Competency-based Assessment of Ultrasound-guided Joint Injection Skills

October 25, 2022 updated by: Stine Maya Dreier Carstensen, Rigshospitalet, Denmark

Competency-based Assessment of Ultrasound-guided Joint Injection Skills: A Validity Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • COPECARE (Copenhagen Center for Arthritis Research)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Novices
Measurement of competence
Other: Ultrasound guided joint injection
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.
EXPERIMENTAL: Intermediates
Measurement of competence
Other: Ultrasound guided joint injection
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.
EXPERIMENTAL: Experts
Measurement of competence
Other: Ultrasound guided joint injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance score
Time Frame: Up to 12 months
Performance score assessed by blinded raters using the modified IUSE assessment tool
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Stine Maya D Carstensen, MD, Afdeling for Rygkirurgi, Led- og Bindevævssygdomme, COPECARE (Copenhagen Center for Arthritis Research) Rigshospitalet, Glostrup Valdemar Hansens vej 17 2600 Glostrup

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2022

Primary Completion (ACTUAL)

June 4, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (ACTUAL)

March 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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