NCT06376188

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

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

April 3, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

communicationpediatricspalliative caresimulationresuscitationbreaking bad news

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 INTERVENTION

no communication training prior to simulation scenario

Communication-Trained

OTHER

communication training prior to simulation scenario

Other: communication training

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)

Communication-Trained

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 24152358BACKGROUND
  • Bittner-Fagan H, Davis J, Savoy M. Improving Patient Safety: Improving Communication. FP Essent. 2017 Dec;463:27-33.

    PMID: 29210557BACKGROUND
  • Brock 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: 30974949BACKGROUND
  • de 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: 32097117BACKGROUND
  • Chumpitazi 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

CommunicationDeathPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jennifer Bettina Brandt, MD MSc

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

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

Locations