Simulation-based Training Improves Competency in Communicating Bad News

Sponsor

Southeast University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05648760

Collaborator

(none)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 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.

Condition or Disease	Intervention/Treatment	Phase
Simulation of Physical Illness	Behavioral: Simulation training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Simulation-based Training Improves Medical Student Competency in Communicating Bad News to Patients: A Randomized Controlled Trial

Actual Study Start Date :

Dec 12, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Usual training Participants randomized to the control condition received a standard training of how to communicate bad news to patients	Behavioral: Simulation training 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	Behavioral: Simulation training Participants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients

Arm

Intervention/Treatment

Other: Usual training

Participants randomized to the control condition received a standard training of how to communicate bad news to patients

Behavioral: Simulation training

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

Behavioral: Simulation training

Participants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients

Outcome Measures

Primary Outcome Measures

Number of Participants with competency in communicating bad news behavioral measure [One month after training]
Number of Participants with competency in communicating bad news behavioral measure

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda hospital	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

Southeast University, China

Investigators

Principal Investigator: Jingyuan Xu, M.D., Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jingyuan,Xu, Principal Investigator, Southeast University, China

ClinicalTrials.gov Identifier:

NCT05648760

Other Study ID Numbers:

2022ZDYYLL01

First Posted:

Dec 13, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jingyuan,Xu, Principal Investigator, Southeast University, China

simulation

competency

Study Results

No Results Posted as of Dec 14, 2022