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

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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.