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

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05547893
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 17.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Educational Activities; Patient Simulation	Other: simulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Clinical Learning Through Extended Immersion in Medical Simulation (CLEIMS)-A New Approach to Teaching Clinical Ethics
• Actual Study Start Date: Sep 29, 2020
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Defining Issues Test (DIT) and self-developed questionnaire [through study completion, an average of 2 years]

   Defining Issues Test (DIT) and self-developed questionnaire for evaluation of moral reasoning

2. ethical decision-making clinical examination [through study completion, an average of 2 years]

   clinical scenario exam designed for testing participants' ability of making ethical decision

3. Problem Identification Test (PIT) and self-developed questionnaire [through study completion, an average of 2 years]

   Problem Identification Test (PIT) and self-developed questionnaire for evaluation of moral sensitivity

4. knowledge test questionnaire [through study completion, an average of 2 years]

   questionnaire for ethics knowledge test

Secondary Outcome Measures

1. results of Objective Structured Clinical Examination [through study completion, an average of 2 years]

   test score of Objective Structured Clinical Examination

2. participant satisfaction questionnaire [through study completion, an average of 2 years]

   satisfaction questionnaire for participating the educational activities

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• medical students in Kaohsiung Medical University

• agree to participate the study

Exclusion Criteria:

• disagree to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University Hospital	Kaohsiung		Taiwan	807

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05547893
• Other Study ID Numbers: KMUHIRB-SV(II)-20200041
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital: medical ethics education; simulation

Study Results

No Results Posted as of Sep 21, 2022