2/2: Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Phase 3 Study (ACUITY 2).

About This Grant

Abstract Over 70% of Emergency Department (ED) visits involve acute pain that continues to be a challenge to manage. Low-risk and effective ways to improve pain management (e.g. acupuncture) are needed in the ED. Prior randomized controlled trials (RCTs) of acupuncture in the ED compared to usual care were promising, but there are numerous gaps. ACUITY was our NCCIH-funded R01 multi-center, feasibility RCT that included 3 centers. ED patients with a variety of acute pain conditions and pain >4 on the 0-10 numeric rating scale (NRS) were randomized to either Acupuncture or Usual Care. NCCIH did not allow any statistical significance testing, but ACUITY’s outcomes were sensitive to change; from Pre- to Post-treatment (~45-60 min later) the acupuncture group (n=76) reported a larger decrease in pain intensity than usual care (N=75). Overall, recruitment and retention were feasible, fidelity to the responsive acupuncture intervention protocol was high (98.1%), and 75% of ED providers and 88% of patients receiving acupuncture reported being “satisfied/very satisfied.” Our team has the necessary evidence and expertise to conduct a multi-center, Phase 3 RCT. Accordingly, we propose to conduct a definitive RCT (UG3/UH3) to examine whether acupuncture is superior to usual care on Pre- to Post-treatment changes in pain intensity (0-10 NRS) in two cohorts of patients: those with musculoskeletal pain and those with non-musculoskeletal pain. In addition to the Clinical Coordinating Center, a Data Coordinating Center (U24) is proposed in this companion application. Due to the complexity and breadth of this study, the DCC at UMass Chan Medical School will provide the statistical and data management leadership across the UG3/UH3 study phases, using innovations based on previous experience and including extensive use of Large Language Models (LLM) to facilitate the operations of this study and support the highest quality reproducible research. Building on existing working relationships within the DCC and half-century of experience in clinical trials with DCC leadership, the central DCC will provide: (1) efficient and effective consortium management to develop robust infrastructure, including project management services to facilitate ACUITY2 objectives; (2) high- level leadership to the scientific methodology, including statistical and data management leadership, efficient implementation of data management tools and approaches, randomization, and systems to ensure clean data; and (3) high-quality study implementation, including a rigorous program of quality assurance (QA) and quality control (QC), study monitoring and DSMB support. Using proven off-the-shelf software and LLM apps, this DCC will be able to maximize efficiency and functionality while minimizing development time and cost, in support of the UG3/UH3 milestone metrics.