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临床试验/NCT01895868
NCT01895868已完成不适用

Long-terms Effects of Simulation-based Ultrasound Training: A Randomized Trial

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Technical ultrasound performances

研究概览

简要总结

The clinical effects of simulation-based ultrasound training has not yet been explored. To examine the long-term effects of training, we plan to conduct a trial, where half of all new residents are randomized to simulation-based training and the other half to traditional clinical training only. The effects are assessed after two months of practice by evaluating two ultrasound scans performed by the residents. These scans are subsequently evaluated by a blinded consultant gynecologist and rated using the Objective Structured Assessment of Ultrasound Skills, which has been validated in previous studies.

详细描述

Ultrasonography has become increasingly used in many medical specialties over the last decades as smaller and less expensive ultrasound equipment has become available. Although ultrasound imaging traditionally is considered safe, its use is highly operator dependent (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that eventually compromise patient safety due to unnecessary tests or interventions (Moore & Copel 2011). Clinical ultrasound training is challenged with long learning curves and is therefore both time consuming and requires large teacher resources (Jang et al. 2010). Some trainees may therefore never acquire the basic skills and knowledge needed for independent practice (Tolsgaard et al. 2012). In the search for effective training methods, simulation-based training has proven to be an effective adjunct to clinical training, which has been documented in several studies on interventional procedures (Larsen et al. 2009, Zendejas et al 2011, Barsuk et al. 2009). Most comparative studies on simulation-based training have, however, only examined the initial effects of simulation-based training on the first couple of procedures, it is not known if VR simulation training provides sustained improvements trainee performance throughout their learning curves until they reach clinical proficiency. Large resources are currently being allocated to simulation training in many different specialties but the effects of simulation may easily be over-estimated if only evaluating the immediate effects of simulation training. A small difference in the number of supervised ultrasound examinations needed for proficiency may not justify the financial costs associated with investing in simulation equipment, space for simulation training as well as teacher resources during simulation training. Therefore, the research questions of this study was:

In a group of ultrasound novices, what are the implications of simulation-based training compared to clinical training alone on the technical quality of scans performed after two months of training?

Methods

Study design This study is reported according to the CONSORT statement (www.consort-statement.org). A randomized observer-blind study to compare VR ultrasound training with traditional supervised practice on subsequent patient scans (see Figure 1 for flowchart of study design). Ethical approval was obtained from the Regional Ethical Committee of the Capital Region, Denmark. The Danish Data Protection Agency approved the storing of patient relevant information. This randomized trial is reported to clinicaltrials.gov prior to inclusion of participants.

Setting This study is carried out at the Departments of Gynecology at the Juliane Marie Centre, Copenhagen University Hospital, Denmark, Næstved Hospital, and Hillerød Hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • proficiency in written and oral Danish, 2) informed written consent.

排除标准

  • prior employment at an OB/GYN department in a clinical position, 2) any formal ultrasound training with or without hands-on practice and (3) prior experience with virtual reality simulation.

结局指标

主要结局

Technical ultrasound performances

时间窗: 2 months

The main outcome measure is the technical proficiency after two months of practice. Two scans from the emergency department are recorded and subsequently assessed by a blinded clinician, who also had access to the ultrasound descriptions that corresponded to each scan. The assessments were performed using the Objective Structured Assessment of Ultrasound Skills (Tolsgaard et al. 2013), which has been validated in a construct validity study including 30 clinicians with different levels of experience prior to this trial.

次要结局

  • Diagnostic accuracy(Two months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin G. Tolsgaard

MD PhD

Rigshospitalet, Denmark

研究点 (2)

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