Communication ResearchNCT04308707
Breaking Bad News Skills of Doctors and Residents in the Surgical Setting
An observational study of Communication Research and Patient Satisfaction, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Breaking bad news is a very stressful and difficult situation for health care professionals, especially clinical doctors and surgeons. Acquiring skills for this sort of communication is very important due to the large volume of times that these professionals will have to deal with it and because it can affect the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication Research, Patient Satisfaction, Communication Programs
- What is being tested?
- Breaking bad news skills
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents and Doctors specialized in surgical specialties or anesthesiology.
Who may be able to join
- Doctors working in the Surgical Setting that accept and answer the specialized questionnaire.
Who cannot join
- Questionnaire answered out of the time-frame
- Incomplete questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clinic of Barcelona, Hospital Uiversitari Mútua de Terrassa
Barcelona, 08036
About this study
Official title: Breaking Bad News Skills of Doctors and Residents in Anesthesia and Surgical Specialties in Spain: a Cross-sectional Survey
Breaking bad news is a very stressful and difficult situation for health care professionals, especially clinical doctors and surgeons. Acquiring skills for this sort of communication is very important due to the large volume of times that these professionals will have to deal with it and because it can affect the doctor-patient relationship forever.
The objective of this study is to evaluate the skill of surgeons and residents in surgical specialties in breaking bad news to patients and families across Spanish hospitals. This will be done by analyzing the subjects in terms of their knowledge and experience using a specialized questionnaire based on breaking bad news protocol, designed in the "Hospital Sant Joan de Déu" Children's hospital in Barcelona.
- Conditions
- Communication Research, Patient Satisfaction, Communication Programs, Doctor Patient Relation
- Being tested
- Breaking bad news skills
- Keywords
- Breaking bad news, Communication skills, Surveys and Questionnaires, Health Knowledge, Attitudes, Practice, Anesthesiology, Specialties, Surgical
- Medical subject headings
- Patient Satisfaction, Communication, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breaking bad news skillsOther
Communication skills analyzed by a specialized questionnaire designed from a Breaking bad news protocol developed in 2018-2019 in Barcelona.
| Study group | Role | What they receive |
|---|---|---|
| Surgical specialties | Not described Receives: Other: Breaking bad news skills | |
| Anesthesiology | Not described Receives: Other: Breaking bad news skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times having to communicate a bad new in the last year.
Question on our questionnaire. The answer will be a number, expected to be from 0 to 200, approximately.
Measured: Two months
Number of hours in training in communication and breaking bad news skills.
Question on our questionnaire. The answer will be the number of hours of professional training in the specific field of communication to patients.
Measured: Two months
Self-evaluation of the skills in breaking bad news and their self-perceived quality.
In the self-administered questionnaire, 21 questions reflect specific and important items in communication designed from "La Primera notícia", a Breaking bad news protocol designed I the pediatric hospital "Hospital Sant Joan de Déu" in Barcelona.
Data will be analyzed using GraphPad.
Measured: Two months
Knowledge of Second victim concept
Direct question in our questionnaire: we ask the health-care professionals to define the Second victim concept.
Measured: Two months
Secondary outcomes (1)
Where have the professionals acquired their skills in breaking bad news if they have not taken a training program?
Question on our questionnaire. Possible answers are:
- With the observation of peers and seniors.
- Studying by themselves from books and papers.
- Studying by themselves from videos and other internet content.
- With the experience of years of working.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start16 Mar 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication ResearchStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Carrero, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308707
- Sponsor's protocol ID
- BBNS-SS
- Status last verified
- Oct 2024
- First submitted
- 11 Mar 2020
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Bad News Skills of Doctors and Residents in Anesthesia and Surgical Specialties in Spain: a Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT04308707
- Acronym / sponsor ID
- BBNS-SS
- Conditions
- Communication Research, Patient Satisfaction, Communication Programs, Doctor Patient Relation
- Keywords
- Breaking bad news, Communication skills, Surveys and Questionnaires, Health Knowledge, Attitudes, Practice, Anesthesiology, Specialties, Surgical
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2020 (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 is a very stressful and difficult situation for health care professionals, especially clinical doctors and surgeons. Acquiring skills for this sort of communication is very important due to the large volume of times that these professionals will have to deal with it and because it can affect the doctor-patient relationship forever.
The objective of this study is to evaluate the skill of surgeons and residents in surgical specialties in breaking bad news to patients and families across Spanish hospitals. This will be done by analyzing the subjects in terms of their knowledge and experience using a specialized questionnaire based on breaking bad news protocol, designed in the "Hospital Sant Joan de Déu" Children's hospital in Barcelona.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical specialties | – | Other: Breaking bad news skills |
| Anesthesiology | – | Other: Breaking bad news skills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents and Doctors specialized in surgical specialties or anesthesiology.
Key inclusion criteria (1 listed)
- Doctors working in the Surgical Setting that accept and answer the specialized questionnaire.
Key exclusion criteria (2 listed)
- Questionnaire answered out of the time-frame
- Incomplete questionnaires
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 |
|---|---|---|
| Breaking bad news skillsCommunication skills analyzed by a specialized questionnaire designed from a Breaking bad news protocol developed in 2018-2019 in Barcelona. | Other | Anesthesiology, Surgical specialties |
Primary outcome
Number of times having to communicate a bad new in the last year.
Time frame: Two months
Question on our questionnaire. The answer will be a number, expected to be from 0 to 200, approximately.
Number of hours in training in communication and breaking bad news skills.
Time frame: Two months
Question on our questionnaire. The answer will be the number of hours of professional training in the specific field of communication to patients.
Self-evaluation of the skills in breaking bad news and their self-perceived quality.
Time frame: Two months
In the self-administered questionnaire, 21 questions reflect specific and important items in communication designed from "La Primera notícia", a Breaking bad news protocol designed I the pediatric hospital "Hospital Sant Joan de Déu" in Barcelona. Data will be analyzed using GraphPad.
Knowledge of Second victim concept
Time frame: Two months
Direct question in our questionnaire: we ask the health-care professionals to define the Second victim concept.
1 secondary outcome
Where have the professionals acquired their skills in breaking bad news if they have not taken a training program?
Time frame: Two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication Research and Patient Satisfaction, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of times having to communicate a bad new in the last year. (time frame: Two months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.