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Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum

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: NCT04083924
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Satoshi Jujo, University of Hawaii

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Echocardiography Medical Student Transthoracic Echocardiography Education Other: Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-post education intervention study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Preclinical Medical Student Handheld Echocardiography Training American Society of Echocardiography Curriculum
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Findings of post-training predefined survey [ Time Frame: Immediately after hands-on training. ]
    Findings of post-training predefined survey regarding usefulness of training.

  10. Findings of post-training predefined survey [ Time Frame: Eight weeks after hands-on training. ]
    Findings of post-training predefined survey regarding usefulness of training.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04083924


Locations
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United States, Hawaii
SimTiki Simulation Center, John A. Burns school of medicine, University of Hawaii at Manoa
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
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Study Director: Benjamin W Berg, MD SimTiki Simulation Center, John A. Burns School of Medicine.
Additional Information:
Publications:
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Responsible Party: Satoshi Jujo, Research Scholar, University of Hawaii
ClinicalTrials.gov Identifier: NCT04083924    
Other Study ID Numbers: 2019-00265
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Satoshi Jujo, University of Hawaii:
Preclinical medical students
Handheld ultrasound
Butterfly iQ
Basic cardiac ultrasound
Focused cardiac ultrasound
Point of care
Training
Education
Flipped classroom