Clinical trial NCT05952908: Effect of Simulation-based Procedure Training for Novice Cardiac Device Implanters Towards Implant Proficiency
Official title: Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: Proficiency-based progression
Training
Simulation
Metrics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of procedural Steps Completed in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Number of Errors in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Number of Critical Errors in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Number of Errors All Combined (Errors + Critical Errors) in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
Secondary outcomes:
measure: Procedure duration (min) in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Fluoroscopy duration (min) in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Cineradiography duration (s) in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Contrast Media injected (ml) in the final skills assessment (median per group)
timeFrame: 1 hour post-intervention
measure: Score obtained in the online knowledge test (percentage of correct answers per group, from 0 [minimum, worst outcome] to 100 [maximum, best outcome])
timeFrame: 1 hour post-intervention
measure: Number of trainees per study group demonstrating the proficiency benchmark in the final assessment
timeFrame: 1 hour post-intervention
measure: Participants' satisfaction level at the end of the training curriculum (mean score per group on a Likert scale, from 0 [minimum, worst outcome] to 10 [maximum, best outcome])
timeFrame: 3 hours post-intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: KU Leuven
name: Jorio Mascheroni
role: PRINCIPAL_INVESTIGATOR
References: