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

NCT05952908 | Completed

• 1 other identifier: KUL0912559-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Knowledge, Attitudes, Practice

Keywords

Proficiency-based progression; Training; Simulation; Metrics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

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

  1 hour post-intervention

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

  1 hour post-intervention

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

  1 hour post-intervention

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

  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])

  1 hour post-intervention

Study Arms (2)

Proficiency-Based Progression training group

EXPERIMENTAL

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

Traditional training group

ACTIVE COMPARATOR

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

Interventions

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.

Proficiency-Based Progression training group

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.

Traditional training group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Jorio Mascheroni: lead

Study Sites (1)

KU Leuven

Leuven, Belgium

Location

Related Publications (1)

• Mascheroni J, Stockburger M, Patwala A, Mont L, Rao A, Retzlaff H, Garweg C, Verbelen T, Gallagher AG. Effect of Metrics-Based Simulation Training to Proficiency on Procedure Quality and Errors Among Novice Cardiac Device Implanters: The IMPROF Randomized Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2322750. doi: 10.1001/jamanetworkopen.2023.22750.

  PMID: 37651144 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Jorio Mascheroni

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 19, 2023
• Study Start: March 8, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Proposals may be submitted up to 36 months following article publication.
• 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.

Locations

BE (1)