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Completed

NCT Number: NCT07679672

Simulation-Based Learning on Clinical Reasoning, Knowledge Retention, and Transfer in Undergraduate Medical Education

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.

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Key information

Conditions

Clinical Reasoning Medical Education Simulation Training

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altinbas University MP Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral

Other

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: Digital video-based clinical-reasoning simulation

Lecture

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Altinbas University

Other

Registry information

Official study title

Does Video-Based Patient Simulation Improve Clinical Reasoning Skills in Medical Students?

Acronym: SIMCORE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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