- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07663760
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX: A Multicenter Study in Anesthesiology and Intensive Care Medicine
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mhamed Sami Mebazaa, professor
- Telefonnummer: 00216 22252589
- E-post: msmebazaa@gmail.com
Studer Kontakt Backup
- Navn: Ben Haj youssef, assistant
- Telefonnummer: 00216 96874336
- E-post: amani.benhajyoussef@fmt.utm.tn
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Fifth-year medical students (DCEM3) enrolled at the Faculty of Medicine of Tunis within the acute medicine program.
- Students completing their clinical clerkship during the second semester of the 2025-2026 academic year in one of the three participating anesthesiology and intensive care departments.
- Students who voluntarily agree to participate and have provided written informed consent.
Exclusion Criteria:
- Students who do not complete the entire educational curriculum (absence from either of the two assessments).
- Students who have already received similar training.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: DCEM3 students
Fifth-year medical students in the second cycle during their internship in anesthesiology and intensive care.
|
Mini-CEX educational assessment during pre-anesthetic consultation: Volunteer fifth-year medical students were assessed by trained anesthesiology faculty using the mini-CEX tool.
The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
students' overall performance
Tidsramme: Through study completion, up to 4 weeks
|
measured by the mean score on the Mini-CEX checklist, compared between simulated consultation and real consultation. The overall performance is assessed using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX) checklist. The global score is measured on a 9-point Likert scale, ranging from 1 (insufficient/unsatisfactory performance) to 9 (exceptional/exemplary performance). Higher scores indicate a better clinical performance and greater student autonomy. |
Through study completion, up to 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Scores for each domain
Tidsramme: at the and of each Mini-CEX , Through study completion, up to 4 weeks
|
Scores for each domain (history taking, physical examination, clinical judgment, communication skills, professionalism, organization and efficiency, and overall clinical performance).
Measured by the Mini-Clinical Evaluation Exercise (Mini-CEX) checklist, compared between the simulated consultation (baseline) and the real clinical consultation.
The checklist uses a 9-point Likert scale where 1 represents the lowest performance (insufficient) and 9 represents the highest performance (exceptional).
Higher scores indicate a better clinical outcome.
|
at the and of each Mini-CEX , Through study completion, up to 4 weeks
|
|
Inter-rater reproducibility of Mini-CEX
Tidsramme: at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
|
Inter-rater reproducibility was evaluated using the Intraclass Correlation Coefficient (ICC
|
at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
|
|
Individual performance gain
Tidsramme: at the end of the internship, Through study completion, up to 4 weeks
|
Individual performance gain (delta between simulated and real Mini-CEX scores) Calculated as the change score between the real clinical consultation and the simulated consultation (Real score minus Simulated score) using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX).
The original Mini-CEX scale ranges from a minimum value of 1 (insufficient performance) to a maximum value of 9 (exceptional performance).
The resulting performance gain score ranges from -8 to +8.
A higher or positive score indicates a better outcome (improvement/performance gain), a score of 0 indicates no change, and a negative score indicates a decrease in performance.
|
at the end of the internship, Through study completion, up to 4 weeks
|
|
Learner and faculty satisfaction
Tidsramme: at the end of internship, Through study completion, up to 4 weeks
|
Learner and faculty satisfaction, as well as their recommendation for the use of the Mini-CEX throughout the curriculum, assessed using a Likert scale.
Assessed via a post-internship questionnaire completed by both students (learners) and professors (faculty) regarding their satisfaction with the Mini-Clinical Evaluation Exercise (Mini-CEX) and their recommendation for its integration throughout the curriculum.
Responses are evaluated on a 5-point Likert scale, ranging from a minimum score of 1 (Strongly disagree / Very dissatisfied) to a maximum score of 5 (Strongly agree / Very satisfied).
Higher scores indicate a better outcome, representing higher levels of satisfaction and a stronger recommendation for curriculum implementation.
|
at the end of internship, Through study completion, up to 4 weeks
|
|
The time required to complete the consultation
Tidsramme: at the end of each Mini-Cex, Through study completion, up to 4 weeks
|
The time required to complete the consultation (measured in minutes)
|
at the end of each Mini-Cex, Through study completion, up to 4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Simulated mini-CEX
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .