NCT04347811

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

April 12, 2020

Last Update Submit

February 3, 2023

Conditions

Keywords

Critical CareNursesPhysiciansHealthcare WorkersDeathGriefStress, PsychologicalOccupational StressBehavioral SymptomsCoping SkillsClinical Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the time of enrollment and at 1 month, 3 months, 6 months after enrollment

Secondary Outcomes (2)

  • Differences in Depression as measured by the Patient Health Questionnaire 8 (PHQ-8)

    At the time of enrollment and at 1 month, 3 months, 6 months after enrollment

  • Differences in Anxiety as measured by the Generalized Anxiety Disorder 7 Scale (GAD-7)

    At the time of enrollment and at 1 month, 3 months, 6 months after enrollment

Study Arms (2)

Death Cafe Arm

EXPERIMENTAL

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

Behavioral: Death Cafe

Control Arm

NO INTERVENTION

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

Interventions

Death CafeBEHAVIORAL

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.

Death Cafe Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

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  • Bateman ME, Chung CH, Mascarenhas E, Hammer R, Ravindran N, Panjshiri F, Mehta P, Byrne A, Lasky S, Denson R, Brown M, Halton B, Chiurco J, Ferrell S, Ruiz B, Wentowski C, Shukla I, Bauer H, Sarma A, Bhyravabhotla K, Zu Y, Peacock E, Lefante J, Epere J, Denson JL. STOPTHEBURN: A Randomized Controlled Trial of Death Cafes for Burnout Prevention in Intensive Care Unit Employees. Ann Am Thorac Soc. 2024 Nov;21(11):1572-1582. doi: 10.1513/AnnalsATS.202312-1024OC.

  • Bateman ME, Hammer R, Byrne A, Ravindran N, Chiurco J, Lasky S, Denson R, Brown M, Myers L, Zu Y, Denson JL. Death Cafes for prevention of burnout in intensive care unit employees: study protocol for a randomized controlled trial (STOPTHEBURN). Trials. 2020 Dec 11;21(1):1019. doi: 10.1186/s13063-020-04929-4.

MeSH Terms

Conditions

Burnout, PsychologicalBurnout, ProfessionalAnxiety DisordersDepressionDeathStress, PsychologicalOccupational StressBehavioral Symptoms

Condition Hierarchy (Ancestors)

BehaviorOccupational DiseasesMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marjorie E Bateman, MD

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Joshua Denson, MD

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 15, 2020

Study Start

July 20, 2020

Primary Completion

December 26, 2022

Study Completion

December 26, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations