Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05201950 |
| Other study ID # |
DSRB 2021/00542 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
February 10, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
National University Hospital, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
