Supporting Laypeople Addressing Prehospital Hemorrhage Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemorrhage, Laceration

Intervention / Treatment
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* Behavioral: Audio kit
* Behavioral: Instructional flashcard
* Behavioral: In-person training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand spoken and written English Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audio recording and instructional flashcard with tourniquet (audio kit) - 6 month follow-up<br>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 | Behavioral: Audio kit<br>* MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application<br>|
| Experimental: Instructional flashcard with tourniquet - 6 month follow-up<br>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 | Behavioral: Instructional flashcard<br>* Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application<br>|
| Experimental: In-person training with tourniquet - 6 month follow-up<br>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 | Behavioral: In-person training<br>* Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt<br>|
| No Intervention: Control group with no in-person training and no point-of-care instruction access - 6 month follow-up<br>There is no in-person training or point-of-care (POC) instructional interventions for this group for tourniquet application attempt. Participants repeat the tourniquet application attempt without any in-person training or POC instructional interventions at 6 month follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct tourniquet application at initial encounter | Number of participants who meet all criteria for correct application of the tourniquet | After initial intervention (up to 20 minutes) | 
| Correct tourniquet application at 6-month follow-up | Number of participants who meet all criteria for correct application of the tourniquet | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Participant Confidence initially | Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident | After initial intervention (up to 20 minutes) | 
| Level of Participant Confidence at 6-month follow-up | Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident | 6 months |