NCT05648760

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

December 5, 2022

Last Update Submit

December 12, 2022

Conditions

Simulation of Physical Illness

Keywords

simulationcompetency

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with competency in communicating bad news behavioral measure

    Number of Participants with competency in communicating bad news behavioral measure

    One month after training

Study Arms (2)

Usual training

OTHER

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

Behavioral: Simulation training

Simulation training

EXPERIMENTAL

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

Interventions

Simulation trainingBEHAVIORAL

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

Simulation trainingUsual training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents working at the Intensive Care Unit.

You may not qualify if:

  • Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

  • Jingyuan Xu, M.D.

    Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

86-025-8326255013851417209@163.com

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

December 12, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)