Evaluation of Ultra-portable Ultrasound in General Practice

Pneumonia Clinical Trial

— EPEMedG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127149
• Other study ID #: 69HCL18_1004
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: October 20, 2021

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Ultrasound scan
The group uses an ultrasound device for the consultation.

Locations

Country	Name	City	State
France	Maison de santé pluridisciplinaire Léopold Ollier	Les Vans

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Consultation duration	The day of the first consultation, the general practitioner writes the time spent	Two weeks after inclusion in the study