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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Martin G. Tolsgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01801462
First received: February 23, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 Intervention
Conditions Related to Early Pregnancy
Other: Simulation-based training

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 46
Study Start Date: March 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801462

Contacts
Contact: Martin G Tolsgaard, MD, PhD +45 61 30 30 72 martintolsgaard@gmail.com

Locations
Denmark
Juliane Marie Center, Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Martin G Tolsgaard, MD, PhD    +45 61 30 30 72    martintolsgaard@gmail.com   
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Martin G. Tolsgaard, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01801462     History of Changes
Other Study ID Numbers: H-3-2012-162
Study First Received: February 23, 2013
Last Updated: November 21, 2013
Health Authority: Denmark: Danish Regional Committee on Biomedical Research

Keywords provided by Rigshospitalet, Denmark:
Medical education
Simulation
Ultrasound training
Patient safety

ClinicalTrials.gov processed this record on July 23, 2014