Study of Virtual Simulated Resuscitation in Junior Clinicians
Condition: Education, Medical
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Outcome assessment:

        -  Scores obtained based on number of correct actions completed in a timely manner, during
           simulated resuscitation with a high fidelity manikin around the end of the 3rd month of
           their posting, as compared to a checklist of required actions derived from expert
           consensus among NUH emergency department clinicians, and aligned to established
           international guidelines for resuscitation in sepsis or trauma (e.g. Advanced Trauma
           Life Support 10th edition).

        -  Two trained and standardised assistants, playing the roles of one nurse and one doctor,
           will be present to assist the medical officer, who will take the role of resuscitation
           team leader.

        -  Each study participant will be observed and marked on two scenarios: one scenario on
           major trauma resuscitation, and one scenario on resuscitation of a patient with sepsis.
           Marking will be performed independently by two investigators (E and F) who will
           calibrate and standardise their ratings by watching one investigator (A) perform
           simulated resuscitation at different levels of competence, and using that as a stimulus
           to calibrate their ratings.

        -  All assistants and assessors doing marking will be blinded to participant allocation,
           and will not be involved in team based in situ simulated resuscitation during the study
           period.

      Other data collection:

        -  Learner demographic data, level of post graduate experience generally and in emergency
           medicine, and views regarding assigned intervention (i.e. Kirkpatrick level of
           reaction), will be collected via an online questionnaire.

        -  The following virtual simulation metrics will be automatically captured: Number of
           attempts for each unique case, time spent on each attempt, scores obtained during each
           attempt as marked by a virtual patient simulator

      Data analysis:

      - Descriptive statistics of the following will be tabulated:

        -  Baseline characteristics of learners in each group, to determine effectiveness of
           randomisation

        -  Learner reaction data, to determine extent of acceptability of virtual patient
           simulation based on learner perception

        -  Mean, median, and measures of spread (either standard deviationor interquartile range,
           depending on whether data is normally distributed) of scores obtained

      Analysis for associations:

        -  Primary outcome: Association between exposure to virtual patient simulation (categorical
           variable) and marks obtained during observed in-situ resuscitation using a high fidelity
           manikin (likely to be a continuous variable with normal distribution, and this pilot
           study would help to determine if that is true), as measured by number of correct actions
           completed on a checklist derived from local expert consensus, rated by two independent
           observers (Investigators E and F) with statistical testing using a 2-tailed student
           t-test.

           --> Interobserver agreement will be measured using intra class correlation

        -  The investigators acknowledge that as a pilot, the analyses are unlikely to be
           adequately powered. Nonetheless, understanding the distribution of marks in each group,
           including mean/median/measures of variance, would be useful for planning further study.
    

Intervention name(s): Virtual simulation; Team based in situ simulation
Intervention type(s): Other; Other
Intervention description(s): Virtual simulation using Full-Code, a virtual simulation software with a bank of emergency medicine cases; In situ simulation, using a high fidelity manikin in the critical care area of the emergency department, with team members consisting of multiple junior doctors and nurses, facilitated by senior emergency medicine doctors and nurses.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to learning through either virtual simulation, or team based in situ simulation, and are not planned to cross over during the study period.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other