Improving Breaking Bad News in Pediatrics by Simulated Communication (SimCom)

April 16, 2024 updated by: Jennifer Bettina Brandt; MD MSc, Medical University of Vienna

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
no communication training prior to simulation scenario
Other: Communication-Trained
communication training prior to simulation scenario
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 hour after the simulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score by participants
Time Frame: up to 1 hour after the simulation
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
score of video analysis
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Jennifer Bettina Brandt, MD MSc, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1582/2021 SimCom

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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