- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07679672
Simulation-Based Learning on Clinical Reasoning, Knowledge Retention, and Transfer in Undergraduate Medical Education (SIMCORE)
Does Video-Based Patient Simulation Improve Clinical Reasoning Skills in Medical Students?
This randomized controlled trial evaluates whether a digital, video-based clinical-reasoning simulation improves clinical-reasoning performance compared with conventional lecture-based teaching across multiple clinical disciplines, including orthopedics and ophthalmology.
Within each discipline, participants are randomly allocated 1:1 to an intervention group or a control group. The intervention group learns the assigned topic through an interactive, web-based simulation built on real patient video cases with structured clinical-reasoning steps. The control group receives the same learning objectives and content through a standard didactic lecture, over a comparable duration.
After the learning session, all participants complete the same set of standardized clinical scenarios, scored with a predefined rubric. The primary outcome is the post-intervention clinical-reasoning score. Secondary outcomes include diagnostic accuracy, confidence, and satisfaction.
The trial uses a shared protocol across discipline-specific cohorts to allow consistent, pre-specified comparison of simulation-based versus lecture-based instruction.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Background. Clinical reasoning is a core competency across medical disciplines, yet traditional lectures offer limited interactive practice. A digital simulation using authentic patient cases may strengthen reasoning, but comparative evidence is limited.
Objective. To compare a digital, video-based clinical-reasoning simulation with conventional lecture-based teaching on clinical-reasoning performance, using a single shared design applied across discipline-specific cohorts (e.g., orthopedics, ophthalmology, paediatrics).
Design. Single-center, parallel-group, two-arm randomized controlled trial with 1:1 allocation, replicated as pre-specified cohorts by clinical discipline under one common protocol.
Participants. Eligible learners (medical students / residents) within each discipline-specific cohort at primarily Altinbas University.
Randomization. Computer-generated 1:1 randomization performed separately within each cohort; outcome assessors blinded to allocation.
Interventions. Intervention - interactive, web-based clinical-reasoning simulation using real patient video cases with structured reasoning steps. Control - didactic lecture delivering identical learning objectives and content over a comparable duration.
Outcomes. Primary - post-intervention clinical-reasoning score on standardized scenarios rated with a predefined rubric. Secondary - diagnostic accuracy, participant confidence, satisfaction.
Cohorts & analysis. Each discipline-specific cohort is analyzed separately with an independent-samples t-test; inter-rater reliability assessed where applicable. Total target enrollment (n=250) across all cohorts.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Istanbul, Turkki (Türkiye)
- Altinbas University MP Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Enrolled as a [final-year medical student / resident] in the relevant discipline (orthopedics or ophthalmology) at the participating institution
- Completed the baseline orientation and agreed to participate
- Available for the full learning session and the post-session assessment
Exclusion Criteria:
- Prior completion of the same simulation module or equivalent structured training on the topic
- Did not complete the assigned learning session
- Incomplete post-session assessment data
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Simulation
Interactive, web-based clinical-reasoning simulation built on real patient video cases.
Learners actively work through structured decision points (history, examination, differential diagnosis, investigation, management) and receive immediate feedback.
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Interactive, web-based clinical-reasoning simulation built on real patient video cases.
Learners actively work through structured decision points (history, examination, differential diagnosis, investigation, management) and receive immediate feedback.
Muut nimet:
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Active Comparator: Lecture
Instructor-led didactic lecture delivering identical learning objectives through expert explanation and slides.
Learners receive content passively, without interactive decision steps or video-based case progression.
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Instructor-led didactic lecture delivering identical learning objectives through expert explanation and slides.
Learners receive content passively, without interactive decision steps or video-based case progression.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Clinical-reasoning performance score
Aikaikkuna: Immediately after the learning session (same day)
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Performance on a set of standardized clinical scenarios completed after the learning session, rated with a predefined scoring rubric.
Higher scores indicate better clinical-reasoning performance.
Assessed separately within each discipline-specific cohort.
Scored using the five-domain Clinical Reasoning Score System; total range 0-100, with higher scores indicating better clinical-reasoning performance.
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Immediately after the learning session (same day)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Diagnostic accuracy
Aikaikkuna: Immediately after the learning session (same day)
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Proportion of standardized scenarios in which the participant reached the correct diagnosis, scored against a predefined answer key.
Reported as the percentage of scenarios with a correct diagnosis (0-100%); higher values indicate better performance.
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Immediately after the learning session (same day)
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Participant confidence
Aikaikkuna: Immediately after the learning session (same day)
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Self-reported confidence in clinical decision-making, measured on a structured rating scale after the session.
Measured on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater confidence.
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Immediately after the learning session (same day)
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Participant satisfaction
Aikaikkuna: Immediately after the learning session (same day)
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Self-reported satisfaction with the learning method, measured on a structured rating scale after the session.
Measured on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater satisfaction.
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Immediately after the learning session (same day)
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojen puheenjohtaja: Omer Tontus, MD
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- Altinbas
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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