Determine the Most Effective Intervention for Hemorrhage Control Readiness for Laypersons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- Correct application of tourniquet at initial training and retention training
研究概览
简要总结
This is a randomized controlled study evaluating the ability of laypersons to correctly apply a tourniquet using different instructional methods. There are four arms being evaluated: flashcards, audio-kit with visual aids, formal in person Bleeding Control Basic (B-Con) course, and a control arm. All participants will then undergo B-Con training at the end of each session and then participants will be evaluated within a 3-6 month time period to evaluate their retention of knowledge and skills taught by the B-Con course.
详细描述
Trauma is the number one cause of mortality in the US for individuals under 45 and uncontrolled hemorrhage is the leading cause of preventable deaths. Recent military experience has shown rapid intervention and control of extremity hemorrhage with tourniquets improves survival, decreasing preventable deaths by over 50%.
Multiple different courses are available to the public to train them in hemorrhage control.
One of the prominent examples of these courses is the American College of Surgeon's Bleeding Control for the injured (B-Con) basic course. Hemorrhage control training for the general public is resource intensive. Commercial devices have been developed and deployed by industry to act at point-of-care prompts to enable lay people to control hemorrhage without prior training.
Point-of-care prompts are well studied with proven effectiveness for AEDs. We will evaluate the efficacy of flashcards and an audio-kit with visual cues ability to improve lay peoples ability to correctly apply a tourniquet.
The retention of the knowledge and skills taught during the B-Con course also has not been evaluated as applied to the civilian sector. In the military setting, hemorrhage control training and tourniquets have been credited with saving 2000 lives between 2006-2009. It would be difficult to evaluate the number of lives saved in the civilian sector by tourniquets but a surrogate that investigators will evaluate is the retention over time of the knowledge and skills taught during the B-Con course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •employees of Gillette Stadium >18 years old
排除标准
- •participants who self-report prior hemorrhage control training will be excluded from the final analysis for tourniquet application but included in randomization
研究组 & 干预措施
Bleeding Control (B-Con) training
Study subjects in this arm were given the American College of Surgeons Bleeding Control Basic (B-Con) in-person training course by qualified instructors. This curriculum was developed by a collaboration between American College of Surgeons and the Hartford Consensus. The session included a multimedia presentation in a class format that included some background information about extremity hemorrhage and potential benefits of immediate first-response and hemorrhage control, steps to take in a mass casualty scenario and instructional videos on hemorrhage control modalities and their appropriate use. This was followed by hands-on training in hemorrhage control, with 1:4, instructor to trainee ratio.
干预措施: B-Con training (Behavioral)
Control
Study subjects in this arm of the trial received no intervention (no training or access to point-of-care prompts) to assess baseline competence in hemorrhage control.
Flashcards
Study participants in this arm of the trial received bleeding control flashcards that contain diagrams and figures to correctly identify the severity of the injury and visual instructions on the appropriate application of pressure dressing, hemostatic packing, and tourniquet.
干预措施: Flashcards (Behavioral)
Audio-kit
Study subjects in this arm received a commercially available audio bleeding control kit. The kit included a diagram and visual aids to identify the correct severity of the injury and determine the appropriate method of bleeding control. The kit also had buttons on it to play stepwise audio instructions on the application of compression dressing, hemostatic packing and tourniquet application in two languages (English and Spanish). The audio kits were bought at the market price and the name of the manufacturer was not mentioned in the manuscript to avoid conflict of interest.
干预措施: Audio-kit (Behavioral)
Retention of B-Con course
Control, Audio-kit, and flashcard arms undergo B-Con training at the completion of the initial evaluation, and the B-Con arm completed training prior to testing in order that all participants obtain training and then can be evaluated at retention testing. a. 3-9 months after the trial, investigators planned to test all study subjects with a simulated mass causality scenario for retention of knowledge and skills. This test will be the same as the initial test for competence at tourniquet placement in the trial and the same evaluation form will be used to evaluate the study subjects.
干预措施: B-Con training retention (Behavioral)
结局指标
主要结局
Correct application of tourniquet at initial training and retention training
时间窗: 4 hours and 6 Months Average
Correct Tourniquet Application ( Yes/No) is comprised of 3 measures (participants must succeed at All 3 Elements: Length of Time, Tension, Location must be correct for appropriate tourniquet application) 1. Timing (Minutes and Seconds) 2. Tension (Tightness) of Tourniquet (Yes or No, is determined by attempting to forcefully slide a Kelly clamp under between the tourniquet and the extremity of the mannequin) 3. Location of Tourniquet ( Measurement in Inches from wound site )
次要结局
- Time to tourniquet application(4 hours)
- Reasons for incorrect tourniquet application(immediately and 3-9 months after intial training (retention testing))
- Layperson Empowerment before and after B-Con training(Change over time immediately after training and 3-9 months later)
研究者
Eric Goralnick
Assistant Professor
Brigham and Women's Hospital