a manualized acupuncture intervention; and AIM 2. Conduct a feasibility RCT to examine the feasibility of data collection and acupuncture intervention implementation. Successful conduct of the proposed multi-site U01 will inform implementation of a future, pragmatic, multi-site, non-inferiority RCT of Acupuncture compared with Usual Care in additional BraveNet clinic-affiliated EDs. Completion of the proposed U01 and the subsequent, pragmatic RCT (UG3/UH3) could provide critical evidence to support inclusion of acupuncture in EDs across the US. If successful, such an expansion could provide Americans with additional non-pharmacologic methods for robust pain management and ideally reduce patients’ opioid use.

疼痛占急诊室（ED）患者就诊的78％，而ED的急性疼痛继续受到当前治疗（例如阿片类药物）的不当管理。联合委员会（TJC）敦促在医院中使用阿片类药物，自2018年1月1日起，TJC要求其认可的医院/设施提供疼痛的非药物选择，并以针灸为一种选择。在ED中，需要采用低风险和有效的方法来改善疼痛管理，例如针灸。 在我们最近的初步，随机对照试验（RCT）中，在0-10数字评级量表（NRS）上表现出疼痛> 4的ED患者被随机分为针灸（n = 23）或通常的护理（n = 23）。患者报告了针灸的疼痛强度变化评分（基线至60分钟）为-3.0单位，常规护理的-1.56单位。 NRS上的-1.3至-2.0单元的范围减小被认为具有临床意义。 答应了该试点RCT的结果。但是，要标准化干预措施，以准备未来的多站点务实的，确定的RCT，需要进一步的步骤。在这项U01务实的试验建议中，我们建议：1）对针灸干预制定“响应式手动化”； 2）进行实施评估，评估（a）参与者在RCT中招聘和数据收集的可行性； b）针灸干预的实施，包括实施结果，过程，障碍和促进者。 一些系统的评论得出结论，ED中针灸缓解疼痛的证据是有希望的，但是下一步需要将来的多站点RCT。根据，我们建议在基于Bravenet实践的研究网络中测试我们精致研究程序的可行性，该研究网络是一组15个活跃的美国综合医学诊所。我们的U01包括爱因斯坦的Bravenet协调中心和Bravenet诊所关联的ED网站：大学医院/Case Western Reserve University；范德比尔特大学医学中心；和加利福尼亚大学迭戈分校。共有150名受试者（每个站点50个）将被随机分为针灸或通常的护理（1：1分配）。此外，RCT参与的患者和每个站点的ED提供者将参加结构化访谈，以支持实施未来的多站点，确定的RCT。 我们的具体目的是：目标1。开发手动针灸干预；和目标2。执行可行性RCT，以检查数据收集和针灸干预实施的可行性。与其他Bravenet诊所相关的ED相比，拟议的多站点U01的成功进行将告知实施未来的，务实的，多站点，非效率RCT RCT。拟议的U01的完成以及随后的务实RCT（UG3/UH3）可以提供关键的证据，以支持在美国各地的ED中包含针灸。如果成功的话，这种扩张可以为美国人提供其他非药物方法，以良好的疼痛管理，理想地减少患者的阿片类药物使用。