- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02963792
Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER) (BUPHER)
Values and Virtues in Medical Practice: Quasi-Experimental Intervention for Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER) in a Hospital Surgical Division
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Orit Karnieli-Miller, PhD
- Phone Number: +972502060619
- Email: oritkm@gmail.com
Study Contact Backup
- Name: Nathaniel Laor, MD; PhD
- Phone Number: +972546441354
- Email: nlaor@me.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Structured group intervention
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. |
Other Names:
|
Experimental: Semi-Structured group intervention
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. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
|
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)
|
Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
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)
|
14 item questionnaire developed by Teserman, Morton, Loo, Worthle & Lamberton, 1996
|
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)
|
A newly developed questionnaire focused on self efficacy to intervene when a physician acts immorally and actual experience with acting in such cases.
|
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)
|
20 items questionnaire developed by Hojat, Mangione, Nasca, Cohen, Gonnella, Erdmann & Magee, 2001
|
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)
|
29 items questionnaire developed by Leiter & Maslach, 2004 to measure 6 factors related to work load, control, appreciation, community, fairness and values
|
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)
|
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.
|
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)
|
3 item questionnaire focused on general life satisfaction.
|
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)
|
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.
|
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)
|
6 item questionnaire developed by Greenhaus & Powell, 2006)
|
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)
|
24 items questionnaire developed by Wolmer, Hamiel & Laor (2105)
|
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)
|
12 items questionnaire developed by Karnieli-Miller & Michael to measure satisfaction with different life domains (e.g., relationships, financial etc).
|
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)
|
6 item questionnaire developed by Smith et al., 2008
|
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)
|
23 items questionnaire focused on patient-physician communication skills and satisfaction from care.
|
Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)
|
Physician Transcendence Scale (PTS)
Time Frame: Baseline
|
A 16 items newly developed questionnaire focused on the physicians' transcendence.
Laor, Wolmer & Hamiel
|
Baseline
|
Demographic information questions
Time Frame: Baseline
|
questions concerning gender, age, seniority, specialty, country of birth,
|
Baseline
|
Life Events Scale
Time Frame: Baseline
|
Assessing life events the individual experienced, such as divorce, a death of a loved one, etc.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-16-GL-0426-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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