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

August 28, 2026 updated by: Jianyong Zhao, Chaohu Hospital of Anhui Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Chaohu, Anhui, China, 238000
        • The Fourth Affiliated Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group (LBL Alone)
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)
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.
Experimental: Experimental Group 1 (PBL+LBL)
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
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: Experimental Group 2 (Integrated PBL-CBL-CTTM)
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately post-intervention (upon completion of the 12-hour curriculum)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Immediately post-intervention
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.
Baseline (pre-intervention) and immediately post-intervention
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.
Baseline (pre-intervention) and immediately post-intervention
Teaching satisfaction scale score
Time Frame: Immediately post-intervention
5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
Immediately post-intervention
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.
Within 1 week post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chaohu Hospital of Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KYXM-202508-021 (Other Identifier: Ethics Approval Number)
  • AHWJ2025BAp20022 (Other Grant/Funding Number: Anhui Provincial Health Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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