UltrasoundNCT05274581
General Practitioners' POCUS Competence Following Structured Training
An observational study of Ultrasound and General Practice, run by Aalborg University at 1 site in Denmark.
Trial summary
The overarching aim of this study is to investigate whether a new educational point-of-care ultrasound course tailored for general practitioners working in office-based general practice can lead to scanning competence at the end of the training program (three months after baseline) and if scanning competence can be… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, General Practice, Family Medicine
- What is being tested?
- A new type of ultrasound course
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2022to 2 Dec 2022
- Phase
- Observational
- 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
Study population: Twenty GPs working in office-based general practice in Denmark, who have signed up for a PLO-e ultrasound course, will be invited to participate in the study. To participate a GPs must fulfill the inclusion criteria and not the exclusion criteria
Who may be able to join
- GP, i.e., be a postgraduate medical doctor with a specialization in general practice.
- Work in office-based general practice in Denmark
- Have access to an ultrasound device in the practice during the study period
Who cannot join
- GPs with a possible conflict of interest (e.g., industry affiliation related to the use of ultrasound)
- No signed informed consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Scanning Competence Following a Structured POCUS Training Program for General Practitioners - A Hybrid Effectiveness-implementation Study
The overarching aim of this study is to investigate whether a new educational point-of-care ultrasound course tailored for general practitioners working in office-based general practice can lead to scanning competence at the end of the training program (three months after baseline) and if scanning competence can be maintained six months after baseline.
Read the detailed description
Type of study:
This is a hybrid effectiveness-implementation study . The investigators will test the effectiveness of a new type of point-of-care ultrasound course, tailored to meet the educational needs of office-based general practitioners, in a real-world setting while gathering information on its delivery and the implementation of the intervention.
Setting:
This study will be conducted in office-based general practice in Denmark with the educational sessions taking place at an ultrasound educational facility.
The intervention:
The ultrasound course consists of three teaching seminars over three months, a curriculum of 10 point-of-care ultrasound (POCUS) applications, an online learning platform providing educational support before, during and after the teaching sessions.
The online platform includes instruction videos demonstrating the performance of POCUS, suggestions for additional literature, flashcards training the recognition of pathology, participant assignments to support the development of skills, self-quizzes to focus attention of learning outcomes and specific actioncards for each of the 10 POCUS applications framing the examinations in the clinical context. In addition, the online platform gives participants access to webinars and communication with other participants and teachers. A detailed description of the educational elements in the ultrasound course can be found in the attached study protocol.
Data collection:
The primary outcomes are the Objective Structured Assessment of Ultrasound Skills (OSAUS) score scored three (outcome 1) and six months (outcome 2) after baseline.
The OSAUS assessment tool has been developed and validated as a generic tool for assessing scanning competence. The OSAUS scale consists of seven items: 'indication for the examination', 'applied knowledge of ultrasound equipment', 'image optimization', 'systematic examination', 'interpretation of images', 'documentation of the examination' and 'medical decision-making' and each item is rated using a provided five-point Likert-scale with descriptions of performance ranging from very poor (score = 1) to excellent (score = 5). All items are weighted equally, as high inter-item correlation have been found previously. Hence, for each scanning modality a total score from 7 to 35 points may be achieved.
On the third teaching seminar (three months after baseline) and again six months after baseline, participants will have their scanning competence assessed by external experts. These experts are blinded to the participants previous experience and learning process.
The experts will assess the participants by asking the following questions:
- In which clinical scenarios would you perform this POCUS examination (Item 1 in the OSAUS)
The experts will ask participants to demonstrate the POCUS examination (for maximum five minutes) to assess the following:
- Applied knowledge of the ultrasound equipment (Item 2 in the OSAUS)
- Image optimazation (Item 3 in the OSAUS)
- Systematic examination (Item 4 in the OSAUS)
- Interpretation of images (Item 5 in the OSAUS)
The experts will present the participants with two picture of common pathology and ask the participants the following questions:
- How would you interpret these ultrasound findings? (Item 5 in the OSAUS)
- If you were to describe this examination in the medical record, what would you write? (Item 6 in the OSAUS)
- What would you do if you found it? (Item 7 in the OSAUS) The OSAUS score will also be used for secondary outcomes S1, S2 and S3)
Immediately before each competence assessment by experts, participants will be asked to fill out a questionnaire where they declare whether or not they have POCUS scanning competence within this scanning modality to perform the scan un-supervised in general practice (outcomes 6 and 7). The expert assessor are blinded to this declaration.
In addition, the following process-related outcomes will be collected:
The GPs keep a log book of all scans they perform. The number of scans of the 10 POCUS modalities performed during months 1 to 3 and month 4 to 6 are summarized (outcome 8).
The GPs will register the number of adverse events and near-miss cases associated with their use of POCUS during months 1 to 6, in a questionnaire specifically designed for this purpose (outcome 9).
The GPs activity on the online platform will be registered during the educational period (months 1-3) (outcome 10).
Background characteristics of participating GPs At baseline the following participant characteristics will be collected: Age (years), gender (M, F, other), previous use of ultrasound (number of months with regular use), previous ultrasound courses of minimum 1 day duration (yes/no), scanner type (low range, mid range, high end), type of practice (collaboration, partnership, solo), location of practice (urban, rural, mixed), number of patients assigned to the practice, number of GPs working in the practice will be presented.
Data analysis:
All statistical analyses will be performed using STATA version 17 (StataCorp, Texas, USA) and analyzed according to a predefined statistical analysis plan, which will be uploaded prior to the data collection for the primary outcome (three months after baseline).
- Conditions
- Ultrasound, General Practice, Family Medicine, Education, Competence
- Being tested
- A new type of ultrasound course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new type of ultrasound courseOther
All participants will receive the educational intervention. The educations intervention consists of three teaching seminars over three months, a curriculum of 10 point-of-care ultrasound applications, an online learning platform providing educational support before, during and after the teaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| Course participants | Course participants er general practitioners who have signed-up to participate in an ultrasound course Receives: Other: A new type of ultrasound course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' ultrasound competence score after three months
Participants' ultrasound competence score across ten scanning modalities (The Objective Structured Assessment of Ultrasound Skills (OSAUS)) after the educational period
Measured: three months after baseline
Participants' ultrasound compentence score after six months
Participants' ultrasound competence score across ten scanning modalities (The Objective Structured Assessment of Ultrasound Skills (OSAUS)) six months after baseline
Measured: six months after baseline
Secondary outcomes (5)
Participants' ultrasound competence items scores
Participants' total ultrasound competence score (The Objective Structured Assessment of Ultrasound Skills (OSAUS) 7-35) and the item scores (1-5), for each of the ten scanning modalities included in the curriculum.
Measured: three months after baseline
Participants' ultrasound compentence scores above avarage after three months
The proportion of participants, who have an ultrasound competence score (OSAUS score) of three or more, after the educational period, in all of the seven OSAUS items, for each of the ten scanning modalities included in the curriculum
Measured: three months after baseline
Participants' ultrasound compentence scores above avarage after six months
The proportion of participants, who have an ultrasound competence score (OSAUS score) of three or more, in all of the seven OSAUS items, for each of the ten scanning modalities included in the curriculum
Measured: six months after baseline
Participants' self-rated ultrasound compentence after three months
The proportion of participants, who rate themselves to be competent to perform un-supervised POCUS in general practice, after the educational period, for each of the ten scanning modalities included in the curriculum.
Measured: three months after baseline
Participants' self-rated ultrasound compentence after six months
The proportion of participants, who rate themselves to be competent to perform un-supervised POCUS in general practice, six months after baseline, for each of the ten scanning modalities included in the curriculum.
Measured: six months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start3 Mar 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Aakjær Andersen, Aalborg University
- Investigators
- Camilla A Andersen, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274581
- Sponsor's protocol ID
- ID 242-2
- Status last verified
- Sep 2024
- First submitted
- 2 Mar 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We aim to publish positive, negative or inconclusive results of the study in a peer-reviewed journal. The project group will also present results at conferences.
Publications
Andersen CA, Lundbye-Christensen S, Riis A, Mehnert U, Lokkegaard T, Mengel-Jorgensen T, Rasmussen LD, Soll N, Stork B, Andersen SK, Pil L, Stjernebjerg C, Graumann O, Jensen MB. General practitioners' scanning competence following tailored ultrasound training: a hybrid effectiveness-implementation study. BMC Med Educ. 2025 May 20;25(1):733. doi: 10.1186/s12909-025-07356-8.
PubMed 40394656
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Scanning Competence Following a Structured POCUS Training Program for General Practitioners - A Hybrid Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT05274581
- Acronym / sponsor ID
- ID 242-2
- Conditions
- Ultrasound, General Practice, Family Medicine, Education, Competence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 10 Mar 2022 (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 overarching aim of this study is to investigate whether a new educational point-of-care ultrasound course tailored for general practitioners working in office-based general practice can lead to scanning competence at the end of the training program (three months after baseline) and if scanning competence can be maintained six months after baseline.
Detailed description
Type of study:
This is a hybrid effectiveness-implementation study . The investigators will test the effectiveness of a new type of point-of-care ultrasound course, tailored to meet the educational needs of office-based general practitioners, in a real-world setting while gathering information on its delivery and the implementation of the intervention.
Setting:
This study will be conducted in office-based general practice in Denmark with the educational sessions taking place at an ultrasound educational facility.
The intervention:
The ultrasound course consists of three teaching seminars over three months, a curriculum of 10 point-of-care ultrasound (POCUS) applications, an online learning platform providing educational support before, during and after the teaching sessions.
The online platform includes instruction videos demonstrating the performance of POCUS, suggestions for additional literature, flashcards training the recognition of pathology, participant assignments to support the development of skills, self-quizzes to focus attention of learning outcomes and specific actioncards for each of the 10 POCUS applications framing the examinations in the clinical context. In addition, the online platform gives participants access to webinars and communication with other participants and teachers. A detailed description of the educational elements in the ultrasound course can be found in the attached study protocol.
Data collection:
The primary outcomes are the Objective Structured Assessment of Ultrasound Skills (OSAUS) score scored three (outcome 1) and six months (outcome 2) after baseline.
The OSAUS assessment tool has been developed and validated as a generic tool for assessing scanning competence. The OSAUS scale consists of seven items: 'indication for the examination', 'applied knowledge of ultrasound equipment', 'image optimization', 'systematic examination', 'interpretation of images', 'documentation of the examination' and 'medical decision-making' and each item is rated using a provided five-point Likert-scale with descriptions of performance ranging from very poor (score = 1) to excellent (score = 5). All items are weighted equally, as high inter-item correlation have been found previously. Hence, for each scanning modality a total score from 7 to 35 points may be achieved.
On the third teaching seminar (three months after baseline) and again six months after baseline, participants will have their scanning competence assessed by external experts. These experts are blinded to the participants previous experience and learning process.
The experts will assess the participants by asking the following questions:
- In which clinical scenarios would you perform this POCUS examination (Item 1 in the OSAUS)
The experts will ask participants to demonstrate the POCUS examination (for maximum five minutes) to assess the following:
- Applied knowledge of the ultrasound equipment (Item 2 in the OSAUS)
- Image optimazation (Item 3 in the OSAUS)
- Systematic examination (Item 4 in the OSAUS)
- Interpretation of images (Item 5 in the OSAUS)
The experts will present the participants with two picture of common pathology and ask the participants the following questions:
- How would you interpret these ultrasound findings? (Item 5 in the OSAUS)
- If you were to describe this examination in the medical record, what would you write? (Item 6 in the OSAUS)
- What would you do if you found it? (Item 7 in the OSAUS) The OSAUS score will also be used for secondary outcomes S1, S2 and S3)
Immediately before each competence assessment by experts, participants will be asked to fill out a questionnaire where they declare whether or not they have POCUS scanning competence within this scanning modality to perform the scan un-supervised in general practice (outcomes 6 and 7). The expert assessor are blinded to this declaration.
In addition, the following process-related outcomes will be collected:
The GPs keep a log book of all scans they perform. The number of scans of the 10 POCUS modalities performed during months 1 to 3 and month 4 to 6 are summarized (outcome 8).
The GPs will register the number of adverse events and near-miss cases associated with their use of POCUS during months 1 to 6, in a questionnaire specifically designed for this purpose (outcome 9).
The GPs activity on the online platform will be registered during the educational period (months 1-3) (outcome 10).
Background characteristics of participating GPs At baseline the following participant characteristics will be collected: Age (years), gender (M, F, other), previous use of ultrasound (number of months with regular use), previous ultrasound courses of minimum 1 day duration (yes/no), scanner type (low range, mid range, high end), type of practice (collaboration, partnership, solo), location of practice (urban, rural, mixed), number of patients assigned to the practice, number of GPs working in the practice will be presented.
Data analysis:
All statistical analyses will be performed using STATA version 17 (StataCorp, Texas, USA) and analyzed according to a predefined statistical analysis plan, which will be uploaded prior to the data collection for the primary outcome (three months after baseline).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Course participants | – | Other: A new type of ultrasound courseCourse participants er general practitioners who have signed-up to participate in an ultrasound course |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty GPs working in office-based general practice in Denmark, who have signed up for a PLO-e ultrasound course, will be invited to participate in the study. To participate a GPs must fulfill the inclusion criteria and not the exclusion criteria
Key inclusion criteria (3 listed)
- GP, i.e., be a postgraduate medical doctor with a specialization in general practice.
- Work in office-based general practice in Denmark
- Have access to an ultrasound device in the practice during the study period
Key exclusion criteria (2 listed)
- GPs with a possible conflict of interest (e.g., industry affiliation related to the use of ultrasound)
- No signed informed consent to participate.
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 |
|---|---|---|
| A new type of ultrasound courseAll participants will receive the educational intervention. The educations intervention consists of three teaching seminars over three months, a curriculum of 10 point-of-care ultrasound applications, an online learning platform providing educational support before, during and after the teaching sessions. | Other | Course participants |
Primary outcome
Participants' ultrasound competence score after three months
Time frame: three months after baseline
Participants' ultrasound competence score across ten scanning modalities (The Objective Structured Assessment of Ultrasound Skills (OSAUS)) after the educational period
Participants' ultrasound compentence score after six months
Time frame: six months after baseline
Participants' ultrasound competence score across ten scanning modalities (The Objective Structured Assessment of Ultrasound Skills (OSAUS)) six months after baseline
5 secondary outcomes
Participants' ultrasound competence items scores
Time frame: three months after baseline
Participants' ultrasound compentence scores above avarage after three months
Time frame: three months after baseline
Participants' ultrasound compentence scores above avarage after six months
Time frame: six months after baseline
Participants' self-rated ultrasound compentence after three months
Time frame: three months after baseline
Participants' self-rated ultrasound compentence after six months
Time frame: six months after baseline
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 1 Oct 2024.
- Derived from this study: PubMed 40394656Andersen CA, Lundbye-Christensen S, Riis A, Mehnert U, Lokkegaard T, Mengel-Jorgensen T, Rasmussen LD, Soll N, Stork B, Andersen SK, Pil L, Stjernebjerg C, Graumann O, Jensen MB. General practitioners' scanning competence following tailored ultrasound training: a hybrid effectiveness-implementation study. BMC Med Educ. 2025 May 20;25(1):733. doi: 10.1186/s12909-025-07356-8.
- Individual participant dataSharing planned: Undecided. We aim to publish positive, negative or inconclusive results of the study in a peer-reviewed journal. The project group will also present results at conferences.
Related trials for Ultrasound
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
Recruiting
Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study
Pulmonary Aspiration, Emergency Surgery
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.
Camilla A Andersen principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and General Practice, run by Aalborg University at 1 site in Denmark.
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 3 inclusion and 2 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 1 Oct 2024. 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 Denmark. 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?
Participants' ultrasound competence score after three months (time frame: three months after baseline). The study lists 2 primary outcomes in all. 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 NCT05274581, which also lists 1 linked publication.
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 1 Oct 2024.