Acupuncture in the Emergency Department for Pain Management

Not Applicable

Active, not recruiting

Conditions: Pain Management
Emergency Department
Acute Pain
Acupuncture

Interventions: Procedure: Acupuncture for pain management
Other: Usual care for pain management

Registration Number: NCT04880733

Lead Sponsor: Case Western Reserve University

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).

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 290

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Usual care for pain management	This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.
Usual Care	Usual care for pain management	This arm will receive usual care for pain management.
Acupuncture	Acupuncture for pain management	This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.

Primary Outcome Measures

Name	Time	Method
Successful Recruitment of Participants Into the Study.	At Enrollment	The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Question 1 at Post-treatment	At post-treatment (45-60 minutes after baseline)	Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Patient Satisfaction Question 2 at Post-treatment	At post-treatment (45-60 minutes after baseline)	"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Provider Satisfaction Question 3	After enrollment at the provider's site completed (~6 months after first enrollee).	"How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better
Patient Satisfaction Question 1 at 1-Week	One week after participant was discharged from the ED	"How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Patient Satisfaction Question 2 at 1 Week	One week after participant was discharged from the ED	"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Provider Satisfaction Question 2	After enrollment at the provider's site completed (~6 months after first enrollee).	"Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.
Percentage of Participants Retained in the Study at Post Treatment	At post treatment (45-60 minutes)	Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.
Percentage of Patients Retained at 1-week Follow up	One-week after the participant was discharged from the ED	Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.
Provider Satisfaction Question1	After enrollment at the provider's site completed (~6 months after first enrollee).	"Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.
Provider Satisfaction Que4	After enrollment at the provider's site completed (~6 months after first enrollee).	"Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better

Trial Locations

Locations (4): University of California San Diego
🇺🇸
La Jolla, California, United States
Einstein School of Medicine
🇺🇸
Bronx, New York, United States
University Hospitals/Case Western Reserve University- Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Vandebilt University Medical Center
🇺🇸
Nashville, Tennessee, United States