Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 7
- 主要终点
- Successful Recruitment of Participants Into the Study.
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Data collector will be masked to study outcomes via electronic data collection
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Successful Recruitment of Participants Into the Study.
时间窗: At Enrollment
The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.
次要结局
- Patient Satisfaction Question 1 at Post-treatment(At post-treatment (45-60 minutes after baseline))
- Patient Satisfaction Question 2 at Post-treatment(At post-treatment (45-60 minutes after baseline))
- Provider Satisfaction Question 3(After enrollment at the provider's site completed (~6 months after first enrollee).)
- Patient Satisfaction Question 1 at 1-Week(One week after participant was discharged from the ED)
- Patient Satisfaction Question 2 at 1 Week(One week after participant was discharged from the ED)
- Provider Satisfaction Question 2(After enrollment at the provider's site completed (~6 months after first enrollee).)
- Percentage of Participants Retained in the Study at Post Treatment(At post treatment (45-60 minutes))
- Percentage of Patients Retained at 1-week Follow up(One-week after the participant was discharged from the ED)
- Provider Satisfaction Question1(After enrollment at the provider's site completed (~6 months after first enrollee).)
- Provider Satisfaction Que4(After enrollment at the provider's site completed (~6 months after first enrollee).)
研究者
Jeffery Dusek, PhD
Professor
University of California, Irvine