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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06376188
Other study ID # 1582/2021 SimCom
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2022

Study information

Verified date April 2024
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Conversations about death and dying present discomfort for both healthcare professionals, patients and their families. These conversations, emotionally laden, pose lasting challenges and impact decision-making. Despite extensive medical training, physicians often lack adequate communication skills for such conversations, leading to frustration and distress. Delivering bad news, particularly in pediatrics, requires managing not only medical intricacies but also emotional impact. Communication skills, crucial for such scenarios, are typically developed over time through observation and practice, yet are often inadequately emphasized in medical training. Our study aimed to assess the impact of communication training on medical students delivering death notifications to simulation parents in pediatric simulation scenarios.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date September 30, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - quality of the obtained video recordings were unsatisfactory and not usable for analysis - unmet inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
communication training
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)

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & 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. — View Citation

Bittner-Fagan H, Davis J, Savoy M. Improving Patient Safety: Improving Communication. FP Essent. 2017 Dec;463:27-33. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 score by participants self-evaluation of breaking bad news by participants, via a newly created questionnaire, measured in points, minimum score of zero points, maximum score of 63 points, the higher the score the better the outcome up to 1 hour after the simulation
Secondary score of video analysis evaluation of breaking bad news by video raters, via a newly created questionnaire, measured in points, minimum score of zero points, maximum score of 270 points, the higher the score the better the outcome through study completion, an average of 1 year
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