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Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees (STOPTHEBURN)

Primary Purpose

Burnout, Burnout, Professional, Burnout, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Death Cafe
Sponsored by
Tulane University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout focused on measuring Critical Care, Nurses, Physicians, Healthcare Workers, Death, Grief, Stress, Psychological, Occupational Stress, Behavioral Symptoms, Coping Skills, Clinical Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physicians, nurses, pharmacists, or therapists working in the Intensive Care Unit and have worked for the full-time equivalent of at least 1 week in the preceding 4 weeks

Exclusion Criteria:

  • Not physicians, nurses, pharmacists, or therapists
  • Have worked less than the full-time equivalent of at least 1 week in the preceding 4 weeks

Sites / Locations

  • Tulane Medical Center
  • University Medical Center
  • Children's Hospital New Orleans
  • Ochsner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Death Cafe Arm

Control Arm

Arm Description

Participants undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.

Participants do not undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.

Outcomes

Primary Outcome Measures

Differences in Burnout as measured by the Maslach Burnout Inventory Score (MBI).
This is a validated 22-item, self-reported questionnaire that asks respondents to indicate on a 7 point Likert scale the frequency of certain feelings related to their job. Presence of burnout is defined by high values of depersonalization and emotional exhaustion with low values for personal accomplishment. Changes in mean scores between groups and within groups over time will be assessed.

Secondary Outcome Measures

Differences in Depression as measured by the Patient Health Questionnaire 8 (PHQ-8)
This is an 8 question validated questionnaire that asks respondents to indicate the frequency with which they have experienced certain symptoms consistent with depression. Higher scores mean higher frequency of depression symptoms, and a score of 10 or higher will be considered to indicate clinically significant depression. Changes in mean scores between groups and within groups over time will be assessed.
Differences in Anxiety as measured by the Generalized Anxiety Disorder 7 Scale (GAD-7)
This is a 7 question validated questionnaire that asks respondents to indicate the frequency with which they have experienced certain symptoms consistent with anxiety. Higher scores mean higher frequency of anxiety symptoms, and a score of 10 or higher will be considered to indicate clinically significant anxiety. Changes in mean scores between groups and within groups over time will be assessed.

Full Information

First Posted
April 12, 2020
Last Updated
February 3, 2023
Sponsor
Tulane University School of Medicine
Collaborators
Spirit of Charity Foundation - University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04347811
Brief Title
Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees
Acronym
STOPTHEBURN
Official Title
Systematic Trial Of PrevenTing Healthcare Employee Burnout: Using Reflection & Nourishment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
December 26, 2022 (Actual)
Study Completion Date
December 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University School of Medicine
Collaborators
Spirit of Charity Foundation - University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Burnout affects a significant number of healthcare employees and leads to worsened mental health, increased job turnover, and patient safety events. Those caring for critically ill patients may be especially susceptible due to high patient mortality, long hours, and regular encounters with traumatic and ethical issues. Preliminary studies suggest that debriefing opportunities may reduce burnout through reflection on distressing patient events, enhancement of social support, and interprofessional collaboration. Death Cafés are a specific form of debriefing that focus on discussing death, dying, loss, and illness. The purpose of this study is to evaluate whether biweekly Death Cafe group debriefing sessions can prevent burnout in ICU physicians and staff.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Burnout, Professional, Burnout, Psychological, Anxiety, Depression
Keywords
Critical Care, Nurses, Physicians, Healthcare Workers, Death, Grief, Stress, Psychological, Occupational Stress, Behavioral Symptoms, Coping Skills, Clinical Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Death Cafe Arm
Arm Type
Experimental
Arm Description
Participants undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants do not undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Death Cafe
Intervention Description
Death Cafés are a specific form of debriefing that focuses on discussing death, dying, loss, and illness. Nourishment in the form of cake is provided. These sessions may allow for reflection on distressing patient events while developing a sense of community and collaboration among hospital employees.
Primary Outcome Measure Information:
Title
Differences in Burnout as measured by the Maslach Burnout Inventory Score (MBI).
Description
This is a validated 22-item, self-reported questionnaire that asks respondents to indicate on a 7 point Likert scale the frequency of certain feelings related to their job. Presence of burnout is defined by high values of depersonalization and emotional exhaustion with low values for personal accomplishment. Changes in mean scores between groups and within groups over time will be assessed.
Time Frame
At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
Secondary Outcome Measure Information:
Title
Differences in Depression as measured by the Patient Health Questionnaire 8 (PHQ-8)
Description
This is an 8 question validated questionnaire that asks respondents to indicate the frequency with which they have experienced certain symptoms consistent with depression. Higher scores mean higher frequency of depression symptoms, and a score of 10 or higher will be considered to indicate clinically significant depression. Changes in mean scores between groups and within groups over time will be assessed.
Time Frame
At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
Title
Differences in Anxiety as measured by the Generalized Anxiety Disorder 7 Scale (GAD-7)
Description
This is a 7 question validated questionnaire that asks respondents to indicate the frequency with which they have experienced certain symptoms consistent with anxiety. Higher scores mean higher frequency of anxiety symptoms, and a score of 10 or higher will be considered to indicate clinically significant anxiety. Changes in mean scores between groups and within groups over time will be assessed.
Time Frame
At the time of enrollment and at 1 month, 3 months, 6 months after enrollment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physicians, nurses, pharmacists, or therapists working in the Intensive Care Unit and have worked for the full-time equivalent of at least 1 week in the preceding 4 weeks Exclusion Criteria: Not physicians, nurses, pharmacists, or therapists Have worked less than the full-time equivalent of at least 1 week in the preceding 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie E Bateman, MD
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Denson, MD
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees

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