- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04347811
Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees (STOPTHEBURN)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane Medical Center
-
New Orleans, Louisiana, United States, 70118
- Children's Hospital New Orleans
-
New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
-
New Orleans, Louisiana, United States, 70112
- University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Death Cafe Arm
Participants undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.
|
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.
|
NO_INTERVENTION: Control Arm
Participants do not undergo biweekly Death Café sessions hosted by a trained psychotherapist for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Depression as measured by the Patient Health Questionnaire 8 (PHQ-8)
Time Frame: At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
|
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.
|
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)
Time Frame: At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
|
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.
|
At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.
- Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Embriaco N, Papazian L, Kentish-Barnes N, Pochard F, Azoulay E. Burnout syndrome among critical care healthcare workers. Curr Opin Crit Care. 2007 Oct;13(5):482-8. doi: 10.1097/MCC.0b013e3282efd28a.
- Johnson-Coyle L, Opgenorth D, Bellows M, Dhaliwal J, Richardson-Carr S, Bagshaw SM. Moral distress and burnout among cardiovascular surgery intensive care unit healthcare professionals: A prospective cross-sectional survey. Can J Crit Care Nurs. 2016 Jan;27(4):27-36.
- Edmondson EK, Kumar AA, Smith SM. Creating a Culture of Wellness in Residency. Acad Med. 2018 Jul;93(7):966-968. doi: 10.1097/ACM.0000000000002250.
- Lu DW, Dresden S, McCloskey C, Branzetti J, Gisondi MA. Impact of Burnout on Self-Reported Patient Care Among Emergency Physicians. West J Emerg Med. 2015 Dec;16(7):996-1001. doi: 10.5811/westjem.2015.9.27945. Epub 2015 Dec 11.
- Schwarzkopf D, Ruddel H, Thomas-Ruddel DO, Felfe J, Poidinger B, Matthaus-Kramer CT, Hartog CS, Bloos F. Perceived Nonbeneficial Treatment of Patients, Burnout, and Intention to Leave the Job Among ICU Nurses and Junior and Senior Physicians. Crit Care Med. 2017 Mar;45(3):e265-e273. doi: 10.1097/CCM.0000000000002081.
- Sklar DP. Fostering Student, Resident, and Faculty Wellness to Produce Healthy Doctors and a Healthy Population. Acad Med. 2016 Sep;91(9):1185-8. doi: 10.1097/ACM.0000000000001298. No abstract available.
- Shanafelt TD, Balch CM, Bechamps G, Russell T, Dyrbye L, Satele D, Collicott P, Novotny PJ, Sloan J, Freischlag J. Burnout and medical errors among American surgeons. Ann Surg. 2010 Jun;251(6):995-1000. doi: 10.1097/SLA.0b013e3181bfdab3.
- Dewa CS, Loong D, Bonato S, Trojanowski L, Rea M. The relationship between resident burnout and safety-related and acceptability-related quality of healthcare: a systematic literature review. BMC Med Educ. 2017 Nov 9;17(1):195. doi: 10.1186/s12909-017-1040-y.
- Baer TE, Feraco AM, Tuysuzoglu Sagalowsky S, Williams D, Litman HJ, Vinci RJ. Pediatric Resident Burnout and Attitudes Toward Patients. Pediatrics. 2017 Mar;139(3):e20162163. doi: 10.1542/peds.2016-2163.
- Block L, Wu AW, Feldman L, Yeh HC, Desai SV. Residency schedule, burnout and patient care among first-year residents. Postgrad Med J. 2013 Sep;89(1055):495-500. doi: 10.1136/postgradmedj-2012-131743. Epub 2013 Jul 14.
- Kang EK, Lihm HS, Kong EH. Association of intern and resident burnout with self-reported medical errors. Korean J Fam Med. 2013 Jan;34(1):36-42. doi: 10.4082/kjfm.2013.34.1.36. Epub 2013 Jan 28.
- Kiymaz D, Koc Z. Identification of factors which affect the tendency towards and attitudes of emergency unit nurses to make medical errors. J Clin Nurs. 2018 Mar;27(5-6):1160-1169. doi: 10.1111/jocn.14148. Epub 2018 Feb 21.
- Mohammadi M, Peyrovi H, Mahmoodi M. The Relationship Between Professional Quality of Life and Caring Ability in Critical Care Nurses. Dimens Crit Care Nurs. 2017 Sep/Oct;36(5):273-277. doi: 10.1097/DCC.0000000000000263.
- Passalacqua SA, Segrin C. The effect of resident physician stress, burnout, and empathy on patient-centered communication during the long-call shift. Health Commun. 2012;27(5):449-56. doi: 10.1080/10410236.2011.606527. Epub 2011 Oct 4.
- Prins JT, van der Heijden FM, Hoekstra-Weebers JE, Bakker AB, van de Wiel HB, Jacobs B, Gazendam-Donofrio SM. Burnout, engagement and resident physicians' self-reported errors. Psychol Health Med. 2009 Dec;14(6):654-66. doi: 10.1080/13548500903311554.
- West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.
- Fahrenkopf AM, Sectish TC, Barger LK, Sharek PJ, Lewin D, Chiang VW, Edwards S, Wiedermann BL, Landrigan CP. Rates of medication errors among depressed and burnt out residents: prospective cohort study. BMJ. 2008 Mar 1;336(7642):488-91. doi: 10.1136/bmj.39469.763218.BE. Epub 2008 Feb 7.
- West CP, Huschka MM, Novotny PJ, Sloan JA, Kolars JC, Habermann TM, Shanafelt TD. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study. JAMA. 2006 Sep 6;296(9):1071-8. doi: 10.1001/jama.296.9.1071.
- Shanafelt TD, Bradley KA, Wipf JE, Back AL. Burnout and self-reported patient care in an internal medicine residency program. Ann Intern Med. 2002 Mar 5;136(5):358-67. doi: 10.7326/0003-4819-136-5-200203050-00008.
- Walsh AL, Lehmann S, Zabinski J, Truskey M, Purvis T, Gould NF, Stagno S, Chisolm MS. Interventions to Prevent and Reduce Burnout Among Undergraduate and Graduate Medical Education Trainees: a Systematic Review. Acad Psychiatry. 2019 Aug;43(4):386-395. doi: 10.1007/s40596-019-01023-z. Epub 2019 Feb 1.
- Jarden RJ, Sandham M, Siegert RJ, Koziol-McLain J. Strengthening workplace well-being: perceptions of intensive care nurses. Nurs Crit Care. 2019 Jan;24(1):15-23. doi: 10.1111/nicc.12386. Epub 2018 Sep 21.
- Govindan M, Keefer P, Sturza J, Stephens MR, Malas N. Empowering Residents to Process Distressing Events: A Debriefing Workshop. MedEdPORTAL. 2019 Feb 27;15:10809. doi: 10.15766/mep_2374-8265.10809.
- McDermott A, Brook I, Ben-Isaac E. Peer-Debriefing After Distressing Patient Care Events: A Workshop for Pediatric Residents. MedEdPORTAL. 2017 Sep 5;13:10624. doi: 10.15766/mep_2374-8265.10624.
- Hellyar M, Madani C, Yeaman S, O'Connor K, Kerr KM, Davidson JE. Case Study Investigation Decreases Burnout While Improving Interprofessional Teamwork, Nurse Satisfaction, and Patient Safety. Crit Care Nurs Q. 2019 Jan/Mar;42(1):96-105. doi: 10.1097/CNQ.0000000000000243.
- Lederer W, Kinzl JF, Traweger C, Dosch J, Sumann G. Fully developed burnout and burnout risk in intensive care personnel at a university hospital. Anaesth Intensive Care. 2008 Mar;36(2):208-13. doi: 10.1177/0310057X0803600211.
- Ricou B, Gigon F, Durand-Steiner E, Liesenberg M, Chemin-Renais C, Merlani P, Delaloye S. Initiative for Burnout of ICU Caregivers: Feasibility and Preliminary Results of a Psychological Support. J Intensive Care Med. 2020 Jun;35(6):562-569. doi: 10.1177/0885066618768223. Epub 2018 Apr 11.
- Browning ED, Cruz JS. Reflective Debriefing: A Social Work Intervention Addressing Moral Distress among ICU Nurses. J Soc Work End Life Palliat Care. 2018 Jan-Mar;14(1):44-72. doi: 10.1080/15524256.2018.1437588. Epub 2018 Feb 28.
- Eagle S, Creel A, Alexandrov A. The effect of facilitated peer support sessions on burnout and grief management among health care providers in pediatric intensive care units: a pilot study. J Palliat Med. 2012 Nov;15(11):1178-80. doi: 10.1089/jpm.2012.0231. Epub 2012 Aug 21.
- Colville GA, Smith JG, Brierley J, Citron K, Nguru NM, Shaunak PD, Tam O, Perkins-Porras L. Coping With Staff Burnout and Work-Related Posttraumatic Stress in Intensive Care. Pediatr Crit Care Med. 2017 Jul;18(7):e267-e273. doi: 10.1097/PCC.0000000000001179.
- Schmidt M, Haglund K. Debrief in Emergency Departments to Improve Compassion Fatigue and Promote Resiliency. J Trauma Nurs. 2017 Sep/Oct;24(5):317-322. doi: 10.1097/JTN.0000000000000315.
- Leff V, Klement A, Galanos A. A Successful Debrief Program for House Staff. J Soc Work End Life Palliat Care. 2017 Apr-Sep;13(2-3):87-90. doi: 10.1080/15524256.2017.1314234. Epub 2017 Apr 20.
- Klein SD, Bucher HU, Hendriks MJ, Baumann-Holzle R, Streuli JC, Berger TM, Fauchere JC, On Behalf Of The Swiss Neonatal End-Of-Life Study Group. Sources of distress for physicians and nurses working in Swiss neonatal intensive care units. Swiss Med Wkly. 2017 Aug 3;147:w14477. doi: 10.4414/smw.2017.14477. eCollection 2017.
- Ziegelstein RC. Creating Structured Opportunities for Social Engagement to Promote Well-Being and Avoid Burnout in Medical Students and Residents. Acad Med. 2018 Apr;93(4):537-539. doi: 10.1097/ACM.0000000000002117.
- Abrams MP. Improving Resident Well-Being and Burnout: The Role of Peer Support. J Grad Med Educ. 2017 Apr;9(2):264. doi: 10.4300/JGME-D-16-00805.1. No abstract available.
- Miles L, Corr CA. Death Cafe. Omega (Westport). 2017 Jun;75(2):151-165. doi: 10.1177/0030222815612602. Epub 2015 Oct 29.
- Nelson KE, Wright R, Abshire M, Davidson PM. All Things Death and Dying: Health Professional Students Participating in the Death Cafe Model. J Palliat Med. 2018 Jun;21(6):850-852. doi: 10.1089/jpm.2017.0440. Epub 2018 Feb 2.
- Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of Burnout Among Physicians: A Systematic Review. JAMA. 2018 Sep 18;320(11):1131-1150. doi: 10.1001/jama.2018.12777.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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