The POCUS in Practice Study. Implementation of Point-of-care Ultrasonography in General Practice: A Stepped Wedge Cluster Randomized Trial

Aalborg University1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新: 2025年3月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 200
试验地点: 1
主要终点: Change in number of referrals for secondary care

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In a stepped-wedge cluster randomized trial, the effects of an educational intervention will be determined by estimating the uptake of point-of-care ultrasound by general practitioners (outcome P1), change in referral from primary care to secondary care (outcome P2), change in number of consultations delivered in primary care (outcome S1), GPs job satisfaction, level of stress, and burn-out (outcomes S2-4), as well as the number of point-of-care ultrasound related adverse events (outcome S5), a health economic evaluation (outcome S6) and the patient experience of point-of-care ultrasound (outcome S7).

Two-hundred general practitioners (GPs) will participate in the study. Participants will be randomized to participate in clusters with a training facility close to their clinic. All participants will be offered the educational intervention. Ten clusters will receive the intervention at different timepoints.

详细描述

In a stepped-wedge cluster randomized trial the effects of an educational intervention, where general practitioners (GPs) are trainined in the use of point-of-care ultrasound (POCUS) in office-based general practice, will be dertermined.

The intervention is in line with international recommendations for ultrasound education and consists of three teaching seminars over a three month time period, a curriculum of 10 POCUS applications, and 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, assignments to support the development of skills, self-tests 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, who will act as mentors during the learning process.

Two-hundred GPs will participate in the study. Participants will be randomized to participate in clusters. Ten clusters will receive the educational intervention at different timepoints. Each cluster will consists of a group of 20 GPs from the same geographical area (the five Danish regions).Hence, the study will include two clusters from each of the five Danish regions, who will receive the educational intervention at a location in the specific region ( Copenhagen, Lyngby, Roskilde, Næstved, Odense, Vejle, Aarhus, Herning, Sæby and Aalborg) at different timepoints.

Participants Recruitment All GPs working in Danish general practice will be invited to participate in the study by an e-mail circulated by the Organisation of General Practitioners in Denmark (Praktiserende Lægers Organisation - PLO) to all PLO members. The e-mail will contain a link to a questionnaire in which the GPs will be asked to specify their name, practice, location of practice (region in Denmark), distance to nearest ultrasound scanning service, whether or not they are already using POCUS, whether or not they will have access to an ultrasound device during the educational intervention, and whether or not they are willing to share data. There will be a deadline for responding to the invitation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Diagnostic
盲法: Single (Outcomes Assessor)

盲法说明

Due to the nature of the study the intervention cannot be blinded to the participants, but for statistical assessment, data will be blinded as regard to time of collection and location.

入排标准

性别: All
接受健康志愿者: 是

入选标准

•GPs who are postgraduate medical doctor with a specialization in general practice
•GPs who work in office-based Danish general practice
•GPs who have access to an ultrasound device in the practice during the study period

排除标准

•GPs not willing to participate in the data collection or share data for this study
•No signed informed consent to participate

研究组 & 干预措施

Cluster 1

Other

Participants are randomised into clusters. Each cluster includes 20 participants. All clusters receive the same educational intervention but at different time-points. Each cluster contributes with both exposed and unexposed outcomes and as such acts as its own control.

Cluster one contributes with 3 months unexposed and 18 months exposed outcomes.