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

NCT07679672 | Completed

• 1 other identifier: Altinbas
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clinical Reasoning; Medical Education; Simulation Training

Keywords

Clinical reasoning; Simulation-based education; Video-based simulation; Undergraduate medical education; Randomized controlled trial; Knowledge retention; Diagnostic accuracy; Medical students

Outcome Measures

Primary Outcomes (1)

• Clinical-reasoning performance score

  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 Outcomes (3)

• Diagnostic accuracy

  Immediately after the learning session (same day)

• Participant confidence

  Immediately after the learning session (same day)

• Participant satisfaction

  Immediately after the learning session (same day)

Study Arms (2)

Simulation

EXPERIMENTAL

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: Behavioral

Lecture

ACTIVE COMPARATOR

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.

Behavioral: Lecture

Interventions

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.

Also known as: Digital video-based clinical-reasoning simulation

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.

Lecture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altinbas University: lead

Study Sites (1)

Altinbas University MP Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Omer Tontus, MD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 1, 2026
• Study Start: May 20, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)