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OpenTrials
Completed

NCT Number: NCT05396768

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

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.

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Key information

Age range

24 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment using the ACTION-tool.

Other

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

Primary outcomes

  1. Score on on the ACTION-tool

    Time frame: Immediately 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).

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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