Acupuncture in the Emergency Department for Pain Management

Study Overview
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Brief Summary
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Our goal is to use the U01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a  9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists ( 10 per site) and acupuncture patients ( 15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Detailed Description
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The goal is to use the U01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a  9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists ( 10 per site) and acupuncture patients ( 15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

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

Conditions
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Acupuncture, Pain Management, Emergency Department, Acute Pain

Intervention / Treatment
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* Procedure: Acupuncture for pain management
* Other: Usual care for pain management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age Ability to communicate in English. Level 3, 4, 5 on triage rate scale Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury. Exclusion Criteria: Fever exceeding 100° F Presenting with a chief complaint of a psychological / psychiatric concern Presenting with chief complaint of Migraine Patient arriving via ambulance or skipping triage Current Pregnancy Self-reported opioid medication taken orally within 4 hours Presenting with chief complaint of Joint Dislocation Presenting with chief complaint of Bone Fracture Confirmed or suspected COVID-19

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. | Procedure: Acupuncture for pain management<br>* A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.<br>Other: Usual care for pain management<br>* Patient will receive usual care for pain management.<br>|
| Active Comparator: Usual Care<br>This arm will receive usual care for pain management. | Other: Usual care for pain management<br>* Patient will receive usual care for pain management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful recruitment of eligible participants into the study. | The recruitment rate (# enrolled / # eligible) will be assessed for the overall study. Separate recruitment rates will be calculated by site | At Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants retained in the study | Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at ED discharge, 1 week and 4-week follow-up assessments. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. Separate retention rates will also be calculated for each of the three timeframes. | Immediately after the acupuncture intervention or usual care (an average of 60 minutes), at the end of individual patient's discharge from the ED (expected average of 2 hours), 1-week and 4-week follow-up assessments | 
| Patient acceptability of pain management and treatment within the Emergency Department | Participants will be asked to rate their satisfaction with how their pain was managed and their satisfaction with assigned treatment at ED discharge. Separate scores will be calculated for the 1 and 4-week follow-up assessments. All enrolled participants will be asked to answer one question: How satisfied are you with how your pain was managed during your ED visit on the 5-point Likert scale (1-Very Satisfied--5-Strongly Dissatisfied). A second question will be asked only of acupuncture-assigned patients: Overall how satisfied are you with the acupuncture treatment you received your ED visit? on the same 5-point Likert Scale. | Immediately after the acupuncture intervention or usual care (an average of 60 minutes), at the end of individual patient's discharge from the ED (expected average of 2 hours), 1-week and 4-week follow-up assessments | 
| Provider satisfaction with acupuncture treatment within the Emergency Department | ED clinical providers (MD, DO, NP, PA) who had patients enrolled in the study will be asked to rate their general satisfaction with how their patients' pain was managed by acupuncture as part of the study. Questions included their general satisfaction with acupuncture as a treatment in the ED by answering Do you view acupuncture in general as an appropriate intervention for the ED setting? (Likert scale (0-Very inappropriate-4-Very appropriate) and Do you view acupuncture in general as helpful in managing patient pain in the ED? (Likert scale (0-Not at all helpful-4- Very helpful). To assess their general satisfaction with how ACUITY was delivered in the ED, we asked providers Were you satisfied with how the ACUITY acupuncture intervention was delivered in your setting? (Likert scale (0-Very dissatisfied-4-Very satisfied) and Did the ACUITY project impose a burden on ED staff in your setting? (Likert Scale 0- Not a burden-4- Extreme burden). | At end of enrollment period for ED provider's site |