- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye)
- Altinbas University MP Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Aktiv komparator: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical-reasoning performance score
Tidsram: Immediately after the learning session (same day)
|
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.
|
Immediately after the learning session (same day)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic accuracy
Tidsram: Immediately after the learning session (same day)
|
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.
|
Immediately after the learning session (same day)
|
|
Participant confidence
Tidsram: Immediately after the learning session (same day)
|
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.
|
Immediately after the learning session (same day)
|
|
Participant satisfaction
Tidsram: Immediately after the learning session (same day)
|
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.
|
Immediately after the learning session (same day)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Omer Tontus, MD
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Altinbas
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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