Acupuncture in the Emergency Department for Pain Management

Acute Pain Clinical Trial

— ACUITY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04880733
• Other study ID #: R01AT010598-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: August 31, 2024
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Acute Pain
• Emergencies
• Emergency Department
• Pain Management

Intervention

Procedure:
• Acupuncture for pain management
A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.

Other:
• Usual care for pain management
Patient will receive usual care for pain management.

Locations

Country	Name	City	State
United States	Einstein School of Medicine	Bronx	New York
United States	University Hospitals/Case Western Reserve University- Cleveland Medical Center	Cleveland	Ohio
United States	University of California San Diego	La Jolla	California
United States	Vandebilt University Medical Center	Nashville	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Case Western Reserve University	Albert Einstein College of Medicine, University of California, San Diego, University of Massachusetts, Worcester, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Recruitment of Participants Into the Study.	The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.	At Enrollment
Secondary	Percentage of Participants Retained in the Study at Post Treatment	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.	At post treatment (45-60 minutes)
Secondary	Percentage of Patients Retained at 1-week Follow up	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.	One-week after the participant was discharged from the ED
Secondary	Patient Satisfaction Question 1 at Post-treatment	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).	At post-treatment (45-60 minutes after baseline)
Secondary	Patient Satisfaction Question 2 at Post-treatment	"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).	At post-treatment (45-60 minutes after baseline)
Secondary	Patient Satisfaction Question 1 at 1-Week	"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).	One week after participant was discharged from the ED
Secondary	Patient Satisfaction Question 2 at 1 Week	"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).	One week after participant was discharged from the ED
Secondary	Provider Satisfaction Question1	"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.	After enrollment at the provider's site completed (~6 months after first enrollee).
Secondary	Provider Satisfaction Question 2	"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.	After enrollment at the provider's site completed (~6 months after first enrollee).
Secondary	Provider Satisfaction Question 3	"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	After enrollment at the provider's site completed (~6 months after first enrollee).
Secondary	Provider Satisfaction Que4	"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	After enrollment at the provider's site completed (~6 months after first enrollee).