Breaking Bad News - Optimizing Stress Response and Communication Performance in Medical Students (BPSM)
Primary Purpose
Stress Reaction
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Stress arousal reappraisal
Worked examples
Sponsored by
About this trial
This is an interventional basic science trial for Stress Reaction focused on measuring Breaking bad news, Stress, Stress arousal reappraisal, Stressful communication, Communication skills, Worked example, Biopsychosocial model
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
Sites / Locations
- Institute for Medical EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Stress arousal reappraisal
Worked examples
Stress arousal reappraisal + Worked examples
Control
Arm Description
Outcomes
Primary Outcome Measures
Breaking bad news performance
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
Secondary Outcome Measures
Change in self-reported mood
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)
Change in heart rate
Heart beats per minute
Change in pre-ejection period
Defined as the time in ms from the initiation of left-ventricle contraction to aortic-valve opening
Change in challenge-threat cardiovascular index
Sum of cardiac output and reverse scored total peripheral resistance, z-Score
Change in anabolic balance
Ratio of salivary cortisol to salivary dehydroepiandrosterone
Change in salivary alpha-amylase
Concentration
Change in self-reported task resources-demands differential
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
Full Information
NCT ID
NCT05037318
First Posted
August 31, 2021
Last Updated
September 20, 2022
Sponsor
University of Bern
Collaborators
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05037318
Brief Title
Breaking Bad News - Optimizing Stress Response and Communication Performance in Medical Students
Acronym
BPSM
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction
Keywords
Breaking bad news, Stress, Stress arousal reappraisal, Stressful communication, Communication skills, Worked example, Biopsychosocial model
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants know the content of their intervention, however, they do not know what other interventions there are and which group they belong to.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress arousal reappraisal
Arm Type
Experimental
Arm Title
Worked examples
Arm Type
Experimental
Arm Title
Stress arousal reappraisal + Worked examples
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Stress arousal reappraisal
Intervention Description
Participants will watch a video explaining that stress arousal is not harmful but rather functional and adaptive for performance in stressful situations.
Intervention Type
Behavioral
Intervention Name(s)
Worked examples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breaking bad news performance
Description
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
Time Frame
After 2 hours. Duration: 12 minutes
Secondary Outcome Measure Information:
Title
Change in self-reported mood
Description
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)
Time Frame
During 3 hours, multiple pre and post intervention measures
Title
Change in heart rate
Description
Heart beats per minute
Time Frame
During 3 hours, multiple pre and post intervention measures
Title
Change in pre-ejection period
Description
Defined as the time in ms from the initiation of left-ventricle contraction to aortic-valve opening
Time Frame
During 3 hours, multiple pre and post intervention measures
Title
Change in challenge-threat cardiovascular index
Description
Sum of cardiac output and reverse scored total peripheral resistance, z-Score
Time Frame
During 3 hours, multiple pre and post intervention measures
Title
Change in anabolic balance
Description
Ratio of salivary cortisol to salivary dehydroepiandrosterone
Time Frame
During 3 hours, multiple pre and post intervention measures
Title
Change in salivary alpha-amylase
Description
Concentration
Time Frame
During 3 hours, multiple pre and post intervention measures
Title
Change in self-reported task resources-demands differential
Description
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
Time Frame
3 minutes before the intervention, 3 minutes before the BBN task, and 3 minutes after the BBN task
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Berendonk, PD Dr.
Phone
+41 31 684 62 24
Email
christoph.berendonk@iml.unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Berendonk, PD Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Medical Education
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Berendonk, PD Dr.
Phone
+41 31 684 62 24
Email
christoph.berendonk@iml.unibe.ch
First Name & Middle Initial & Last Name & Degree
Felix Schmitz, Dr.
First Name & Middle Initial & Last Name & Degree
Michel Bosshard, MSc
First Name & Middle Initial & Last Name & Degree
Christoph Berendonk, PD Dr.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Learn more about this trial
Breaking Bad News - Optimizing Stress Response and Communication Performance in Medical Students
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