CommunicationSimComNCT06376188
Improving Breaking Bad News in Pediatrics by Simulated Communication
A study testing communication training in people with Communication and End of Life, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Communication, End of Life, Pediatric ALL
- What is being tested?
- communication training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- quality of the obtained video recordings were unsatisfactory and not usable for analysis
- unmet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Breaking Bad News in Pediatrics by Simulated Communication: The Prospective Randomized Controlled SimCom Study
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
Read the detailed 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.
- Conditions
- Communication, End of Life, Pediatric ALL
- Being tested
- communication training
- Keywords
- communication, pediatrics, palliative care, simulation, resuscitation, breaking bad news
- Medical subject headings
- Communication, Death, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication trainingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | no communication training prior to simulation scenario |
| Communication-Trained | Other | communication training prior to simulation scenario Receives: Other: communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 hour after the simulation
Secondary outcomes (2)
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
Measured: up to 1 hour after the simulation
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Sep 2021
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Bettina Brandt; MD MSc, Medical University of Vienna
- Investigators
- Jennifer Bettina Brandt, MD MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376188
- Sponsor's protocol ID
- 1582/2021 SimCom
- Acronym
- SimCom
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24152358Bittner-Fagan H, Davis J, Savoy M. Improving Patient Safety: Improving Communication. FP Essent. 2017 Dec;463:27-33.
PubMed 29210557Brock 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.
PubMed 30974949de 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.
PubMed 32097117Chumpitazi 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.
PubMed 27335708
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Breaking Bad News in Pediatrics by Simulated Communication: The Prospective Randomized Controlled SimCom Study
- ClinicalTrials.gov ID
- NCT06376188
- Acronym / sponsor ID
- SimCom / 1582/2021 SimCom
- Conditions
- Communication, End of Life, Pediatric ALL
- Keywords
- communication, pediatrics, palliative care, simulation, resuscitation, breaking bad news
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –no communication training prior to simulation scenario |
| Communication-Trained | Other | Other: communication trainingcommunication training prior to simulation scenario |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- quality of the obtained video recordings were unsatisfactory and not usable for analysis
- unmet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication trainingThe 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) | Other | Communication-Trained |
Primary outcome
score by simulation parents
Time frame: up to 1 hour after the simulation
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
2 secondary outcomes
score by participants
Time frame: up to 1 hour after the simulation
score of video analysis
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 24152358Babu 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.
- Background: PubMed 29210557Bittner-Fagan H, Davis J, Savoy M. Improving Patient Safety: Improving Communication. FP Essent. 2017 Dec;463:27-33.
- Background: PubMed 30974949Brock 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.
- Background: PubMed 32097117de 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.
- Background: PubMed 27335708Chumpitazi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Bettina Brandt, MD MSc principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication training in people with Communication and End of Life, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score by simulation parents (time frame: up to 1 hour after the simulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376188, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.