Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03233750 |
| Other study ID # |
20170081-01H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2017 |
| Est. completion date |
August 30, 2019 |
Study information
| Verified date |
March 2023 |
| Source |
Ottawa Hospital Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Previous research has shown that health professionals can experience stress responses during
high acuity events such as trauma resuscitations. These stress responses can lead to impaired
clinical performance. The goal of this proposed project is to adapt Stress Inoculation
Training (SIT) to the healthcare setting. Stress Inoculation Training is a
cognitive-behavioural approach to stress management that has proven effective in reducing
stress and improving performance in domains outside of healthcare.
Thirty-two emergency medicine residents will be randomly divided into two groups. The SIT
group will receive the simulation-based stress inoculation training. We will measure the
effectiveness of the training by looking at reduction of stress levels and improvements in
clinical performance in a pre-intervention and a post-intervention simulated trauma scenario.
The control group will be exposed to the same simulation scenarios and pre/post intervention
scenarios as the SIT group, but will not receive the stress inoculation training.
Description:
Health care contains many stressors for health professionals, both chronic and acute. There
is accumulating evidence that clinical performance can be significantly impaired by stress
responses during acute events, both in the psychology and healthcare domains. Paramedics,
medical residents and surgeons have all shown impaired performance when faced with high
acuity situations that triggered subjective and physiological stress responses. Impairments
have been observed in the ability to perform drug calculations, trauma and cardiac
resuscitations, in technical skills, as well as on tasks that rely on memory recall. In some
cases, the magnitude of the stress response has been associated with the degree of
performance impairments. In many studies in which performance impairments have been observed,
baseline levels of performance were acceptable, suggesting that these impairments are not due
to a lack of relevant knowledge or skills required to provide patient care in these
situations.
The findings of impaired performance with stress responses suggests that training for high
acuity events needs to go beyond training that is oriented solely towards the acquisition of
clinical skills and knowledge. Training needs to also include interventions aimed at
developing the trainees' ability to cope with stressors and to minimize their personal stress
responses. In the psychology, aviation and military domains, several approaches have been
developed to optimize performance during stressful events. These can be categorized either as
skills-based training (providing individuals or teams with the specific skills required
during a crisis) or as stress management interventions (modifying the individual's appraisal
of potentially stressful situations).
The implementation of skill based training, such as crisis resource management (CRM), has
resulted in improved performance in team interactions. However, CRM-type of training requires
that health professionals be able to remember those skills that were learned, yet memory
recall is often impaired under stress. As for overlearning, it can lead to rigid approaches
to problem solving, and is less likely to be efficient in dynamic situations that require
flexibility in approaches and judgment. Therefore, educators also need to develop
complementary approaches to train health professionals in recognizing stress responses and in
managing and minimizing their emotional responses. Stress management approaches are focused
on reducing the emotional and physiological response itself. The premise is that by reducing
the stress response, the cognitive facilities (including recall of relevant knowledge and
skills) required during a high acuity situation are more likely to remain intact.
Two important predictors of stress responses to high acuity events are individuals' coping
styles and their cognitive appraisals of the situation. Task-oriented coping styles, as well
as appraisals of perceived resources being equal to or above the perceived demands of a
situation, are associated with lower stress responses in high acuity events. As such, stress
management approaches focused on coping styles and cognitive structuring are likely to reduce
the subjective and physiological stress responses of clinicians and trainees during high
acuity events.
A promising method of reducing stress responses and performance impairments under acutely
stressful conditions is stress inoculation training (SIT). This 3-phase cognitive-behavioural
approach to stress management has proven effective in domains outside of healthcare. SIT has
been found to be effective in reducing general state anxiety, performance anxiety (anxiety
specific to the skills being addressed in the training), and in enhancing performance under
stress. SIT appears to be effective when run with groups of 8-10 participants and it can be
implemented successfully without an inordinate number of training sessions. Finally, the
beneficial effects of the SIT can generalize to novel stress conditions and novel tasks,
which is crucial for any applied area in which the conditions of real life environments are
often dynamic, ambiguous and emergent.
The proposed study consists of the adaptation and evaluation of a simulation-based stress
inoculation training (SIT) intervention for Emergency Medicine and Surgery residents during
trauma rotations.
SPECIFIC AIMS AND HYPOTHESES The study hypothesis is that residents who have received the SIT
intervention will have lower stress levels and higher performance levels during a
post-intervention simulated trauma scenario than will residents in a control group.
SIGNIFICANCE During high acuity events, such as pre-hospital, trauma and cardiac
resuscitations, patient care must be provided in conditions that can be noisy, chaotic, time
pressured and with uncertainty. These conditions, and the urgent nature of the care required,
are very unforgiving to gaps in recall, attention or decision-making. In these environments,
research has shown that health professionals experience significant stress responses and that
these stress responses can lead to impairments in memory, attention and clinical performance.
Adapting a proven stress training approach to healthcare has the possibility of significantly
improving care to patients during high acuity events, both in terms of care during the high
acuity component of care, as well as further along in the chain of care.
INNOVATION If, as predicted, the results of this study reveal that stress inoculation
training is effective for preparing emergency medicine and surgery residents, in terms of
reducing their stress levels and increasing their performance during simulated trauma
resuscitation, this proposed study will be further developed for a multi-centre study with
outcome measures of stress and performance during actual patient events.
In the development of the course content and scenarios for the SIT training in the context, a
course manual will be produced. This manual will be shared with colleagues internationally,
for the purposes of adapting and validating the course internationally and in a variety of
clinical contexts.
APPROACH The proposed study of stress inoculation training (SIT) intervention will be for
emergency medicine and surgery residents during trauma rotations. The adaptation of SIT to
the trauma context will consist of a 3-phase training intervention, conducted over one 1/2
day session.
Phase 1: Conceptualization / Educational Phase (60 minutes) The goal of this phase is to help
individuals gain a better understanding of the nature of stress and its effects. This phase
will focus on the provision of preparatory information, to allow the participants to form
accurate expectations regarding the stress environment and stress reaction that can occur
during trauma cases. The goal is to provide the participants with a sense of predictability
and control. This phase will consist of descriptions of the stressors encountered in the
clinical setting, the provision of information about how these stressors might make the
participants feel affect performance.
Phase 2: Skill Acquisition and Rehearsal (60 minutes) The objective of this phase is the
development and practice of cognitive restructuring techniques and relaxing training to
reduce anxiety and enhance the individual's capacity to respond effectively to stressful
situations. The cognitive restructuring techniques will provide the participants with the
skills to regulate negative emotions and distracting thoughts brought on by stressors. The
relaxation training will provide the participants with the skills to enhance physiological
control, such as awareness and control of muscle tension and breathing. The session will
include mental imagery and visualization exercises to allow the participants to practice the
skills in a low stress environment.
Phase 3: Application of Coping Skills (180 minutes) In this phase, the coping skills are
applied in increasingly stressful conditions that approximate the real-world stressor
environment. Participants will practice the cognitive restructuring and relaxation skills in
a series of simulated trauma scenarios in which they will be exposed to increasing levels of
stress in a gradual manner. All of the scenarios will be developed using a combination of
computerized mannequin-based simulators and standardized patients (SP). The use of simulation
modalities allows investigators to carefully manipulate the levels of stressors inherent in
each scenario and to control for any extraneous factors beyond the intervention that could
influence stress responses and performance.
