UltrasoundNCT04021693
Learning Outcomes With Point-of-Care Ultrasound
A study testing Handheld Ultrasound Devices in people with Ultrasound, run by Stanford University at 1 site in United States.
Trial summary
Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound
- What is being tested?
- Handheld Ultrasound Devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2017to 30 Jun 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Internal Medicine Intern Physicians at Stanford University
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Improved Access to a Portable Ultrasound Device Improve Trainee Learning With Point-of-care Ultrasonography: A Randomized Trial
Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether handheld ultrasound devices, along with a year-long lecture series, improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning vs. no personal access. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and lecture attendance.
- Conditions
- Ultrasound
- Being tested
- Handheld Ultrasound Devices
- Keywords
- Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld Ultrasound DevicesOther
Interns in the handheld ultrasound device arm shall carry a personal handheld ultrasound device to be used for self-directed learning
| Study group | Role | What they receive |
|---|---|---|
| Handheld Ultrasound Devices | Experimental | Not described Receives: Other: Handheld Ultrasound Devices |
| No Handheld Ultrasound Devices | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Correct On Image Assessments at 1 year
Image assessments will include videos and photographs of ultrasound images that will require the intern to interpret the image.
Measured: 1 year
Secondary outcomes (2)
Mean Reported Device Usage Rates at 1 year
Self-reported usage rates of the ultrasound devices per week by the interns
Measured: 1 year
Mean Lecture Attendance at 1 year
Mean Lecture Attendance per Study Arm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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 UltrasoundStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intern physicians were randomized 1:1 to receive personal access to a handheld ultrasound device vs. no device. The groups did not cross over in which intervention they received.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Kumar, Stanford University
- Investigators
- Andre D Kumar, MD, MEd, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021693
- Sponsor's protocol ID
- 42094
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar A, Kugler J, Jensen T. Evaluation of Trainee Competency with Point-of-Care Ultrasonography (POCUS): a Conceptual Framework and Review of Existing Assessments. J Gen Intern Med. 2019 Jun;34(6):1025-1031. doi: 10.1007/s11606-019-04945-4.
PubMed 30924088Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
PubMed 21345104
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Improved Access to a Portable Ultrasound Device Improve Trainee Learning With Point-of-care Ultrasonography: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04021693
- Acronym / sponsor ID
- 42094
- Conditions
- Ultrasound
- Keywords
- Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Jul 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.
Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether handheld ultrasound devices, along with a year-long lecture series, improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning vs. no personal access. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and lecture attendance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intern physicians were randomized 1:1 to receive personal access to a handheld ultrasound device vs. no device. The groups did not cross over in which intervention they received.
| Arm | Type | Receives |
|---|---|---|
| Handheld Ultrasound Devices | Experimental | Other: Handheld Ultrasound Devices |
| No Handheld Ultrasound Devices | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Internal Medicine Intern Physicians at Stanford University
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 |
|---|---|---|
| Handheld Ultrasound DevicesInterns in the handheld ultrasound device arm shall carry a personal handheld ultrasound device to be used for self-directed learning | Other | Handheld Ultrasound Devices |
Primary outcome
Mean Percent Correct On Image Assessments at 1 year
Time frame: 1 year
Image assessments will include videos and photographs of ultrasound images that will require the intern to interpret the image.
2 secondary outcomes
Mean Reported Device Usage Rates at 1 year
Time frame: 1 year
Mean Lecture Attendance at 1 year
Time frame: 1 year
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 16 Jul 2019.
- Background: PubMed 30924088Kumar A, Kugler J, Jensen T. Evaluation of Trainee Competency with Point-of-Care Ultrasonography (POCUS): a Conceptual Framework and Review of Existing Assessments. J Gen Intern Med. 2019 Jun;34(6):1025-1031. doi: 10.1007/s11606-019-04945-4.
- Background: PubMed 21345104Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
- Individual participant dataSharing planned: No
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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.
Andre D Kumar, MD, MEd principal investigator
Clinical Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld Ultrasound Devices in people with Ultrasound, run by Stanford University 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 1 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 16 Jul 2019. 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?
Mean Percent Correct On Image Assessments at 1 year (time frame: 1 year). 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 NCT04021693, 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 16 Jul 2019.