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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04347811
Other study ID # 2019-908
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date December 26, 2022

Study information

Verified date February 2023
Source Tulane University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date December 26, 2022
Est. primary completion date December 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Behavioral:
Death Cafe
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.

Locations

Country Name City State
United States Children's Hospital New Orleans New Orleans Louisiana
United States Ochsner Medical Center New Orleans Louisiana
United States Tulane Medical Center New Orleans Louisiana
United States University Medical Center New Orleans Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Tulane University School of Medicine Spirit of Charity Foundation - University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (52)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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Miles L, Corr CA. Death Cafe. Omega (Westport). 2017 Jun;75(2):151-165. doi: 10.1177/0030222815612602. Epub 2015 Oct 29. — View Citation

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. — View Citation

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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. — View Citation

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* Note: There are 52 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
Secondary 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. At the time of enrollment and at 1 month, 3 months, 6 months after enrollment
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