Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER) (BUPHER)

November 14, 2016 updated by: michal roll

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Enhancing professional professional conduct
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:
  • Enhancing professional professional conduct

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

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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