Hemorrhage, Laceration
Conditions
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.
Interventions
BEHAVIORALAudio kit
MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application
BEHAVIORALInstructional flashcard
Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application
BEHAVIORALIn-person training
Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt
Sponsors
Washington University School of Medicine
LFR International
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor only enters the laboratory after the participant has attempted to apply the tourniquet. Therefore, the outcomes assessor is unaware of the instructional intervention that was employed. The outcomes assessor will assess (1) tourniquet placement sufficient distance above the injury defined as at least 2 inches proximal to the amputation, (2) turning on an external diaphragm pump that attempts to force water through tubing in the mannequin extremity bypassing the tourniquet.
Intervention model description
Participants are randomized to 1 of 4 educational interventions. Once the initial instructional intervention is completed, participants subsequently present for a 6-month follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Understand spoken and written English
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Correct tourniquet application at 6-month follow-up | 6 months | Number of participants who meet all criteria for correct application of the tourniquet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed