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

Tourniquet Placement Clinical Trial

Official title:

Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293211
• Other study ID #: Stop The Bleed
• Status: Completed
• Start date: January 19, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: February 2020
• Source: White Plains Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 31, 2019
• Est. primary completion date: May 15, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Tourniquet Placement
• Wound Packing

Intervention

Other:
• Simulation
To measure the efficacy of adding a high-fidelity simulation versus low fidelity simulation to the current B-Con Course. This will be assessed by evaluation of applying tourniquets properly and packing traumatic wounds as well as retention of these skills over a period of time amongst school teachers and security personnel.

Locations

Country	Name	City	State
United States	White Plains Hospital	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
White Plains Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment by Evaluation of Applying Tourniquets	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).	6 months
Secondary	Assessment by Evaluation of Packing Traumatic Wounds	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	6 months
Secondary	Retention of Skills Over a Period of Time	Tourniquet and wound packing based on above rubric and biofeedback device, 3-8 months after training	8 months
Secondary	Evaluate the Change in Length of Time to Tourniquet Placement with Simulation Scenario	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).	6 months