- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07801170
Integrated PBL-CBL-CTTM Teaching to Enhance Clinical Self-Efficacy in Endocrine Critical Illness Among Internal Medicine Residents: An RCT (PBL-CBL-CTTM)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Anhui
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Chaohu, Anhui, Porcelana, 238000
- The fourth affiliated hospital of Anhui medical university
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
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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.
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|
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.
|
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical skills assessment score
Periodo de tiempo: Immediately post-intervention (upon completion of the 12-hour curriculum)
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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.
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Immediately post-intervention (upon completion of the 12-hour curriculum)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Theoretical examination score
Periodo de tiempo: Immediately post-intervention
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Closed-book written examination graded by blinded faculty.
Total score range: 0-50 points, covering endocrine and metabolic critical illness knowledge.
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Immediately post-intervention
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General Self-Efficacy Scale (GSES) score
Periodo de tiempo: Baseline (pre-intervention) and immediately post-intervention
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10-item standardized self-efficacy scale (Cronbach's α=0.89), completed anonymously.
Higher scores indicate greater general self-efficacy.
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Baseline (pre-intervention) and immediately post-intervention
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Endocrine High-Risk Management Self-Efficacy Source Questionnaire score
Periodo de tiempo: Baseline (pre-intervention) and immediately post-intervention
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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.
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Baseline (pre-intervention) and immediately post-intervention
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Teaching satisfaction scale score
Periodo de tiempo: Immediately post-intervention
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5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
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Immediately post-intervention
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Focus group interview themes
Periodo de tiempo: Within 1 week post-intervention
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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.
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Within 1 week post-intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KYXM-202508-021 (Otro identificador: Ethics Approval Number)
- AHWJ2025BAp20022 (Otro número de subvención/financiamiento: Anhui Provincial Health Commission)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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