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BurnoutSTOPTHEBURNNCT04347811

Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees

A study testing Death Cafe in people with Burnout and Burnout, Professional, run by Tulane University School of Medicine at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Death Cafe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
4 sitesUnited States
Study dates
20 Jul 2020to 26 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • University Medical Center

    New Orleans, Louisiana, 70112

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

Other trials in United States

About this study

Official title: Systematic Trial Of PrevenTing Healthcare Employee Burnout: Using Reflection & Nourishment

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.

Being tested
Death Cafe
Keywords
Critical Care, Nurses, Physicians, Healthcare Workers, Death, Grief, Stress, Psychological, Occupational Stress, Behavioral Symptoms, Coping Skills, Clinical Trial
Medical subject headings
Burnout, Psychological, Burnout, Professional, Anxiety Disorders, Depression, Death, Stress, Psychological, Occupational Stress, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Death CafeBehavioural

    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.

Study groups in NCT04347811
Study groupRoleWhat they receive
Death Cafe ArmExperimentalParticipants undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.
Receives: Behavioral: Death Cafe
Control ArmNo interventionParticipants do not undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start20 Jul 2020
  3. Primary completion26 Dec 2022
  4. Study completion26 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347811
Sponsor's protocol ID
2019-908
Acronym
STOPTHEBURN
Status last verified
Feb 2023
First submitted
12 Apr 2020
Last updated
6 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.

    PubMed 11148311

  • Hammer R, Ravindran N, Nielsen N. Can Death Cafes resuscitate morale in hospitals? Med Humanit. 2021 Mar;47(1):2-3. doi: 10.1136/medhum-2018-011607. Epub 2019 Jan 19.

    PubMed 30661041

  • Rodrigues H, Cobucci R, Oliveira A, Cabral JV, Medeiros L, Gurgel K, Souza T, Goncalves AK. Burnout syndrome among medical residents: A systematic review and meta-analysis. PLoS One. 2018 Nov 12;13(11):e0206840. doi: 10.1371/journal.pone.0206840. eCollection 2018.

    PubMed 30418984

  • Elmariah H, Thomas S, Boggan JC, Zaas A, Bae J. The Burden of Burnout. Am J Med Qual. 2017 Mar/Apr;32(2):156-162. doi: 10.1177/1062860615625802. Epub 2016 Jul 9.

    PubMed 26917807

  • Holmes EG, Connolly A, Putnam KT, Penaskovic KM, Denniston CR, Clark LH, Rubinow DR, Meltzer-Brody S. Taking Care of Our Own: A Multispecialty Study of Resident and Program Director Perspectives on Contributors to Burnout and Potential Interventions. Acad Psychiatry. 2017 Apr;41(2):159-166. doi: 10.1007/s40596-016-0590-3. Epub 2016 Jul 19.

    PubMed 27436125

  • Thrush CR, Guise JB, Gathright MM, Messias E, Flynn V, Belknap T, Thapa PB, Williams DK, Nada EM, Clardy JA. A One-Year Institutional View of Resident Physician Burnout. Acad Psychiatry. 2019 Aug;43(4):361-368. doi: 10.1007/s40596-019-01043-9. Epub 2019 Feb 28.

    PubMed 30820845

  • Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.

    PubMed 15598920

  • Ishak WW, Lederer S, Mandili C, Nikravesh R, Seligman L, Vasa M, Ogunyemi D, Bernstein CA. Burnout during residency training: a literature review. J Grad Med Educ. 2009 Dec;1(2):236-42. doi: 10.4300/JGME-D-09-00054.1.

    PubMed 21975985

  • Dzau VJ, Kirch DG, Nasca TJ. To Care Is Human - Collectively Confronting the Clinician-Burnout Crisis. N Engl J Med. 2018 Jan 25;378(4):312-314. doi: 10.1056/NEJMp1715127. No abstract available.

    PubMed 29365296

  • Moss M, Good VS, Gozal D, Kleinpell R, Sessler CN. An Official Critical Care Societies Collaborative Statement-Burnout Syndrome in Critical Care Health-care Professionals: A Call for Action. Chest. 2016 Jul;150(1):17-26. doi: 10.1016/j.chest.2016.02.649.

    PubMed 27396776

  • Filho FA, Rodrigues MCS, Cimiotti JP. Burnout in Brazilian Intensive Care Units: A Comparison of Nurses and Nurse Technicians. AACN Adv Crit Care. 2019 Spring;30(1):16-21. doi: 10.4037/aacnacc2019222.

    PubMed 30842069

  • Zhang XC, Huang DS, Guan P; SUBLIN Study Team. Job burnout among critical care nurses from 14 adult intensive care units in Northeastern China: a cross-sectional survey. BMJ Open. 2014 Jun 19;4(6):e004813. doi: 10.1136/bmjopen-2014-004813.

    PubMed 24948747

  • Guntupalli KK, Wachtel S, Mallampalli A, Surani S. Burnout in the intensive care unit professionals. Indian J Crit Care Med. 2014 Mar;18(3):139-43. doi: 10.4103/0972-5229.128703.

    PubMed 24701063

  • Ahmadi O, Azizkhani R, Basravi M. Correlation between workplace and occupational burnout syndrome in nurses. Adv Biomed Res. 2014 Jan 24;3:44. doi: 10.4103/2277-9175.125751. eCollection 2014.

    PubMed 24627852

  • Poncet MC, Toullic P, Papazian L, Kentish-Barnes N, Timsit JF, Pochard F, Chevret S, Schlemmer B, Azoulay E. Burnout syndrome in critical care nursing staff. Am J Respir Crit Care Med. 2007 Apr 1;175(7):698-704. doi: 10.1164/rccm.200606-806OC. Epub 2006 Nov 16.

    PubMed 17110646

Questions about this trial

What is this clinical trial studying?

A study testing Death Cafe in people with Burnout and Burnout, Professional, run by Tulane University School of Medicine at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Burnout as measured by the Maslach Burnout Inventory Score (MBI). (time frame: At the time of enrollment and at 1 month, 3 months, 6 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347811, which also lists 54 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.

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