Effect of Video-based Guided Self-reflection on Intraoperative Skills

NCT04643314 | Unknown

• 1 other identifier: 2020-6348
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Self-assessment and reflection are integral parts of medical experiential learning; however the value of video-based self-reflection in enhancing surgical skill acquisition remains to be determined. The objective of the proposed pilot study is to investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) aimed to evaluate the effectiveness of coached video-based self-reflection approach on surgical trainee performance of laparoscopic cholecystectomy.

Conditions

Laparoscopy

Keywords

laparoscopic surgical skills; self-reflection; operative recording; laparoscopic cholecystectomy; surgical education

Outcome Measures

Primary Outcomes (4)

• Feasibility: Rate of recruitment (acceptability of the trial by trainees)

  % of eligible residents who agree to participate in the study

  1 year

• Feasibility: Rate of recruitment (acceptability of the trial by attending surgeons)

  % of eligible attending surgeons who agree to participate in the study

  1 year

• Feasibility: Adherence to intervention

  % of adherence with intervention (surgeons: intra-operative assessments; trainees: video-based assessments)

  1 year

• Feasibility: Rate of missing assessment data

  % of missing responses

  1 year

Secondary Outcomes (5)

• Intraoperative performance- In-person: attending surgeon

  1 year

• Procedural times

  1 year

• Perceived usefulness

  through study completion, an average of 1 year

• Mindset

  through study completion, an average of 1 year

• Intraoperative performance-Video-based: blinded expert assessor

  1 year

Study Arms (2)

Guided video-based self-evaluation

EXPERIMENTAL

In addition to their usual residency training, participants randomized to this group will undergo the following interventions: The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure.

Other: Guided video-based self-evaluation

Traditional intraoperative teaching

NO INTERVENTION

Subjects randomized to this group will undergo their usual residency training. The recordings of the 5 submitted consecutive laparoscopic cholecystectomy procedures performed by the participant as the primary operator will be stored. However participants in this arm of the study will not have access to the uploaded videos until the end of the study.

Interventions

Guided video-based self-evaluation OTHER

In addition to their usual residency training, participants randomized to this group will undergo the following interventions: The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure.

Guided video-based self-evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All residents involved at the McGill General Surgery Program (total of 35 residents on clinical rotations)

You may not qualify if:

• None

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H8N0C8, Canada

RECRUITING

Study Officials

• Liane S Feldman, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liane S Feldman, MD

CONTACT

5149341934; liane.feldman@mcgill.ca

Saba Balvardi, MD

CONTACT

saba.balvardi@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, the participants (resident trainees) cannot be blinded, however the assessors (attending surgeons) who will rate performance will be unaware of group allocation. Any inadvertent unblinding will be reported.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Chief of the Division of General Surgery at McGill University

Model Details: The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: November 25, 2020
• Study Start: August 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)