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

Knowledge, Attitudes, Practice Clinical Trial

— IMPROF  

Official title:

Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05952908
• Other study ID #: KUL0912559-001
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: November 24, 2022

Study information

• Verified date: July 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 24, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Knowledge, Attitudes, Practice

Intervention

Other:
• Proficiency-Based Progression simulation training
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
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.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Jorio Mascheroni

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour post-intervention
Primary	Number of Errors in the final skills assessment (median per group)	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.	1 hour post-intervention
Primary	Number of Critical Errors in the final skills assessment (median per group)	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.	1 hour post-intervention
Primary	Number of Errors All Combined (Errors + Critical Errors) in the final skills assessment (median per group)	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.	1 hour post-intervention
Secondary	Procedure duration (min) in the final skills assessment (median per group)	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).	1 hour post-intervention
Secondary	Fluoroscopy duration (min) in the final skills assessment (median per group)	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).	1 hour post-intervention
Secondary	Cineradiography duration (s) in the final skills assessment (median per group)	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).	1 hour post-intervention
Secondary	Contrast Media injected (ml) in the final skills assessment (median per group)	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).	1 hour post-intervention
Secondary	Score obtained in the online knowledge test (percentage of correct answers per group, from 0 [minimum, worst outcome] to 100 [maximum, best outcome])	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].	1 hour post-intervention
Secondary	Number of trainees per study group demonstrating the proficiency benchmark in the final assessment	The number of trainees per study group demonstrating the proficiency benchmark in the video-recorded performance at the end of the training curriculum.	1 hour post-intervention
Secondary	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])	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].	3 hours post-intervention