Improving Breaking Bad News in Pediatrics by Simulated Communication
SimCom
1 other identifier
interventional
46
1 country
1
Brief Summary
Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved. This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
1 active site
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
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
April 3, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedApril 19, 2024
April 1, 2024
12 months
April 3, 2024
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
score by simulation parents
evaluation of breaking bad news by simulation parents, via a newly created questionnaire, measured in points, minimum score of zero points, maximum score of 69 points, the higher the score the better the outcome
up to 1 hour after the simulation
Secondary Outcomes (2)
score by participants
up to 1 hour after the simulation
score of video analysis
through study completion, an average of 1 year
Study Arms (2)
Control
NO INTERVENTIONno communication training prior to simulation scenario
Communication-Trained
OTHERcommunication training prior to simulation scenario
Interventions
The intervention group received a communication training session prior to the prebriefing and familiarization of the scenario, including advice on how to improve communication skills as well as how to create an optimal setting for difficult medical conversations. This communication training session has been created on the basis of an in-depth literature research.(Brock et al., 2019; Chumpitazi et al., 2016; Collins et al., 2018; Grant et al., 2016; Tobler et al., 2014; Vaidya et al., 1999; Yuan et al., 2019)
Eligibility Criteria
You may qualify if:
- Medical students, enrolled at the Medical University of Vienna.
- Successful completion the mandatory basic life support training "Block 16" in the third year of medical training and
- Successful completion of the mandatory communication seminar "Ärztliche Gesprächsführung B" also in the third year of medical training.
- Obtained written informed consent.
You may not qualify if:
- quality of the obtained video recordings were unsatisfactory and not usable for analysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (5)
Babu TA. Breaking bad news in the paediatric ICU: need for ethical practice. Indian J Med Ethics. 2013 Oct-Dec;10(4):278-9. doi: 10.20529/IJME.2013.085. No abstract available.
PMID: 24152358BACKGROUNDBittner-Fagan H, Davis J, Savoy M. Improving Patient Safety: Improving Communication. FP Essent. 2017 Dec;463:27-33.
PMID: 29210557BACKGROUNDBrock KE, Tracewski M, Allen KE, Klick J, Petrillo T, Hebbar KB. Simulation-Based Palliative Care Communication for Pediatric Critical Care Fellows. Am J Hosp Palliat Care. 2019 Sep;36(9):820-830. doi: 10.1177/1049909119839983. Epub 2019 Apr 11.
PMID: 30974949BACKGROUNDde Moura Villela EF, Bastos LK, de Almeida WS, Pereira AO, de Paula Rocha MS, de Oliveira FM, Bollela VR. Effects on Medical Students of Longitudinal Small-Group Learning about Breaking Bad News. Perm J. 2020;24:19.157. doi: 10.7812/TPP/19.157. Epub 2020 Feb 14.
PMID: 32097117BACKGROUNDChumpitazi CE, Rees CA, Chumpitazi BP, Hsu DC, Doughty CB, Lorin MI. Creation and Assessment of a Bad News Delivery Simulation Curriculum for Pediatric Emergency Medicine Fellows. Cureus. 2016 May 1;8(5):e595. doi: 10.7759/cureus.595.
PMID: 27335708BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Bettina Brandt, MD MSc
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 3, 2024
First Posted
April 19, 2024
Study Start
September 1, 2021
Primary Completion
August 31, 2022
Study Completion
September 30, 2022
Last Updated
April 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share