Point of Care Ultrasound Use by General Practitioners in France (Echo-MG)

Sponsor
Sorbonne University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04583670
Collaborator
(none)
600
1
2
299.4

Study Details

Study Description

Brief Summary

This study explores how Point of Care Ultrasound (POC-US) is used in general practice in France and how it affects the diagnostic process and treatment of patients.

General practitioners (GPs) will register information each time they use POC-US during a one month period.

The aim of this study is to describe the use of POCUS and its role in the diagnostic and therapeutic process in general medicine.

  • Description of the use of POCUS through indication, organs scanned, findings, frequency , time consumption.

  • Analysis of the role of POCUS in the diagnostic process: change of diagnostic hypotheses and change of certainty in the main diagnostic hypothesis.

  • Analysis of the role of POCUS in the therapeutic process: change in the care pathway and the therapeutic initial plan.

This is an observational study without any intervention.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    How Point-of-care Ultrasound Affects the Diagnostic and Therapeutic Process in General Practice. A Prospective Follow-up Study in France
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Nov 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    30 general practitioners, who will use ultrasound during their consultations

    Outcome Measures

    Primary Outcome Measures

    1. Change in the diagnostic [2021]

      Before the use of POCUS: one main diagnostic hypothesis other diagnostic hypotheses After the use of POCUS, the GPs are asked if these diagnoses have changed and specify.

    2. Change in confidence [2021-2022]

      The GPs are asked to register any change in their confidence in the diagnostic hypothesis after the use of POCUS by choosing one of the following variables on an ordinal scale: increased confidence more confident unchanged confidence less confident reduced confidence

    3. Change in the therapeutic plan for the patient [2021-2022]

      Before using POC-US: acute admission to hospital subacute referral to hospital normal referral to hospital subacute referral to specialist normal referral to specialist referral for radiology other referral (e.g. to physiotherapist, etc) follow-up in the clinic no plan for follow-up other After using POC-US the GP is shown the "before POC-US plan for the patient" and asked if this plan has changed. If the plan has changed, the GP is asked to specify.

    4. Change in the planned treatment [2021-2022]

      The GPs register their planned treatment before POCUS by choosing one or more of the following categorical variables: medical treatment non-medical treatment no treatment other After using POCUS, the GP is shown the "before POC-US planned treatment for the patient" and asked if this planned treatment has changed. If the planned treatment has changed, the GP is asked to specify.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • minimum use of POCUS on two anatomical areas

    • GP activity for minimum two days / week

    • A minimum of two scanning probes

    • Previous participation in formal education in the use of POC-US

    • Minimum six-month experience with POCUS in general practice.

    • Estimated use of POCUS on a daily basis (average)

    Exclusion Criteria:
    • Conflict of interest, e.g. if the GP is part of the research group or if the GP has/had direct financial interest in selling ultrasound devices.

    • If less than five patients have been enrolled

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departement de Medecine Generale Sorbonne Paris France 75012

    Sponsors and Collaborators

    • Sorbonne University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sorbonne University
    ClinicalTrials.gov Identifier:
    NCT04583670
    Other Study ID Numbers:
    • Echo-MG
    First Posted:
    Oct 12, 2020
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sorbonne University

    Study Results

    No Results Posted as of May 12, 2021