Video-based Collaborative Learning to Improve Ventral Hernia Repair

NCT04173884 | Completed DMC

• 5 other identifiers: 22-2309A539713SMPH/SURGERY/SURG ONC1R01HS025989-01Protocol Version 3/1/2019
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies demonstrate the critical role of individual surgeon performance, including both the approach they take to an operation as well as their technical skill, in determining patient outcomes. Utilizing the rich data collected by the Abdominal Core Health Quality Collaborative (ACHQC), formerly Americas Hernia Society Quality Collaborative (AHSQC), for its 200 members performing ventral hernia repair in the United States, the investigators will examine the effectiveness of video-based collaborative learning to provide feedback and improve surgical performance and patient outcomes. A prospective randomized trial comparing two interventions is proposed, comparing live video-based surgical coaching and video-based feedback using time-stamped annotations that can be reviewed at a later time to a wait-list control group drawn from the same cohort of surgeons. The results have the immediate potential to improve the quality of care for the 350,000 patients requiring ventral hernia repair each year, while also providing critical evidence to support a novel approach to surgical performance improvement more broadly.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (3)

• Change in Technical Skill as Measured by OSATS Score

  A repeated measures ANOVA will be used to assess the Objective Structured Assessment of Technical Skills (OSATS) score between the two baseline and two follow-up measures for surgeons randomly assigned to the Coaching and Constructive Feedback intervention arms, as compared with the wait-list control group. The modified OSATS instrument is a validated rubric that assesses a surgeon's overall technical skill. Skill is measured as both a summary score on a scale from 1 (deficient) to 5 (expert), or as a total score across five subdomains (gentleness, tissue exposure, instrument handling, time and motion, flow of operation). Each domain is rated on the same 1 to 5 point Likert scale, leading to overall scores ranging from 5-25. Scoring will continue until a minimum of 15 scores are obtained for each video.

  1 year

• Change in Surgical Site Occurrence Rates

  The approach to the assessment of change in Surgical Site Occurrence (SSO) rates from baseline to follow-up will be assessed similarly to technical skill; however, in this case longitudinal mixed model Poisson regression will be used, with group assignment as the primary explanatory variable. The data will be examined for over dispersion. SSO is a well-defined measure for ventral hernia repair and a composite measure of several outcomes collected through the ACHQC. This includes surgical site infection, seroma, wound dehiscence, and enterocutaneous fistula.

  1 year

• Intervention Adherence: Number of Surgeon Participants who Complete All Requisite Training and Session

  Intervention adherence will be assessed as the proportion of surgeon participants in each of the arms that complete all of the requisite training and sessions. Based on previous experience, an estimate of 75% of surgeons will complete all 3 sessions in the real-time coaching arm, while 50% will complete all 3 cases in the Asynchronous Feedback arm. This is the hypothesis based on challenges in prior studies in coordinating stand-alone activities with surgeons. Prior work suggests all surgeons who volunteer will participate in a minimum of one intervention component.

  1 year

Secondary Outcomes (3)

• Recurrence Rates at 1 and 2 Years

  2.5 years

• Perceived Value

  2.5 years

• Time Efficiency Measured by the Amount of Time Spent in Activities Related to the Program

  2.5 years

Study Arms (3)

Live Surgical Peer Coaching

ACTIVE COMPARATOR

Coaches will facilitate an initial, individual, introductory phone call with participants prior to the first formal coaching session. The objective of this call is to develop rapport, explore each other's background, experience, and motivation for participation in the program, set overall goals for the program, set specific goals for the first coaching session, develop an action plan including identification of the key characteristics of the first case for review, and develop a timeline and plan for meetings. Peer coaching sessions will be scheduled at three national meetings that are commonly attended by ACHQC surgeons. In advance of each meeting, participants will record and upload a self-selected video to a secure server maintained by the study team, and coaches will have the opportunity to review the video if they wish to prepare. A live coaching session will be organized at the meeting where the coaches and participants will have parallel one-hour coaching sessions.

Other: Coaching

Asynchronous Video-based Constructive Feedback

ACTIVE COMPARATOR

There will be no real-time interpersonal contact between coaches and participants in this arm. Participants will upload their self-selected procedural video to the video review platform, together with a short description of the case and any specific questions. The coach will review the video within one week of its posting and provide time-stamped feedback on the video platform. Participants will then review the coach's feedback within one week with the ability to respond to the comments. The coach and participant will continue communication via the internet-based review platform until no further comments are made by either party. Coach-participant dyads are expected to review three videos during the 6 month intervention period.

Other: Constructive Feedback

Wait-List Control

ACTIVE COMPARATOR

One-third of participants will be randomized to an intervention, but wait-listed to provide a control group. These surgeons will submit two videos for technical skill evaluation during each of the baseline and follow-up periods, and ACHQC data will be tracked for short-term outcomes prior to their crossover to the intervention for long-term follow-up. Selecting the control group using the identical sampling frame of ACHQC surgeons participating in the interventions affords the opportunity for a comparable group with outcome metrics recorded systematically.

Other: Coaching; Other: Constructive Feedback

Interventions

Coaching OTHER

Surgical coaching is based on a peer coaching model that has been proven to be highly effective in other disciplines and for surgeons in training. Surgical coaching can improve technical performance in one of two ways: 1) identifying new or alternative approaches to the procedure; or 2) improving surgeon technical skill, which can lead to improvements in patient outcomes. In this proposal, our primary objective is to evaluate the effectiveness of video-based collaborative learning for surgeons.

Live Surgical Peer Coaching; Wait-List Control

Constructive Feedback OTHER

Constructive feedback is critical for performance improvement. It is currently unknown, however, whether asynchronous constructive feedback alone, without interactive discussions with a coach, would be as acceptable and valued as formal in-person coaching. Furthermore, the effectiveness of either approach to collaborative learning in improving surgical performance and outcomes is not known.

Asynchronous Video-based Constructive Feedback; Wait-List Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACHQC membership in good standing
• submission of a minimum of 10 eligible cases within the 6 months preceding the time of enrollment in the trial

You may not qualify if:

• not an ACHQC member
• not submitting cases to ACHQC within the 6 months preceding the time of enrollment in the trial

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• University of Wisconsin, Madison: collaborator
• Abdominal Core Health Quality Collaborative: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792-1690, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Caprice C Greenberg, MD MPH

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: September 1, 2019
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: November 10, 2025

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)