- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372053
Evaluation of an Online Application for Point of Care Ultrasound Training in General Internal Medicine Residents
This study compares Point of Care Ultrasound (POCUS) training in two hospitals, one that uses an online application for supervision and one that does not use the application. The goal of this trial is to learn if POCUS supervision using the online application is associated with improved POCUS skills in residents in General Internal Medicine (GIM). The main question it aims to answer is:
- Do POCUS skills improve more during 6 months in GIM residents supervised using the application than in GIM residents who do not use the application?
Further questions the study aims to answer are:
- Do residents using the application perform more POCUS exams during 6 months than residents not using the application?
- Are residents using the application more satisfied with their POCUS training than residents not using the application?
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tudor Cosma, MD
- Phone Number: +41564862502
- Email: tudor.cosma@ksb.ch
Study Locations
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-
Canton of Aargau
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Baden, Canton of Aargau, Switzerland, 5404
- Kantonsspital Baden
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Contact:
- Tudor Cosma, MD
- Phone Number: +41564862502
- Email: tudor.cosma@ksb.ch
-
Principal Investigator:
- Tudor Cosma, MD
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Canton of Zurich
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Schlieren, Canton of Zurich, Switzerland, 8952
- Spital Limmattal Schlieren
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Principal Investigator:
- Tudor Cosma, MD
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Contact:
- Yann Hausherr, MD
- Phone Number: +41447332246
- Email: yann.hausherr@spital-limmattal.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- General Internal Medicine resident employed at one of the study sites for at least 2 months
- Probably or definitely interested in achieving POCUS certification (mandatory for the General Internal Medicine specialisation in Switzerland)
- Basic ultrasound course completed (Basic course Abdominal ultrasound or Emergency ultrasound)
- Will spend at least 3 months within a rotation where POCUS training is offered during the 6 months after baseline assessment
Exclusion Criteria:
- Definitely or probably not interested in achieving POCUS certification
- Has already performed more than 80 supervised and more than 160 total POCUS exams
- Will end employment at the study site less than 7 months after baseline assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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POCUS supervision using application
This group is supervised using the online application.
|
|
Usual POCUS supervision
This group receives usual POCUS supervision, without using the application.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in POCUS skills
Time Frame: Post-test 6 months (+/- 2 weeks) from pre-test
|
POCUS skills will be evaluated on healthy volunteers by video-recorded OSCE
|
Post-test 6 months (+/- 2 weeks) from pre-test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of POCUS exams performed
Time Frame: During 6 months after baseline assessment (pre-test)
|
In the cohort using the application, the number is automatically recorded.
The usual supervision cohort will manually record the number of exams.
|
During 6 months after baseline assessment (pre-test)
|
|
Number of supervised POCUS exams performed
Time Frame: During 6 months after baseline assessment (pre-test)
|
In the cohort using the application, the number is automatically recorded.
The usual supervision cohort will manually record the number of exams.
|
During 6 months after baseline assessment (pre-test)
|
|
Number of directly supervised POCUS exams performed
Time Frame: During 6 months after baseline assessment (pre-test)
|
Direct supervision means that the supervisor is present during the exam.
In the cohort using the application, the number is automatically recorded.
The usual supervision cohort will manually record the number of exams.
|
During 6 months after baseline assessment (pre-test)
|
|
Change in satisfaction and engagement with POCUS training
Time Frame: Follow-up assessment 6 months (+/- 2 weeks) after baseline assessment
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Measured with a survey
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Follow-up assessment 6 months (+/- 2 weeks) after baseline assessment
|
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Change in self-assessed POCUS competency
Time Frame: Follow-up assessment 6 months (+/- 2 weeks) after baseline assessment
|
Assessed with a survey.
Included since the objective evaluation (primary outcome) will not assess all regions that residents are trained to examine, in order to keep the evaluation feasible.
|
Follow-up assessment 6 months (+/- 2 weeks) after baseline assessment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usefulness of the online application
Time Frame: 6 months (+/- 2 weeks) after baseline assessment
|
Assessed with a survey, only in the cohort using the application
|
6 months (+/- 2 weeks) after baseline assessment
|
|
Change from baseline in POCUS skills within the individual cohorts
Time Frame: Post-test 6 month (+/- 2 weeks) from pre-test
|
Evaluating how POCUS skills evolve during 6 months in each of the individual study arms.
|
Post-test 6 month (+/- 2 weeks) from pre-test
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Maria M Wertli, MD PhD, Kantonsspital Baden
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-01470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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