NCT07820137

Brief Summary

This prospective, three-arm, parallel-group, cluster randomized controlled educational trial was conducted among third-year undergraduate medical students undertaking nephrology clerkship at The Second Hospital of Shandong University. The study aimed to compare the effects of lecture-based learning, BOPPPS combined with case-based learning, and artificial intelligence-integrated BOPPPS combined with case-based learning on students' theoretical knowledge, clinical reasoning, clinical case analysis, and critical appraisal of AI-generated clinical recommendations. Existing clinical clerkship teaching groups, rather than individual students, were randomized to one of three educational interventions: lecture-based learning (LBL), BOPPPS combined with case-based learning (BOPPPS-CBL), or artificial intelligence-integrated BOPPPS combined with case-based learning (AI-BOPPPS-CBL). Twelve teaching groups were randomized in a 1:1:1 ratio, with four teaching groups assigned to each arm. All groups received standardized instruction on acute kidney injury and chronic renal failure delivered by the same teaching team. The BOPPPS-CBL intervention incorporated structured learning activities including case discussion, progressive case disclosure, clinical reasoning exercises, and feedback. The AI-integrated group additionally used AI-generated clinical scenarios and diagnostic and treatment recommendations as materials for critical appraisal. Students identified potential errors or limitations in AI-generated content and proposed revisions based on textbooks, clinical guidelines, and evidence-based resources. The primary outcome was the clinical case analysis score. Secondary outcomes included theoretical test scores, knowledge gain, clinical reasoning score, AI critical appraisal score, and course feedback.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
Last Updated

September 15, 2026

Status Verified

August 1, 2026

Enrollment Period

14 days

First QC Date

August 24, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

Artificial intelligenceMedical educationBOPPPSCase-based learningClinical reasoningNephrology clerkship

Outcome Measures

Primary Outcomes (1)

  • Study-Specific Clinical Case Analysis Assessment Total Score

    Clinical case analysis performance was assessed using a study-specific three-case written assessment developed by the nephrology teaching team. The assessment evaluated students' ability to apply nephrology knowledge to clinical case analysis, diagnostic reasoning, treatment planning, and critical appraisal of AI-generated clinical recommendations. Total scores ranged from 0 to 70 points, with higher scores indicating better overall clinical case analysis performance.

    Immediately after completion of the educational intervention

Secondary Outcomes (5)

  • Study-Specific Post-Class Theoretical Knowledge Test Score

    Immediately after completion of the educational intervention

  • Study-Specific Clinical Case Analysis Assessment: Clinical Reasoning Component Score

    Immediately after completion of the educational intervention

  • Study-Specific Clinical Case Analysis Assessment: AI Critical Appraisal Component Score

    Immediately after completion of the educational intervention

  • Knowledge Gain in Theoretical Knowledge Test Score

    Change from immediately before the educational intervention to immediately after completion of the educational intervention

  • Study-Specific Course Feedback Questionnaire Total Score

    Immediately after completion of the educational intervention

Study Arms (3)

Lecture-Based Learning

ACTIVE COMPARATOR

Students received traditional lecture-based learning during nephrology clerkship education. Standardized instruction on acute kidney injury and chronic renal failure was provided by the teaching team.

Behavioral: Lecture-Based Learning

BOPPPS Combined With Case-Based Learning

EXPERIMENTAL

Students received a BOPPPS structured teaching model combined with case-based learning activities. The intervention included progressive clinical case discussion, clinical reasoning exercises, and feedback during nephrology clerkship education.

Behavioral: BOPPPS Combined With Case-Based Learning

AI-Integrated BOPPPS Combined With Case-Based Learning

EXPERIMENTAL

Students received an artificial intelligence-integrated BOPPPS case-based learning model. AI-generated clinical scenarios and diagnostic and treatment recommendations were used as learning materials for critical appraisal. Students evaluated AI-generated content and revised potential errors based on clinical guidelines and evidence-based resources.

Behavioral: AI-Integrated BOPPPS Combined With Case-Based Learning

Interventions

Students received traditional lecture-based learning during nephrology clerkship education. Standardized teaching on acute kidney injury and chronic renal failure was delivered by the teaching team using conventional instructional methods.

Lecture-Based Learning

Students received a structured BOPPPS teaching model combined with case-based learning activities during nephrology clerkship education. The intervention included case discussion, progressive case disclosure, clinical reasoning exercises, and feedback from instructors.

BOPPPS Combined With Case-Based Learning

Students received an artificial intelligence-integrated BOPPPS case-based learning model. AI-generated clinical scenarios and diagnostic and treatment recommendations were used as learning materials for critical appraisal. Students evaluated AI-generated content and identified potential errors or limitations based on clinical guidelines and evidence-based resources.

AI-Integrated BOPPPS Combined With Case-Based Learning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Third-year undergraduate medical students in the clinical medicine program of Shandong University undertaking the nephrology clerkship at The Second Hospital of Shandong University.
  • Completion of the required theoretical courses in pathophysiology and internal medicine before study participation.
  • Provision of written informed consent.

You may not qualify if:

  • \- Previous nephrology clinical clerkship or internship experience, or previous participation in additional nephrology-focused training beyond the standard pre-clerkship curriculum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Study Officials

  • Fulin Dou

    The Second Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Students and instructors could not be blinded because of the nature of the educational interventions. Examination papers were coded without group information, and personnel responsible for scoring the written assessments were blinded to group allocation. Personnel performing the statistical analysis were also blinded to group allocation during the primary analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This was a three-arm, parallel-group, cluster randomized controlled educational trial. Existing clinical clerkship teaching groups were the units of randomization. Twelve teaching groups were randomized in a 1:1:1 ratio, with four teaching groups assigned to each arm. Students within each teaching group received the same assigned educational intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 15, 2026

Study Start

November 17, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 15, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available because the dataset contains individual-level educational performance and assessment information from medical students, and sharing such data may pose privacy and confidentiality concerns. Aggregated study results will be reported in scientific publications.

Locations