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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Simulation-based Ultrasound Training to Improve Patient Comfort and Decrease the Need for Re-examination. A Randomized Trial.|
- Patient comfort levels [ Time Frame: Participants will be followed for 6 months. ] [ Designated as safety issue: Yes ]Patient comfort levels is surveyed for all patients being treated in the gynecological emergency departments.
- Need for re-examination of patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]All participants (physicians with no prior OB-GYN experience) register if they needed supervision during the ultrasound examination or if a senior gynecologists needed to perform a second ultrasound examination.
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Simulation-based ultrasound training
The initial training is provided on 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. 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.
|Other: Simulation-based training|
No Intervention: 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01801462
|Contact: Martin G Tolsgaard, MD, PhD||+45 61 30 30 firstname.lastname@example.org|
|Juliane Marie Center, Copenhagen University Hospital Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Martin G Tolsgaard, MD, PhD +45 61 30 30 72 email@example.com|