The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures: Evaluation of Cost Savings, Radiation Exposure, and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
The goal of this intervention trial is to learn if a ultrasound diagnosis of elbow fractures can improve care in pediatric patients seen in the emergency room. The main questions it aims to answer are:
The primary outcomes measured are cost of the emergency visit, radiation exposure, time spent in the emergency department and patient satisfaction.
Patients who are evaluated with ultrasounds of the elbow will be compared to patients who have x-rays of the elbow.
Participants will be assigned either to the ultrasound group or x-rays group when they present with elbow pain.
详细描述
The goal of this study is to evaluate whether the use of point-of-care ultrasonography (PoCUS) for elbow trauma evaluation results in less radiation exposure, less cost of treatment and shorter length of stay in Emergency Room (ER) than use of radiography. The study team will use PoCUS to screen for isolated elbow fractures presented to the ER. The researchers will compare cost of treatment both for patients and health care system and length of stay in both the groups. This study will also evaluate whether the use of PoCUS alleviates discomfort to pediatric patients and increases satisfaction of the families as compared to the use of radiography. Family satisfaction surveys and patient pain surveys will act as direct measures of family satisfaction. The study team will use length of stay and cost of treatment as indirect measures of satisfaction. The researchers will compare amount of comfort and satisfaction with and without the use of PoCUS to evaluate the overall patient comfortability and patient satisfaction. The researchers hypothesize that the use of PoCUS will reduce time of emergency department length of stay, radiation exposure, pain or discomfort and cost, and will increase patient's and family satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patient with elbow pain
排除标准
- •Polytrauma (more than one injury)
- •Deformity of the arm including the elbow
- •Pain in any other location than the elbow
- •Pain in other parts of the same limb including the, wrist, forearm, shoulder, hand
- •Pain in other limbs,
- •Puckering of the skin (skin indentation)
- •Obvious fracture
- •Open wound at or around the elbow
- •Pain and swelling without trauma
- •Concerns for tumor or infection
- •Suspected nursemaid's elbow
研究组 & 干预措施
Patients elbow pain diagnosed with ultrasound
Patients with elbow pain will receive an ultrasound of the elbow to evaluate for the present of an elbow fractures, hemarthrosis and/or lipohemarthrosis
干预措施: Ultrasound of the elbow (Diagnostic Test)
Patient elbow pain diagnosed with x-ray
Patients with elbow pain will review a standard two view elbow x-ray (anterior- posterior and lateral) to evaluate for a fracture around the elbow and/or hemarthrosis.
干预措施: X-ray of elbow (Diagnostic Test)
结局指标
主要结局
Patient Satisfaction
时间窗: Day 1
The patient satisfaction scores will be collected by the research assistant using the Emergency Department Consumer Assessment of Healthcare Providers and Systems Survey (ED CAHPS Survey) Version 1.0. The survey will be scored based on the recommended guidelines from CAHPS. Please see the attached scoring guidelines for further information.
cost of treatment
时间窗: Day 1
Cost of treatment: will be based from hospital charges in United States Dollars (USD). The cost will be based off the cash charge for the 3-4 view x-rays of the elbow. This information is readily available online and is currently $652.00 . It would be impossible to base from reimbursement as each insurance provider reimburses at a different rate. No cost will be assigned for the ultrasound as it is a point of care (POC) device that has no charge.
次要结局
- Length of Stay(Day1)
- Pain During Imaging Procedure(Day 1)
研究者
Jason Malone
Pediatric Orthopedic Surgeon
Nemours Children's Clinic