Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills

June 9, 2023 updated by: Dan Poenaru, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Regular debriefing
Experimental: Intervention
Structured debriefing in non-technical skills
Other: Debriefing
Structured debriefing in non-technical skills. (This is an educational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the student's participation in the simulated scenarios (four hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of interventions performed
Time Frame: During the student's participation in the simulated scenarios (four hours)
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.
During the student's participation in the simulated scenarios (four hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Dan Poenaru, McGill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-7561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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