Communication Clinical Trial
— SimComOfficial title:
Improving Breaking Bad News in Pediatrics by Simulated Communication: The Prospective Randomized Controlled SimCom Study
Verified date | April 2024 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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
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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