Professional-Patient RelationsBUPHERNCT02963792
Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER)
A study testing Preventing Professionals burnout in people with Professional-Patient Relations and Burnout, Professional, run by michal roll.
Trial summary
Due to their difficult and stressful work surgeons are under continuous physical and mental stress exposing them to increased risk for burnout and lack of professionalism. The present intervention focuses on providing time and a safe space to debrief and explore personal and group experiences and dilemmas, as well as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Professional-Patient Relations, Burnout, Professional
- What is being tested?
- Preventing Professionals burnout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All physicians (residents and experts) of the Surgical Division at Tel Aviv Sourasky Medical Center.
- All medical students studying at the Sackler Faculty of Medicine, Tel Aviv University, and attending a surgery round at the Surgical Division at Tel Aviv Sourasky Medical Center.
- Patients (and/or family members) in the Surgical Division at Tel Aviv Sourasky Medical Center following their surgery.
Who cannot join
- The research will not include children and/or judgment-impaired patients;
- population not met by inclusion criteria;
- non-Hebrew speaking patients;
- ventilated patients;
- patients in surgical intensive care;
- patients medically defined as suffering from clouding of conscious or delirium;
- subjects who decided to stop their participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Values and Virtues in Medical Practice: Quasi-Experimental Intervention for Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER) in a Hospital Surgical Division
Due to their difficult and stressful work surgeons are under continuous physical and mental stress exposing them to increased risk for burnout and lack of professionalism. The present intervention focuses on providing time and a safe space to debrief and explore personal and group experiences and dilemmas, as well as acquire coping skills related to burnout, communication and professionalism.
- Being tested
- Preventing Professionals burnout
- Keywords
- Professionalism, Burnout prevention, Resiliency, Student education
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing Professionals burnoutOther
Also called Enhancing professional professional conduct
| Study group | Role | What they receive |
|---|---|---|
| Structured group intervention | Experimental | Experimental: Structured group intervention a 'structured' intervention, leaning mostly on tools designed to prevent burnout and promote resilience, including predetermined exercises and topics as discussion goals in each meeting.
Fidelity will be checked and monitored at the end of each meeting, when facilitators fill out a form that summarizes the content, topics and coping skills acquired in each session. Receives: Other: Preventing Professionals burnout |
| Semi-Structured group intervention | Experimental | Experimental: Semi-Structured group intervention a 'semi-structured' intervention, based on tools for developing an emotional discourse, building a supporting team and self reflection.
The 'semi-structured' intervention offers predetermined contents that are discussed through the stories and needs presented by group members.
Fidelity will be checked and monitored at the end of each meeting, when facilitators fill out a form that summarizes the content, topics and coping skills acquired in each session. Receives: Other: Preventing Professionals burnout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professionalism Culture Scale
12 item scale developed by the American Board of Internal Medicine, by (DeLisa, Foye, Jain, Kirshblum, \& Christodoulou, 2001
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Abbreviated Burnout Scale
Nine item scale focused on 3 burnout factors (Iverson, Olekalns \& Erwin, 1998)
Measured: Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
Secondary outcomes (16)
Adapted Professionalism Mini-Evaluation Scale Exercise scale
originally included 24 items developed by Cruess, McIlroy, Cruess, Ginsburg, and Steinert (2006). Translated and adapted by the research team, and now include 31 items.
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Cynicism in Medicine Questionnaire (CMQ)
14 item questionnaire developed by Teserman, Morton, Loo, Worthle \& Lamberton, 1996
Measured: Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
Moral & Cognitive Courage Scale
A newly developed questionnaire focused on self efficacy to intervene when a physician acts immorally and actual experience with acting in such cases.
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Jefferson Health Professionals Empathy Scale
20 items questionnaire developed by Hojat, Mangione, Nasca, Cohen, Gonnella, Erdmann \& Magee, 2001
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
The Areas of Work life Scale (AWS)
29 items questionnaire developed by Leiter \& Maslach, 2004 to measure 6 factors related to work load, control, appreciation, community, fairness and values
Measured: Change (increase in balance) from baseline to short and long term measurements (after one year, 3 years, respectively)
Professionals Self Care Practices questionnaire
43 items comprised from two questionnaires focused on different aspects of self care (Teng, Yen \& Fetzer \& Shananfelt et al., 2005). the combination of these two questionnaires was assessed by Karnieli-Miller \& Michael.
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Life satisfaction questionnaire
3 item questionnaire focused on general life satisfaction.
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Perceived Stress Scale (PSS)
10 item scale focused on perceived stress in the clinics (4 items validated in Ben-Zur \& Michael) and 6 items developed by the research team to assess concern and fear from medical mistakes and hierarchy.
Measured: Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
Work-Life Balance
6 item questionnaire developed by Greenhaus \& Powell, 2006)
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Resilient Coping Questionnaire (RCQ)
24 items questionnaire developed by Wolmer, Hamiel \& Laor (2105)
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Specific Life Satisfaction Questionnaire
12 items questionnaire developed by Karnieli-Miller \& Michael to measure satisfaction with different life domains (e.g., relationships, financial etc).
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Brief Resilience Scale (BRS)
6 item questionnaire developed by Smith et al., 2008
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Patient Satisfaction questionnaire
23 items questionnaire focused on patient-physician communication skills and satisfaction from care.
Measured: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Physician Transcendence Scale (PTS)
A 16 items newly developed questionnaire focused on the physicians' transcendence. Laor, Wolmer \& Hamiel
Measured: Baseline
Demographic information questions
questions concerning gender, age, seniority, specialty, country of birth,
Measured: Baseline
Life Events Scale
Assessing life events the individual experienced, such as divorce, a death of a loved one, etc.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Professional-Patient RelationsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- michal roll
- Sponsor type
- Other government
- Collaborators
- Association for Children at Risk, Tel Aviv University
- Responsible party
- Sponsor-investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963792
- Sponsor's protocol ID
- TASMC-16-GL-0426-CTIL
- Acronym
- BUPHER
- Status last verified
- Nov 2016
- First submitted
- 4 Sep 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The participants data will be shared with the research team from the Department of Medical Education, Sackler Faculty of Medicine, Tel Aviv University and Cohen-Harris Resilience Center
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Values and Virtues in Medical Practice: Quasi-Experimental Intervention for Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER) in a Hospital Surgical Division
- ClinicalTrials.gov ID
- NCT02963792
- Acronym / sponsor ID
- BUPHER / TASMC-16-GL-0426-CTIL
- Keywords
- Professionalism, Burnout prevention, Resiliency, Student education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- michal rollOther government
- Collaborators
- Association for Children at Risk, Tel Aviv University
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 15 Nov 2016 (estimated)
- 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.
Due to their difficult and stressful work surgeons are under continuous physical and mental stress exposing them to increased risk for burnout and lack of professionalism. The present intervention focuses on providing time and a safe space to debrief and explore personal and group experiences and dilemmas, as well as acquire coping skills related to burnout, communication and professionalism.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured group intervention | Experimental | Other: Preventing Professionals burnoutExperimental: Structured group intervention a 'structured' intervention, leaning mostly on tools designed to prevent burnout and promote resilience, including predetermined exercises and topics as discussion goals in each meeting. Fidelity will be checked and monitored at the end of each meeting, when facilitators fill out a form that summarizes the content, topics and coping skills acquired in each session. |
| Semi-Structured group intervention | Experimental | Other: Preventing Professionals burnoutExperimental: Semi-Structured group intervention a 'semi-structured' intervention, based on tools for developing an emotional discourse, building a supporting team and self reflection. The 'semi-structured' intervention offers predetermined contents that are discussed through the stories and needs presented by group members. Fidelity will be checked and monitored at the end of each meeting, when facilitators fill out a form that summarizes the content, topics and coping skills acquired in each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All physicians (residents and experts) of the Surgical Division at Tel Aviv Sourasky Medical Center.
- All medical students studying at the Sackler Faculty of Medicine, Tel Aviv University, and attending a surgery round at the Surgical Division at Tel Aviv Sourasky Medical Center.
- Patients (and/or family members) in the Surgical Division at Tel Aviv Sourasky Medical Center following their surgery.
Key exclusion criteria (7 listed)
- The research will not include children and/or judgment-impaired patients;
- population not met by inclusion criteria;
- non-Hebrew speaking patients;
- ventilated patients;
- patients in surgical intensive care;
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 |
|---|---|---|
| Preventing Professionals burnoutAlso: Enhancing professional professional conduct | Other | Semi-Structured group intervention, Structured group intervention |
Primary outcome
Professionalism Culture Scale
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
12 item scale developed by the American Board of Internal Medicine, by (DeLisa, Foye, Jain, Kirshblum, \& Christodoulou, 2001
Abbreviated Burnout Scale
Time frame: Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
Nine item scale focused on 3 burnout factors (Iverson, Olekalns \& Erwin, 1998)
16 secondary outcomes
Adapted Professionalism Mini-Evaluation Scale Exercise scale
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Cynicism in Medicine Questionnaire (CMQ)
Time frame: Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
Moral & Cognitive Courage Scale
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Jefferson Health Professionals Empathy Scale
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
The Areas of Work life Scale (AWS)
Time frame: Change (increase in balance) from baseline to short and long term measurements (after one year, 3 years, respectively)
Professionals Self Care Practices questionnaire
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Life satisfaction questionnaire
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Perceived Stress Scale (PSS)
Time frame: Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
Work-Life Balance
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Resilient Coping Questionnaire (RCQ)
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Specific Life Satisfaction Questionnaire
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Brief Resilience Scale (BRS)
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Patient Satisfaction questionnaire
Time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
Physician Transcendence Scale (PTS)
Time frame: Baseline
Demographic information questions
Time frame: Baseline
Life Events Scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: Yes. The participants data will be shared with the research team from the Department of Medical Education, Sackler Faculty of Medicine, Tel Aviv University and Cohen-Harris Resilience Center
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Preventing Professionals burnout in people with Professional-Patient Relations and Burnout, Professional, run by michal roll.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orit Karnieli-Miller, PhD (+972502060619, oritkm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Professionalism Culture Scale (time frame: Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)). The study lists 2 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 15 Nov 2016.