EchocardiographyNCT04083924
Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum
A study testing Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound in people with Echocardiography and Medical Student, run by University of Hawaii at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Medical Student, Transthoracic Echocardiography
- What is being tested?
- Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
SimTiki Simulation Center, John A. Burns school of medicine, University of Hawaii at Manoa
Honolulu, Hawaii, 96813
About this study
Official title: 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.
Read the 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.
- Being tested
- Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound
- Keywords
- Preclinical medical students, Handheld ultrasound, Butterfly iQ, Basic cardiac ultrasound, Focused cardiac ultrasound, Point of care, Training, Education, Flipped classroom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic cardiac ultrasound training with Butterfly iQ handheld ultrasoundOther
Pre-training online module of the American society of Echocardiography and hands-on training of basic cardiac ultrasound with Butterfly iQ handheld ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Basic cardiac ultrasound training | Experimental | Single group education intervention study. No control group. Pre-post educational outcomes only. Receives: Other: Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality score change from pre-training to eight weeks after 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.
Measured: Eight weeks after hands-on training.
Secondary outcomes (10)
Image quality score change from pre-training to immediately after 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.
Measured: Immediately after hands-on training.
Knowledge test score change from pre-training to eight weeks after 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.
Measured: Eight weeks after hands-on training.
Knowledge test score change from pre-training to immediately after 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.
Measured: Immediately after hands-on training.
Overall 5-point Likert scale participants training satisfaction
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.
Measured: Immediately after hands-on training.
Overall 5-point Likert scale participants training satisfaction
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.
Measured: Eight weeks after hands-on training.
Participant confidence in basic cardiac ultrasound.
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.
Measured: Immediately before hands-on training.
Participant confidence in basic cardiac ultrasound.
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.
Measured: Immediately after hands-on training.
Participant confidence in basic cardiac ultrasound.
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.
Measured: Eight weeks after hands-on training.
Findings of post-training predefined survey
Findings of post-training predefined survey regarding usefulness of training.
Measured: Immediately after hands-on training.
Findings of post-training predefined survey
Findings of post-training predefined survey regarding usefulness of training.
Measured: Eight weeks after hands-on training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start9 Sep 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post education intervention study
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoshi Jujo, University of Hawaii
- Investigators
- Benjamin W Berg, MD, Study director, SimTiki Simulation Center, John A. Burns School of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083924
- Sponsor's protocol ID
- 2019-00265
- Other IDs
- 2019
- Status last verified
- Nov 2020
- First submitted
- 3 Sep 2019
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johri AM, Durbin J, Newbigging J, Tanzola R, Chow R, De S, Tam J. Cardiac Point-of-Care Ultrasound: State-of-the-Art in Medical School Education. J Am Soc Echocardiogr. 2018 Jul;31(7):749-760. doi: 10.1016/j.echo.2018.01.014. Epub 2018 Mar 15.
PubMed 29550326Jujo S, Lee-Jayaram JJ, Sakka BI, Nakahira A, Kataoka A, Izumo M, Kusunose K, Athinartrattanapong N, Oikawa S, Berg BW. Pre-clinical medical student cardiac point-of-care ultrasound curriculum based on the American Society of Echocardiography recommendations: a pilot and feasibility study. Pilot Feasibility Stud. 2021 Sep 14;7(1):175. doi: 10.1186/s40814-021-00910-3.
PubMed 34521479
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Medical Student Handheld Echocardiography Training American Society of Echocardiography Curriculum
- ClinicalTrials.gov ID
- NCT04083924
- Acronym / sponsor ID
- 2019-00265
- Keywords
- Preclinical medical students, Handheld ultrasound, Butterfly iQ, Basic cardiac ultrasound, Focused cardiac ultrasound, Point of care, Training, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post education intervention study
| Arm | Type | Receives |
|---|---|---|
| Basic cardiac ultrasound training | Experimental | Other: Basic cardiac ultrasound training with Butterfly iQ handheld ultrasoundSingle group education intervention study. No control group. Pre-post educational outcomes only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic cardiac ultrasound training with Butterfly iQ handheld ultrasoundPre-training online module of the American society of Echocardiography and hands-on training of basic cardiac ultrasound with Butterfly iQ handheld ultrasound. | Other | Basic cardiac ultrasound training |
Primary outcome
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.
10 secondary outcomes
Image quality score change from pre-training to immediately after training.
Time frame: 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.
Knowledge test score change from pre-training to immediately after training.
Time frame: Immediately after hands-on training.
Overall 5-point Likert scale participants training satisfaction
Time frame: Immediately after hands-on training.
Overall 5-point Likert scale participants training satisfaction
Time frame: 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.
Time frame: Immediately after hands-on training.
Participant confidence in basic cardiac ultrasound.
Time frame: 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
Time frame: Eight weeks after hands-on training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 29550326Johri AM, Durbin J, Newbigging J, Tanzola R, Chow R, De S, Tam J. Cardiac Point-of-Care Ultrasound: State-of-the-Art in Medical School Education. J Am Soc Echocardiogr. 2018 Jul;31(7):749-760. doi: 10.1016/j.echo.2018.01.014. Epub 2018 Mar 15.
- Derived from this study: PubMed 34521479Jujo S, Lee-Jayaram JJ, Sakka BI, Nakahira A, Kataoka A, Izumo M, Kusunose K, Athinartrattanapong N, Oikawa S, Berg BW. Pre-clinical medical student cardiac point-of-care ultrasound curriculum based on the American Society of Echocardiography recommendations: a pilot and feasibility study. Pilot Feasibility Stud. 2021 Sep 14;7(1):175. doi: 10.1186/s40814-021-00910-3.
- Online training module for Cardiovascular Point-of-Care Imaging for the Medical Student and Novice User on American Society of Echocardiography web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Echocardiography
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Heart Failure
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin W Berg, MD study director
SimTiki Simulation Center, John A. Burns School of Medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound in people with Echocardiography and Medical Student, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality score change from pre-training to eight weeks after training. (time frame: Eight weeks after hands-on training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.