NCT05384327

Brief Summary

The goal of the proposed study design is to develop and gather validity evidence of a theoretical test about cognitive skills which are important when performing Chest Tube Insertion (CTI). This study consists of two parts:

  • The development of the theoretical test and its items. The test content will be based on a broad literature search, and on semi-structured interviews with content experts.
  • The subsequent collection of validity evidence for this theoretical test and final selection of the test items, by testing groups that differ based on their expertise. The item analysis and observed difference in mean score between the groups will provide the validity evidence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

May 13, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

Chest TubeAssessment

Outcome Measures

Primary Outcomes (1)

  • Validity evidence for the theoretical test

    Validity evidence following Messick's framework for a new theoretical test will be collected. The score will reflect the number of questions participants scored correctly; X/Y, where X=the number of questions answered correctly, and Y=the total number of questions. This score can be transformed in a percentage score accordingly. A higher score means the participant answered more questions correctly.

    Participants are assessed once: the score of each participant is recorded immediately after completion of the test.

Study Arms (4)

Interview

OTHER

Content experts who will be interviewed in order to collect their opinion on theoretical knowledge.

Other: Interview

Novices

OTHER

Medical students who will complete the test

Other: Multiple Choice Question (MCQ) Test

Intermediates

OTHER

Junior residents (surgery, pneumology, emergency medicine) who will complete the test.

Other: Multiple Choice Question (MCQ) Test

Experienced

OTHER

Faculty members (surgery, pneumology, emergency medicine) who will complete the test.

Other: Multiple Choice Question (MCQ) Test

Interventions

Interviews consist of semi-structured interviews focused on the theoretical knowledge a physician should possess before placing chest tube insertions.

Interview

The test contains multiple choice questions based on these interviews. Participants will complete this test. Validity evidence will be collected based on the results of this test.

ExperiencedIntermediatesNovices

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Content experts will be recruited from the departments of surgery, pulmonology, and emergency medicine of various hospitals in Flanders and the Netherlands. They must have finished their residency training and be actively involved in training of junior physicians. A maximum of six experts will be recruited, and a minimum of one physician from each department will be included.
  • The novice group will attract medical students at Ghent University, within their 5th or 6th year of undergraduate training, while having no experience with CTI.
  • The intermediate group will include residents of the departments of surgery, pulmonology and emergency medicine of Ghent University Hospital, within their 1st - 3rd year of residency training and must have placed less than 20 chest tubes themselves.
  • The experienced group will be recruited from the departments of surgery, pulmonology, and emergency medicine of Ghent University Hospital. They must have finished the residency training in their respective fields and must have performed more than 20 CTI independently. The content experts will not be eligible for participation.

You may not qualify if:

  • For the novice and intermediate group: having to much experience in CTI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Wouter Willaert, Prof. Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 20, 2022

Study Start

May 5, 2022

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations