Clinical trial NCT05274581: General Practitioners' POCUS Competence Following Structured Training
Official title: Evaluating Scanning Competence Following a Structured POCUS Training Program for General Practitioners - A Hybrid Effectiveness-implementation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
General Practice
Family Medicine
Education
Competence
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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).

Eligibility criteria: Inclusion criteria:

1. GP, i.e., be a postgraduate medical doctor with a specialization in general practice.
2. Work in office-based general practice in Denmark
3. Have access to an ultrasound device in the practice during the study period

Exclusion criteria:

1. GPs with a possible conflict of interest (e.g., industry affiliation related to the use of ultrasound)
2. No signed informed consent to participate.

Primary outcomes:
measure: Participants' ultrasound competence score after three months
timeFrame: three months after baseline
measure: Participants' ultrasound compentence score after six months
timeFrame: six months after baseline
Secondary outcomes:
measure: Participants' ultrasound competence items scores
timeFrame: three months after baseline
measure: Participants' ultrasound compentence scores above avarage after three months
timeFrame: three months after baseline
measure: Participants' ultrasound compentence scores above avarage after six months
timeFrame: six months after baseline
measure: Participants' self-rated ultrasound compentence after three months
timeFrame: three months after baseline
measure: Participants' self-rated ultrasound compentence after six months
timeFrame: six months after baseline
Other outcomes:
measure: Number of performed POCUS examinations
timeFrame: months 1-6 after baseline
measure: Number of adverse events and near-miss cases
timeFrame: months 1-6 after baseline
measure: Participants' completion of educational elements
timeFrame: months 1-3 after baseline
Locations:
city: Aalborg
country: Denmark
facility: Center for General Practice at Aalborg University
Study officials:
affiliation: Aalborg University
name: Camilla A Andersen
role: PRINCIPAL_INVESTIGATOR
References: