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

Jorio Mascheroni

Status: Completed

Conditions: Knowledge, Attitudes, Practice

Treatments: Other: Proficiency-Based Progression simulation training; Other: Traditional simulation training

Study type: Interventional

Funder types: Other

Identifiers

NCT05952908

KUL0912559-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Physicians actively practicing cardiac device implantation at time of enrolment
• Minimum 20 pacemaker/defibrillator systems previously implanted as 1st operator
• Minimum 3 cardiac resynchronization therapy (CRT) systems previously implanted at least as 2nd operator
• Familiarity with English language (written and spoken)

Exclusion criteria

• Having previously implanted ≥ 200 CRT systems as 1st operator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Proficiency-Based Progression training group

Experimental group

Description:

Trainees in this group will follow the simulation-based implant training curriculum (same content/tools in both study arms) and they will be required to demonstrate a quantitatively defined proficiency benchmark at each training stage to be able to advance to the next stage (proficiency-based progression \[PBP\] approach).

Treatment:

Other: Proficiency-Based Progression simulation training

Traditional training group

Active Comparator group

Description:

Trainees in this group will follow the simulation-based implant training curriculum (same content/tools in both study arms) but they will not be required to demonstrate a quantitatively defined proficiency benchmark at each training stage to be able to advance to the next stage.

Treatment:

Other: Traditional simulation training