Clinical trial NCT04880733: Acupuncture in the Emergency Department for Pain Management
Official title: Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acupuncture
Pain Management
Emergency Department
Acute Pain
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: University of California, San Diego
name: Albert Einstein College of Medicine
name: University of Massachusetts, Worcester
First posted: 2021-05-11
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our goal is to use the R01 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: The goal is to use the R01 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).

Eligibility criteria: 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

Primary outcomes:
measure: Successful Recruitment of Participants Into the Study.
timeFrame: At Enrollment
Secondary outcomes:
measure: Percentage of Participants Retained in the Study at Post Treatment
timeFrame: At post treatment (45-60 minutes)
measure: Percentage of Patients Retained at 1-week Follow up
timeFrame: One-week after the participant was discharged from the ED
measure: Patient Satisfaction Question 1 at Post-treatment
timeFrame: At post-treatment (45-60 minutes after baseline)
measure: Patient Satisfaction Question 2 at Post-treatment
timeFrame: At post-treatment (45-60 minutes after baseline)
measure: Patient Satisfaction Question 1 at 1-Week
timeFrame: One week after participant was discharged from the ED
measure: Patient Satisfaction Question 2 at 1 Week
timeFrame: One week after participant was discharged from the ED
measure: Provider Satisfaction Question1
timeFrame: After enrollment at the provider's site completed (~6 months after first enrollee).
measure: Provider Satisfaction Question 2
timeFrame: After enrollment at the provider's site completed (~6 months after first enrollee).
measure: Provider Satisfaction Question 3
timeFrame: After enrollment at the provider's site completed (~6 months after first enrollee).
measure: Provider Satisfaction Que4
timeFrame: After enrollment at the provider's site completed (~6 months after first enrollee).
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Bronx
country: United States
facility: Einstein School of Medicine
state: New York
city: Cleveland
country: United States
facility: University Hospitals/Case Western Reserve University- Cleveland Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vandebilt University Medical Center
state: Tennessee
Study officials:
affiliation: University California-Irvine
name: Jeffery A Dusek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: M. Diane McKee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dusek JA, Kallenberg GA, Hughes RM, Storrow AB, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, McKee MD. Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study. Medicine (Baltimore). 2022 Mar 4;101(9):e28961. doi: 10.1097/MD.0000000000028961.
citation: Nielsen A, Olson J, Quesada M, Zhu C, Raskin E, Vang B, Painovich J, Scott M, Xiong VJ, Dusek JA. Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1.
citation: Dyer NL, Surdam J, Dusek JA. A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action. Pain Med. 2022 Jan 3;23(1):189-210. doi: 10.1093/pm/pnab151.