Clinical trial NCT05910515: Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills
Official title: Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injuries
Keywords: child
non-technical skills
pediatric trauma
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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:

1. Assess the ratings of medical students and general surgery trainees using the Non-Technical Skills for Surgeons (NOTSS) assessment tool.
2. Investigate the impact of individual differences, such as training experience, on NOTSS scores.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. Canadian cohort

   * McGill University, years 3 or 4 medical students. or
   * McGill University Health Centre general surgery residents
2. Brazilian cohort

   * Medical students, years 5 or 6. or
   * Brazilian general surgery residents

Exclusion Criteria:

1. Canadian cohort

   * Medical students of years 1 and 2;
   * Residents that are not from the General Surgery service;
2. Brazilian cohort

   * Medical students of years 1, 2, 3 \& 4.
   * Residents that are not from the General Surgery service;

Primary outcomes:
measure: NOTSS score
timeFrame: During the student's participation in the simulated scenarios (four hours)
Secondary outcomes:
measure: Number of interventions performed
timeFrame: During the student's participation in the simulated scenarios (four hours)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Medical schools in Brazil
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill
name: Dan Poenaru
role: PRINCIPAL_INVESTIGATOR
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