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

Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills

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.

Study Overview

• Status: Completed
• Conditions: Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: Proficiency-Based Progression simulation training; Other: Traditional simulation training

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proficiency-Based Progression training group; 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).	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.
Active Comparator: Traditional training group; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jorio Mascheroni
• Investigators: Principal Investigator: Jorio Mascheroni, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): November 24, 2022
• Study Completion (Actual): November 24, 2022

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Training; Simulation; Metrics; Proficiency-based progression
• Other Study ID Numbers: KUL0912559-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data that underlie results in publications, as well as data dictionaries, will be made available when access criteria are met.
• IPD Sharing Time Frame: Proposals may be submitted up to 36 months following article publication.
• IPD Sharing Access Criteria: Types of analyses: For individual participant data meta-analysis. Who can access the data: Investigators whose proposed used of the data has been approved by an independent review committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No