NCT05812352

Supporting Laypeople Addressing Prehospital Hemorrhage Study

Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemorrhage
• Laceration

Interventions

Type	Name	Description
BEHAVIORAL	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
BEHAVIORAL	Instructional flashcard	Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application
BEHAVIORAL	In-person training	Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt

Timeline

• Start date: 2023-01-24
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-04-13
• Last updated: 2023-12-13

Locations

1 site across 1 country: United States