Effect of Simulation-based Procedure Training for Novice Cardiac Device Implanters Towards Implant Proficiency

Jorio Mascheroni32 enrolled

Overview

This is an educational research study involving novice cardiac device implanters willing to further enhance their device implant skills through optional simulation-based training. The goal is to prospectively compare the effect of two different simulation-based training approaches on the quality of operators' implant performance in a simulated environment. The hypothesis is that a novel simulation training curriculum requiring trainees to demonstrate predefined proficiency benchmarks to advance (proficiency-based progression method) would generate superior performances compared to a traditional simulation training curriculum without proficiency requirements but identical content/tools. At the end of the instruction each trainee will perform a final simulated implant procedure which will be (anonymously) video-recorded and consequently scored by independent reviewers using previously validated intraoperative performance metrics. The effect of the two training approaches will be evaluated and performances compared by group for each metric independently.

BACKGROUND: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels prior to in-vivo practice. Patients are potentially exposed to risks related to operators' early learning curve. A novel approach to enhance the learning outcome could be a metric-based, simulation training to proficiency. Such an approach to training is known as proficiency-based progression (PBP) and requires trainees to demonstrate a predefined proficiency benchmark, quantified by validated procedure performance metrics, before proceeding to the next stage of training. Published results in various domains of procedural medicine show that PBP trainees perform \~60% better compared to their non-PBP trained peers. This approach has never been tested for device implant training yet. INTERVENTION: The training curriculum developed for the study purpose will cover a triple chamber device system implantation (i.e., cardiac resynchronization therapy = CRT) and will comprise two mandatory modules: a self-paced e-learning component and a peer-to-peer simulation-based component at a skill center. The content, the resources and the agenda of the training curriculum will be the same for both study groups; only the criteria for the trainees to proceed through the training stages will differ. STUDY IMPLICATIONS: Compared to traditional simulation training, metrics-based training to proficiency may ensure a superior, consistent, objectively assessed target-level of operator's performance before they advance to (supervised) in-vivo practice.

Study Type

Interventions

Proficiency-Based Progression simulation trainingOTHER

The simulation-based training curriculum is delivered - with proficiency requirements - with the aim of further enhancing trainees' implant skills, as an optional supplement to their academic/institutional training.

Traditional simulation trainingOTHER

The simulation-based training curriculum is delivered - without proficiency requirements - with the aim of further enhancing trainees' implant skills, as an optional supplement to their academic/institutional training.

Outcomes

Primary Outcomes

Number of procedural Steps Completed in the final skills assessment (median per group)

Procedural Steps Completed is an intraoperative performance metric objectively assessed/scored from each trainee's (anonymous) simulated implant video-recording acquired at the end of the training as a final skills assessment. The analysis will compare the medians of each group.