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Acupuncture in the Emergency Department for Pain Management (ACUITY)

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ClinicalTrials.gov Identifier: NCT04880733
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Collaborators:
Vanderbilt University Medical Center
University of California, San Diego
Albert Einstein College of Medicine
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Jeffery Dusek, PhD, Case Western Reserve University

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 disease Intervention/treatment Phase
Acupuncture Pain Management Emergency Department Acute Pain Procedure: Acupuncture for pain management Other: Usual care for pain managment Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/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 managment
Patient will receive usual care for pain managment.

Active Comparator: Usual Care
This arm will receive usual care for pain management.
Other: Usual care for pain managment
Patient will receive usual care for pain managment.




Primary Outcome Measures :
  1. Successful recruitment of eligible participants into the study. [ Time Frame: 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 [ Time Frame: Immediately after the acupuncture intervention or usual care (an average of 60 minutes), at the end of individial 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. [ Time Frame: 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 [ Time Frame: Immediately after the acupuncture intervention or usual care (an average of 60 minutes), at the end of individial 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 [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880733


Contacts
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Contact: Jeffery A Dusek, PhD 617-519-8082 Jeffery.Dusek@UHhospitals.org
Contact: Jessica O Surdam, MPH 216-844-7925 Jessica.Surdam@UHhospitals.org

Locations
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United States, California
University of California San Diego Not yet recruiting
La Jolla, California, United States, 92093
Contact: Gene A Kallenberg, MD       gkallenberg@ucsd.edu   
Contact: Christopher Coyne, MD       cjcoyne@health.ucsd.edu   
United States, New York
Einstein School of Medicine Not yet recruiting
Bronx, New York, United States, 10461
Contact: Alison Karasz, PhD       alison.karasz@einsteinmed.org   
United States, Ohio
University Hospitals- Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jeffery A Dusek, PhD       jeffery.dusek@UHhospitals.org   
Contact: Robert Hughes, DO    (216)844-1636    Robert.Hughes@UHhospitals.org   
United States, Tennessee
Vandebilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Alan B Storrow, MD       alan.storrow@vumc.org   
Contact: David Vago, MD       david.vago@vanderbilt.edu   
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
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Principal Investigator: Jeffery A Dusek, PhD Case Western Reserve University
Principal Investigator: M. Diane McKee, MD University of Massachusetts, Worcester
  Study Documents (Full-Text)

Documents provided by Jeffery Dusek, PhD, Case Western Reserve University:
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Responsible Party: Jeffery Dusek, PhD, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT04880733    
Other Study ID Numbers: U01AT010598-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations