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Clinical 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 maintained six months after baseline.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05274581
Study type Observational
Source Aalborg University
Contact
Status Completed
Phase
Start date March 3, 2022
Completion date December 2, 2022

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