Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00425295 |
| Other study ID # |
0501050 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 1
|
| First received |
January 19, 2007 |
| Last updated |
December 2, 2014 |
| Start date |
October 2006 |
| Est. completion date |
December 2007 |
Study information
| Verified date |
December 2014 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The main purpose of this study is to assess the effectiveness of human simulation in the
training of the leadership, cognitive, and psychomotor skills required to lead medical
crisis management teams. All participants in the study are trainees in the University of
Pittsburgh Medical Center (UPMC) Multi-Disciplinary Critical Care Training Program (MCCTP.)
All trainees will have received the standard critical care medicine-training curriculum
including basic airway management, management of hypotension, unstable cardiac arrhythmias,
difficult airway management and crisis team training. The participants will have also
completed six months of baseline clinical training, which includes responding to medical
emergencies at UPMC.
The specific aims of this study are:
1. To assess the effectiveness of Human Simulation Training (HST) as an educational tool
for teaching medical crisis management.
2. To determine the effect of HST on objective measures of performance in the domains of
communication, leadership, cognition and psychomotor skills.
Description:
The use of Medical Emergency Teams (METS) for handling in-hospital medical crisis decreases
mortality and improves patient safety. Adverse in-hospital events occur in about 4-17% of
hospital admissions. Of these, 70% are thought to be preventable. The most serious adverse
in-hospital event is unexpected cardiac arrest which carries a mortality rate of 50-80% [1].
One approach to reducing this adverse event is the use of METS. Unlike traditional
cardiopulmonary resuscitation teams, which respond to cardiac arrests, METS respond to
medical crises early on and aim to prevent the progression of problems into unstable
situations. The implementation of METS have been found to decrease the number of unexpected
cardiac arrests, intensive care unit transfers and in-hospital mortality [1]. Bellomo et al.
further found that the implementation of a MET not only decreases hospital mortality but
also decreases incidence of post-operative complications [2]. As an integral part of the
MET, a critical care physician must have the communication and leadership skills to
effectively manage the team, the cognitive skills to adequately assess/judge the situation
and guide plan of actions, and the psychomotor skills to perform necessary procedures.
Existing methods for teaching medical crisis management are inadequate. The instruction of
medical trainees in the management of acute medical crisis is often done through didactic
teaching, problem based learning, and apprenticeship. It is not uncommon for a trainee's
first experience managing medical crisis to be on a real patient who is experiencing a real
medical crisis with significant consequences. This form of training is limited and clearly
sub-optimal for many reasons. Didactic training and problem based learning may be useful in
instilling medical knowledge but is often inadequate in teaching the communication skills
and critical thinking that is involved in managing medical crises. Further, the urgency and
complexity of medical crisis is not well understood without first-hand experience. In
general, although medical crises are relatively common, trainees get limited opportunities
for the repetition required to hone their management skills. Some medical crises, such as
respiratory distress with difficult airway, are extremely rare and will not often be
experienced by most trainees. Moreover, when they do occur, trainees may not have enough
supervision and hence do not receive appropriate feedback. Thirdly, clinical apprenticeship
does not provide for standardization of training and feedback for the trainees. Lastly, most
trainees are not allowed to view the consequences of the errors made while managing medical
crises as most supervisors will intervene to prevent patient injury or harm [3-6].
HST can be used as an educational tool for teaching medical crisis management. Simulation
training has been used in other fields, such as aviation and the military, to train people
to do complex tasks with potentially dangerous consequences [7-13]. A curriculum using HST
may be a useful at surpassing some of the limitations of traditional training noted
above[14]. The full body human simulator such as Laerdal's Sim Man, can be programmed to
present a wide range of physiologic conditions and physical exam findings. Using this human
simulator, a wide variety of medical crises can be programmed to recreate real-life
situations. The human simulator also allows the re-creation of clinically important but rare
situations. The human simulator will also allow trainees to manage medical crises
repetitively until a satisfactory level of proficiency can be reached.
Most importantly, HST allows trainees to repetitively experience dangerous situations and
practice their crisis management skills. Trainees can now benefit by seeing their management
errors run their course without placing patients at risk. HST allows for providing immediate
feedback. This technology is portable and hence allows for trainees from various
institutions within a particular region to have standardized training and feedback. The 1999
Institute of Medicine Report, "To Err is Human," challenged the medical community to
confront the issue of medical error. One innovative approach that was mentioned for
performance improvement and healthcare training was the use of human simulators [15].
Human Simulators are a valuable and valid performance evaluation tool. Human simulators have
long been used in the field of medicine for evaluation. In particular, the field of
anesthesia has taken the lead in terms of using advanced full body simulators for resident
and physician training and evaluation. Instructors in the field of anesthesia have used
human simulators to re-create dangerous and complex intra-operative crises to help their
trainees acquire, test, and practice skills of crisis resource management without placing
patients at risk [16-18]. By using evaluation techniques such as videotaped review and
checklists, anesthesia instructors have been able to assess the behavioral and technical
performances of trainees[18-21].
The effectiveness of HST as a training tool in medical crisis management needs to be
explored.
Due to the success of human simulation as an educational tool for anesthesia crisis, HST is
now being used as a tool for training medical emergency teams for dealing with medical
crisis. Lighthall et al. has showed that HST can be used to teach crisis management to
internal medicine residents[22]. This study showed that the majority of participants felt
that simulator training had an educational value, but did not quantify their performance of
technical and non-technical skills. DeVita et al. looked at the effect of HST on improving
crisis team skills. This study found that repeated experience using the simulator with
immediate feedback improved team performance in terms of correctly completing the steps
necessary for patient/simulator survival[23]. There are no studies, which look at whether
HST improves crisis management skills in a randomized study design.
2.2 Significance The field of simulation education is highly evolved in other high-risk
industries such as aviation and nuclear power plants. Its time is coming in medical
education, particularly with the emerging emphasis on improved patient safety. Proven and
practical outcome based educational programs are needed to support the cultural changes
necessary to influence the changes in fields of education in clinically relevant domains
such as medical crisis resource management.
Medical crisis management skills are essential to the function of METS. HST is a useful tool
that can safely re-create medical crises to teach and evaluate trainees in these skills.
Although HST has been widely studied in anesthesia crisis management, there are no studies
that look at the effect of HST on medical crisis management skills. We feel that this study
will help to determine what effect if any, HST has on the communication, leadership,
cognitive and psychomotor skill level needed to be effective at medical crisis management.
The participants for this prospective, blinded, randomized cross over trial will be
consenting critical care trainees from the MCCTP at UPMC(Appendix 1 for consent forms). All
participants will have similar baseline education in basic airway management, management of
cardiovascular emergencies, and difficult airway management before testing occurs. Further,
each participant will have similar clinical experience as a critical care trainee
participating in METS at UPMC.
Each participant will undergo baseline testing using HST . Using 4 simulated clinical
scenarios using the human simulator will test each participant. Participants will then be
randomized into two groups. Control group (A) will receive no further training, while the
intervention group ( B) will receive HST curriculum for medical crisis management. The
groups will then be tested again after an interval of 1 month using 4 different simulated
clinical scenarios. The groups will then be crossed over. The original control group (A)
will now receive HST and the original intervention group ( B) will receive no further
training. These two groups will again be tested using a third new set of simulated clinical
scenarios. This study design is summarized in Appendix 2.
Both testing and the intervention will occur at the Peter Winter Institute for Simulation,
Education and Research (WISER Center). All instructors and evaluators will be critical care
faculty or senior fellows who have undergone training at WISER and are familiar with
simulation teaching and evaluation.
The four medical crisis scenarios used for testing are designed to represent the most common
medical crises experienced at UPMC. Each scenario will be programmed into the Laerdal SimMan
human simulator. The basic physiologic problem and expected responses will be the same for
all participants and all phases of testing; however, the scripted presentation will be
varied to prevent pattern recognition. Participant performance will be evaluated using a
checklist of expected actions as determined by the investigators. Each item will represent a
communication skill, cognitive skill or a psychomotor skill. A total score as well as domain
specific scores will be recorded at the end of each testing session for each participant.
Blinded evaluators will perform all evaluations.
The intervention for this study will be a HST Curriculum. The curriculum will consist of two
parts. One is a didactic review of crisis management principles. The second part is a
simulation-based curriculum consisting of two scenarios. Each participant will undergo both
scenarios and receive immediate feedback regarding their communication, cognitive and
psychomotor performance.
