NCT07801170

Brief Summary

This randomized controlled trial evaluates whether an integrated online-offline multimodal teaching approach combining Problem-Based Learning (PBL), Case-Based Learning (CBL), and Case Three-Dimensional Teaching Method (CTTM) improves clinical self-efficacy and hands-on proficiency in managing endocrine and metabolic critical illness among internal medicine residents, compared to traditional lecture-based learning (LBL). Ninety internal medicine residents on their first endocrine rotation will be randomly assigned in a 1:1:1 ratio to three groups: (1) Control group receiving traditional LBL alone; (2) Experimental group 1 receiving PBL plus LBL; (3) Experimental group 2 receiving the integrated PBL-CBL-CTTM closed-loop teaching program. All groups receive a standardized 12-hour curriculum on endocrine and metabolic critical illness, including diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, and refractory hypoglycemia. The primary outcome is the clinical skills assessment score (0-50 points). Secondary outcomes include theoretical examination scores, General Self-Efficacy Scale (GSES) scores, a self-developed Endocrine High-Risk Management Self-Efficacy Source Questionnaire (four dimensions based on Bandura's self-efficacy theory), teaching satisfaction, and semi-structured focus group interviews. The study was conducted from September 2025 to August 2026 at the Fourth Affiliated Hospital of Anhui Medical University, Chaohu, China. This study aims to establish an evidence-based, replicable teaching model that addresses the gap between theoretical knowledge and clinical confidence in managing endocrine emergencies among residents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 28, 2026

Last Update Submit

August 28, 2026

Conditions

Keywords

Problem-Based LearningCase-Based LearningClinical Self-EfficacyInternal Medicine ResidentsRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Clinical skills assessment score

    Assessed by group-blinded evaluators using a standardized clinical skills checklist immediately after the 12-hour intervention. Total score range: 0-50 points. Higher scores indicate better clinical proficiency in managing endocrine and metabolic critical illness.

    Immediately post-intervention (upon completion of the 12-hour curriculum)

Secondary Outcomes (5)

  • Theoretical examination score

    Immediately post-intervention

  • General Self-Efficacy Scale (GSES) score

    Baseline (pre-intervention) and immediately post-intervention

  • Endocrine High-Risk Management Self-Efficacy Source Questionnaire score

    Baseline (pre-intervention) and immediately post-intervention

  • Teaching satisfaction scale score

    Immediately post-intervention

  • Focus group interview themes

    Within 1 week post-intervention

Study Arms (3)

Control Group (LBL Alone)

ACTIVE COMPARATOR

Received only in-person one-way didactic lectures (lecture-based learning, LBL) with self-directed review after class. No online discussions, ward-based training, CTTM resources, or post-class debriefing. Total 12-hour standardized curriculum on endocrine and metabolic critical illness. n=30.

Behavioral: Lecture-based learning (LBL)

Experimental Group 1 (PBL+LBL)

EXPERIMENTAL

Received pre-class online problem-based learning (PBL) via DingTalk (open-ended critical case questions, independent literature search, online group discussion) plus standardized in-person lectures (LBL), with self-directed review after class. No ward-based CTTM training or post-class debriefing. Total 12-hour standardized curriculum. n=30.

Behavioral: PBL plus LBL

Experimental Group 2 (Integrated PBL-CBL-CTTM)

EXPERIMENTAL

Received integrated closed-loop teaching: pre-class PBL (identical to experimental group 1) plus standardized in-person lectures plus post-class ward-based case-based learning (CBL) with attending-supervised hands-on critical case training, case three-dimensional teaching method (CTTM) resources, and post-class debriefing. Total 12-hour standardized curriculum. n=30.

Behavioral: Integrated PBL-CBL-CTTM

Interventions

In-person one-way didactic lectures with self-directed review after class. Total 12-hour standardized curriculum on endocrine and metabolic critical illness, including diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, and refractory hypoglycemia.

Control Group (LBL Alone)
PBL plus LBLBEHAVIORAL

Pre-class online problem-based learning (PBL) via DingTalk (open-ended critical case questions, independent literature search, online group discussion) plus standardized in-person lectures (LBL), with self-directed review after class. Total 12-hour standardized curriculum.

Experimental Group 1 (PBL+LBL)

Integrated closed-loop teaching: pre-class online PBL (identical to experimental group 1) plus standardized in-person lectures plus post-class ward-based case-based learning (CBL) with attending-supervised hands-on critical case training, case three-dimensional teaching method (CTTM) resources, and post-class debriefing. Total 12-hour standardized curriculum.

Experimental Group 2 (Integrated PBL-CBL-CTTM)

Eligibility Criteria

Age22 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full-time internal medicine residents undergoing their first endocrine rotation at the Fourth Affiliated Hospital of Anhui Medical University
  • No prior endocrine remedial training or advanced study experience
  • No independent management experience with endocrine and metabolic critical cases
  • Ability to complete all 12 hours of standardized curriculum and all post-intervention assessments
  • Voluntary participation with written informed consent

You may not qualify if:

  • Prior completion of an endocrine rotation or specialized endocrine training
  • Prior independent management experience in diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, or refractory hypoglycemia
  • Inability to complete the full 12-hour teaching schedule due to clinical duties, leave, or rotation transfer
  • Concurrent participation in other teaching intervention research projects
  • Decline to provide written informed consent or withdrawal before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital of Anhui Medical University

Chaohu, Anhui, 238000, China

Location

MeSH Terms

Conditions

Endocrine System DiseasesCritical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors (theoretical exam graders and clinical skills evaluators) were blinded to group allocation. Participants and teaching faculty could not be blinded due to the inherent differences among the three teaching modalities.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician, Department of Endocrinology

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 3, 2026

Study Start

September 1, 2025

Primary Completion

August 28, 2026

Study Completion

August 28, 2026

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

This is a medical education randomized controlled trial. All data were collected through anonymous questionnaires and blinded assessments, and all participant identifiers were removed at the time of data collection. No individual participant-level clinical data exist that could be shared. Aggregated study data are presented in the published manuscript.

Locations