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.

疼痛占急诊科（艾德）患者就诊的78%，并且艾德中的急性疼痛继续受到当前治疗（例如阿片类药物）的控制或控制不当。联合委员会（TJC）敦促谨慎对待在医院使用阿片类药物，自2018年1月1日起，TJC要求其认可的医院/设施提供非药物治疗疼痛的选择，针灸是其中一种选择。ED需要低风险和有效的方法来改善疼痛管理，如针灸。 在我们最近的初步随机对照试验（RCT）中，艾德患者在0-10数字评分量表（NRS）上表现为疼痛>4分，被随机分配到针灸组（n=23）或康复护理组（n=23）。患者报告的疼痛强度变化评分（基线至60分钟）为针灸组-3.0个单位，疼痛护理组-1.56个单位。NRS上-1.3至-2.0单位范围内的降低被认为具有临床意义。 这项试点RCT的结果是有希望的。然而，为了使干预标准化，为将来的多中心、务实的、明确的随机对照试验做准备，还需要采取进一步的措施。在本U 01实用试验提案中，我们建议：1）开发针灸干预的“响应手册”; 2）进行实施评估，评估（a）RCT中参与者招募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。 一些系统性综述得出结论，针灸缓解艾德疼痛的证据是有希望的，但下一步需要未来的多中心随机对照试验。因此，我们建议在BraveNet基于实践的研究网络中测试我们改进的研究程序的可行性，BraveNet基于实践的研究网络是一组15个活跃的美国综合医学诊所。我们的U 01包括爱因斯坦的BraveNet协调中心和BraveNet诊所附属的艾德站点：大学医院/凯斯西储大学;范德比尔特大学医学中心;和加州大学圣地亚哥分校。共150例受试者（每个研究中心50例）将被随机分配至针灸组或康复护理组（1：1分配）。此外，每个研究中心的RCT参与患者和艾德提供者将参与结构化访谈，以支持未来多中心确定性RCT的实施。 我们的目标是：目标1。开发手动针灸干预;和AIM 2。进行可行性随机对照试验，以检查数据收集和针灸干预实施的可行性。成功开展拟定的多中心U 01将为将来在其他BraveNet诊所附属ED中实施针灸治疗与泌尿外科治疗相比的实用、多中心、非劣效性RCT提供信息。完成拟定的U 01和后续的实用RCT（UG 3/UH 3）可以提供关键证据，支持将针灸纳入美国的ED。如果成功的话，这种扩展可以为美国人提供额外的非药物方法来进行强有力的疼痛管理，并理想地减少患者的阿片类药物使用。