Evaluation of Ultra-portable Ultrasound in General Practice (EPEMedG)

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Renal Colic; Phlebitis; Pleural Effusion; Hepatic Colic or Cholecystitis; Subcutaneous Abscess or Cyst; Fracture of Long Bones; Intra-uterine Pregnancy or Extra-uterine Pregnancy or Miscarriage
• Intervention / Treatment: Diagnostic test: Ultrasound scan

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Les Vans, France, 07140
    • Maison de santé pluridisciplinaire Léopold Ollier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group with ultrasound; 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; The group uses an ultrasound device for the consultation.
No Intervention: Group without ultrasound; 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?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Francis PELLET, MD, Maison de sante pluridisciplinaire Leopold Ollier Les Vans

Publications and helpful links

General Publications

• Dasse-Hartaut J, Couture S. Pragmatic evaluation of handheld point-of-care ultrasound in general practice. MD thesis. Claude Bernard University Lyon 1; 2021. Thesis supervisor: Dr Francis Pellet.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: general practice; ultrasound scanner; sonogram
• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Neoplasms; Pathological Conditions, Anatomical; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Biliary Tract Diseases; Peripheral Vascular Diseases; Gallbladder Diseases; Vasculitis; Pleural Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abortion, Spontaneous; Pneumonia; Pleural Effusion; Cholecystitis; Renal Colic; Cysts; Pregnancy, Ectopic; Phlebitis; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 69HCL18_1004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No