Clinical Learning Through Extended Immersion in Medical Simulation (CLEIMS)-A New Approach to Teaching Clinical Ethics

Study objective: This study is planning to develop a new simulation-based ethics education model and evaluate the effectiveness of the model to develop medical students' knowledge, moral reasoning, communication skills, and problem-solving abilities. Several strategies will be conducted to achieve this goal, including faculty development, ethics courses development, and case scenario development.

Methods: The transnational learning and workshops will be arranged for faculty to develop competence for simulation-based ethics education. The workshops will gather the interdisciplinary experts together to discuss and develop the core curriculum and case scenario. The students will be assigned randomly into the simulated clinical ethical situation with simulation patients for the intervention group, and into the workshop discussing clinical ethics case scenario for the control group. The instruments will be developed and the quantitative and qualitative analysis will be conducted.

Study Overview

• Status: Recruiting
• Conditions: Patient Simulation; Educational Activities
• Intervention / Treatment: Other: simulation

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yenko Lin; Phone Number: 7579 +886-7-3121101; Email: yenko@ms16.hinet.net

Study Locations

• Taiwan
  • Taiwan
    • Kaohsiung, Taiwan, Taiwan, 807
      • Recruiting
      • Kaohsiung Medical University Hospital
      • Contact: Yenko Lin; Phone Number: 7579 +886-7-3121101; Email: yenko@ms16.hinet.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• medical students in Kaohsiung Medical University
• agree to participate the study

Exclusion Criteria:

• disagree to participate

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; workshop discussing the clinical ethical case scenario
Experimental: Intervention group; a simulated clinical ethical situation with simulation patients	Other: simulation; participating a simulated clinical ethical situation with simulation patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defining Issues Test (DIT) and self-developed questionnaire	Defining Issues Test (DIT) and self-developed questionnaire for evaluation of moral reasoning	through study completion, an average of 2 years
ethical decision-making clinical examination	clinical scenario exam designed for testing participants' ability of making ethical decision	through study completion, an average of 2 years
Problem Identification Test (PIT) and self-developed questionnaire	Problem Identification Test (PIT) and self-developed questionnaire for evaluation of moral sensitivity	through study completion, an average of 2 years
knowledge test questionnaire	questionnaire for ethics knowledge test	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
results of Objective Structured Clinical Examination	test score of Objective Structured Clinical Examination	through study completion, an average of 2 years
participant satisfaction questionnaire	satisfaction questionnaire for participating the educational activities	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: simulation; medical ethics education
• Other Study ID Numbers: KMUHIRB-SV(II)-20200041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No