Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT05396768
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2022-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a New Assessment Tool for Chest Tube Insertion (ACTION) on Two Different Simulators
Sponsor:
University Ghent
Organization:
Study Overview
Official Title:
Validation of a New Assessment Tool for Chest Tube Insertion (ACTION) on Two Different Simulators
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: