A Randomized Controlled Trial of Acupuncture in the Emergency Department: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department
研究概览
简要总结
The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory (and potential cycle) of medication misuse by providing an alternative at a critical point of contact within the healthcare system, potentially disrupting the pathway from ED visit to opioid usage after discharge.
详细描述
The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory (and potential cycle) of medication misuse by providing an alternative at a critical point of contact within the healthcare system, potentially disrupting the pathway from ED visit to opioid usage after discharge. In this study, the investigators will assess the feasibility of implementation, practicality, and expansion of an acupuncture RCT in the ED environment. The study will prospectively measure and analyze change in pain intensity after treatment with acupuncture or usual care, use of opioids during ED visit, prescriptions written for opioids at ED discharge, and use of opioids at 30-day follow-up.
Study data will be collected using electronic health record (EHR) data and patient-reported outcomes. Patient-reported outcomes will be collected via an electronic database and solely for research purposes. The acupuncture intervention provided in the ED will be provided at no cost to the patient and will be paid for by the study sponsor. The practice of providing acupuncture in ANW's ED at no charge to the patient has been in place since November 2013. In conducting this pilot study, it will assess the ability to implement and carry out a RCT of acupuncture in the ED. By comparing pain change and opioid utilization among patients who receive acupuncture versus those who receive usual emergency department care, and by conducting follow-up data collection, the investigators will be able to better understand the potential role of a common non-pharmacological pain management strategy for mitigating pain and reducing opioid use in the emergency medicine setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •≥ 18 years of age
- •Ability to communicate in English
- •Non-critical status as determined at triage and / or by a clinic provider
- •Presentation to the emergency department with acute musculoskeletal, back, pelvic, non-cardiac chest, abdominal, and headache pain (≥ 4 on the numerical rating scale), due to non-penetrating injury. Acute pain is defined by pain occurring within 72 hours of ED presentation (this can be an acute flare-up of a chronic pain condition).
排除标准
- •Current pregnancy
- •Need for emergent treatment as determined at triage and / or by a clinic provider (Level 1 or 2 on triage rating scale)
- •Bone fracture
- •Joint dislocation
- •Fever exceeding 100° F
- •Opioid medication taken orally within 4 hours (determined per patient report)
- •Current use of a pharmaceutical analgesic patch
- •Presenting with a chief complaint of a psychological / psychiatric concern
- •Presenting with a migraine
- •Having a unique treatment plan (UTP) on file with Abbott Northwestern Hospital
- •Patient arriving via ambulance due to skipping triage
- •Currently participating in this study due to previous ED admission
- •Medical provider decision / clinical judgement
研究组 & 干预措施
Acupuncture
One session of acupuncture prior to receiving pain medications after arriving to the emergency department with pain as a symptom.
干预措施: Acupuncture (Other)
Usual Care
Usual care for pain, without intervention, after arriving to the emergency department with pain as a symptom.
结局指标
主要结局
Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department
时间窗: At study completion, one year
Assess feasibility of triaging and treating patients presenting to the emergency department with protocol defining criteria and then having that patient participate in a randomized controlled trial comparing acupuncture to usual care. This will be assessed by the number of patients approached compared to the number of patients consented and by the number of patients able to receive acupuncture while in the Emergency Department.
次要结局
- Pain Reduction(During day 1 of study participation)
- Opioid use(At study completion, one year)