EducationNCT05086783
Video-based Coaching (VBC) in Gynecologic Surgery
A study testing Video-based coaching and Standard surgical teaching (master-apprentice model - (MAM)) in people with Education and Surgery, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Surgery, Gynecologic Cancer
- What is being tested?
- Video-based coaching and Standard surgical teaching (master-apprentice model - (MAM))
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Oct 2021to Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous participation in study on another rotation
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Danielle Vicus, MD, (416) 480-4378, danielle.vicus@sunnybrook.ca
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1Z5
Evan Tannenbaum, MD, MSc, 416-586-4800 ext. 3758, Evan.Tannenbaum@sinaihealth.ca
- Not yet recruiting
University Health Network
Toronto, Ontario, M5G 1Z5
Stephane Laframboise, MD, (416) 946-2254, stephane.laframboise@uhn.ca
About this study
Official title: A Multicentre, Randomized Controlled Trial to Assess Video-based Feedback for Surgical Coaching in Gynecology and Gynecologic Oncology
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.
Read the detailed 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.
- Conditions
- Education, Surgery, Gynecologic Cancer
- Being tested
- Video-based coaching, Standard surgical teaching (master-apprentice model - (MAM))
- Keywords
- Surgical education, Coach, Laparoscopy, Gynecologic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based coachingOther
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))Other
Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM).
| Study group | Role | What they receive |
|---|---|---|
| Video-based coaching | Experimental | Participants in the intervention arm will receive the standard surgical teaching while in the operating room (master-apprentice model (MAM)), plus the intervention of reviewing the recorded video with the surgical coach after performing their first attempt at laparoscopic closure of the vaginal vault. Receives: Other: Video-based coaching; Other: Standard surgical teaching (master-apprentice model - (MAM)) |
| Standard surgical teaching | Placebo comparator | Participants in the control arm will receive the standard surgical teaching while in the operating room (master-apprentice model-(MAM)). Receives: Other: Standard surgical teaching (master-apprentice model - (MAM)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (4)
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).
Measured: Desirability will be calculated at the end of study enrolment within 1 year,
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.
Measured: Questionnaire to be completed by participant within 1 month of second attempt.
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
Measured: Questionnaire to be completed by surgical coach on day of coaching session and all questionnaires will be completed within 1 year.
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
Measured: The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start6 Oct 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies 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
- Model description
- Participants will be randomized to the intervention (video-based coaching plus standard surgical teaching following the master-apprentice model) or the control (standard surgical teaching following the master-apprentice model)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, University Health Network, Toronto
- Responsible party
- Principal investigator, Evan Tannenbaum, Mount Sinai Hospital, Canada
- Investigators
- Evan Tannenbaum, MD, MSc, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086783
- Sponsor's protocol ID
- 3629
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized Controlled Trial to Assess Video-based Feedback for Surgical Coaching in Gynecology and Gynecologic Oncology
- ClinicalTrials.gov ID
- NCT05086783
- Acronym / sponsor ID
- 3629
- Conditions
- Education, Surgery, Gynecologic Cancer
- Keywords
- Surgical education, Coach, Laparoscopy, Gynecologic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, University Health Network, Toronto
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Oct 2021 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to the intervention (video-based coaching plus standard surgical teaching following the master-apprentice model) or the control (standard surgical teaching following the master-apprentice model)
| Arm | Type | Receives |
|---|---|---|
| Video-based coaching | Experimental | Other: Video-based coaching, Other: Standard surgical teaching (master-apprentice model - (MAM))Participants in the intervention arm will receive the standard surgical teaching while in the operating room (master-apprentice model (MAM)), plus the intervention of reviewing the recorded video with the surgical coach after performing their first attempt at laparoscopic closure of the vaginal vault. |
| Standard surgical teaching | Placebo comparator | Other: Standard surgical teaching (master-apprentice model - (MAM))Participants in the control arm will receive the standard surgical teaching while in the operating room (master-apprentice model-(MAM)). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Previous participation in study on another rotation
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 |
|---|---|---|
| Video-based coachingThe 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. | Other | Video-based coaching |
| Standard surgical teaching (master-apprentice model - (MAM))Standard surgical teaching that conventionally occurs in the operating room follows a master-apprentice model (MAM). | Other | Standard surgical teaching, Video-based coaching |
Primary outcome
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
Time frame: 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.
The modified OSATS score is a standardized rubric for assessing technical skills
4 secondary outcomes
Participant assessment of desirability of video-based surgical coaching
Time frame: Desirability will be calculated at the end of study enrolment within 1 year,
Participant assessment of usefulness of video-based surgical coaching
Time frame: Questionnaire to be completed by participant within 1 month of second attempt.
Surgical coach assessment of feasibility of video-based surgical coaching
Time frame: Questionnaire to be completed by surgical coach on day of coaching session and all questionnaires will be completed within 1 year.
Inter-rater reliability of the video evaluations by the blinded, experienced laparoscopists
Time frame: The blinded assessors will complete the evaluation of the surgical videos for performance within 6 months of study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Evan Tannenbaum, MD, MSc principal investigator
MOUNT SINAI HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based coaching and Standard surgical teaching (master-apprentice model - (MAM)) in people with Education and Surgery, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
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 2 inclusion and 1 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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. Some participants in this study may receive a placebo. 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 Brenna Swift (647-520-8468, brenna.swift@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2021.