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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02963792
Other study ID # TASMC-16-GL-0426-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 4, 2016
Last updated November 14, 2016
Start date November 2016
Est. completion date September 2020

Study information

Verified date November 2016
Source Tel-Aviv Sourasky Medical Center
Contact Orit Karnieli-Miller, PhD
Phone +972502060619
Email oritkm@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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 acquire coping skills related to burnout, communication and professionalism.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date September 2020
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Preventing Professionals burnout


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
michal roll Association for Children at Risk, Tel Aviv University

Outcome

Type Measure Description Time frame Safety issue
Primary Professionalism Culture Scale 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) No
Primary Abbreviated Burnout Scale 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) No
Secondary 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. Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary Cynicism in Medicine Questionnaire (CMQ) 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) No
Secondary 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. Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary Jefferson Health Professionals Empathy Scale 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) No
Secondary 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 Change (increase in balance) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary 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. Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary Life satisfaction questionnaire 3 item questionnaire focused on general life satisfaction. Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary 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. Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary Work-Life Balance 6 item questionnaire developed by Greenhaus & Powell, 2006) Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively) No
Secondary Resilient Coping Questionnaire (RCQ) 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) No
Secondary Specific Life Satisfaction Questionnaire 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) No
Secondary Brief Resilience Scale (BRS) 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) No
Secondary Patient Satisfaction questionnaire 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) No
Secondary Physician Transcendence Scale (PTS) A 16 items newly developed questionnaire focused on the physicians' transcendence. Laor, Wolmer & Hamiel Baseline No
Secondary Demographic information questions questions concerning gender, age, seniority, specialty, country of birth, Baseline No
Secondary Life Events Scale Assessing life events the individual experienced, such as divorce, a death of a loved one, etc. Baseline No
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