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临床试验/NCT05201950
NCT05201950已完成不适用

Pilot Randomised Controlled Trial of Virtual Patient Simulation Versus In-situ Simulation for Improving Performance in Trauma and Sepsis Resuscitation in Junior Clinicians in the Emergency Department

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Score obtained in outcome assessment simulation

研究概览

简要总结

The investigators seek to examine the impact of virtual patient simulation on junior clinicians' resuscitation skills in an academic emergency department.

Exposure to real life resuscitation cases is opportunistic, with variation in case mix across different junior clinicians. Junior clinicians are closely supervised during resuscitations, with limited independence to make decisions, for patient safety.

High fidelity simulation, such as in-situ mock codes with a high fidelity manikin, is resource intensive. Constraints in facilitator and learner time and manpower reduce the feasibility of holding large numbers of simulations for large numbers of learners, leading to limited breadth of case mix exposure in simulation cases.

Virtual patient simulation may allow greater and more uniform breadth of exposure and allow automated feedback and rapid cycle deliberate practiceacross a wide range of cases, with reduced resource intensiveness, and prepare them to better utilise limited opportunities for resuscitation during real life or high fidelity simulation.

Virtual simulators have been found to be useful for improving skills rather than knowledge or attitudes in health professions education. Such skills include communication, radiograph interpretation, dermatological diagnosis, and cardiac arrest procedures.

What is not known is:

  1. Whether going directly to in-situ simulation with a high fidelity manikin is the best learning approach for resuscitation, given its potentially detrimental high cognitive load, compared to going first to virtual patient simulation.
  2. Whether the benefits of virtual simulation extend beyond cardiac arrest and to other resuscitation scenarios, such as trauma, sepsis, and others.

The investigators' hypothesis is that in junior clinicians in the emergency department who have received didactic materials in trauma and sepsis resuscitation, proceeding next to learning by virtual patient resuscitation simulation is associated with improved scores in resuscitation performance for trauma and sepsis, as measured by checklists of required actions during observed in-situ simulation with a high-fidelity manikin, compared to proceeding next to learning by team-based in-situ simulation with a high fidelity manikin. This pilot study aims to determine the feasibility of a randomised controlled trial to test the above hypothesis.

详细描述

Sample size: For a pilot study, a sample size of at 24-50 participants is advisable to be informative regarding population characteristics such as expected means and standard deviation, to facilitate future study, where sample size calculation will target a small standardised effect size of 0.2, where standardised effect size would be the difference in means divided by standard deviation. About 50 junior clinicians are anticipated to rotate through NUH emergency department for at least 3 months in 2022.

Randomisation:

  • After informed consent and recruitment, participants will be randomised to virtual simulation versus in-situ simulation groups, through the use of opaque sealed envelopes. The randomisation sequence will be generated by one investigator (A), with block randomisation in varying block sizes, while another investigator (B) will open envelopes to allocate learners to their groups, to maintain allocation concealment.

Interventions:

  • Two investigators (C and D) will schedule participants for assigned interventions, namely virtual simulation or team-based in-situ simulation. As team-based in-situ simulation sessions are dispersed across each month, virtual simulation sessions will be matched to in-situ simulation days, to prevent confounding by time from outcome assessment. All interventions will be scheduled after didactic materials for resuscitation have been delivered to learners as part of standard departmental curriculum.
  • Virtual simulation group: Participants will log in to the virtual simulation software from home and play 2 cases (1 case of sepsis, 1 case of trauma). Participants are instructed to play each case as many times as personally desired within 70 minutes, to reach the highest score possible in that time. This process is proctored, with participants sharing their screen over video conferencing with two investigators (C and D) to ensure adherence to time limit and cases played.
  • Team based in situ simulation group: Faculty observing and debriefing learners at the mock code will be variable and consist of a wide range of NUH emergency department faculty outside of this study, due to logistical constraints in having the same faculty being present consistently in the entire year. The in situ simulation will cover 1 case of sepsis, and 1 case of trauma, with case content matched to the cases in the virtual simulation group, and time matched at 70 minutes.

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 (Investigator, Outcomes Assessor)

盲法说明

Participants: it is not feasible to mask participants from their educational intervention Investigator: Two investigators (JCL and LZY) will not be masked as they will be scheduling and delivering interventions. The remaining investigators will be masked, including those assisting participants as standardised assistants during outcome assessment simulation.

Outcome assessors: They will be masked from participants' group assignment.

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Junior doctors scheduled to rotate through NUH emergency department for at least 3 months

排除标准

  • •Pregnant women will be excluded from the study as the study procedures do involve additional exposure to fellow healthcare workers, with the associated risk of COVID transmission, while there is no direct benefit in terms of generalisable knowledge about pregnancy or the fetus.

研究组 & 干预措施

Virtual simulation

Experimental
  • Virtual simulation group: Participants will log in to the virtual simulation software from home and play 2 cases (1 case of sepsis, 1 case of trauma). Learners are instructed to play each case as many times as they like within 70 minutes, to reach the highest score possible in that time. This process is proctored, with participants sharing their screen over video conferencing with study team members (JCL or LZY) to ensure adherence to time limit and cases played.

干预措施: Virtual simulation (Other)

Team based in situ simulation

Active Comparator
  • Team based in situ simulation group: Faculty observing and debriefing learners at the mock code will be variable and consist of a wide range of NUH emergency department faculty outside of this study, due to logistical constraints in having the same faculty being present consistently in the entire year. The in situ simulation will cover 1 case of sepsis, and 1 case of trauma, with case content matched to the cases in the virtual simulation group, and time matched at 70 minutes.

干预措施: Team based in situ simulation (Other)

结局指标

主要结局

Score obtained in outcome assessment simulation

时间窗: At end of 3rd month of junior clinicians' emergency medicine rotation

Participants will be assessed by 2 independent assessors using a standardised checklist during simulation with a high fidelity manikin and standardised assistants in two scenarios: trauma, and sepsis

次要结局

  • Learner satisfaction(Within one week after completion of assigned intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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