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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Denmark1 site
  • Center for General Practice at Aalborg University

    Aalborg, 9220

Other trials in Denmark

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).

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 groups in NCT05274581
Study groupRoleWhat they receive
Course participantsCourse 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted10 Mar 2022
  2. Study start3 Mar 2022
  3. Primary completion2 Dec 2022
  4. Study completion2 Dec 2022

Resources

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)
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

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.

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