InjuriesNCT05910515
Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills
A study testing Debriefing in people with Injuries, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in 2 countries.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries
- What is being tested?
- Debriefing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Brazil1 site, 1 recruiting
- Recruiting
Medical schools in Brazil
Belo Horizonte
Fabio Botelho, fabio.botelho@mail.mcgill.ca
Fabio Botelho, MD
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec
Fabio Botelho, fabio.botelho@mail.mcgill.ca
Fabio Botelho, MD
About this study
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?
Read more
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.
Read the detailed description
BACKGROUND AND STUDY RATIONALE Pediatric trauma is a global epidemic, and improving pediatric trauma care requires a focus on healthcare provider education. Studies have shown that inadequate training and poor non-technical skills contribute to errors in trauma care. Non-technical skills, including teamwork communication, leadership, situational awareness, and decision-making, are crucial in delivering effective healthcare.
These skills were initially recognized in the aviation industry and have since been studied and applied in various settings. However, the intentional teaching of non-technical skills in healthcare contexts is lacking. While medical content and technical skills have transitioned from the classroom to practical settings and simulation labs, non-technical skills have not received the same attention, leading to suboptimal quality of medical care.
The Non-Technical Skills for Surgeons (NOTSS) is a valuable tool for assessing these skills in surgeons. It employs a numeric scale to score surgeons' attitudes, enabling educators to identify strengths and weaknesses. NOTSS evaluates four main behavioral categories: situation awareness, decision-making, teamwork, and leadership. Each category consists of four elements that are assessed based on the original NOTSS handbook. Adequate performance is indicated by a score above 0.7 in each category. This scoring system facilitates personalized feedback and highlights areas for improvement.
Although NOTSS is primarily used in the operating room rather than in simulation training, there is currently a lack of studies evaluating the training of non-technical skills in pediatric trauma courses. This highlights the need to develop educational resources specifically focused on teaching non-technical skills in pediatric trauma education.
OBJECTIVES \& HYPOTHESIS
The hypothesis of this study is that teaching and evaluating non-technical skills in pediatric trauma scenarios will enhance the overall clinical performance of medical students and general surgery trainees. The study aims to achieve the following objectives:
- Assess the ratings of medical students and general surgery trainees using the Non-Technical Skills for Surgeons (NOTSS) assessment tool.
- Investigate the impact of individual differences, such as training experience, on NOTSS scores.
- Evaluate the effectiveness of standardized debriefing sessions in improving NOTSS scores and outcomes in simulated assessments of pediatric trauma.
STUDY METHODS
Study Design:
The study will be a randomized controlled trial using the NOTSS score and debriefing strategies. Two rounds of pediatric trauma-simulated scenarios will be conducted. After the first round, participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive formal debriefing on non-technical and technical performance, while the control group will only receive feedback on technical skills.
Participant Recruitment:
Collaboration will be sought from the McGill Faculty of Medicine and Health Sciences Undergraduate Education Office and the McGill Postgraduate Education Office to invite students and residents to participate. Flyers will be displayed, and announcements will be made on social media. In Brazil, invitations will be sent via email lists of participating universities and social media platforms.
Study Duration:
The study is expected to run from September 1, 2022, to September 1, 2024.
Data Analysis:
Data will be collected using Microsoft Forms, Excel, and Word, and analyzed using R version 3.2.5. Descriptive analysis will be conducted for participants' profile features and outcome variables. Inferential analysis will compare data before and after intervention/debriefings, between medical students and surgical residents, and between control and intervention groups using appropriate statistical tests.
Ethical Considerations:
The study will adhere to ethical guidelines and receive approval from the relevant ethics boards. Confidentiality measures will be implemented, and informed consent will be obtained from all participants. Data will be deidentified, stored securely, and destroyed after the study's completion. A dissemination plan is in place, targeting the academic community, policymakers, and the general public, while ensuring participant anonymity.
- Conditions
- Injuries
- Being tested
- Debriefing
- Keywords
- child, non-technical skills, pediatric trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebriefingOther
Structured debriefing in non-technical skills. (This is an educational study)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Regular debriefing |
| Intervention | Experimental | Structured debriefing in non-technical skills Receives: Other: Debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the student's participation in the simulated scenarios (four hours)
Secondary outcomes (1)
Number of interventions performed
The evaluation of student performance in each simulated scenario involves a total of 12 steps. The number of steps successfully completed by the student will be recorded and expressed as a percentage for each scenario. This measurement provides an objective assessment of the student's ability to effectively carry out the required tasks in the given scenario.
Measured: During the student's participation in the simulated scenarios (four hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Poenaru, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Dan Poenaru, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910515
- Sponsor's protocol ID
- 2022-7561
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once study is published, according to the journal's/editor's policies.
Publications
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.
PubMed 28384795Kiragu 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.
PubMed 31073425Kiragu 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.
PubMed 29915778Roberts 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.
PubMed 24468024Ziesmann 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.
PubMed 24158191Higashi 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.
PubMed 25008243Lee 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.
PubMed 32839149Jung 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.
PubMed 29478826Patel 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.
PubMed 30573294Helmreich RL, Merritt AC, Wilhelm JA; New Collective Author. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32. doi: 10.1207/s15327108ijap0901_2.
PubMed 11541445Sevdalis 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.
PubMed 18558392Jensen 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.
PubMed 31589193Yule 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.
PubMed 22269259Leenstra 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.
PubMed 32732816Sanfey H. Assessment of surgical training. Surgeon. 2014 Dec;12(6):350-6. doi: 10.1016/j.surge.2014.07.001. Epub 2014 Jul 31.
PubMed 25087505
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills
- ClinicalTrials.gov ID
- NCT05910515
- Acronym / sponsor ID
- 2022-7561
- Conditions
- Injuries
- Keywords
- child, non-technical skills, pediatric trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND AND STUDY RATIONALE Pediatric trauma is a global epidemic, and improving pediatric trauma care requires a focus on healthcare provider education. Studies have shown that inadequate training and poor non-technical skills contribute to errors in trauma care. Non-technical skills, including teamwork communication, leadership, situational awareness, and decision-making, are crucial in delivering effective healthcare.
These skills were initially recognized in the aviation industry and have since been studied and applied in various settings. However, the intentional teaching of non-technical skills in healthcare contexts is lacking. While medical content and technical skills have transitioned from the classroom to practical settings and simulation labs, non-technical skills have not received the same attention, leading to suboptimal quality of medical care.
The Non-Technical Skills for Surgeons (NOTSS) is a valuable tool for assessing these skills in surgeons. It employs a numeric scale to score surgeons' attitudes, enabling educators to identify strengths and weaknesses. NOTSS evaluates four main behavioral categories: situation awareness, decision-making, teamwork, and leadership. Each category consists of four elements that are assessed based on the original NOTSS handbook. Adequate performance is indicated by a score above 0.7 in each category. This scoring system facilitates personalized feedback and highlights areas for improvement.
Although NOTSS is primarily used in the operating room rather than in simulation training, there is currently a lack of studies evaluating the training of non-technical skills in pediatric trauma courses. This highlights the need to develop educational resources specifically focused on teaching non-technical skills in pediatric trauma education.
OBJECTIVES \& HYPOTHESIS
The hypothesis of this study is that teaching and evaluating non-technical skills in pediatric trauma scenarios will enhance the overall clinical performance of medical students and general surgery trainees. The study aims to achieve the following objectives:
- Assess the ratings of medical students and general surgery trainees using the Non-Technical Skills for Surgeons (NOTSS) assessment tool.
- Investigate the impact of individual differences, such as training experience, on NOTSS scores.
- Evaluate the effectiveness of standardized debriefing sessions in improving NOTSS scores and outcomes in simulated assessments of pediatric trauma.
STUDY METHODS
Study Design:
The study will be a randomized controlled trial using the NOTSS score and debriefing strategies. Two rounds of pediatric trauma-simulated scenarios will be conducted. After the first round, participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive formal debriefing on non-technical and technical performance, while the control group will only receive feedback on technical skills.
Participant Recruitment:
Collaboration will be sought from the McGill Faculty of Medicine and Health Sciences Undergraduate Education Office and the McGill Postgraduate Education Office to invite students and residents to participate. Flyers will be displayed, and announcements will be made on social media. In Brazil, invitations will be sent via email lists of participating universities and social media platforms.
Study Duration:
The study is expected to run from September 1, 2022, to September 1, 2024.
Data Analysis:
Data will be collected using Microsoft Forms, Excel, and Word, and analyzed using R version 3.2.5. Descriptive analysis will be conducted for participants' profile features and outcome variables. Inferential analysis will compare data before and after intervention/debriefings, between medical students and surgical residents, and between control and intervention groups using appropriate statistical tests.
Ethical Considerations:
The study will adhere to ethical guidelines and receive approval from the relevant ethics boards. Confidentiality measures will be implemented, and informed consent will be obtained from all participants. Data will be deidentified, stored securely, and destroyed after the study's completion. A dissemination plan is in place, targeting the academic community, policymakers, and the general public, while ensuring participant anonymity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Regular debriefing |
| Intervention | Experimental | Other: DebriefingStructured debriefing in non-technical skills |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Canadian cohort
- Brazilian cohort
Key exclusion criteria (6 listed)
- Canadian cohort
- Brazilian cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DebriefingStructured debriefing in non-technical skills. (This is an educational study) | Other | Intervention |
Primary outcome
NOTSS score
Time frame: During the student's participation in the simulated scenarios (four hours)
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.
1 secondary outcome
Number of interventions performed
Time frame: During the student's participation in the simulated scenarios (four hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 28384795Global 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.
- Background: PubMed 31073425Kiragu 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.
- Background: PubMed 29915778Kiragu 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.
- Background: PubMed 24468024Roberts 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.
- Background: PubMed 24158191Ziesmann 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.
- Background: PubMed 25008243Higashi 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.
- Background: PubMed 32839149Lee 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.
- Background: PubMed 29478826Jung 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.
- Background: PubMed 30573294Patel 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.
- Background: PubMed 11541445Helmreich RL, Merritt AC, Wilhelm JA; New Collective Author. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32. doi: 10.1207/s15327108ijap0901_2.
- Background: PubMed 18558392Sevdalis 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.
- Background: PubMed 31589193Jensen 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.
- Individual participant dataSharing planned: Yes. Once study is published, according to the journal's/editor's policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Poenaru principal investigator
McGill University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debriefing in people with Injuries, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio Botelho, MD (5148208667, fabio.botelho@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOTSS score (time frame: During the student's participation in the simulated scenarios (four hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910515, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.