Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01895868 |
| Other study ID # |
H-3-2012-154 |
| Secondary ID |
H-3-2012-154 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
July 7, 2013 |
| Last updated |
April 4, 2014 |
| Start date |
July 2013 |
Study information
| Verified date |
April 2014 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: Danish Dataprotection Agency |
| Study type |
Interventional
|
Clinical Trial Summary
The clinical effects of simulation-based ultrasound training has not yet been explored. To
examine the long-term effects of training, we plan to conduct a trial, where half of all new
residents are randomized to simulation-based training and the other half to traditional
clinical training only. The effects are assessed after two months of practice by evaluating
two ultrasound scans performed by the residents. These scans are subsequently evaluated by a
blinded consultant gynecologist and rated using the Objective Structured Assessment of
Ultrasound Skills, which has been validated in previous studies.
Description:
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). Clinical ultrasound training is challenged with long learning curves and is
therefore both time consuming and requires large teacher resources (Jang et al. 2010). Some
trainees may therefore never acquire the basic skills and knowledge needed for independent
practice (Tolsgaard et al. 2012). In the search for effective training methods,
simulation-based training has proven to be an effective adjunct to clinical training, which
has been documented in several studies on interventional procedures (Larsen et al. 2009,
Zendejas et al 2011, Barsuk et al. 2009). Most comparative studies on simulation-based
training have, however, only examined the initial effects of simulation-based training on
the first couple of procedures, it is not known if VR simulation training provides sustained
improvements trainee performance throughout their learning curves until they reach clinical
proficiency. Large resources are currently being allocated to simulation training in many
different specialties but the effects of simulation may easily be over-estimated if only
evaluating the immediate effects of simulation training. A small difference in the number of
supervised ultrasound examinations needed for proficiency may not justify the financial
costs associated with investing in simulation equipment, space for simulation training as
well as teacher resources during simulation training. Therefore, the research questions of
this study was:
In a group of ultrasound novices, what are the implications of simulation-based training
compared to clinical training alone on the technical quality of scans performed after two
months of training?
Methods
Study design This study is reported according to the CONSORT statement
(www.consort-statement.org). A randomized observer-blind study to compare VR ultrasound
training with traditional supervised practice on subsequent patient scans (see Figure 1 for
flowchart of study design). Ethical approval was obtained from the Regional Ethical
Committee of the Capital Region, Denmark. The Danish Data Protection Agency approved the
storing of patient relevant information. This randomized trial is reported to
clinicaltrials.gov prior to inclusion of participants.
Setting This study is carried out at the Departments of Gynecology at the Juliane Marie
Centre, Copenhagen University Hospital, Denmark, Næstved Hospital, and Hillerød Hospital.
Participants Participants are all new OB/GYN residents at three different hospitals in
Eastern Denmark. Inclusion criteria are 1) proficiency in written and oral Danish, 2)
informed written consent. The exclusion criteria are 1) prior employment at an OB/GYN
department in a clinical position, 2) any formal ultrasound training with or without
hands-on practice and (3) prior experience with virtual reality simulation.
Randomization A research fellow at The Center for Clinical Education, Rigshospitalet,
independently performs randomisation 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 during the enrolment of participants.
Once informed consent has been signed and a participant number has been provided, the
allocation sequence is retrieved per telephone.
Intervention Participants in the intervention group receive simulation training using two
types of ultrasound simulators (see Figure 2 for flowchart of the simulation programme).
Participants are introduced 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. Participants train on this type of simulator until a predefined
proficiency-level has been attained. The selection of modules is based on a previous
validation study and only modules and items that discriminate between novice and expert
performances are included in the training programme (Madsen et al. 2013). All participants
are provided feedback after completing each module. When all modules are passed on the VR
simulator, the participants receive proficiency-based training training on the low-fidelity
simulator (BluePhantom) to allow participants to review the functions, they just trained,
using real ultrasound equipment. The simulator performances are assessed using the Objective
Structured Examination of Ultrasound Skills (OSAUS) and feedback is provided using this
framework after each trial. Proficiency is set according pass/fail-scores established in a
previous study (Tolsgaard et al. 2013).
Clinical training Participants in both groups receive traditional clinical training. This
includes supervised practice in terms of apprenticeship learning followed by supervision
during independent practice. The new residents do not usually go on calls for the first one
to two weeks. Local department rules dictates which types of examinations that always
requires a second examination by a supervising clinicians (e.g. fetal demise or pregnancy of
unknown location).
Main outcome measure The main outcome measure is the technical proficiency after two months
of practice. Two scans from the emergency department are recorded and subsequently assessed
by a blinded clinician, who also had access to the ultrasound descriptions that corresponded
to each scan. The assessments were performed using the Objective Structured Assessment of
Ultrasound Skills (Tolsgaard et al. 2013), which has been validated in a construct validity
study including 30 clinicians with different levels of experience prior to this trial.
Sample size calculation Sample size calculations are based on previous studies on clinical
performances of ultrasound novices with the performance of medical students, who completed a
simulation-based training programme (Tolsgaard et al. 2013). The average difference in OSAUS
scores between these groups was 0.85 (2.65-1.8 (mean SD 0.4). It was anticipated that these
differences would be diluted according to literature from other areas of simulation-based
technical skills training (Smith et al. 2010), where simulation effects persisted after 3
months of training but the differences between groups was diminished to 55% of the initial
effects. Assuming a 55% dilution, an alpha-level of 0.05 and a power of 0.80, the total
number of participants needed was 26.
