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Competency-based Assessment of Ultrasound-guided Joint Injection Skills

Primary Purpose

Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ultrasound guided joint injection
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Musculoskeletal Diseases focused on measuring Training, Ultrasound, Medical education

Eligibility Criteria

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

Inclusion Criteria:

  • Physicians attending the yearly international conference EULAR (Denmark 2022)

    1. Novices: No or little experience with ultrasound guided joint injections.
    2. Intermediates: Participated and completed at least one formal musculoskeletal ultrasound course and performed more than 100 ultrasound guided joint injections.
    3. Experts: Physicians with a long experience with musculoskeletal ultrasound and ultrasound guided joint injections doing the procedure almost daily and providing teaching and/or research within this field.

Exclusion Criteria:

  • No informed consent
  • Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections.

Sites / Locations

  • COPECARE (Copenhagen Center for Arthritis Research)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Novices

Intermediates

Experts

Arm Description

Measurement of competence

Measurement of competence

Measurement of competence

Outcomes

Primary Outcome Measures

Performance score
Performance score assessed by blinded raters using the modified IUSE assessment tool

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
October 25, 2022
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05303974
Brief Title
Competency-based Assessment of Ultrasound-guided Joint Injection Skills
Official Title
Competency-based Assessment of Ultrasound-guided Joint Injection Skills: A Validity Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 29, 2022 (Actual)
Primary Completion Date
June 4, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

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
Ultrasound-guided joint injections and aspirations are frequently used in the treatment of rheumatological diseases. Studies have shown that intra-articular glucocorticoid injections (IAGCs) in the early treatment of rheumatoid arthritis is essential and leads to improved disease control and earlier achievement of remission. Unfortunately, many rheumatologists feel insecure performing IAGC due to poor and unstructured training opportunities, which can result in suboptimal treatment and potentially poorer patient outcome. Nowadays, the gold standard training method has shifted towards competency-based education were objective assessment tools are necessary. A previous study has developed a scale for assessment of invasive ultrasound procedures, the Interventional Ultrasound Skills Evaluation (IUSE) tool. Although expert consensus supports evidence of content validity of the assessment tool, it is not known if the tool can discriminate differences in performance scores between the different levels of experience.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Training, Ultrasound, Medical education

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Novices
Arm Type
Experimental
Arm Description
Measurement of competence
Arm Title
Intermediates
Arm Type
Experimental
Arm Description
Measurement of competence
Arm Title
Experts
Arm Type
Experimental
Arm Description
Measurement of competence
Intervention Type
Other
Intervention Name(s)
Ultrasound guided joint injection
Intervention Description
The participants will perform two ultrasound guided joint injections on a mannequin. The performance of both procedures are videorecorded. All videos will be rated by two blinded raters using the modified IUSE assessment tool.
Primary Outcome Measure Information:
Title
Performance score
Description
Performance score assessed by blinded raters using the modified IUSE assessment tool
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physicians attending the yearly international conference EULAR (Denmark 2022) Novices: No or little experience with ultrasound guided joint injections. Intermediates: Participated and completed at least one formal musculoskeletal ultrasound course and performed more than 100 ultrasound guided joint injections. Experts: Physicians with a long experience with musculoskeletal ultrasound and ultrasound guided joint injections doing the procedure almost daily and providing teaching and/or research within this field. Exclusion Criteria: No informed consent Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stine Maya D Carstensen, MD
Organizational Affiliation
Afdeling for Rygkirurgi, Led- og Bindevævssygdomme, COPECARE (Copenhagen Center for Arthritis Research) Rigshospitalet, Glostrup Valdemar Hansens vej 17 2600 Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
COPECARE (Copenhagen Center for Arthritis Research)
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33201282
Citation
Kahr Rasmussen N, Nayahangan LJ, Carlsen J, Ekberg O, Brabrand K, Albrecht-Beste E, Nielsen MB, Konge L. Evaluation of competence in ultrasound-guided procedures-a generic assessment tool developed through the Delphi method. Eur Radiol. 2021 Jun;31(6):4203-4211. doi: 10.1007/s00330-020-07280-z. Epub 2020 Nov 17.
Results Reference
result
PubMed Identifier
22120466
Citation
Mandl P, Naredo E, Conaghan PG, D'Agostino MA, Wakefield RJ, Bachta A, Backhaus M, Hammer HB, Bruyn GA, Damjanov N, Filippucci E, Grassi W, Iagnocco A, Jousse-Joulin S, Kane D, Koski JM, Moller I, De Miguel E, Schmidt WA, Swen WA, Szkudlarek M, Terslev L, Ziswiler HR, Ostergaard M, Balint PV. Practice of ultrasound-guided arthrocentesis and joint injection, including training and implementation, in Europe: results of a survey of experts and scientific societies. Rheumatology (Oxford). 2012 Jan;51(1):184-90. doi: 10.1093/rheumatology/ker331. Epub 2011 Nov 24.
Results Reference
result
PubMed Identifier
22302316
Citation
Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1. Erratum In: Ann Rheum Dis. 2012 Nov;71(11):1918.
Results Reference
result
PubMed Identifier
19393570
Citation
Bruyn GA, Schmidt WA. How to perform ultrasound-guided injections. Best Pract Res Clin Rheumatol. 2009 Apr;23(2):269-79. doi: 10.1016/j.berh.2008.11.001.
Results Reference
result

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Competency-based Assessment of Ultrasound-guided Joint Injection Skills

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