NCT02963792

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

September 4, 2016

Last Update Submit

November 14, 2016

Conditions

Keywords

ProfessionalismBurnout preventionResiliencyStudent education

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (16)

  • Adapted Professionalism Mini-Evaluation Scale Exercise scale

    Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)

  • Cynicism in Medicine Questionnaire (CMQ)

    Change (decrease) from baseline to short and long term measurements (after one year, 3 years, respectively)

  • Moral & Cognitive Courage Scale

    Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)

  • Jefferson Health Professionals Empathy Scale

    Change (increase) from baseline to short and long term measurements (after one year, 3 years, respectively)

  • The Areas of Work life Scale (AWS)

    Change (increase in balance) from baseline to short and long term measurements (after one year, 3 years, respectively)

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Other: Preventing Professionals burnout

Interventions

Also known as: Enhancing professional professional conduct
Semi-Structured group interventionStructured group intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The research will not include children and/or judgment-impaired patients;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Orit Karnieli-Miller, PhD

CONTACT

Nathaniel Laor, MD; PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal of the department of surgery and the unit of surgical oncology

Study Record Dates

First Submitted

September 4, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

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