How Point-of-care Ultrasound Affects the Diagnostic and Therapeutic Process in General Practice. A Prospective Follow-up Study in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 655
- 试验地点
- 10
- 主要终点
- Change in the diagnostic confidence
研究概览
简要总结
This study explores how Point of Care Ultrasound (POC-US) is used in general practice in France and how it affects the diagnostic process and treatment of patients.
General practitioners (GPs) will register information each time they use POC-US during a one month period.
The aim of this study is to describe the use of POCUS and its role in the diagnostic and therapeutic process in general medicine.
- Description of the use of POCUS through indication, organs scanned, findings, frequency , time consumption.
- Analysis of the role of POCUS in the diagnostic process: change of diagnostic hypotheses and change of certainty in the main diagnostic hypothesis.
- Analysis of the role of POCUS in the therapeutic process: change in the care pathway and the therapeutic initial plan.
This is an observational study without any intervention.
详细描述
There are few studies describing the use of POCUS in general medicine. Most of them are descriptive studies made more than ten years ago while recent technological development has resulted in better quality images. There is no study with high level of evidence, and the majority of the literature is made of descriptive reports based on the activity of a small number of physicians.
Unlike other countries, France has currently no recommendations on the modalities of use for POCUS. There are no guidelines on the GP curriculum nor on the appropriate equipment for general practitioners, nor on the certification process.
In the current state of knowledge, it seems relevant to establish an overview of the practice of POCUS in general medicine in France. This work is part of an international European reflection on the use of POCUS in general practice and its role in the diagnostic process, therapeutic process and the patients' care pathway in Denmark, in Norway and in France.
The current protocol was written in collaboration with the GP Research Unit of Aalborg. The Danish protocol was completed between January 2018 and July 2019 in Denmark, registered at clinicaltrials.gov NCT03375333. This part of the protocol constitutes the French study.
The aim of this study is to describe the use of POCUS and its role in the diagnostic and therapeutic process in general medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum use of POCUS on two anatomical areas
- •GP activity for minimum two days / week
- •A minimum of two scanning probes
- •Previous participation in formal education in the use of POC-US
- •Minimum six-month experience with POCUS in general practice.
- •Estimated use of POCUS on a daily basis (average)
排除标准
- •Conflict of interest, e.g. if the GP is part of the research group or if the GP has/had direct financial interest in selling ultrasound devices.
- •If less than five patients have been enrolled
结局指标
主要结局
Change in the diagnostic confidence
时间窗: From January 2023 to December 2023
The GPs are asked to register any change in their confidence in the diagnostic hypothesis after the use of POCUS by choosing one of the following variables on an ordinal scale: increased confidence, more confident, unchanged confidence, less confident, reduced confidence
Change in the therapeutic plan for the patient
时间窗: From January 2023 to December 2023
Before using POC-US: * acute admission to hospital * subacute referral to hospital * normal referral to hospital * subacute referral to specialist * normal referral to specialist * referral for radiology * other referral (e.g. to physiotherapist, etc) * follow-up in the clinic * no plan for follow-up * other After using POC-US the GP is shown the "before POC-US plan for the patient" and asked if this plan has changed. If the plan has changed, the GP is asked to specify.
Change in the planned treatment
时间窗: From January 2023 to December 2023
The GPs register their planned treatment before POCUS by choosing one or more of the following categorical variables: * medical treatment * non-medical treatment * no treatment * other After using POCUS, the GP is shown the "before POC-US planned treatment for the patient" and asked if this planned treatment has changed. If the planned treatment has changed, the GP is asked to specify.
Change in the diagnosis
时间窗: From January 2023 to December 2023
GPs will register their diagnoses before and after the use of POCUS and a change in diagnosis will be described * one main diagnostic hypothesis * other diagnostic hypotheses After the use of POCUS, the GPs are asked if these diagnoses have changed and specify.
次要结局
未报告次要终点
研究者
Gladys IBANEZ
Head of General Medicine Department
Sorbonne University