Breaking Bad News - Optimizing Stress Response and Communication Performance in Medical Students (BPSM)

March 4, 2024 updated by: University of Bern

From Threat to Challenge - Improving Medical Students' Stress Response and Communication Skills Performance Through the Combination of Stress Arousal Reappraisal and Preparatory Worked Example-based Learning When Breaking Bad News to Simulated Patients

Breaking bad news (e.g., telling patients that they have cancer) is not only very stressful for the patients concerned, but also for the physicians delivering the diagnosis. It is unclear how this burden and the associated communication performance can be optimized. The project contributes to this goal.

The main goal of the project is to scientifically analyze to what extent the stress reaction and communication performance of medical students can be optimized when breaking bad news. Two strategies will be employed and tested for their effectiveness: First, "stress arousal reappraisal", which consists in reinterpreting physiological arousal (e.g., increased heart rate) as adaptive and beneficial for task performance. Second, medical students can be well prepared for breaking bad news by learning from worked examples (step-by-step demonstrations of how to break bad news).

The investigators hypothesize that both strategies will shift the interpretation of breaking bad news from a threat to a challenge state. This will lead to better communication performance during the task.

To test the hypothesis, about 200 medical students' communication performance, cardiovascular activity, stress hormone release, and subjective stress perception when communicating a serious cancer diagnosis to a simulated patient (actor) will be measured.

The results of the study provide a first comprehensive picture of the psychophysiological stress patterns of medical students who are entrusted with a stressful communication task. Ultimately, this may promote stress management and communication skills in future physicians.

Study Overview

Detailed Description

Breaking bad news (BBN; e.g., telling patients that they have cancer) is a frequent task in the medical field. Appropriate communication when BBN is crucial for patient-related outcomes. For many physicians, BBN is a very demanding task often associated with high levels of stress, which can negatively impact their communication skills and health. It is thus important to provide future physicians with effective tools that enable them to cope successfully with their stress response and to perform the BBN task at their best. The planned project aims to contribute to this important goal in novel ways. One promising approach to improve people's stress response to demanding tasks is stress arousal reappraisal, which consists in reinterpreting physiological arousal as adaptive and beneficial for task performance. Recent work suggests that medical students can be well prepared for BBN by learning from worked examples (step-by-step demonstrations of how to break bad news).

Overall objectives: The study adopts the biopsychosocial model (BPSM) of challenge and threat as organizing theoretical framework to investigate the effects of stress arousal reappraisal and preparatory worked example-based BBN learning on the psychophysiological responses and communication skills performance of medical students tasked with BBN to simulated patients (SPs). The BPSM of challenge and threat holds that individuals are in a threat state when perceived resources fall short of perceived demands in a motivated performance situation, whereas they are in a challenge state when evaluated resources outweigh perceived demands. These states are primarily assessed with a self-reported resources-demands differential (perceived resources minus perceived demands) and a cardiovascular index (sum of cardiac output and reverse scored total peripheral resistance), with larger scores reflecting greater challenge. Secondarily, as suggested by recent research, they are also associated with salivary indices of the activity of the hypothalamic-pituitary-adrenal axis (cortisol and dehydroepiandrosterone) and of the sympatho-adrenal-medullary system (alpha-amylase). Compared to threats, challenge-type responses are associated with better task performance and better health outcomes.

Specific aims: The idea guiding the planned research is that both stress arousal reappraisal and preparatory worked example-based BBN learning will shift medical students' psychophysiological state from threat to challenge and by doing so their task performance will improve.

The hypotheses are: 1) students receiving stress arousal reappraisal instructions will show (i) more challenge-type psychophysiological responses and (ii) better BBN skills performance than students receiving no stress arousal reappraisal instructions; 2) students learning from a BBN-related worked example will show (iii) more challenge-type psychophysiological responses and (iv) better BBN skills performance than students not learning from a BBN-related worked example; 3) the challenge-threat resources-demands differential and cardiovascular index will be mediators of the effects of the interventions on BBN skills performance.

Method: A randomized controlled trial with a 2 (stress arousal reappraisal vs. no stress arousal reappraisal) x 2 (preparatory BBN learning with worked example vs. without worked example) between-subjects design with N = 200 Swiss medical students is envisioned. The investigators will assess participants' perceived task demands and coping resources, record their cardiovascular activity and collect their saliva before, during and after a videotaped BBN encounter with an SP. Three assessors will independently rate participants' BBN skills performance from the recordings.

Implications and relevance: Findings will support determining to what extent medical students' BBN-related stress responses and communication performance can be examined and understood from the challenge and threat perspective. Stress arousal reappraisal and preparatory worked example-based learning could be easily incorporated into the curriculum of medical students to help promote more adaptive challenge-type responses when facing BBN situations and potentially other stress-inducing communications with patients. This would ultimately have beneficial effects for both physicians and patients.

Study Type

Interventional

Enrollment (Actual)

229

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 Contact

Study Locations

      • Bern, Switzerland, 3012
        • Institute for Medical Education

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being currently enrolled as a third-year medical student
  • Being German speaker
  • Signed consent form

Exclusion Criteria:

  • Cardiovascular diseases known to affect the variables under investigation
  • Neuroendocrine conditions known to affect the variables under investigation
  • Use of psychotropic drugs or any medication known to affect the variables under investigation (e.g., corticosteroids, cardioactive medication)
  • Wearing a pacemaker
  • Pregnancy/Breastfeeding

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Stress arousal reappraisal
Participants will watch a video explaining that stress arousal is not harmful but rather functional and adaptive for performance in stressful situations.
Experimental: Worked examples
The worked example will be in form of brief video sequences showing a physician (played by an actor) delivering the bad diagnosis of lung cancer to an SP following the SPIKES protocol.
Experimental: Stress arousal reappraisal + Worked examples
Participants will watch a video explaining that stress arousal is not harmful but rather functional and adaptive for performance in stressful situations.
The worked example will be in form of brief video sequences showing a physician (played by an actor) delivering the bad diagnosis of lung cancer to an SP following the SPIKES protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breaking bad news performance
Time Frame: After 2 hours. Duration: 12 minutes
SPIKES (6 items) and global Bad News Assessment Scale (glBAS; 5 items); both five-point ratings ranging from 1 to 5, glBAS is scored in reverse to match SPIKES scale, the higher the score, the better the performance
After 2 hours. Duration: 12 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported mood
Time Frame: During 3 hours, multiple pre and post intervention measures
Multidimensional Mood State Questionnaire Short-scale; three dimensions, (8 items in total); 8-point scale; items have bipolar anchors (e.g., for valence, 1 = bad & 8 = good; calmness, 1 = tense, 8 = calm; energetic arousal, 1 = tired, 8 = awake)
During 3 hours, multiple pre and post intervention measures
Change in heart rate
Time Frame: During 3 hours, multiple pre and post intervention measures
Heart beats per minute
During 3 hours, multiple pre and post intervention measures
Change in pre-ejection period
Time Frame: During 3 hours, multiple pre and post intervention measures
Defined as the time in ms from the initiation of left-ventricle contraction to aortic-valve opening
During 3 hours, multiple pre and post intervention measures
Change in challenge-threat cardiovascular index
Time Frame: During 3 hours, multiple pre and post intervention measures
Sum of cardiac output and reverse scored total peripheral resistance, z-Score
During 3 hours, multiple pre and post intervention measures
Change in anabolic balance
Time Frame: During 3 hours, multiple pre and post intervention measures
Ratio of salivary cortisol to salivary dehydroepiandrosterone
During 3 hours, multiple pre and post intervention measures
Change in salivary alpha-amylase
Time Frame: During 3 hours, multiple pre and post intervention measures
Concentration
During 3 hours, multiple pre and post intervention measures
Change in self-reported task resources-demands differential
Time Frame: 3 minutes before the intervention, 3 minutes before the BBN task, and 3 minutes after the BBN task
2 items; "How demanding do you expect the task to be / was the task?", "How able are you / were you to cope with the demands of BBN task?"; 6-point Likert scale ranging from 1 "not at all" to 6 "extremely", score of first item is subtracted from the score of the second item, the higher the score, the more so is the task evaluated as a challenge, and less as a threat
3 minutes before the intervention, 3 minutes before the BBN task, and 3 minutes after the BBN task

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Christoph Berendonk, PD Dr., University of Bern

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)

April 21, 2022

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBN BPSM
  • 100019_200831 (Other Grant/Funding Number: Swiss National Science Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be shared.

IPD Sharing Time Frame

Data will be available as soon as the study is published.

IPD Sharing Access Criteria

The investigators will make supplementary files and key datasets accompanying a publication to demonstrate reproducibility openly available in appropriate digital data repositories that conform to the Fair Data principles and maintained by a non-profit organisation. Specific datasets will be shared via domain-specific public repositories. Unstructured data will be shared via data repository Zenodo or Dryad. These data repositories fulfill biomedical journals' and SNSF's requirements (allowing publishing FAIR data, non-commercial).

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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