NCT04512560

Brief Summary

Surgical coaching, defined as a constructive relationship that provides objective feedback to individuals about a broad range of factors influencing operative performance, is a key strategy for integrating adult learning theory into the traditionally didactic arena of surgical education. It is gaining momentum as an area of potential growth and innovation, and may become a more meaningful method of ongoing professional development for practicing surgeons. Effective coaching interactions encourage discussion, provide feedback, affirm positive beliefs and challenge pre-existing assumptions. The effectiveness and uptake of coaching interventions in surgery can be influenced by the identity of the coach, and cultural or individual surgeon attitudes. Surgical coaching has been linked to improvements in technical and procedural skills in both simulated and clinical environments. In 2015, a systematic review of surgical coaching showed a positive impact of surgical coaching interventions on learners' perceptions and attitudes, their technical and nontechnical skills, and their performance measures. The investigators propose to conduct a multicenter randomized controlled trial of structured remote surgical coaching (SRSC) versus conventional surgical training for laparoscopic cholecystectomy performed by surgery residents at three institutions, in Canada and Australia, to not only provide additional evidence in support of validity and generalizability of a structured surgical coaching intervention for surgery trainees, but also to demonstrate improvement in accuracy of self-assessment of operative performance and the feasibility of remote coaching.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 17, 2024

Status Verified

July 1, 2024

Enrollment Period

3.5 years

First QC Date

March 31, 2020

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Skill set during performance of a laparoscopic cholecystectomy in the operating room

    Technical skills during a laparoscopic cholecystectomy in the operating room will be one of the primary outcomes for this study. The Global Operative Assessment of Laparoscopic Skills (GOALS) scale will be used to measure this outcome.

    90 days

  • Technical errors made during a laparoscopic cholecystectomy in the operating room

    Technical errors during a laparoscopic cholecystectomy in the operating room will be one of the primary outcomes for this study. The Generic Error Rating Tool (GERT) will be used to measure this outcome.

    90 days

Secondary Outcomes (2)

  • Subjective assessment of the usefulness of SRSC program

    90 days

  • Accuracy of self-assessment

    90 days

Study Arms (2)

Structured Remote Surgical Coaching

EXPERIMENTAL

Participants randomized to the intervention group will participate in a 3-month SRSC program in addition to CST. Participants will be asked to provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon prior to the coaching session. Each coach will review the video recording and will identify key themes for discussion. Coaching sessions will be structured using the modified PRACTICE model, will be conducted outside of the clinical environment, and will employ facilitative coaching methods to encourage participants to define specific intra-operative problems and conceptually troubleshoot various solutions.

Behavioral: Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training

Conventional Surgical Training

ACTIVE COMPARATOR

Participants randomized to the control group will continue of their usual general surgery residency training including attending scheduled teaching sessions, and continuing with assigned responsibilities on the ward and in the OR.

Behavioral: Surgical Training using Conventional Training Program

Interventions

General surgery residents (PGY 1-5) will provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon. The coach will identify key moments or themes for discussion on how to improve technical skills and reduce intra-operative errors during five, 30-45 minute remote coaching sessions .

Structured Remote Surgical Coaching

General surgery residents (PGY 1-5) will continue their usual residency training.

Conventional Surgical Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General surgery residents (PGY 1-5) who routinely perform components of laparoscopic cholecystectomy as a primary surgeon (under supervision).

You may not qualify if:

  • Individuals with injuries that preclude performance in the operating room will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L4V1, Canada

Location

Study Officials

  • Boris Zevin, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Technical skills and technical errors will be assessed by a trainer rater blinded to the participant's group allocation and level of training.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor & Medical Education Scholar

Study Record Dates

First Submitted

March 31, 2020

First Posted

August 13, 2020

Study Start

February 1, 2021

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

October 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations