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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05086783
Other study ID # 3629
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 6, 2021
Est. completion date December 2022

Study information

Verified date October 2021
Source Mount Sinai Hospital, Canada
Contact Brenna Swift
Phone 647-520-8468
Email brenna.swift@mail.utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This multi-centre, randomized controlled trial aims to assess the role of video-based coaching (VBC) in residency education in gynecologic and gynecologic oncology surgery. It involves a trainee and a surgical coach, who together review a recording of the trainee performing a surgical skill or procedure and coaching is provided for skill improvement. Resident performance will be evaluated using a standardized scoring scale by two experienced surgeons before and after the intervention and compared to the control group receiving the standard surgical teaching curriculum.


Description:

Achieving technical excellence is a core component of surgical training. Historically, a combination of didactic teaching, surgical simulation and the master-apprentice model (MAM) were the cornerstone of surgical education. With restrictions on resident duty hours and operating time with the COVID-19 pandemic and a shift to competency-based medical education, there is an opportunity to transform surgical education and improve educational efficiency. The purpose of this study is to assess the effect of video-based coaching (VBC) on resident skill acquisition in laparoscopic suturing of the vaginal vault at the time of laparoscopic hysterectomy. Participants will include year 3 to 5 Obstetrics and Gynecology residents completing gynecology and gynecologic oncology rotations at the study sites. Participants will be randomized to the control (standard surgical curriculum) and intervention (standard curriculum and VBC) arms on the day of the first attempt. The effectiveness of VBC will be measured by the difference in baseline and post-intervention standardized blinded score between the intervention and control group during laparoscopic closure of the vaginal cuff. All residents will be video recorded performing laparoscopic closure of the vaginal cuff at the time of hysterectomy using video recording built into the laparoscopic equipment in the operating rooms. Residents in the control group will receive standard surgical teaching (MAM), then they will be video-recorded performing the skill at their second attempt. Residents in the intervention group will receive the standard surgical teaching plus the intervention of reviewing the recorded video with the surgical coach at the end of the procedure (MAM plus VBC). The surgical coach will provide specific personalized feedback on performance and suggestions for improvement following the Wisconsin Coaching Framework during their coaching session. Participants will then be recorded on their subsequent attempt. All raw video footage will be edited to include only the relevant portion of the film. This will facilitate the assessment process (i.e., the assessors will view only the relevant footage). The edited video segments for both groups on both attempts will be scored independently using the validated surgical assessment tool by two blinded, experienced gynecologic laparoscopists to evaluate surgical performance (blinded to attempt number and randomization group). The average score between both assessors will be used for statistical analysis. The effectiveness of VBC will be evaluated by comparing the difference in assessment scores between the baseline and post-intervention scores between the control and intervention groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2022
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Postgraduate year (PGY) 3 to 5 residents in the Obstetrics and Gynaecology program at the University of Toronto - Completing chief gynecology rotation at Mount Sinai Hospital (MSH) and Sunnybrook Health Sciences Centre (SHSC), and gynecologic oncology rotation at University Health Network (UHN) and SHSC form Sept 2021 until June 2022 Exclusion Criteria: - Previous participation in study on another rotation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video-based coaching
The coaching session will follow the Wisconsin Coaching Framework (Greenberg 2015). The surgical coaching session will last at maximum 30 minutes and will occur within 1-2 week following the procedure. The surgical coaching session will occur over Zoom. The second attempt will occur within 1 week following the coaching session.
Standard surgical teaching (master-apprentice model - (MAM))
Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).

Locations

Country Name City State
Canada Mount Sinai Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
Mount Sinai Hospital, Canada Sunnybrook Health Sciences Centre, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in modified-OSATS (Objective Structured Assessment of Technical Skill) score after video-based coaching intervention compared to control of standard surgical teaching The modified OSATS score is a standardized rubric for assessing technical skills The first and second attempt will occur within a 1 month timeframe. The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
Secondary Participant assessment of desirability of video-based surgical coaching Desirability of the intervention will be evaluated based on the proportion of eligible residents who enrol in the study (number enrolled/number eligible). Desirability will be calculated at the end of study enrolment within 1 year,
Secondary Participant assessment of usefulness of video-based surgical coaching Participants in the intervention arm will complete a surgical coachee questionnaire to determine if the participants in the intervention arm found the coaching experience to be useful for developing their surgical skills. Questionnaire to be completed by participant within 1 month of second attempt.
Secondary Surgical coach assessment of feasibility of video-based surgical coaching Surgical coach will complete a questionnaire immediately after the coaching activity, which will collect time for video-editing, time for coaching session and receptivity of the participant to coaching Questionnaire to be completed by surgical coach on day of coaching session and all questionnaires will be completed within 1 year.
Secondary Inter-rater reliability of the video evaluations by the blinded, experienced laparoscopists The intraclass correlation coefficient (ICC) between the two score for each video will be calculated The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
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