NCT05547893

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2020Jul 2026

Study Start

First participant enrolled

September 29, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

September 4, 2022

Last Update Submit

February 9, 2026

Conditions

Keywords

medical ethics educationsimulation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • results of Objective Structured Clinical Examination

    through study completion, an average of 2 years

  • participant satisfaction questionnaire

    through study completion, an average of 2 years

Study Arms (2)

control group

NO INTERVENTION

workshop discussing the clinical ethical case scenario

Intervention group

EXPERIMENTAL

a simulated clinical ethical situation with simulation patients

Other: simulation

Interventions

participating a simulated clinical ethical situation with simulation patients

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • disagree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 807, Taiwan

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2022

First Posted

September 21, 2022

Study Start

September 29, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations