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Simulation-based Ultrasound Training to Improve Patient Comfort and Decrease the Need for Re-examination. A Randomized Trial.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01801462
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Martin G. Tolsgaard, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment
Conditions Related to Early Pregnancy Other: Simulation-based training

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : March 2013
Primary Completion Date : September 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Patient comfort levels [ Time Frame: Participants will be followed for 6 months. ]
    Patient comfort levels is surveyed for all patients being treated in the gynecological emergency departments.


Secondary Outcome Measures :
  1. Need for re-examination of patients [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria require that participants 1) are medical graduates and 2) provide written informed consent.

Exclusion Criteria:

Exclusion criteria are 1) any formal ultrasound training or 2) previous independent use of ultrasound.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801462


Locations
Denmark
Juliane Marie Center, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Responsible Party: Martin G. Tolsgaard, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01801462     History of Changes
Other Study ID Numbers: H-3-2012-162
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Martin G. Tolsgaard, Rigshospitalet, Denmark:
Medical education
Simulation
Ultrasound training
Patient safety