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Determine the Most Effective Intervention for Hemorrhage Control Readiness for Laypersons: The PATTS Trial (PATTS)

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ClinicalTrials.gov Identifier: NCT03479112
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
The Gillian Reny Stepping Strong Center for Trauma Innovation
Gillette Children's Specialty Healthcare
Information provided by (Responsible Party):
Eric Goralnick, Brigham and Women's Hospital

Brief Summary:
This is a randomized controlled study evaluating the ability of laypersons to correctly apply a tourniquet using different instructional methods. There are four arms being evaluated: flashcards, audio-kit with visual aids, formal in person Bleeding Control Basic (B-Con) course, and a control arm. All participants will then undergo B-Con training at the end of each session and then participants will be evaluated within a 3-6 month time period to evaluate their retention of knowledge and skills taught by the B-Con course.

Condition or disease Intervention/treatment Phase
Traumatic Hemorrhage Behavioral: Flashcards Behavioral: Audio-kit Behavioral: B-Con training Behavioral: B-Con training retention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Determine the Most Effective Intervention for Hemorrhage Control Readiness for Laypersons
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Flashcards
Study participants in this arm of the trial received bleeding control flashcards that contain diagrams and figures to correctly identify the severity of the injury and visual instructions on the appropriate application of pressure dressing, hemostatic packing, and tourniquet.
Behavioral: Flashcards
Participants will be provided with Flashcards depicting how to correctly apply a tourniquet to an extremity wound.

Experimental: Audio-kit
Study subjects in this arm received a commercially available audio bleeding control kit. The kit included a diagram and visual aids to identify the correct severity of the injury and determine the appropriate method of bleeding control. The kit also had buttons on it to play stepwise audio instructions on the application of compression dressing, hemostatic packing and tourniquet application in two languages (English and Spanish). The audio kits were bought at the market price and the name of the manufacturer was not mentioned in the manuscript to avoid conflict of interest.
Behavioral: Audio-kit
Participants will be provided with an audio-kit with accompanying visual cues describing and depicting how to correctly apply a tourniquet to an extremity wound.

Experimental: Bleeding Control (B-Con) training
Study subjects in this arm were given the American College of Surgeons Bleeding Control Basic (B-Con) in-person training course by qualified instructors. This curriculum was developed by a collaboration between American College of Surgeons and the Hartford Consensus. The session included a multimedia presentation in a class format that included some background information about extremity hemorrhage and potential benefits of immediate first-response and hemorrhage control, steps to take in a mass casualty scenario and instructional videos on hemorrhage control modalities and their appropriate use. This was followed by hands-on training in hemorrhage control, with 1:4, instructor to trainee ratio.
Behavioral: B-Con training
Participants will undergo the Bleeding control for the injured (B-Con) basic course.

No Intervention: Control
Study subjects in this arm of the trial received no intervention (no training or access to point-of-care prompts) to assess baseline competence in hemorrhage control.
Experimental: Retention of B-Con course
Control, Audio-kit, and flashcard arms undergo B-Con training at the completion of the initial evaluation, and the B-Con arm completed training prior to testing in order that all participants obtain training and then can be evaluated at retention testing. a. 3-9 months after the trial, investigators planned to test all study subjects with a simulated mass causality scenario for retention of knowledge and skills. This test will be the same as the initial test for competence at tourniquet placement in the trial and the same evaluation form will be used to evaluate the study subjects.
Behavioral: B-Con training retention
Evaluation of retention of Bleeding Control for the injured basic course




Primary Outcome Measures :
  1. Correct application of tourniquet at initial training and retention training [ Time Frame: 4 hours and 6 Months Average ]
    Correct Tourniquet Application ( Yes/No) is comprised of 3 measures (participants must succeed at All 3 Elements: Length of Time, Tension, Location must be correct for appropriate tourniquet application) 1. Timing (Minutes and Seconds) 2. Tension (Tightness) of Tourniquet (Yes or No, is determined by attempting to forcefully slide a Kelly clamp under between the tourniquet and the extremity of the mannequin) 3. Location of Tourniquet ( Measurement in Inches from wound site )


Secondary Outcome Measures :
  1. Time to tourniquet application [ Time Frame: 4 hours ]
    Minutes and Seconds

  2. Layperson Empowerment before and after B-Con training [ Time Frame: Change over time immediately after training and 3-9 months later ]
    Evaluation of layperson self-reported empowerment before and after B-Con training assessing parameters such as their willingness to assist in an emergency and their comfort level controlling hemorrhage using a Likert Scale (1-5).

  3. Reasons for incorrect tourniquet application [ Time Frame: immediately and 3-9 months after intial training (retention testing) ]
    The criteria for incorrect tourniquet application include inadequate tightness, not incorrect anatomical placement, and greater than 7 minutes needed to place the tourniquet which will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • employees of Gillette Stadium >18 years old

Exclusion Criteria:

  • participants who self-report prior hemorrhage control training will be excluded from the final analysis for tourniquet application but included in randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479112


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
The Gillian Reny Stepping Strong Center for Trauma Innovation
Gillette Children's Specialty Healthcare
Investigators
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Principal Investigator: Eric Goralnick, MD, MS Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Eric Goralnick, Brigham and Women's Hospital:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Goralnick, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03479112     History of Changes
Other Study ID Numbers: 2016P002631
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Goralnick, Brigham and Women's Hospital:
Tourniquets, Layperson, hemorrhage control, first responder
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes