Tele-Ultrasound: VIrtual Hands-on Education for Novice Users

January 29, 2024 updated by: University of Colorado, Denver
This study is intended to perform a comparative analysis of novice ultrasound users when taught in person versus virtually. This study aims to show that students will not demonstrate a statistical difference in scores learning in in a virtual environment, guided by professionals, when compared to students learning ultrasound in a traditional, in-person format. Utilizing a Butterfly ultrasound machine, a hand held personal ultrasound device, students wil be guided through a FAST (Focused assessment with sonography in trauma) examination and imaging of the carpal tunnel using modules and instructor aid. The FAST (Focused assessment with sonography in trauma) exam images the heart and abdomen for free flowing blood. The carpal tunnel is a region in the wrist that houses the tendons for finger movement. Participants will be assessed on the ability to identify key regions, anatomical landmarks and confidence in utilize the ultrasound machine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project intends to adapt previous research ("Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners") to assess the effectiveness of tele-education using the Butterfly handheld ultrasound device when compared to in person education imaging devices, learning modules and assessments will be kept constant across experimental groups. This experiment aims to adapt the current ultrasound modules used by the University of Colorado Anschutz school of Medicine and Modern Human Anatomy program to formulate in depth modules that outline the following: Carpal Tunnel (wrist), Brachial Plexus (shoulder), and FAST "Focused Assessment with Sonography in Trauma". Additionally, participants will be provided an orientation module that will be completed prior to the live session. Participants will be divided into either the in-person group or virtual group and participate in a live session where participants go through each module with a trained instructor. Participants will be asked to complete a pre/post assessment to determine prior knowledge and the level of learning that took place during the session as well as participant satisfaction and confidence levels.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80110
        • logan T scott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • First year medical students enrolled at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.
  • First year graduate students enrolled in the Modern Human Anatomy program (MHA) at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.

Exclusion Criteria:

  • individuals younger than the age of 18.
  • individuals not enrolled in the medical school or Modern Human Anatomy program (MHA) programs at Anschutz Medical Campus
  • Individuals with greater than minimal ultrasound experience.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: In-Person ultrasound participants
In-Person ultrasound participant's will receive ultrasound training that is guided by online modules (identical to virtual) with trained faculty in the same room with a ration of 4 students to 1 instructor.
Combination product: Butterfly handheld ultrasound machine
Both arms of study will utilize the Butterfly ultrasound machine. Only the virtual learners will utilize zoom for their virtual education
Other Names:
  • Zoom
Active Comparator: Virtual ultrasound participants
Virtual ultrasound participants will receive ultrasound training that is guided by online modules (identical to in-person) with trained faculty present in a private zoom classroom. Faculty will be rotating between breakout rooms and will share the same ratio of participants to staff.
Combination product: Butterfly handheld ultrasound machine
Both arms of study will utilize the Butterfly ultrasound machine. Only the virtual learners will utilize zoom for their virtual education
Other Names:
  • Zoom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of participant assesment scores when asked to identify key features of the FAST and Carpal Tunnel between in person learners and virtual learners.
Time Frame: 10 minutes
Scores are measured on a pass (1) or fail (0) grading system with a total number of 17 points per participant. An Anderson-Darling test will determine if the data is normally distributed. If the data demonstrates normal distribution, either a parametric analysis via a two-way ANOVA or non-parametric equivalent analysis via pairwise Mann-Whitney U will be performed to compare responses from the different groups. Further a Bran-Altman Test will be considered.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Student comparative confidence levels in ultrasound between virtual learners and in-person learners.
Time Frame: 1.5 hours
Likert Scale measures participant's subjective opinion on a question. Five answer choices are provided on a scale of 0 to 5 with an extreme on both ends, a neutral choice and a middle ground answer for both ends of the spectrum. A higher score represents a greater degree of confidence in the material. Lower scores indicate little to no confidence in the material.
1.5 hours
Student comparative satisfaction levels in ultrasound between virtual learners and in-person learners.
Time Frame: 1.5 hours
Likert Scale measures participant's subjective opinion on a question. Five answer choices are provided on a scale of 0 to 5 with an extreme on both ends, a neutral choice and a middle ground answer for both ends of the spectrum. Higher scores indicate high satisfaction levels with the learning modality. Low scores indicate that participant's did not enjoy the learning modality.
1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: logan T scott, B.S., Graduate Student, Masters in Modern Human Anatomy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

October 4, 2023

Study Completion (Actual)

October 4, 2023

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-3964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will not be shared with other researchers. Statistical analysis and results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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