Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control Course in Regards to Proper Tourniquet Placement Amongst School Personnel

Completed

• Conditions: Tourniquet Placement; Wound Packing
• Interventions: Other: Simulation

• Registration Number: NCT04293211
• Lead Sponsor: White Plains Hospital

Brief Summary

This is a joint project by the White Plains School District and White Plains Hospital regarding the training of over 66 school personnel regarding the American College of Surgeons (ACS) "Stop the Bleed" campaign for mass casualty incidents. This project developed from an outreach from White Plains Hospital and an interest from the White Plains School District to work together to train staff in the event of a mass casualty incident / active shooter.

Detailed Description

From January through June 2019, participants will be requested to attend one of six sessions that will be held at the hospital simulation center. Participants will be randomized into 1 of 2 study arms. Each participant that enters the B-Con course will be randomized using a "random generator." At the start of the program, all participants will be explained the purpose of the research study and the two groups (Control versus High Fidelity). An option will be given for participants to be able to opt out. So that our participants all have the same opportunities afforded to their colleagues, we will also offer the control group the option to participate in the high fidelity simulation at the conclusion of the entire program.

All groups will sit through the exact same B-Con powerpoint presentation by trained STB instructors. This course includes the powerpoint presentation that reviews how to call for help, assess those affected, identify the location of life-threatening bleed, apply pressure, pack a wound and/or apply a tourniquet and when to do this. Tourniquet placement is taught as is wound packing placement. Participants will each be given tourniquets to practice alongside the instructor. The presentation will cover the first hour of the curriculum. This is considered to be the standard for this course.

Upon conclusion of the course, the control group and high fidelity group will be separated into two rooms based on their randomization. In groups of 2, participants will be trained in tourniquet placement, wound packing. The High Fidelity group will have a simulation intervention in addition and the wound packing will be performed on a device that has biofeedback. Upon conclusion of this one hour session, both groups will be tested on wound packing and tourniquet placement. They will again be tested 3-8 months later on retention for wound packing and tourniquet placement.

Study Timeline

• Study Start: 2019-01-19
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Study First Posted: 2020-03-03
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• any volunteer employee who is over the age of 18 that is a staff member at the White Plains School District.

Exclusion Criteria

• any participants who have prior hemorrhage control training. However, although excluded from the study, they are welcome to participate in the program

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simulation	Simulation	This group will have to interact with a panicked actor/actress as well as the SIM MAN 3G who will have two wounds under his clothes. One that will be actively pumping a large amount of arterial blood that will require tourniquet placement and the other wound with trace venous bleeding that will require simple pressure with a clean cloth. Participants will be given feedback on items that they missed. The observer will fill out the rubric and give feedback to the group.

Primary Outcome Measures

Name	Time	Method
Assessment by Evaluation of Applying Tourniquets	6 months	Measure correct tourniquet placement based on internally validated scale. Binomial variable (correct or incorrect). Indications for incorrect placement will also be documented (too loose, incorrect location, longer than 7 minutes, participant requested to discontinue).

Secondary Outcome Measures

Name	Time	Method
Assessment by Evaluation of Packing Traumatic Wounds	6 months	Amount of pressure placed for 90 seconds using a biofeedback device with a threshold of 25psi based on prior studies on hemorrhage control on porcine models
Retention of Skills Over a Period of Time	8 months	Tourniquet and wound packing based on above rubric and biofeedback device, 3-8 months after training
Evaluate the Change in Length of Time to Tourniquet Placement with Simulation Scenario	6 months	Measure correct tourniquet placement based on internally validated scale. Binomial variable (correct or incorrect). Indications for incorrect placement will also be documented (too loose, incorrect location, longer than 7 minutes, participant requested to discontinue).

Trial Locations

Locations (1)

White Plains Hospital; 🇺🇸 White Plains, New York, United States