Conditions Related to Early Pregnancy Clinical Trial
Official title:
Simulation-based Ultrasound Training to Improve Patient Comfort and Decrease the Need for Re-examination. A Randomized Trial.
Ultrasonography has become increasingly used in many medical specialties over the last decades as smaller and less expensive ultrasound equipment has become available. Although ultrasound imaging traditionally is considered safe, its use is highly operator dependent (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that eventually compromise patient safety due to unnecessary tests or interventions (Moore & Copel 2011). A recent report from the British National Health Service (NHS) analyzed maternity claims reported to the NHS over the past decade and identified antenatal fetal ultrasound investigations as one of the four major risk areas in obstetric care (NHS 2012). This study therefore aims to explore the effects of simulation-based ultrasound training on patient comfort levels and the need for re-examination by a second physician due to diagnostic uncertainty.
Background Ultrasonography has become increasingly used in many medical specialties over the
last decades as smaller and less expensive ultrasound equipment has become available.
Although ultrasound imaging traditionally is considered safe, its use is highly operator
dependent (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic
errors that eventually compromise patient safety due to unnecessary tests or interventions
(Moore & Copel 2011). A recent report from the British National Health Service (NHS)
analyzed maternity claims reported to the NHS over the past decade and identified antenatal
fetal ultrasound investigations as one of the four major risk areas in obstetric care (NHS
2012). Traditional ultrasound training is challenged with long learning curves and lack of
standardization of competency-based training (Salvesen et al. 2010). Given the long learning
curve characterizing traditional clinical training (Jang et al. 2010), proficiency in terms
of independence and acceptable diagnostic accuracy may not occur during the first many
months of training. Thus, some residents may not be sufficiently trained to manage
independent ultrasound examinations expected from them safely. Accelerating learning curves
is therefore essential from a patient safety perspective and for patient discomfort during
intimate examinations such as transvaginal ultrasound scans. However, it may also be
important from an organizational viewpoint as insufficiently trained residents may not be as
effective in managing patients as those, who are trained until proficiency.
Simulation-based training has become increasingly used in several medical domains because it
provides a safe environment to practice. Virtual Reality (VR) simulation has previously been
shown to improve technical performance and shorten operation time in laparoscopic surgery
(Larsen et al. 2009) and this type of training may therefore be useful as an adjunct to
supervised clinical ultrasound practice. In previous studies of the effect of VR simulation,
control groups have been assigned 'traditional training', which often means 'no training'.
Consequently, it is not known if VR simulation - including ultrasound simulation - is
superior to optimal clinical training using real patients. Furthermore, no studies have
explored the effects of ultrasound simulation on patient related outcomes such as diagnostic
accuracy, patient discomfort and their perception of safety during the ultrasound
examinations. The effects on an organizational level such as the use of time per ultrasound
examination, the need for re-examination by a senior clinician or the need for ambulatory
control due to diagnostic uncertainty are also unknown.
Hence, we aim to explore the following research questions:
1) What are the effects of simulation-based training compared to traditional training in a
group of OB/GYN residents without prior ultrasound experience, on the following outcomes:
1. Patients' discomfort levels and perception of safety immediately after a transvaginal
ultrasound examination in a gynecological care unit.
2. Need for re-examination of the patients by a clinical supervisor after the initial
examination.
3. Number of ambulatory controls needed due to diagnostic uncertainty.
Methods
Study setup In a randomized observer-blinded study, the effects of simulation-based
ultrasound training compared to traditional training are examined from April 1st 2013 to
January 31st 2014. Flowchart of study design is shown in Figure 3. Ethical approval is
obtained from the Regional Ethical Committee of the Capital Region. The study is conducted
in accordance with the Helsinki Declaration and in accordance with the CONSORT statement
(www.consort-statement.org).
Participants All OB/GYN departments in eastern Denmark (Zealand) are contacted by e-mail and
invited to participate in the study (N=7). Inclusion criteria require that participants 1)
are medical graduates and 2) provide written informed consent. Exclusion criteria are 1) any
formal ultrasound training or 2) previous independent use of ultrasound. The estimated
number of eligible residents from each of the seven departments is eight during the 12
months of the study, giving a total of 56 potential participants, provided a participation
rate of 100%. All participants are surveyed regarding age, years of post-graduate clinical
practice, gender, handedness, and experience with video-gaming.
Randomization The Clinical Trials Unit, Rigshospitalet, independently performs simple
randomization of participants by computer to either intervention group (simulation training)
or control group (clinical training only). The allocation of participants is concealed to
the primary investigator until all data is loaded to a database for statistical processing.
Intervention Simulation programme. Participants in the intervention group receive simulation
training using two types of ultrasound simulators (see Figure 4 for flowchart of the
simulation programme). A short theoretical introduction to pelvic ultrasound is presented
before simulation training begins. Theoretical reading material concerning early pregnancy
complications is provided all participants prior to simulation training. A final theoretical
test is provided to assess knowledge about equipment, ultrasound safety, anatomical
landmarks and basic pathology.
Content of simulation training. A low-fidelity simulator (BluePhantom), which allows
participants to introduce the probe and familiarize themselves with the ultrasound
equipment, is used for the initial training. Participants train for 30 minutes on this
simulator before moving on to a high-fidelity Virtual-Reality (VR) simulator (Scantrainer,
Medaphor). The VR simulator provides images obtained from real patients and haptic feedback
from the ultrasound probe. The basic gynecologic and advanced gynecologic modules are
selected for training purposes. The selection of modules is based on a previous pilot study,
in which 10 OB/GYN residents rated the usefulness of each of the modules on the VR
simulator. Only modules that are rated as four or five out of five in usefulness are
included in the training programme. When all modules are passed on the VR simulator, the
participants receive 30 minutes of training on the low-fidelity simulator (BluePhantom) to
allow participants to review the functions, they just trained, using real ultrasound
equipment.
Instructor-feedback during simulations. The participants receive 30 minutes of introduction
to the VR simulator and are allowed another two times 10 minutes of instructor-feedback at a
time of their choice (Østergaard et al. 2012).
Control Participants randomized to the control group receive traditional clinical
introduction locally in the departments. This may include observation and supervised
practice and the different types of clinical training provided by each department are
gathered through the department's head of education and registered.
Follow-up and outcome All participants will be followed for six months. Patients eligible
for participation are those who are having a pelvic ultrasound examination performed, are
able to understand and read Danish, and willing to provide informed consent. Consenting
patients are surveyed after the pelvic ultrasound examination regarding discomfort levels
and perception of safety during the ultrasound examination. Both questions are answered
using 10-point Likert scales. The need for re-examination by a supervising clinician, and
need for ambulatory control including reason (e.g. diagnostic uncertainty, routine control
according to department or national guidelines etc.) is registered by the nurse on call.
Sample size calculation A meaningful reduction in the need for a second re-examination by a
senior clinician could be a 33% assuming a standard deviation of eight scans. Thus, a total
sample size of 46 participants is needed using a two-sided alpha of 0.05 and a power of
0.90.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention