- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05648760
Simulation-based Training Improves Competency in Communicating Bad News
Simulation-based Training Improves Medical Student Competency in Communicating Bad News to Patients: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The term "bad news" refers to any information transmitted to patients or their families that directly or indirectly involves a negative change in their lives or view of their future. Existing reports show that practicing doctors and residents lack confidence and skill in performing this task, and most have never received any formal training. Breaking bad news is a complex task requiring many skills including communication, responding to emotional reactions, and involving the family members.
The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families. We hypothesize that simulation-based training intervention will improve medical student competency in communicating bad news to patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jingyuan Xu, M.D.
- Phone Number: 86-025-83262550
- Email: 13851417209@163.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Recruiting
- Zhongda Hospital
-
Contact:
- Jingyyuan Xu, MD
- Phone Number: 86-025-83262550
- Email: 13851417209@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Residents working at the Intensive Care Unit.
Exclusion Criteria:
- Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Usual training
Participants randomized to the control condition received a standard training of how to communicate bad news to patients
|
Participants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients
|
Experimental: Simulation training
Participants randomized to the simulation training group received simulation training based on a standard training of how to communicate bad news to patients
|
Participants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with competency in communicating bad news behavioral measure
Time Frame: One month after training
|
Number of Participants with competency in communicating bad news behavioral measure
|
One month after training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jingyuan Xu, M.D., Southeast university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022ZDYYLL01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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