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

NCT01801462 | Completed

• 1 other identifier: H-3-2012-162
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Conditions Related to Early Pregnancy

Keywords

Medical education; Simulation; Ultrasound training; Patient safety

Outcome Measures

Primary Outcomes (1)

• Patient comfort levels

  Patient comfort levels is surveyed for all patients being treated in the gynecological emergency departments.

  Participants will be followed for 6 months.

Secondary Outcomes (1)

• Need for re-examination of patients

  6 months

Study Arms (2)

Simulation-based ultrasound training

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Simulation-based training OTHER

Simulation-based ultrasound training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Juliane Marie Center, Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: February 28, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

DK (1)