Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum

November 6, 2020 updated by: Satoshi Jujo, University of Hawaii

Preclinical Medical Student Handheld Echocardiography Training American Society of Echocardiography Curriculum

The investigators would like to evaluate how well pre-clinical medical students are able to perform a basic transthoracic echocardiography examination on a healthy volunteer using a hand-held ultrasound (HHU) after completing a flipped classroom echocardiography training methods which consist of pre-training e-learning, hands-on training, and competency assessment after the hands-on training.

Study Overview

Detailed Description

Background There is expanding need for cardiac ultrasound training for medical students, although most of medical schools do not integrate cardiac ultrasound training into their curricula. Most of residency programs already have some standardized cardiac ultrasound training for residents, but there is no standardized cardiac ultrasound training for medical students. Last year, the American Society of Echocardiography (ASE), which takes a leading role in establishing training for echocardiography, presented the recommended training methods of cardiac ultrasound for medical students with flipped classroom methods which consist of pre-training e-learning, hands-on training, and competency assessment after the hands-on training. But no researchers evaluated the effectiveness of the ASE recommended training methods at this moment. In addition, hand-held ultrasound (HHU) probe which enable us to perform echocardiography just connecting to cell phone, have become commercially available this year. The investigators believe most medical students will have their own HHU probe as well as physicians in ten years. Thus, the purpose of this study is to evaluate the ASE cardiac ultrasound training methods with applying the training methods to the pre-clinical medical students in University of Hawaii at Manoa using HHU probe.

Methods The investigators will perform a prospective, experimental educational study investigating the learning effects of ASE recommended echocardiography training in pre-clinical medical students on cognitive and psychomotor skill using HHU device, when performing a basic echocardiography on a healthy volunteer.

The investigators will use e-mail, presentations and public posting on bulletin board in University of Hawaii for recruiting participants of 1st or 2nd year medical students. Target sample size is 130 at maximum. After recruitment of participants, first, participants will take a pre-training knowledge assessment and questionnaire on basic cardiac ultrasound (30 minutes) one week before the day of hands-on training. Second, after the pre-training assessment, participants will independently review the 40 minute American Society of Echocardiography (ASE) recommended e-learning module (https://aseuniversity.org/ase/lessons/47) on basic cardiac ultrasound prior to the hands-on training day. Third, on the day of hands-on training, participants will take a pre-training skill assessment and receive hands-on training for basic cardiac ultrasound with a healthy volunteer (HV) (60 minutes). Immediately after the hands-on training, participants will complete a post-training knowledge and skill assessment on basic cardiac ultrasound with a HV and questionnaire about participants' experience (30 minutes). Finally participants will take another post-training knowledge & skill assessment on basic cardiac ultrasound and questionnaire about participants' experience eight weeks after the hands-on training day to assess retention of their knowledge and skills on basic cardiac ultrasound with a HV (30 minutes).

In this study, investigators plan to use HHU probe, named Butterfly iQ hand-held ultrasound, Butterfly Network, Inc.

The knowledge assessment contains 40 MCQs on 5 basic views. In the skill assessment, participants will be asked to obtain 5 basic views on a HV in 2 minutes per view and the images are to be video-recorded. After de-identification of obtained images, the image quality of 5 basic views will be assessed by three independent blinded assessors using image quality scoring system investigators devised. One of investigators will take a role of a HV for echocardiography throughout this study consistently.

Study Type

Interventional

Enrollment (Actual)

58

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

    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • SimTiki Simulation Center, John A. Burns school of medicine, University of Hawaii at Manoa

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be preclinical medical students (1st year or 2nd year) at John A. Burns School of Medicine, University of Hawaii.
  • Participants are eligible after completion of 1st year medical student core cardiology curriculum at John A. Burns School of Medicine, University of Hawaii.

Exclusion Criteria:

  • None

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basic cardiac ultrasound training
Single group education intervention study. No control group. Pre-post educational outcomes only.
Pre-training online module of the American society of Echocardiography and hands-on training of basic cardiac ultrasound with Butterfly iQ handheld ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality score change from pre-training to eight weeks after training.
Time Frame: Eight weeks after hands-on training.
Image quality score of five basic cardiac ultrasound views assessed by predefined test scoring system. In the scoring system, each view is assessed excellent (2 points), acceptable (1 points), or poor (0 point) for clinical use. Summed, total score, thus, ranges from 0 to 10 points.
Eight weeks after hands-on training.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality score change from pre-training to immediately after training.
Time Frame: Immediately after hands-on training.
Image quality score of five basic cardiac ultrasound views assessed by predefined test scoring system. In the scoring system, each view is assessed excellent (2 points), acceptable (1 points), or poor (0 point) for clinical use. Summed, total score, thus, ranges from 0 to 10 points.
Immediately after hands-on training.
Knowledge test score change from pre-training to eight weeks after training.
Time Frame: Eight weeks after hands-on training.
40 multiple choice questions about anatomical knowledge of five basic cardiac ultrasound views using Google Form. Total score ranges from 0 to 40 points.
Eight weeks after hands-on training.
Knowledge test score change from pre-training to immediately after training.
Time Frame: Immediately after hands-on training.
40 multiple choice questions about anatomical knowledge of five basic cardiac ultrasound views using Google Form. Total score ranges from 0 to 40 points.
Immediately after hands-on training.
Overall 5-point Likert scale participants training satisfaction
Time Frame: Immediately after hands-on training.
Overall participants training satisfaction assessed with 5-point Likert scale. This scale ranges from 1 to 5. Higher Likert scale represents higher participant training satisfaction.
Immediately after hands-on training.
Overall 5-point Likert scale participants training satisfaction
Time Frame: Eight weeks after hands-on training.
Overall participants training satisfaction assessed with 5-point Likert scale. This scale ranges from 1 to 5. Higher Likert scale represents higher participant training satisfaction.
Eight weeks after hands-on training.
Participant confidence in basic cardiac ultrasound.
Time Frame: Immediately before hands-on training.
Participant confidence in basic cardiac ultrasound assessed with 5-point Likert scale. This scale ranges from 1 to 5. Higher Likert scale represents higher participants confidence in basic cardiac ultrasound.
Immediately before hands-on training.
Participant confidence in basic cardiac ultrasound.
Time Frame: Immediately after hands-on training.
Participant confidence in basic cardiac ultrasound assessed with 5-point Likert scale. This scale ranges from 1 to 5. Higher Likert scale represents higher participants confidence in basic cardiac ultrasound.
Immediately after hands-on training.
Participant confidence in basic cardiac ultrasound.
Time Frame: Eight weeks after hands-on training.
Participant confidence in basic cardiac ultrasound assessed with 5-point Likert scale. This scale ranges from 1 to 5. Higher Likert scale represents higher participants confidence in basic cardiac ultrasound.
Eight weeks after hands-on training.
Findings of post-training predefined survey
Time Frame: Immediately after hands-on training.
Findings of post-training predefined survey regarding usefulness of training.
Immediately after hands-on training.
Findings of post-training predefined survey
Time Frame: Eight weeks after hands-on training.
Findings of post-training predefined survey regarding usefulness of training.
Eight weeks after hands-on training.

Collaborators and Investigators

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

Investigators

  • Study Director: Benjamin W Berg, MD, SimTiki Simulation Center, John A. Burns School of Medicine.

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.

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 9, 2019

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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