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

NCT03479112 | Completed

• 1 other identifier: 2016P002631
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Hemorrhage

Keywords

Tourniquets, Layperson, hemorrhage control, first responder

Outcome Measures

Primary Outcomes (1)

• Correct application of tourniquet at initial training and retention training

  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 )

  4 hours and 6 Months Average

Secondary Outcomes (3)

• Time to tourniquet application

  4 hours

• Layperson Empowerment before and after B-Con training

  Change over time immediately after training and 3-9 months later

• Reasons for incorrect tourniquet application

  immediately and 3-9 months after intial training (retention testing)

Study Arms (5)

Flashcards

EXPERIMENTAL

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

Audio-kit

EXPERIMENTAL

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

Bleeding Control (B-Con) training

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Retention of B-Con course

EXPERIMENTAL

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

Interventions

Flashcards BEHAVIORAL

Participants will be provided with Flashcards depicting how to correctly apply a tourniquet to an extremity wound.

Flashcards

Audio-kit BEHAVIORAL

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.

Audio-kit

B-Con training BEHAVIORAL

Participants will undergo the Bleeding control for the injured (B-Con) basic course.

Bleeding Control (B-Con) training

B-Con training retention BEHAVIORAL

Evaluation of retention of Bleeding Control for the injured basic course

Retention of B-Con course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• employees of Gillette Stadium \>18 years old

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Gillian Reny Stepping Strong Center for Trauma Innovation: collaborator
• Gillette Children's Specialty Healthcare: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc.

  PMID: 23192066 BACKGROUND

• Kotwal RS, Montgomery HR, Kotwal BM, Champion HR, Butler FK Jr, Mabry RL, Cain JS, Blackbourne LH, Mechler KK, Holcomb JB. Eliminating preventable death on the battlefield. Arch Surg. 2011 Dec;146(12):1350-8. doi: 10.1001/archsurg.2011.213. Epub 2011 Aug 15.

  PMID: 21844425 BACKGROUND

• Biddinger PD, Baggish A, Harrington L, d'Hemecourt P, Hooley J, Jones J, Kue R, Troyanos C, Dyer KS. Be prepared--the Boston Marathon and mass-casualty events. N Engl J Med. 2013 May 23;368(21):1958-60. doi: 10.1056/NEJMp1305480. Epub 2013 May 1. No abstract available.

  PMID: 23635020 BACKGROUND

• Jacobs LM, McSwain N, Rotondo M, Wade DS, Fabbri WP, Eastman A, Butler FK, Sinclair J; Joint Committee to Create a National Policy to Enhance Survivability from Mass Casualty Shooting Events. Improving survival from active shooter events: the Hartford Consensus. Bull Am Coll Surg. 2013 Jun;98(6):14-6. No abstract available.

  PMID: 23789194 BACKGROUND

• Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002 Oct 17;347(16):1242-7. doi: 10.1056/NEJMoa020932.

  PMID: 12393821 BACKGROUND

• Page RL, Joglar JA, Kowal RC, Zagrodzky JD, Nelson LL, Ramaswamy K, Barbera SJ, Hamdan MH, McKenas DK. Use of automated external defibrillators by a U.S. airline. N Engl J Med. 2000 Oct 26;343(17):1210-6. doi: 10.1056/NEJM200010263431702.

  PMID: 11071671 BACKGROUND

• Goolsby C, Branting A, Chen E, Mack E, Olsen C. Just-in-Time to Save Lives: A Pilot Study of Layperson Tourniquet Application. Acad Emerg Med. 2015 Sep;22(9):1113-7. doi: 10.1111/acem.12742. Epub 2015 Aug 20.

  PMID: 26302453 BACKGROUND

• Goralnick E, Chaudhary MA, McCarty JC, Caterson EJ, Goldberg SA, Herrera-Escobar JP, McDonald M, Lipsitz S, Haider AH. Effectiveness of Instructional Interventions for Hemorrhage Control Readiness for Laypersons in the Public Access and Tourniquet Training Study (PATTS): A Randomized Clinical Trial. JAMA Surg. 2018 Sep 1;153(9):791-799. doi: 10.1001/jamasurg.2018.1099.

  PMID: 29801156 DERIVED

Study Officials

• Eric Goralnick, MD, MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 27, 2018
• Study Start: May 22, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)