NCT04583670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

October 5, 2020

Results QC Date

July 3, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

ultrasoundprimary carediagnosticgeneral practicephysical examinationfamily medicine

Outcome Measures

Primary Outcomes (4)

  • Number of Patients With Change in the Diagnosis After POCUS Examination

    GPs will register their diagnoses before and after the use of POCUS and a change in diagnosis will be described * one main diagnostic hypothesis * other diagnostic hypotheses After the use of POCUS, the GPs are asked if these diagnoses have changed and specify.

    20 to 30 minute consultation

  • Number of Patients With Change in Diagnostic Confidence

    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

    30 minutes

  • Number of Patients With Change in the Referral Plan

    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.

    20 to 30 minute consultation

  • Number of Patients With Change in the Planned Treatment

    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.

    20 to 30 minute consultation

Study Arms (1)

Patient physical examination with ultrasound

No intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General practitioners practicing POCUS in rural or urban areas, alone or in groups with fixed or portable devices will be eligible.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Cabinet de médecine générale

Le Pecq, France, 78230, France

Location

Centre Erdian SOS Médecins

Anglet, 64600, France

Location

Maison de santé

Avon, 77200, France

Location

Cabinet médical

Conches-en-Ouche, 27190, France

Location

Maison Médicale

Égly, 91520, France

Location

CMS Salvador Allende

La Courneuve, 93120, France

Location

Cabinet médical

Limay, 78520, France

Location

Cabinet médical

Mirabeau, 84120, France

Location

Cabinet IPSO

Paris, 75011, France

Location

Cabinet médical

Paris, 75020, France

Location

Maison médicale

Pont-Croix, 29790, France

Location

Cabinet médical

Saint-Etienne, 42000, France

Location

Cabinet médical

Saint-Médard-en-Jalles, 33160, France

Location

Maison médicale

Saint-Nom-la-Bretêche, 78860, France

Location

Cabinet médical

Strasbourg, 67100, France

Location

Cabinet médical Le Vallet

Vallet, 44330, France

Location

SOS médecins

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (33)

  • Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

    PMID: 21345104BACKGROUND
  • Dietrich CF, Goudie A, Chiorean L, Cui XW, Gilja OH, Dong Y, Abramowicz JS, Vinayak S, Westerway SC, Nolsoe CP, Chou YH, Blaivas M. Point of Care Ultrasound: A WFUMB Position Paper. Ultrasound Med Biol. 2017 Jan;43(1):49-58. doi: 10.1016/j.ultrasmedbio.2016.06.021. Epub 2016 Jul 26.

    PMID: 27472989BACKGROUND
  • Wagner M, Shen-Wagner J, Zhang KX, Flynn T, Bergman K. Point-of-Care Ultrasound Applications in the Outpatient Clinic. South Med J. 2018 Jul;111(7):404-410. doi: 10.14423/SMJ.0000000000000835.

    PMID: 29978225BACKGROUND
  • Échographie ciblée pour les cliniciens de soins de première ligne [Internet]. Département de médecine de famille. [Internet]. [cité 1 mai 2020]. Disponible sur: https://www.mcgill.ca/familymed/fr/formation/programme-residence/echographie-ciblee-pour-les-cliniciens-de-soins-de-premiere-ligne

    BACKGROUND
  • Bécotte G, Garner M, Lanctôt J-F, Parent MC. Position conjointe de l'Association des médecins d'urgence du Québec (AMUQ) et de l'Association des spécialistes en médecine d'urgence du Québec (ASMUQ) adoptée le 7 novembre 2012. :16.

    BACKGROUND
  • Mayordomo-Colunga J, Gonzalez-Cortes R, Bravo MC, Martinez-Mas R, Vazquez-Martinez JL, Renter-Valdovinos L, Conlon TW, Nishisaki A, Cabanas F, Bilbao-Sustacha JA, Oulego-Erroz I. [Point-of-care ultrasound: Is it time to include it in the paediatric specialist training program?]. An Pediatr (Engl Ed). 2019 Sep;91(3):206.e1-206.e13. doi: 10.1016/j.anpedi.2019.06.012. Epub 2019 Aug 6. Spanish.

    PMID: 31395389BACKGROUND
  • Torres-Macho J, Aro T, Bruckner I, Cogliati C, Gilja OH, Gurghean A, Karlafti E, Krsek M, Monhart Z, Muller-Marbach A, Neves J, Sabio R, Serra C, Smallwood N, Tana C, Uyaroglu OA, Von Wowern F, Bosch FH; EFIM s ultrasound working group.. Point-of-care ultrasound in internal medicine: A position paper by the ultrasound working group of the European federation of internal medicine. Eur J Intern Med. 2020 Mar;73:67-71. doi: 10.1016/j.ejim.2019.11.016. Epub 2019 Dec 11.

    PMID: 31836177BACKGROUND
  • Bhagra A, Tierney DM, Sekiguchi H, Soni NJ. Point-of-Care Ultrasonography for Primary Care Physicians and General Internists. Mayo Clin Proc. 2016 Dec;91(12):1811-1827. doi: 10.1016/j.mayocp.2016.08.023. Epub 2016 Nov 5.

    PMID: 27825617BACKGROUND
  • Liu RB, Donroe JH, McNamara RL, Forman HP, Moore CL. The Practice and Implications of Finding Fluid During Point-of-Care Ultrasonography: A Review. JAMA Intern Med. 2017 Dec 1;177(12):1818-1825. doi: 10.1001/jamainternmed.2017.5048.

    PMID: 29059269BACKGROUND
  • Vinayak S, Sande J, Nisenbaum H, Nolsoe CP. Training Midwives to Perform Basic Obstetric Point-of-Care Ultrasound in Rural Areas Using a Tablet Platform and Mobile Phone Transmission Technology-A WFUMB COE Project. Ultrasound Med Biol. 2017 Oct;43(10):2125-2132. doi: 10.1016/j.ultrasmedbio.2017.05.024. Epub 2017 Jul 14.

    PMID: 28716434BACKGROUND
  • Ma IWY, Arishenkoff S, Wiseman J, Desy J, Ailon J, Martin L, Otremba M, Halman S, Willemot P, Blouw M; Canadian Internal Medicine Ultrasound (CIMUS) Group*. Internal Medicine Point-of-Care Ultrasound Curriculum: Consensus Recommendations from the Canadian Internal Medicine Ultrasound (CIMUS) Group. J Gen Intern Med. 2017 Sep;32(9):1052-1057. doi: 10.1007/s11606-017-4071-5. Epub 2017 May 11.

    PMID: 28497416BACKGROUND
  • Kimura BJ. Point-of-care cardiac ultrasound techniques in the physical examination: better at the bedside. Heart. 2017 Jul;103(13):987-994. doi: 10.1136/heartjnl-2016-309915. Epub 2017 Mar 4.

    PMID: 28259843BACKGROUND
  • Arora S, Cheung AC, Tarique U, Agarwal A, Firdouse M, Ailon J. First-year medical students use of ultrasound or physical examination to diagnose hepatomegaly and ascites: a randomized controlled trial. J Ultrasound. 2017 Aug 19;20(3):199-204. doi: 10.1007/s40477-017-0261-6. eCollection 2017 Sep.

    PMID: 28900520BACKGROUND
  • Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.

    PMID: 32203708BACKGROUND
  • Hocine S. Part de l'échoscopie dans la pratique de l'échographie par les médecins généralistes français. Faculté de sciences médicales et paramédicales de Marseille; 2019.

    BACKGROUND
  • Delannoy Q. Quel est l'impact diagnostique et thérapeutique de l'échoscopie en pratique courante de Médecine Générale : Étude observationnelle et transversale. [Thèse d'exercice]. Sorbonne Université; 2018.

    BACKGROUND
  • Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4.

    PMID: 31749019BACKGROUND
  • Andersen CA, Davidsen AS, Brodersen J, Graumann O, Jensen MB. Danish general practitioners have found their own way of using point-of-care ultrasonography in primary care: a qualitative study. BMC Fam Pract. 2019 Jun 28;20(1):89. doi: 10.1186/s12875-019-0984-x.

    PMID: 31253102BACKGROUND
  • Lokkegaard T, Todsen T, Nayahangan LJ, Andersen CA, Jensen MB, Konge L. Point-of-care ultrasound for general practitioners: a systematic needs assessment. Scand J Prim Health Care. 2020 Mar;38(1):3-11. doi: 10.1080/02813432.2020.1711572. Epub 2020 Jan 20.

    PMID: 31955658BACKGROUND
  • Rempell JS, Saldana F, DiSalvo D, Kumar N, Stone MB, Chan W, Luz J, Noble VE, Liteplo A, Kimberly H, Kohler MJ. Pilot Point-of-Care Ultrasound Curriculum at Harvard Medical School: Early Experience. West J Emerg Med. 2016 Nov;17(6):734-740. doi: 10.5811/westjem.2016.8.31387. Epub 2016 Sep 12.

    PMID: 27833681BACKGROUND
  • American Academy of Family Physicians. Recommended Curriculum Guidelines for Family Medicine Residents. Point of Care Ultrasound [Internet]. [cité 28 avr 2020]. Disponible sur: https://www.aafp.org/dam/AAFP/documents/medical_education_residency/program_directors/Reprint290D_POCUS.pdf

    BACKGROUND
  • Bornemann P. Assessment of a Novel Point-of-Care Ultrasound Curriculum's Effect on Competency Measures in Family Medicine Graduate Medical Education. J Ultrasound Med. 2017 Jun;36(6):1205-1211. doi: 10.7863/ultra.16.05002. Epub 2017 Feb 16.

    PMID: 28206672BACKGROUND
  • Hoppmann RA, Rao VV, Bell F, Poston MB, Howe DB, Riffle S, Harris S, Riley R, McMahon C, Wilson LB, Blanck E, Richeson NA, Thomas LK, Hartman C, Neuffer FH, Keisler BD, Sims KM, Garber MD, Shuler CO, Blaivas M, Chillag SA, Wagner M, Barron K, Davis D, Wells JR, Kenney DJ, Hall JW, Bornemann PH, Schrift D, Hunt PS, Owens WB, Smith RS, Jackson AG, Hagon K, Wilson SP, Fowler SD, Catroppo JF, Rizvi AA, Powell CK, Cook T, Brown E, Navarro FA, Thornhill J, Burgis J, Jennings WR, McCallum JB, Nottingham JM, Kreiner J, Haddad R, Augustine JR, Pedigo NW, Catalana PV. The evolution of an integrated ultrasound curriculum (iUSC) for medical students: 9-year experience. Crit Ultrasound J. 2015 Dec;7(1):18. doi: 10.1186/s13089-015-0035-3. Epub 2015 Nov 21.

    PMID: 26589313BACKGROUND
  • Andersen CA, Holden S, Vela J, Rathleff MS, Jensen MB. Point-of-Care Ultrasound in General Practice: A Systematic Review. Ann Fam Med. 2019 Jan;17(1):61-69. doi: 10.1370/afm.2330.

    PMID: 30670398BACKGROUND
  • Steinmetz P, Oleskevich S. The benefits of doing ultrasound exams in your office. J Fam Pract. 2016 Aug;65(8):517-23.

    PMID: 27660835BACKGROUND
  • Van Gansbeke V. [Sonography : a future imaging modality for the general practitioner ?]. Rev Med Brux. 2018;37(4):205-213. French.

    PMID: 30320979BACKGROUND
  • Bornemann P, Jayasekera N, Bergman K, Ramos M, Gerhart J. Point-of-care ultrasound: Coming soon to primary care? J Fam Pract. 2018 Feb;67(2):70-80.

    PMID: 29400896BACKGROUND
  • Myklestul HC, Skonnord T, Brekke M. Point-of-care ultrasound (POCUS) in Norwegian general practice. Scand J Prim Health Care. 2020 Jun;38(2):219-225. doi: 10.1080/02813432.2020.1753385. Epub 2020 Apr 21.

    PMID: 32314640BACKGROUND
  • Zayyan M. Objective structured clinical examination: the assessment of choice. Oman Med J. 2011 Jul;26(4):219-22. doi: 10.5001/omj.2011.55.

    PMID: 22043423BACKGROUND
  • Todsen T, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Jensen ML, Ringsted C. Reliable and valid assessment of point-of-care ultrasonography. Ann Surg. 2015 Feb;261(2):309-15. doi: 10.1097/SLA.0000000000000552.

    PMID: 24509198BACKGROUND
  • Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

    PMID: 15804318BACKGROUND
  • Lemanissier M. L'échographe, deuxième stéthoscope du médecin généraliste ? Validation d'une première liste d'indications d'échographies réalisables par le médecin généraliste. [Thèse d'exercice]. Université Paul Sabatier Toulouse III; 2013.

    BACKGROUND
  • Aakjaer Andersen C, Brodersen J, Davidsen AS, Graumann O, Jensen MBB. Use and impact of point-of-care ultrasonography in general practice: a prospective observational study. BMJ Open. 2020 Sep 17;10(9):e037664. doi: 10.1136/bmjopen-2020-037664.

    PMID: 32948563BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mariela Skendi Study Coordinator
Organization
General Practice Department Sorbonne University

Study Officials

  • Mariela Skendi, MD, MSc

    General Practice Department Sorbonne University

    STUDY DIRECTOR
  • Roxane Liard

    General Practice Department Sorbonne University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of General Medicine Department

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 12, 2020

Study Start

January 15, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

January 20, 2026

Results First Posted

January 20, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The data registered are available for the cooperating researchers at the university in Aalborg Denmark. The purpose of further analyses is to compare the external validity of the questionnaire.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2025
Access Criteria
The data are only available for collaborating researchers at the Center for General Practice, University of Aalborg, Denmark. The principal investigator will have access to pseudo-anonymized data registered on the online platform.

Locations