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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05396768
Enrollment
19
Registered
2022-05-31
Start date
2021-11-18
Completion date
2023-01-01
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Tube Insertion, Educational Assessment, Validity

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.

Interventions

OTHERAssessment 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.

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
24 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Score on on the ACTION-toolImmediately after performing a CTI on the simulator.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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026