NCT04293211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 25, 2020

Last Update Submit

February 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Assessment by Evaluation of Packing Traumatic Wounds

    6 months

  • Retention of Skills Over a Period of Time

    8 months

  • Evaluate the Change in Length of Time to Tourniquet Placement with Simulation Scenario

    6 months

Study Arms (2)

Control

Upon completion of B-Con presentation, this group will be tested regarding tourniquet placement using the rubric. A tourniquet is regarded as appropriately placed if it is 2 inches above the wound, not located on a joint, appropriate tightness (meaning a finger cannot be placed under it and it is indenting the mannequin). This is as per prior studies. Feedback will be given at the end of this session.

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.

Other: Simulation

Interventions

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.

Simulation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

White Plains School District employees

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White Plains Hospital

White Plains, New York, 10601, United States

Location

Related Publications (1)

  • Jafri FN, Dadario NB, Kumar A, Silverstein SR, Quintero F, Larsen EA, Fasciglione K, Mirante D, Ellsworth K, Amicucci B, Ricca J. The Addition of High-Technology Into the Stop the Bleed Program Among School Personnel Improves Short-Term Skill Application, Not Long-Term Retention. Simul Healthc. 2021 Dec 1;16(6):e159-e167. doi: 10.1097/SIH.0000000000000546.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 3, 2020

Study Start

January 19, 2019

Primary Completion

May 15, 2019

Study Completion

May 31, 2019

Last Updated

March 3, 2020

Record last verified: 2020-02

Locations