Validation of a New Assessment Tool for Chest Tube Insertion (ACTION) on Two Different Simulators

Validity Clinical Trial

Official title:

Validation of a New Assessment Tool for Chest Tube Insertion (ACTION) on Two Different Simulators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396768
• Other study ID #: BC-10905
• Status: Completed
• Start date: November 18, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to collect validity evidence for the ACTION-tool on two different simulators: a porcine rib model, and Thiel embalmed human cadavers. Validity evidence will be collected following Messick's framework.

Description:

Educational assessments need a validity argument before they are being used to evaluate trainees. An assessment needs to show it can be used as an objective and reliable tool.

Messick's framework of validity collects this evidence from five different sources: content, response process, relation to other variables, internal structure and consequences.

The ACTION-tool has been developed based on a Delphi consensus study (and has established content evidence as a result). This study will collect evidence from the four remaining sources.

Two groups of participants (novices and experienced) will be recruited. All participants will provide informed consent and demographic information. Afterwards, they will be informed of the study, will familiarise themselves with the simulators, watch an educational video, and will be asked to perform two chest tube insertions (CTI).

All participants will be evaluated by a live rater, and will be recorded using a head-mounted GoPro and an overview camera. The recordings will be edited to ensure anonymization, and will be subsequently rated by three blinded raters.

Statistical analysis will evaluate the difference in mean scores between the groups, the internal structure using G-theory, and will establish a pass/fail score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years and older

Eligibility

Inclusion Criteria:

• Experienced participants must hold a degree of Master in Medicine, and must have finished the residency training specific to their field (attending physician).

• Novice participants are defined as junior residents who are graduated as Master in Medicine and must be in their first two years of residency training, or be at least in their 3rd Master year of Medicine and be accepted as starting resident.

Exclusion Criteria:

• Experienced participants who lack experience or the appropriate diplomas will be excluded.

• Novices who have performed more than five CTI or assisted in the placement of more than five procedures will be excluded.

Related Conditions & MeSH terms

• Validity

Intervention

Other:
• Assessment using the ACTION-tool.
Participants will be assessed using the ACTION-tool while they are performing a CTI on a porcine rib model and Thiel embalmed human cadavers.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on on the ACTION-tool	The main goal is the collection of validity evidence for the ACTION-tool following Messick's framework. This is done by recording the score each participant receives while being assessed using the ACTION-tool. The minimum score on the rating scale is 17, the maximum 85 (a higher score indicates a better performance). On the error checklist the minimum score is 0, maximum score is 16 (where a lower score is less observed errors).	Immediately after performing a CTI on the simulator.