Clinical trial NCT05037318: Breaking Bad News - Optimizing Stress Response and Communication Performance in Medical Students
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reaction
Keywords: Breaking bad news
Stress
Stress arousal reappraisal
Stressful communication
Communication skills
Worked example
Biopsychosocial model
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: University of Vienna
First posted: 2021-09-08
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Two interventions are used, participants either receive only a stress reappraisal, only worked examples on breaking bad news, both interventions together, or none of the interventions.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Breaking bad news performance
timeFrame: After 2 hours. Duration: 12 minutes
Secondary outcomes:
measure: Change in self-reported mood
timeFrame: During 3 hours, multiple pre and post intervention measures
measure: Change in heart rate
timeFrame: During 3 hours, multiple pre and post intervention measures
measure: Change in pre-ejection period
timeFrame: During 3 hours, multiple pre and post intervention measures
measure: Change in challenge-threat cardiovascular index
timeFrame: During 3 hours, multiple pre and post intervention measures
measure: Change in anabolic balance
timeFrame: During 3 hours, multiple pre and post intervention measures
measure: Change in salivary alpha-amylase
timeFrame: During 3 hours, multiple pre and post intervention measures
measure: Change in self-reported task resources-demands differential
timeFrame: 3 minutes before the intervention, 3 minutes before the BBN task, and 3 minutes after the BBN task
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Institute for Medical Education
Study officials:
affiliation: University of Bern
name: Christoph Berendonk, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: