- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Altinbas University MP Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
Other Names:
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical-reasoning performance score
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Omer Tontus, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Altinbas
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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