SLAPS: Supporting Laypeople Addressing Prehospital Hemorrhage Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up 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
MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application
|
| Experimental: Instructional flashcard with tourniquet - 6 month follow-up 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
Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application
|
| Experimental: In-person training with tourniquet - 6 month follow-up 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
Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt
|
| No Intervention: Control group with no in-person training and no point-of-care instruction access - 6 month follow-up 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 |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Understand spoken and written English
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering | Saint Louis | Missouri | United States | 63130 |
Sponsors and Collaborators
- University of Michigan
- Washington University School of Medicine
- LFR International
Investigators
- Principal Investigator: Peter Delaney, University of Michigan
- Study Director: Patricia Widder, Washington University in St. Louis - McKelvey School of Engineering
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00229966