Supporting Laypeople Addressing Prehospital Hemorrhage Study (SLAPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Laceration
• Intervention / Treatment: Behavioral: Audio kit; Behavioral: Instructional flashcard; Behavioral: In-person training

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 Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Understand spoken and written English

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Washington University School of Medicine; LFR International
• Investigators: Principal Investigator: Zachary Eisner, BS, University of Michigan; Study Director: Patricia Widder, MS, Washington University in St. Louis - McKelvey School of Engineering

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Lacerations
• Other Study ID Numbers: HUM00229966

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request to the corresponding author
• IPD Sharing Time Frame: Within 18 months of completion of primary outcome measures
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No