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临床试验/NCT06376006
NCT06376006进行中(未招募)不适用

Prospective Multicenter Study Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees Using A Standardized Assessment Tool: A Quality Improvement Initiative

AdventHealth2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
AdventHealth
入组人数
42
试验地点
2
主要终点
Primary Endpoint

研究概览

简要总结

Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs).

详细描述

Baseline and Post-Training Questionnaires: The EMR-STAT Baseline Questionnaire is to better understand the participant's level of comfort with the C-EMR procedure. At the end of their training, the participant will complete the EMR-STAT Post-Training Questionnaire to evaluate their training experience.

Standardized Assessment tool (EMR-STAT) and Grading Protocol (Phase 1): The EMR-STAT is a tool designed for competence assessment. The tool will be used in a continuous fashion during the AETs training in colorectal EMR. The aim of the tool is to evaluate key concepts and core skills necessary for high-quality colorectal EMR as recently outlined by the US Multi-Society Task Force on Colorectal Cancer10. We have previously demonstrated the feasibility of this tool in a prior study9. The instrument evaluates for key cognitive and technical steps, including scope positioning, lesion assessment, submucosal lifting, endoscopic resection, adjunct resection/ablative techniques, management of adverse events, and elective defect closure. A 4-point scoring system was developed to grade each endpoint: 4 (superior), achieves task without instruction; 3 (advanced), achieves with minimal verbal cues; 2 (intermediate), achieves with multiple verbal cues or hands-on assistance; 1 (novice), unable to complete and requires trainer to take over. Setting these pre-defined anchors for specific individual cognitive and technical skills during grading ensures that the data collected are reproducible from one evaluator to the next. In addition, a 10-point overall assessment score (1-3, below average; 4-6, intermediate; 7-9, advanced; 10, superior) will be provided for each case. This grading format for endoscopic performance has been previously validated6,11,12

The trainees will be evaluated during live cases as part of the training experience. There will patient data that will be collected on the EMR_STAT but no patient identifiers will be documented. This data collection is integral to the study because these factors may play a role in the complexity of the procedure and impact trainees' EMR performance (ex. a cancerous lesion is more difficult to dissect than a non-cancerous lesion). This data will be analyzed as part of the learning curve for the trainees

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. All AETs from the participating centers starting their advanced endoscopy fellowship training in the academic year of 2022 (regardless of prior experience with colorectal EMR)
  • 2. Patients 18 years of age or older undergoing colonoscopy with EMR by the AET being evaluated for this study

排除标准

  • 1. AETs in Advanced endoscopy programs that do not train AETs in colorectal EMR or AETs who do not intend to train in colorectal EMR during their fellowship will be excluded

结局指标

主要结局

Primary Endpoint

时间窗: 12 months

The primary endpoint will be the establishment of minimum thresholds in colorectal EMR training, including benchmarks for pre-defined cognitive and technical core skills based on the survey responses from study participants.

次要结局

未报告次要终点

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (2)

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