Clinical trial NCT04173884: Video-based Collaborative Learning to Improve Ventral Hernia Repair
Official title: Video-based Collaborative Learning to Improve Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: University of Wisconsin, Madison
name: Abdominal Core Health Quality Collaborative
First posted: 2019-11-22
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Hernias of the abdominal wall are among the most common surgical disorders, with over 350,000 patients requiring repair annually for a total cost of $3.2 billion. Despite their prevalence, outcomes remain poor and variable, with recurrence rates that range between 32% and 63% at 10 years and a 5-fold difference in recurrence rates between surgeons. With the introduction of new repair techniques and continuous advances in biomedical devices and technology, it is difficult for practicing surgeons to stay abreast of new developments and incorporate these advances into their practice. Collaborative learning through video review can support continuous professional development and aid practicing surgeons in adopting new approaches and continually improving their own technical skills.

Surgeons have limited time to invest in surgical quality improvement despite recognizing its importance. A critical gap in our current knowledge is the optimal approach to video-based collaborative learning. The effectiveness of two approaches to video review and performance feedback are herein proposed to be compared: synchronous surgical coaching versus asynchronous feedback. This study will be performed in partnership with the Abdominal Core Health Quality Collaborative (ACHQC), formerly Americas Hernia Society Quality Collaborative (AHSQC). This name change took place in July 2020. Surgeons will be paired with a coach and will participate in collaborative review of ventral hernia repairs. Participants will be randomized to undergo in-person coaching or asynchronous feedback utilizing a web-based video platform or will be assigned to a wait-list control group. All participants will submit 2 procedural videos pre- and post-intervention for self-assessment and blinded expert review utilizing a previously validated assessment instrument to measure technical skill. The primary outcome is change in 30-day procedural outcomes, which are captured and risk adjusted in the ACHQC. Participants will be followed for 2 years to assess long-term recurrence rates. Other secondary outcomes include intervention adherence, time spent in review, and the perceived value of the different approaches.

These interventions will have immediate impact. Working with the ACHQC, the potential exists to improve quality and decrease costs for the 350,000 patients that require a ventral hernia repair annually. In addition, this will provide a new paradigm for surgical quality improvement and continuing professional development.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Technical Skill as Measured by OSATS Score
timeFrame: 1 year
measure: Change in Surgical Site Occurrence Rates
timeFrame: 1 year
measure: Intervention Adherence: Number of Surgeon Participants who Complete All Requisite Training and Session
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence Rates at 1 and 2 Years
timeFrame: 2.5 years
measure: Perceived Value
timeFrame: 2.5 years
measure: Time Efficiency Measured by the Amount of Time Spent in Activities Related to the Program
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Caprice C Greenberg, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: