NCT05910515

Brief Summary

The goal of this trial is to test a debriefing protocol to improve non-technical skills (NTS) in medical students. The study aims to answer the following questions:

  • Does a debriefing intervention improve medical students' NTS?
  • Does the intervention have an impact on the students' performance in simulated scenarios? Participants in the study will be randomly assigned to one of the teams, each consisting of a trauma team leader and three assistants. The teams will rotate across four different scenarios, allowing participants to switch roles and act as team leaders. The intervention teams will be debriefed using the study protocol, while the control groups will receive standard technical feedback without focusing on NTS. The primary outcome measure will be the Non-Technical Skills for Surgeons (NOTSS) score, which is a validated assessment tool for NTS. Secondary outcome measures include the number of correct interventions performed in each scenario. The study will involve 40 medical students, and the sample size was determined based on previous studies and statistical considerations. A panel of health educators will define the debriefing protocol, and the trial has been approved by the McGill Research Ethics Board office. The study findings are expected to contribute significantly to the training of providers of trauma care for children worldwide. By exploring the impact of debriefing on NTS in pediatric trauma education, this project aims to fill a critical gap in current training models.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

September 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

May 23, 2023

Last Update Submit

June 9, 2023

Conditions

Keywords

childnon-technical skillspediatric trauma

Outcome Measures

Primary Outcomes (1)

  • NOTSS score

    The Non-technical skills for surgeons (NOTSS) score evaluates four major categories of non-technical skills: situation awareness, decision-making, teamwork, and leadership. Each category is assessed based on specific elements outlined in the NOTSS handbook (www.notss.org). It is a continuous variable ranging from 1 to 4. Higher scores on the NOTSS scale indicate better non-technical skills, while lower scores suggest areas that may need improvement. Educators are responsible for observing the trainees and scoring their behaviors during the simulated scenarios.

    During the student's participation in the simulated scenarios (four hours)

Secondary Outcomes (1)

  • Number of interventions performed

    During the student's participation in the simulated scenarios (four hours)

Study Arms (2)

Control

NO INTERVENTION

Regular debriefing

Intervention

EXPERIMENTAL

Structured debriefing in non-technical skills

Other: Debriefing

Interventions

Structured debriefing in non-technical skills. (This is an educational study)

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale, female, non-binary
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Canadian cohort
  • McGill University, years 3 or 4 medical students. or
  • McGill University Health Centre general surgery residents
  • Brazilian cohort
  • Medical students, years 5 or 6. or
  • Brazilian general surgery residents

You may not qualify if:

  • Canadian cohort
  • Medical students of years 1 and 2;
  • Residents that are not from the General Surgery service;
  • Brazilian cohort
  • Medical students of years 1, 2, 3 \& 4.
  • Residents that are not from the General Surgery service;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical schools in Brazil

Belo Horizonte, Brazil

RECRUITING

McGill University

Montreal, Quebec, Canada

RECRUITING

Related Publications (15)

  • Global Burden of Disease Child and Adolescent Health Collaboration; Kassebaum N, Kyu HH, Zoeckler L, Olsen HE, Thomas K, Pinho C, Bhutta ZA, Dandona L, Ferrari A, Ghiwot TT, Hay SI, Kinfu Y, Liang X, Lopez A, Malta DC, Mokdad AH, Naghavi M, Patton GC, Salomon J, Sartorius B, Topor-Madry R, Vollset SE, Werdecker A, Whiteford HA, Abate KH, Abbas K, Damtew SA, Ahmed MB, Akseer N, Al-Raddadi R, Alemayohu MA, Altirkawi K, Abajobir AA, Amare AT, Antonio CAT, Arnlov J, Artaman A, Asayesh H, Avokpaho EFGA, Awasthi A, Ayala Quintanilla BP, Bacha U, Betsu BD, Barac A, Barnighausen TW, Baye E, Bedi N, Bensenor IM, Berhane A, Bernabe E, Bernal OA, Beyene AS, Biadgilign S, Bikbov B, Boyce CA, Brazinova A, Hailu GB, Carter A, Castaneda-Orjuela CA, Catala-Lopez F, Charlson FJ, Chitheer AA, Choi JJ, Ciobanu LG, Crump J, Dandona R, Dellavalle RP, Deribew A, deVeber G, Dicker D, Ding EL, Dubey M, Endries AY, Erskine HE, Faraon EJA, Faro A, Farzadfar F, Fernandes JC, Fijabi DO, Fitzmaurice C, Fleming TD, Flor LS, Foreman KJ, Franklin RC, Fraser MS, Frostad JJ, Fullman N, Gebregergs GB, Gebru AA, Geleijnse JM, Gibney KB, Gidey Yihdego M, Ginawi IAM, Gishu MD, Gizachew TA, Glaser E, Gold AL, Goldberg E, Gona P, Goto A, Gugnani HC, Jiang G, Gupta R, Tesfay FH, Hankey GJ, Havmoeller R, Hijar M, Horino M, Hosgood HD, Hu G, Jacobsen KH, Jakovljevic MB, Jayaraman SP, Jha V, Jibat T, Johnson CO, Jonas J, Kasaeian A, Kawakami N, Keiyoro PN, Khalil I, Khang YH, Khubchandani J, Ahmad Kiadaliri AA, Kieling C, Kim D, Kissoon N, Knibbs LD, Koyanagi A, Krohn KJ, Kuate Defo B, Kucuk Bicer B, Kulikoff R, Kumar GA, Lal DK, Lam HY, Larson HJ, Larsson A, Laryea DO, Leung J, Lim SS, Lo LT, Lo WD, Looker KJ, Lotufo PA, Magdy Abd El Razek H, Malekzadeh R, Markos Shifti D, Mazidi M, Meaney PA, Meles KG, Memiah P, Mendoza W, Abera Mengistie M, Mengistu GW, Mensah GA, Miller TR, Mock C, Mohammadi A, Mohammed S, Monasta L, Mueller U, Nagata C, Naheed A, Nguyen G, Nguyen QL, Nsoesie E, Oh IH, Okoro A, Olusanya JO, Olusanya BO, Ortiz A, Paudel D, Pereira DM, Perico N, Petzold M, Phillips MR, Polanczyk GV, Pourmalek F, Qorbani M, Rafay A, Rahimi-Movaghar V, Rahman M, Rai RK, Ram U, Rankin Z, Remuzzi G, Renzaho AMN, Roba HS, Rojas-Rueda D, Ronfani L, Sagar R, Sanabria JR, Kedir Mohammed MS, Santos IS, Satpathy M, Sawhney M, Schottker B, Schwebel DC, Scott JG, Sepanlou SG, Shaheen A, Shaikh MA, She J, Shiri R, Shiue I, Sigfusdottir ID, Singh J, Silpakit N, Smith A, Sreeramareddy C, Stanaway JD, Stein DJ, Steiner C, Sufiyan MB, Swaminathan S, Tabares-Seisdedos R, Tabb KM, Tadese F, Tavakkoli M, Taye B, Teeple S, Tegegne TK, Temam Shifa G, Terkawi AS, Thomas B, Thomson AJ, Tobe-Gai R, Tonelli M, Tran BX, Troeger C, Ukwaja KN, Uthman O, Vasankari T, Venketasubramanian N, Vlassov VV, Weiderpass E, Weintraub R, Gebrehiwot SW, Westerman R, Williams HC, Wolfe CDA, Woodbrook R, Yano Y, Yonemoto N, Yoon SJ, Younis MZ, Yu C, Zaki MES, Zegeye EA, Zuhlke LJ, Murray CJL, Vos T. Child and Adolescent Health From 1990 to 2015: Findings From the Global Burden of Diseases, Injuries, and Risk Factors 2015 Study. JAMA Pediatr. 2017 Jun 1;171(6):573-592. doi: 10.1001/jamapediatrics.2017.0250.

    PMID: 28384795BACKGROUND
  • Kiragu AW, Dunlop SJ, Wachira BW, Saruni SI, Mwachiro M, Slusher T. Pediatric Trauma Care in Low- and Middle-Income Countries: A Brief Review of the Current State and Recommendations for Management and a Way Forward. J Pediatr Intensive Care. 2017 Mar;6(1):52-59. doi: 10.1055/s-0036-1584676. Epub 2016 Jun 24.

    PMID: 31073425BACKGROUND
  • Kiragu AW, Dunlop SJ, Mwarumba N, Gidado S, Adesina A, Mwachiro M, Gbadero DA, Slusher TM. Pediatric Trauma Care in Low Resource Settings: Challenges, Opportunities, and Solutions. Front Pediatr. 2018 Jun 4;6:155. doi: 10.3389/fped.2018.00155. eCollection 2018.

    PMID: 29915778BACKGROUND
  • Roberts NK, Williams RG, Schwind CJ, Sutyak JA, McDowell C, Griffen D, Wall J, Sanfey H, Chestnut A, Meier AH, Wohltmann C, Clark TR, Wetter N. The impact of brief team communication, leadership and team behavior training on ad hoc team performance in trauma care settings. Am J Surg. 2014 Feb;207(2):170-8. doi: 10.1016/j.amjsurg.2013.06.016. Epub 2013 Oct 2.

    PMID: 24468024BACKGROUND
  • Ziesmann MT, Widder S, Park J, Kortbeek JB, Brindley P, Hameed M, Paton-Gay JD, Engels PT, Hicks C, Fata P, Ball CG, Gillman LM. S.T.A.R.T.T.: development of a national, multidisciplinary trauma crisis resource management curriculum-results from the pilot course. J Trauma Acute Care Surg. 2013 Nov;75(5):753-8. doi: 10.1097/TA.0b013e3182a925df.

    PMID: 24158191BACKGROUND
  • Higashi H, Barendregt JJ, Kassebaum NJ, Weiser TG, Bickler SW, Vos T. Burden of injuries avertable by a basic surgical package in low- and middle-income regions: a systematic analysis from the Global Burden of Disease 2010 Study. World J Surg. 2015 Jan;39(1):1-9. doi: 10.1007/s00268-014-2685-x.

    PMID: 25008243BACKGROUND
  • Lee A, Finstad A, Gawad N, Boet S, Raiche I, Balaa F. Nontechnical Skills (NTS) in the Undergraduate Surgical and Anesthesiology Curricula: Are We Adequately Preparing Medical Students? J Surg Educ. 2021 Mar-Apr;78(2):502-511. doi: 10.1016/j.jsurg.2020.08.001. Epub 2020 Aug 21.

    PMID: 32839149BACKGROUND
  • Jung JJ, Borkhoff CM, Juni P, Grantcharov TP. Non-Technical Skills for Surgeons (NOTSS): Critical appraisal of its measurement properties. Am J Surg. 2018 Nov;216(5):990-997. doi: 10.1016/j.amjsurg.2018.02.021. Epub 2018 Feb 17.

    PMID: 29478826BACKGROUND
  • Patel EA, Aydin A, Desai A, Dasgupta P, Ahmed K. Current status of simulation-based training in pediatric surgery: A systematic review. J Pediatr Surg. 2019 Sep;54(9):1884-1893. doi: 10.1016/j.jpedsurg.2018.11.019. Epub 2018 Dec 8.

    PMID: 30573294BACKGROUND
  • Helmreich RL, Merritt AC, Wilhelm JA. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32. doi: 10.1207/s15327108ijap0901_2.

    PMID: 11541445BACKGROUND
  • Sevdalis N, Davis R, Koutantji M, Undre S, Darzi A, Vincent CA. Reliability of a revised NOTECHS scale for use in surgical teams. Am J Surg. 2008 Aug;196(2):184-90. doi: 10.1016/j.amjsurg.2007.08.070. Epub 2008 Jun 16.

    PMID: 18558392BACKGROUND
  • Jensen AR, McLaughlin C, Subacius H, McAuliff K, Nathens AB, Wong C, Meeker D, Burd RS, Ford HR, Upperman JS. Simulation-based training is associated with lower risk-adjusted mortality in ACS pediatric TQIP centers. J Trauma Acute Care Surg. 2019 Oct;87(4):841-848. doi: 10.1097/TA.0000000000002433.

    PMID: 31589193BACKGROUND
  • Yule S, Paterson-Brown S. Surgeons' non-technical skills. Surg Clin North Am. 2012 Feb;92(1):37-50. doi: 10.1016/j.suc.2011.11.004. Epub 2011 Dec 28.

    PMID: 22269259BACKGROUND
  • Leenstra NF, Jung OC, Cnossen F, Jaarsma ADC, Tulleken JE. Development and Evaluation of the Taxonomy of Trauma Leadership Skills-Shortened for Observation and Reflection in Training: A Practical Tool for Observing and Reflecting on Trauma Leadership Performance. Simul Healthc. 2021 Feb 1;16(1):37-45. doi: 10.1097/SIH.0000000000000474.

    PMID: 32732816BACKGROUND
  • Sanfey H. Assessment of surgical training. Surgeon. 2014 Dec;12(6):350-6. doi: 10.1016/j.surge.2014.07.001. Epub 2014 Jul 31.

    PMID: 25087505BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Crisis Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dan Poenaru

    McGill

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 18, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2023

Study Completion

September 1, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Once study is published, according to the journal's/editor's policies.

Shared Documents
STUDY PROTOCOL, SAP

Locations