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Completed

NCT Number: NCT07801170

Integrated PBL-CBL-CTTM Teaching to Enhance Clinical Self-Efficacy in Endocrine Critical Illness Among Internal Medicine Residents: An RCT

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.

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Key information

Conditions

Medical Education Critical Illness Disease Attributes Endocrine System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of Anhui Medical University

Chaohu, Anhui, 238000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lecture-based learning (LBL)

Behavioral

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.

PBL plus LBL

Behavioral

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.

Integrated PBL-CBL-CTTM

Behavioral

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.

Primary outcomes

  1. Clinical skills assessment score

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

    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.

Secondary outcomes

  1. Theoretical examination score

    Time frame: Immediately post-intervention

    Closed-book written examination graded by blinded faculty. Total score range: 0-50 points, covering endocrine and metabolic critical illness knowledge.

  2. General Self-Efficacy Scale (GSES) score

    Time frame: Baseline (pre-intervention) and immediately post-intervention

    10-item standardized self-efficacy scale (Cronbach's α=0.89), completed anonymously. Higher scores indicate greater general self-efficacy.

  3. Endocrine High-Risk Management Self-Efficacy Source Questionnaire score

    Time frame: Baseline (pre-intervention) and immediately post-intervention

    Self-developed 4-dimension questionnaire based on Bandura's self-efficacy theory (mastery experience, vicarious learning, verbal persuasion, positive affect; Cronbach's α=0.81, CVI=0.92), completed anonymously.

  4. Teaching satisfaction scale score

    Time frame: Immediately post-intervention

    5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.

  5. Focus group interview themes

    Time frame: Within 1 week post-intervention

    Semi-structured focus group interviews (30-40 minutes each) with 24 residents selected via stratified purposive sampling, analyzed using Braun & Clarke six-step thematic analysis method. Explores residents' experiences and psychological mechanisms underlying changes in clinical self-efficacy.

Sponsors and collaborators

Lead sponsor

Chaohu Hospital of Anhui Medical University

Other

Registry information

Official study title

Online-Offline Integrated Multimodal Teaching Combining PBL, CBL, and CTTM to Enhance Clinical Self-Efficacy in Endocrine and Metabolic Critical Illness Among Internal Medicine Residents: A Convergent Parallel Mixed-Methods Randomized Controlled Trial

Acronym: PBL-CBL-CTTM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 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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