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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| LFR International | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up | Experimental | 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 |
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| Instructional flashcard with tourniquet - 6 month follow-up | Experimental | 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 |
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| In-person training with tourniquet - 6 month follow-up | Experimental | 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 |
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| Control group with no in-person training and no point-of-care instruction access - 6 month follow-up | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audio kit | Behavioral | MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary Eisner, BS | University of Michigan | Principal Investigator |
| Patricia Widder, MS | Washington University in St. Louis - McKelvey School of Engineering | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering | St Louis | Missouri | 63130 | United States |
Upon reasonable request to the corresponding author
Within 18 months of completion of primary outcome measures
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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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.
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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.
| Instructional flashcard | Behavioral | Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application |
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| In-person training | Behavioral | Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt |
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Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident |
| 6 months |