Center for General Practice at Aalborg University
Aalborg, 9220, Denmark
NCT Number: NCT05274581
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.
Looking for future studies?
Notify MeAll sexes
Observational
Aalborg, 9220, Denmark
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:
The experts will ask participants to demonstrate the POCUS examination (for maximum five minutes) to assess the following:
The experts will present the participants with two picture of common pathology and ask the participants the following questions:
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
Time frame: three months after baseline
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.
Time frame: three months after baseline
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
Time frame: six months after baseline
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
Time frame: three months after baseline
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.
Time frame: six months after baseline
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.
Time frame: months 1-6 after baseline
The number of performed POCUS examinations by each participant in the first six months after introducing POCUS use in general practice
Time frame: months 1-6 after baseline
The number of adverse events and near-miss cases associated with the use of POCUS reported by the participants in the first six months after introducing POCUS use in general practice
Time frame: months 1-3 after baseline
The proportion of participants, who have completed the different educational elements in the educational intervention three months after baseline
Aalborg University
Other
Evaluating Scanning Competence Following a Structured POCUS Training Program for General Practitioners - A Hybrid Effectiveness-implementation Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05013476
Education, Median Neuropathy
Englewood, Colorado, United States
View Trial DetailsNCT03375333
Diagnostics, General Practice
Aalborg, Denmark
View Trial DetailsNCT03416608
General Practice, Ultrasound
Aalborg, Denmark
View Trial DetailsNCT06837532
Local Anesthesia Infiltration, Postoperative Analgesia
Cairo, Egypt
View Trial Details