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

Primary Purpose

Pneumonia, Pleural Effusion, Renal Colic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound scan
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia focused on measuring ultrasound scanner, sonogram, general practice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group with ultrasound

    Group without ultrasound

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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…)

    Secondary Outcome Measures

    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
    Cost of care
    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 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
    The day of the first consultation, the general practitioner writes the time spent

    Full Information

    First Posted
    October 8, 2019
    Last Updated
    October 14, 2019
    Sponsor
    Hospices Civils de Lyon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04127149
    Brief Title
    Evaluation of Ultra-portable Ultrasound in General Practice
    Acronym
    EPEMedG
    Official Title
    Pragmatic Evaluation of Ultra-portable Ultrasound for a List of Indications in General Practice
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospices Civils de Lyon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    Keywords
    ultrasound scanner, sonogram, general practice

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group with ultrasound
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group without ultrasound
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Ultrasound scan
    Intervention Description
    The group uses an ultrasound device for the consultation.
    Primary Outcome Measure Information:
    Title
    Number of complementary exams
    Description
    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…)
    Time Frame
    Two weeks after inclusion
    Secondary Outcome Measure Information:
    Title
    Number of hospitalisations, specialist orientation or return home
    Description
    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
    Time Frame
    Two weeks after inclusion
    Title
    Cost of care
    Description
    After knowing the patient orientation and the complementary exams they had, an estimation of the cost of care is made.
    Time Frame
    Four weeks after inclusion in the study
    Title
    Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale
    Description
    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.
    Time Frame
    Two weeks after inclusion in the study
    Title
    Consultation duration
    Description
    The day of the first consultation, the general practitioner writes the time spent
    Time Frame
    Two weeks after inclusion in the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francis PELLET, MD
    Phone
    475384848
    Ext
    +33
    Email
    francis.pellet@stamed.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francis PELLET, MD
    Organizational Affiliation
    Maison de sante pluridisciplinaire Leopold Ollier Les Vans
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Ultra-portable Ultrasound in General Practice

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