Supporting Laypeople Addressing Prehospital Hemorrhage Study

Hemorrhage Clinical Trial

— SLAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812352
• Other study ID #: HUM00229966
• Status: Completed
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Understand spoken and written English

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hemorrhage
• Laceration
• Lacerations

Intervention

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

Locations

Country	Name	City	State
United States	Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	LFR International, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Correct tourniquet application at 6-month follow-up	Number of participants who meet all criteria for correct application of the tourniquet	6 months
Secondary	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)
Secondary	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