Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gene A Kallenberg, MD
Photo of Gene A Kallenberg
Gene A Kallenberg

Description

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).

Official Title

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

Details

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).

Keywords

Acupuncture Pain Management Emergency Department Acute Pain Emergencies Acupuncture for pain management

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Vandebilt University Medical Center not yet accepting patients
    Nashville Tennessee 37232 United States

Lead Scientist at UCSD

  • Gene A Kallenberg, MD
    Dr. Kallenberg received his medical degree from the University of Cincinnati College of Medicine in Cincinnati, Ohio, and completed his internship and residency in Family Medicine at Los Angeles County Harbor-UCLA Medical Center, Torrance, California. He was appointed Assistant Professor of Health Care Sciences and Medicine in 1982 at George Washington University.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Case Western Reserve University
ID
NCT04880733
Study Type
Interventional
Last Updated