EPEMedG: Evaluation of Ultra-portable Ultrasound in General Practice

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT04127149

Collaborator

(none)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: Ultrasound scan	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of complementary exams [Two weeks after inclusion]
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…)

Secondary Outcome Measures

Number of hospitalisations, specialist orientation or return home [Two weeks after inclusion]
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
Cost of care [Four weeks after inclusion in the study]
After knowing the patient orientation and the complementary exams they had, an estimation of the cost of care is made.
Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale [Two weeks after inclusion in the study]
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.
Consultation duration [Two weeks after inclusion in the study]
The day of the first consultation, the general practitioner writes the time spent