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Completed

NCT Number: NCT05812352

Supporting Laypeople Addressing Prehospital Hemorrhage Study

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

St Louis, Missouri, 63130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understand spoken and written English

Exclusion criteria

  • None

Treatment and study plan

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

Instructional flashcard

Behavioral

Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application

In-person training

Behavioral

Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt

Primary outcomes

  1. Correct tourniquet application at initial encounter

    Time frame: After initial intervention (up to 20 minutes)

    Number of participants who meet all criteria for correct application of the tourniquet

  2. Correct tourniquet application at 6-month follow-up

    Time frame: 6 months

    Number of participants who meet all criteria for correct application of the tourniquet

Secondary outcomes

  1. Level of Participant Confidence initially

    Time frame: 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

  2. Level of Participant Confidence at 6-month follow-up

    Time frame: 6 months

    Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • LFR International
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: SLAPS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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