search
Back to results

Supporting Laypeople Addressing Prehospital Hemorrhage Study (SLAPS)

Primary Purpose

Hemorrhage, Laceration

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audio kit
Instructional flashcard
In-person training
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Understand spoken and written English Exclusion Criteria: None

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up

Instructional flashcard with tourniquet - 6 month follow-up

In-person training with tourniquet - 6 month follow-up

Control group with no in-person training and no point-of-care instruction access - 6 month follow-up

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Correct tourniquet application at initial encounter
Number of participants who meet all criteria for correct application of the tourniquet
Correct tourniquet application at 6-month follow-up
Number of participants who meet all criteria for correct application of the tourniquet

Secondary Outcome Measures

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
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

Full Information

First Posted
March 30, 2023
Last Updated
May 5, 2023
Sponsor
University of Michigan
Collaborators
Washington University School of Medicine, LFR International
search

1. Study Identification

Unique Protocol Identification Number
NCT05812352
Brief Title
Supporting Laypeople Addressing Prehospital Hemorrhage Study
Acronym
SLAPS
Official Title
Evaluating Instructional Interventions Supporting Laypeople Addressing Prehospital Hemorrhage Study: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Washington University School of Medicine, LFR International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Laceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Audio recording and instructional flashcard with tourniquet ("audio kit") - 6 month follow-up
Arm Type
Experimental
Arm Description
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
Arm Title
Instructional flashcard with tourniquet - 6 month follow-up
Arm Type
Experimental
Arm Description
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
Arm Title
In-person training with tourniquet - 6 month follow-up
Arm Type
Experimental
Arm Description
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
Arm Title
Control group with no in-person training and no point-of-care instruction access - 6 month follow-up
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Audio kit
Intervention Description
MP3 audio files for each of 6 steps and instructional flashcard with pictures corresponding to each of the 6 steps of tourniquet application
Intervention Type
Behavioral
Intervention Name(s)
Instructional flashcard
Intervention Description
Single page (instructional flashcard) with pictures corresponding to each of the 6 steps of tourniquet application
Intervention Type
Behavioral
Intervention Name(s)
In-person training
Intervention Description
Stop the Bleed bleeding control (B-Con) course is used for instruction for tourniquet application attempt
Primary Outcome Measure Information:
Title
Correct tourniquet application at initial encounter
Description
Number of participants who meet all criteria for correct application of the tourniquet
Time Frame
After initial intervention (up to 20 minutes)
Title
Correct tourniquet application at 6-month follow-up
Description
Number of participants who meet all criteria for correct application of the tourniquet
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Level of Participant Confidence initially
Description
Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident
Time Frame
After initial intervention (up to 20 minutes)
Title
Level of Participant Confidence at 6-month follow-up
Description
Participants will self-rate on a Likert scale of 0 - 10, where 0 is no confidence and 10 is absolutely confident
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Understand spoken and written English Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Eisner, BS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Widder, MS
Organizational Affiliation
Washington University in St. Louis - McKelvey School of Engineering
Official's Role
Study Director
Facility Information:
Facility Name
Washington University in St. Louis - McKelvey School of Engineering, Dept. of Biomedical Engineering
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request to the corresponding author
IPD Sharing Time Frame
Within 18 months of completion of primary outcome measures

Learn more about this trial

Supporting Laypeople Addressing Prehospital Hemorrhage Study

We'll reach out to this number within 24 hrs