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Completed

NCT Number: NCT05952908

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

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.

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Key information

Conditions

Knowledge, Attitudes, Practice Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proficiency-Based Progression simulation training

Other

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 training

Other

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.

Primary outcomes

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

    Time frame: 1 hour post-intervention

    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.

  2. Number of Errors in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Procedural Errors 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.

  3. Number of Critical Errors in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Procedural Critical Errors 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.

  4. Number of Errors All Combined (Errors + Critical Errors) in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Procedural Errors All Combined, represents the total amount of deviations from optimal performance (Errors + Critical Errors) and it's an overall indicator of performance quality. The analysis will compare the medians of each group.

Secondary outcomes

  1. Procedure duration (min) in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).

  2. Fluoroscopy duration (min) in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).

  3. Cineradiography duration (s) in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).

  4. Contrast Media injected (ml) in the final skills assessment (median per group)

    Time frame: 1 hour post-intervention

    Four procedural measures will be derived from video-recordings of the implant performances on the virtual reality simulator: Procedure duration, Fluoroscopy duration, Cineradiography duration, amount of Contrast Media injected. The analysis will compare the medians of each group (each variable is compared independently).

  5. Score obtained in the online knowledge test (percentage of correct answers per group, from 0 [minimum, worst outcome] to 100 [maximum, best outcome])

    Time frame: 1 hour post-intervention

    At the completion of the online component of the training curriculum, trainees are required to take a summative knowledge test online. The scale title will be "Percentage of correct answers in the online assessment". The outcome will span from 0 [minimum, worst outcome] to 100 [maximum, best outcome].

  6. Number of trainees per study group demonstrating the proficiency benchmark in the final assessment

    Time frame: 1 hour post-intervention

    The number of trainees per study group demonstrating the proficiency benchmark in the video-recorded performance at the end of the training curriculum.

  7. 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])

    Time frame: 3 hours post-intervention

    Participants' satisfaction level regarding the training received expressed on a Likert scale; feedback will be provided anonymously through the training evaluation forms filled at the end of the program. The scale title will be "Probability of recommending the curriculum to a peer". The outcome will span from 0 [minimum, worst outcome] to 10 [maximum, best outcome].

Sponsors and collaborators

Lead sponsor

Jorio Mascheroni

Other

Registry information

Official study title

Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills

Acronym: IMPROF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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