Educational AssessmentNCT05396768
Validation of a New Assessment Tool for Chest Tube Insertion (ACTION) on Two Different Simulators
An observational study of Educational Assessment and Chest Tube Insertion, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Assessment, Chest Tube Insertion, Validity
- What is being tested?
- Assessment using the ACTION-tool.
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Nov 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will be recruited from Ghent University Hospital. Experienced participants are faculty members, and the novice group is recruited from the resident population.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Educational Assessment, Chest Tube Insertion, Validity
- Being tested
- Assessment using the ACTION-tool.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Novices | Junior residents from the departments of surgery, pneumology or emergency medicine. These participants are in their first or second year of residency, and have observed or placed less than 5 CTIs in their career. Receives: Other: Assessment using the ACTION-tool. | |
| Experienced | Faculty members from Ghent University Hospital from the departments of surgery, pneumology or emergency medicine. These participants must have finished their residency training, and must be involved in resident education. Receives: Other: Assessment using the ACTION-tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after performing a CTI on the simulator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start18 Nov 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational AssessmentStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter Willaert, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396768
- Sponsor's protocol ID
- BC-10905
- Status last verified
- Apr 2023
- First submitted
- 16 May 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Assessment Tool for Chest Tube Insertion (ACTION) on Two Different Simulators
- ClinicalTrials.gov ID
- NCT05396768
- Acronym / sponsor ID
- BC-10905
- Conditions
- Educational Assessment, Chest Tube Insertion, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novices | – | Other: Assessment using the ACTION-tool.Junior residents from the departments of surgery, pneumology or emergency medicine. These participants are in their first or second year of residency, and have observed or placed less than 5 CTIs in their career. |
| Experienced | – | Other: Assessment using the ACTION-tool.Faculty members from Ghent University Hospital from the departments of surgery, pneumology or emergency medicine. These participants must have finished their residency training, and must be involved in resident education. |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be recruited from Ghent University Hospital. Experienced participants are faculty members, and the novice group is recruited from the resident population.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experienced, Novices |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Educational Assessment
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
The Tick App: Changing Behaviors With Educational Messaging
Tick Bites
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Recruiting
Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment
Breast Cancer Females, Newly Diagnosed Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter Willaert, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational Assessment and Chest Tube Insertion, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on on the ACTION-tool (time frame: Immediately after performing a CTI on the simulator.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.