ACUITY: Acupuncture in the Emergency Department for Pain Management

Sponsor
Case Western Reserve University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04880733
Collaborator
Vanderbilt University Medical Center (Other), University of California, San Diego (Other), Albert Einstein College of Medicine (Other), University of Massachusetts, Worcester (Other)
165
Enrollment
4
Locations
2
Arms
27.9
Anticipated Duration (Months)
41.3
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Acupuncture for pain management
  • Other: Usual care for pain management
N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Data collector will be masked to study outcomes via electronic data collection
Primary Purpose:
Other
Official Title:
Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study
Actual Study Start Date :
May 3, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Acupuncture

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
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.

Active Comparator: Usual Care

This arm will receive usual care for pain management.

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

Outcome Measures

Primary Outcome Measures

  1. Successful recruitment of eligible participants into the study. [At Enrollment]

    The recruitment rate (# enrolled / # eligible) will be assessed for the overall study. Separate recruitment rates will be calculated by site

Secondary Outcome Measures

  1. Number of participants retained in the study [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]

    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.

  2. Proportion of Emergency Department clinical provider's eligible participants that are clinically approved for study participation. [At Enrollment]

    Patient adoption rates will be defined as the number of approved individuals for inclusion in the study by ED clinical providers (MD, DO, NP, PA) divided by number of individuals who were prescreened for study participation by the research team for enrollment. Rates will be calculated the overall study and by site.

  3. Patient acceptability of pain management and treatment within the Emergency Department [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]

    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.

  4. Provider satisfaction with acupuncture treatment within the Emergency Department [At end of enrollment period for ED provider's site]

    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. Providers will answer two questions: "How satisfied were you with the acupuncture intervention as delivered in your setting?" and "To what degree was the acupuncture intervention helpful in managing patient pain in your ED setting?" (1-Very satisfied/helpful-5-Very dissatisfied/Not at all helpful).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of California San DiegoLa JollaCaliforniaUnited States92093
2Einstein School of MedicineBronxNew YorkUnited States10461
3University Hospitals- Cleveland Medical CenterClevelandOhioUnited States44106
4Vandebilt University Medical CenterNashvilleTennesseeUnited States37232

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jeffery A Dusek, PhD, Case Western Reserve University
  • Principal Investigator: M. Diane McKee, MD, University of Massachusetts, Worcester

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jeffery Dusek, PhD, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT04880733
Other Study ID Numbers:
  • U01AT010598-01A1
First Posted:
May 11, 2021
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022