Effect of Quality Assured Simulation Training on Cardiac Device Implanter Skills
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Errors in the final skills assessment (median per group)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Having previously implanted ≥ 200 CRT systems as 1st operator
研究组 & 干预措施
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).
干预措施: Proficiency-Based Progression simulation training (Other)
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.
干预措施: Traditional simulation training (Other)
结局指标
主要结局
Number of Errors in the final skills assessment (median per group)
时间窗: 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.
Number of Errors All Combined (Errors + Critical Errors) in the final skills assessment (median per group)
时间窗: 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.
Number of procedural Steps Completed in the final skills assessment (median per group)
时间窗: 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.
Number of Critical Errors in the final skills assessment (median per group)
时间窗: 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.
次要结局
- Cineradiography duration (s) in the final skills assessment (median per group)(1 hour post-intervention)
- Number of trainees per study group demonstrating the proficiency benchmark in the final assessment(1 hour post-intervention)
- Fluoroscopy duration (min) 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)
- 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])(3 hours post-intervention)
- Procedure duration (min) 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)
研究者
Jorio Mascheroni
Principal Investigator
Universitaire Ziekenhuizen KU Leuven