Supporting Laypeople Addressing Prehospital Hemorrhage Study

NCT05812352 | Completed

• 1 other identifier: HUM00229966
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Laceration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Level of Participant Confidence initially

  After initial intervention (up to 20 minutes)

• Level of Participant Confidence at 6-month follow-up

  6 months

Study Arms (4)

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

EXPERIMENTAL

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

Instructional flashcard with tourniquet - 6 month follow-up

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

NO INTERVENTION

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

Interventions

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

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

Instructional flashcard BEHAVIORAL

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

Instructional flashcard with tourniquet - 6 month follow-up

In-person training BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand spoken and written English

You may not qualify if:

• None

Sponsors & Collaborators

• University of Michigan: lead
• Washington University School of Medicine: collaborator
• LFR International: collaborator

Study Sites (1)

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

St Louis, Missouri, 63130, United States

Location

MeSH Terms

Conditions

Hemorrhage; Lacerations

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Zachary Eisner, BS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Patricia Widder, MS

  Washington University in St. Louis - McKelvey School of Engineering

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 13, 2023
• Study Start: January 24, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 18 months of completion of primary outcome measures

Locations

US (1)