Supporting Laypeople Addressing Prehospital Hemorrhage Study
- Conditions
- HemorrhageLaceration
- Interventions
- Behavioral: Audio kitBehavioral: Instructional flashcardBehavioral: In-person training
- Registration Number
- NCT05812352
- Lead Sponsor
- University of Michigan
- Brief Summary
It is unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.
- Detailed Description
Road traffic injuries (RTIs) are the largest contributor to the global trauma burden, which disproportionately affects low- and middle-income countries (LMICs). With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs, called lay first responders (LFRs). In prospective studies of LFR activity across three sub-Saharan African countries comprising 2,039 total patient encounters, LFRs most frequently provided hemorrhage control in 61% of patient encounters. Rapid hemorrhage control for compressible extremity hemorrhage by bystander LFRs has the potential to mitigate exsanguination, reducing mortality secondary to RTIs. Rapid hemorrhage control also has applicability to high-income country settings like the United States that sustain high rates of penetrating trauma due to gun violence. Rapid hemorrhage control using tourniquets for compressible extremity hemorrhage in patients not yet in shock is strongly associated with saved lives demonstrated in battlefield studies, decreasing preventable deaths by more than 50%. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for tourniquet application. Therefore, the investigators developed POC instructional interventions in response to the scalability challenges associated with in-person training to measure comparative effectiveness and skill retention using a randomized controlled trial design.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- Understand spoken and written English
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up Audio kit MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the audio kit at 6 month follow-up Instructional flashcard with tourniquet - 6 month follow-up Instructional flashcard Instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application, used for tourniquet application attempt. Participants repeat the tourniquet application attempt with the instructional flashcard at 6 month follow-up In-person training with tourniquet - 6 month follow-up In-person training Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt. Participants repeat the tourniquet application attempt without any POC instruction or re-training at 6 month follow-up
- Primary Outcome Measures
Name Time Method Correct tourniquet application at 6-month follow-up 6 months Number of participants who meet all criteria for correct application of the tourniquet
Correct tourniquet application at initial encounter After initial intervention (up to 20 minutes) Number of participants who meet all criteria for correct application of the tourniquet
- Secondary Outcome Measures
Name Time Method Level of Participant Confidence at 6-month follow-up 6 months Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident
Level of Participant Confidence initially After initial intervention (up to 20 minutes) Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident
Trial Locations
- Locations (1)
Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering
🇺🇸Saint Louis, Missouri, United States