Determine the Most Effective Intervention for Hemorrhage Control Readiness for Laypersons: The PATTS Trial (PATTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03479112|
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : March 29, 2018
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||562 participants|
|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|
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.
Participants will be provided with Flashcards depicting how to correctly apply a tourniquet to an extremity wound.
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.
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
- 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 )
- Time to tourniquet application [ Time Frame: 4 hours ]Minutes and Seconds
- 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).
- 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.
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
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Eric Goralnick, MD, MS||Brigham and Women's Hospital|