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Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy (ECHOSTEOM)

Primary Purpose

Musculoskeletal; Anomaly

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
musculoskeletal ultrasound
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Musculoskeletal; Anomaly focused on measuring musculoskeletal anomaly, ultrasonography, general practitioners

Eligibility Criteria

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

Inclusion Criteria: Person who has received full information on the organization of the research and has given his/her consent Be over 18 years of age Present a symptomatology leading to suspicion of musculoskeletal pathology Be able to give consent Be affiliated to a social security scheme or benefit from such a scheme Exclusion Criteria: Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.). Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice). Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1. Pregnant women Nursing mothers

Sites / Locations

  • Central Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients

Arm Description

Patient with musculoskeletal anomalies

Outcomes

Primary Outcome Measures

Percentage of patients
Percentage of patients for whom the musculoskeletal point of care ultrasonography led to a change in the GP's overall decision-making strategy (binary yes/no variable) of patients for whom led to a change in the GP's overall decision-making strategy (binary yes/no variable)

Secondary Outcome Measures

Frequency of the anatomical sites
Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned
Frequency of modifications
Frequency of different modifications for each axis and within each axis
Frequency of diagnoses of post-CTA confirmation
List and frequency of diagnoses in the case of post-CTA confirmation
Frequency of diagnoses of post-CTA modifications
List and frequency of diagnoses in the case of post-CTA modifications
Frequency of incidental diagnoses discovered at CTA
Frequency and description of incidental diagnoses discovered at CTA
Frequency of modifications per patient
Frequency of different modifications for each axis and within each axis per patient
Calculation of the cost
Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate
Rates for the examinations and therapies
the rates for the examinations and therapies described
Frequency with which CTA
For each doctor: the frequency with which CTA is carried out in his professional practice
Time taken to carry out the CTA
For each doctor: the time taken to carry out the CTA
Average number of ultrasound prints
For each doctor: the average number of ultrasound image prints
Time taken to produce an CTA report
For each doctor: the time taken to produce an CTA report

Full Information

First Posted
September 22, 2023
Last Updated
September 28, 2023
Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT06068595
Brief Title
Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy
Acronym
ECHOSTEOM
Official Title
The Contribution of Targeted Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy for Patients With Suspected Musculoskeletal Pathology: a Before/After Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2024 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine

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
The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management. The aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).
Detailed Description
The study circuit takes place in a single visit. The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination. The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study. The investigator fills in the e-CRF (appendix III), clinical examination, medical interrogation and his or her decisions according to the 5 axes, which cannot be modified, as the structure of the e-CRF planned in advance does not allow backtracking. The investigator performs the targeted musculoskeletal ultrasound with his or her personal ultrasound machine, following his or her usual operating procedure. The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal; Anomaly
Keywords
musculoskeletal anomaly, ultrasonography, general practitioners

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
Patient with musculoskeletal anomalies
Intervention Type
Other
Intervention Name(s)
musculoskeletal ultrasound
Intervention Description
After clinical examination and medical interrogation, The investigating physician gives her decisions in the e-CRF according to the 5 axes: diagnosis (I), therapy (II), patient referral (III), prescription of additional tests (IV) and follow-up (V). The investigator performs the targeted musculoskeletal ultrasound with his personal ultrasound machine, following his usual operating procedure and give/keep the final diagnostic.
Primary Outcome Measure Information:
Title
Percentage of patients
Description
Percentage of patients for whom the musculoskeletal point of care ultrasonography led to a change in the GP's overall decision-making strategy (binary yes/no variable) of patients for whom led to a change in the GP's overall decision-making strategy (binary yes/no variable)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Frequency of the anatomical sites
Description
Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned
Time Frame
3 years
Title
Frequency of modifications
Description
Frequency of different modifications for each axis and within each axis
Time Frame
3 years
Title
Frequency of diagnoses of post-CTA confirmation
Description
List and frequency of diagnoses in the case of post-CTA confirmation
Time Frame
3 years
Title
Frequency of diagnoses of post-CTA modifications
Description
List and frequency of diagnoses in the case of post-CTA modifications
Time Frame
3 years
Title
Frequency of incidental diagnoses discovered at CTA
Description
Frequency and description of incidental diagnoses discovered at CTA
Time Frame
3 years
Title
Frequency of modifications per patient
Description
Frequency of different modifications for each axis and within each axis per patient
Time Frame
3 years
Title
Calculation of the cost
Description
Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate
Time Frame
3 years
Title
Rates for the examinations and therapies
Description
the rates for the examinations and therapies described
Time Frame
3 years
Title
Frequency with which CTA
Description
For each doctor: the frequency with which CTA is carried out in his professional practice
Time Frame
3 years
Title
Time taken to carry out the CTA
Description
For each doctor: the time taken to carry out the CTA
Time Frame
3 years
Title
Average number of ultrasound prints
Description
For each doctor: the average number of ultrasound image prints
Time Frame
3 years
Title
Time taken to produce an CTA report
Description
For each doctor: the time taken to produce an CTA report
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Person who has received full information on the organization of the research and has given his/her consent Be over 18 years of age Present a symptomatology leading to suspicion of musculoskeletal pathology Be able to give consent Be affiliated to a social security scheme or benefit from such a scheme Exclusion Criteria: Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.). Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice). Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1. Pregnant women Nursing mothers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Gass, Dr
Phone
67467111
Ext
33
Email
boris.gass@univ-lorraine.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Di Patrizio, Pr
Phone
608376920
Ext
33
Email
paolo.di-patrizio@univ-lorraine.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Gass, Pr
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hospital
City
Nancy
State/Province
Vandoeuvre Lès Nancy
ZIP/Postal Code
54500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Gass, Dr
Email
boris.gass@univ-lorraine.fr
First Name & Middle Initial & Last Name & Degree
Paolo Di Patrizio, Pr
Email
paolo.di-patrizio@univ-lorraine.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
31749019
Citation
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.
Results Reference
background
PubMed Identifier
33675099
Citation
Meyer R, Lin C, Yenokyan G, Ellen M. Diagnostic Utility of Ultrasound Versus Physical Examination in Assessing Knee Effusions: A Systematic Review and Meta-analysis. J Ultrasound Med. 2022 Jan;41(1):17-31. doi: 10.1002/jum.15676. Epub 2021 Mar 5.
Results Reference
background
PubMed Identifier
18492916
Citation
Nazarian LN. The top 10 reasons musculoskeletal sonography is an important complementary or alternative technique to MRI. AJR Am J Roentgenol. 2008 Jun;190(6):1621-6. doi: 10.2214/AJR.07.3385.
Results Reference
background
PubMed Identifier
29490335
Citation
Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001.
Results Reference
background
PubMed Identifier
31253102
Citation
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.
Results Reference
background

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Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy

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