Supporting Laypeople Addressing Prehospital Hemorrhage Study (SLAPS)

University of Michigan

Status: Completed

Conditions: Hemorrhage; Laceration

Treatments: Behavioral: Instructional flashcard; Behavioral: Audio kit; Behavioral: In-person training

Study type: Interventional

Funder types: Other

Identifiers

NCT05812352

HUM00229966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Understand spoken and written English

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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205 participants in 4 patient groups

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

Experimental group

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

Treatment:

Behavioral: Audio kit

Instructional flashcard with tourniquet - 6 month follow-up

Experimental group

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

Treatment:

Behavioral: Instructional flashcard

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

Experimental group

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

Treatment:

Behavioral: In-person training

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

No Intervention group

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