Evaluation of Ultra-portable Ultrasound in General Practice

Study Overview
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Brief Summary
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This is an interventional multi-centre study comparing two groups of general practitioners with or without an ultrasound scanner over a period of 6 months. The evaluation focuses on the management of patients for 8 pathologies: Pneumonia Pleural effusion Renal colic Hepatic colic or cholecystitis Subcutaneous abscess or cyst Fracture of long bones Intra-uterine pregnancy or extra-uterine pregnancy or miscarriage Phlebitis The principal hypothesis is that there are fewer complementary exams in the group of doctors using ultrasound scanners. The secondary hypotheses are: There is better patient orientation (emergency care, specialist consultation, return home) in the group of doctors using the ultrasound scanners. The global cost of the care is lower in the group of doctors using the ultrasound. Using ultrasound during the consultation decreases the anxiety of the patient. Using ultrasound increases the duration of the consultation. There is no difference between the predicted and the real orientation of the patients.

Official Title
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Pragmatic Evaluation of Ultra-portable Ultrasound for a List of Indications in General Practice

Conditions
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Pneumonia, Pleural Effusion, Renal Colic, Hepatic Colic or Cholecystitis, Subcutaneous Abscess or Cyst, Fracture of Long Bones, Intra-uterine Pregnancy or Extra-uterine Pregnancy or Miscarriage, Phlebitis

Intervention / Treatment
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* Diagnostic Test: Ultrasound scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients age 18 and over consulting their general practitioner for one of the 8 conditions below Exclusion Criteria: patients who have already received an imagery exam for the acute episode justifying the consult opposition to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group with ultrasound<br>The first group consists of nine general practitioners having received a brief training on the use of ultrasound scanners in general practice. The general practitioner includes all adult patients who are consulting for one of the 8 medical conditions studied and perform an ultrasound scan. Two weeks later, he/she calls each patient to collect the necessary data. | Diagnostic Test: Ultrasound scan<br>* The group uses an ultrasound device for the consultation.<br>|
| No Intervention: Group without ultrasound<br>The second group consists of nine general practitioners. Each physician includes all adult patients who are consulting for one of the 8 medical conditions studied and performs a standard consultation. Two weeks later, he/she calls each patient to collect the necessary data. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complementary exams | Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know: The number of imagery exams they had (ultrasound, MRI, scanner, radiology…) The number of biological analysis (CRP, ASAT, ALAT, Lipase…) | Two weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalisations, specialist orientation or return home | Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know if within the past two weeks, they have been hospitalised, required emergency care, needed to consult a specialist, or returned back home | Two weeks after inclusion | 
| Cost of care | After knowing the patient orientation and the complementary exams they had, an estimation of the cost of care is made. | Four weeks after inclusion in the study | 
| Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale | Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know the result of the anxiety test they took the day of the first consultation. | Two weeks after inclusion in the study | 
| Consultation duration | The day of the first consultation, the general practitioner writes the time spent | Two weeks after inclusion in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound scanner, sonogram, general practice