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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04127149
Other study ID # 69HCL18_1004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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