Burnout Syndrome in the Intensive Care Unit Before and During a Palliative Care Trial

NCT07069010 | Recruiting

• 1 other identifier: 247-24/4/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred ICU doctors, nurses and psychologists from the 28 units participating in the EPIC stepped-wedge trial (ClinicalTrials.gov NCT06605079) will each complete the same four-part survey twice-once during their unit's usual-care phase and again during the EPIC tele-palliative-care intervention. The questionnaire begins with Part A, gathering demographic and professional details such as age, gender, family status, education, role, years of ICU service, shift patterns, leave days and any prior palliative-care or ethics training. Part B then probes 22 workplace stressors and ethical dilemmas-resource constraints, family pressures, moral conflicts, emotional distancing from colleagues, perceived control over decisions and work-life balance-using a five-point frequency scale. Part C merges a 19-item Maslach Burnout Inventory subset (emotional exhaustion, depersonalization, personal accomplishment) on a seven-point frequency scale with a 16-item Oldenburg Burnout Inventory subset (exhaustion, disengagement) on a four-point agreement scale. Finally, Part D employs Neff's 16-item Self-Compassion Scale-rated from almost never to almost always-to assess self-kindness, common humanity, mindfulness, self-judgment, isolation and over-identification. Within-subject, repeated-measures analyses of total and subscale scores will quantify how EPIC's blended-learning curriculum and standardized teleconsultations shift clinician burnout profiles and self-compassion over time.

Conditions

Burnout Syndrome

Keywords

ICU burnout; Moral distress; self compassion; Tele-palliative care; repeated measures survey

Outcome Measures

Primary Outcomes (2)

• Change in clinician burnout by the Maslach Burnout Inventory (MBI)

  Within-subject average percent change in clinician burnout, defined as the average of percent changes in the Emotional Exhaustion, Depersonalization and Personal Accomplishment subscores between the usual care phase and the palliative care intervention phase. Emotional Exhaustion, Depersonalization and Personal Accomplishment subscores range within 0-54, 0-30 and 0-48, respectively. Higher subscores of the first two subcomponents and lower subscore of the third subcomponent indicate worse burnout.

  3 years

• Change in clinician burnout by the Oldenburg Burnout Inventory (OLBI)

  Within-subject average percent change in clinician burnout, defined as the average of percent changes in the Exhaustion and Disengagement subscores between the usual care phase and the palliative care intervention phase. Exhaustion and Disengagement subscores range within 0-32 and 0-32, respectively. Higher subscores of both subcomponents indicate worse burnout.

  3 years

Secondary Outcomes (4)

• ICU stressors and moral dilemmas frequency

  3 years

• Maslach Burnout Inventory subscale scores

  3 years

• Oldenburg Burnout Inventory subscale scores

  3 years

• Self-Compassion Score -Short Form

  3 years

Study Arms (1)

ICU healthcare professionals

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll \~100 multidisciplinary ICU clinicians-staff physicians, registered nurses and advanced practice providers-who have been continuously assigned to participating adult intensive care units for at least three months prior to study start. All participants will complete Greek-language pre- and during-intervention psychometric surveys and engage in the tele-palliative care educational intervention. Temporary or locum staff not continuously on the unit and those on leave during either survey period are excluded.

You may qualify if:

• ICU clinicians (nurses, physicians, advanced practice providers) actively caring for critically ill patients
• Employed in participating ICUs for ≥3 months prior to study start
• Willing to complete both pre- and during-intervention surveys
• Consent to participate in educational tele-palliative care trial

You may not qualify if:

• Locum tenens or temporary staff not continuously assigned to the unit
• Clinicians on leave (medical, parental, or extended leave) during either survey period
• Prior enrollment in similar palliative care training within past 6 months

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

National and Kapodistrian University of Athens

Athens, Greece

RECRUITING

Related Publications (41)

• White DB, Angus DC, Shields AM, Buddadhumaruk P, Pidro C, Paner C, Chaitin E, Chang CH, Pike F, Weissfeld L, Kahn JM, Darby JM, Kowinsky A, Martin S, Arnold RM; PARTNER Investigators. A Randomized Trial of a Family-Support Intervention in Intensive Care Units. N Engl J Med. 2018 Jun 21;378(25):2365-2375. doi: 10.1056/NEJMoa1802637. Epub 2018 May 23.

  PMID: 29791247 BACKGROUND

• Weissman DE, Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting: a consensus report from the Center to Advance Palliative Care. J Palliat Med. 2011 Jan;14(1):17-23. doi: 10.1089/jpm.2010.0347. Epub 2010 Dec 6.

  PMID: 21133809 BACKGROUND

• Martin-Loeches I, De Waele JJ, Timsit JF, Bassetti M. Conventional amphotericin B must be avoided in Candida infections. Intensive Care Med. 2020 Mar;46(3):560-561. doi: 10.1007/s00134-019-05784-x. Epub 2019 Nov 29. No abstract available.

  PMID: 31784799 BACKGROUND

• Vallbracht M, Rehwaldt S, Klupp BG, Mettenleiter TC, Fuchs W. Functional Role of N-Linked Glycosylation in Pseudorabies Virus Glycoprotein gH. J Virol. 2018 Apr 13;92(9):e00084-18. doi: 10.1128/JVI.00084-18. Print 2018 May 1.

  PMID: 29437979 BACKGROUND

• Ubel PA, Scherr KA, Fagerlin A. Empowerment Failure: How Shortcomings in Physician Communication Unwittingly Undermine Patient Autonomy. Am J Bioeth. 2017 Nov;17(11):31-39. doi: 10.1080/15265161.2017.1378753.

  PMID: 29111936 BACKGROUND

• Sundin EC, Horowitz MJ. Impact of Event Scale: psychometric properties. Br J Psychiatry. 2002 Mar;180:205-9. doi: 10.1192/bjp.180.3.205.

  PMID: 11872511 BACKGROUND

• Mark NM, Rayner SG, Lee NJ, Curtis JR. Global variability in withholding and withdrawal of life-sustaining treatment in the intensive care unit: a systematic review. Intensive Care Med. 2015 Sep;41(9):1572-85. doi: 10.1007/s00134-015-3810-5. Epub 2015 Apr 23.

  PMID: 25904183 BACKGROUND

• Barbieri JS, Frieden IJ, Nagler AR. Isotretinoin, Patient Safety, and Patient-Centered Care-Time to Reform iPLEDGE. JAMA Dermatol. 2020 Jan 1;156(1):21-22. doi: 10.1001/jamadermatol.2019.3270. No abstract available.

  PMID: 31664426 BACKGROUND

• Song X, Liu X, Dong R, Kummer KA, Wang C. Implementation of Tele-Intensive Care Unit Services During the COVID-19 Pandemic: A Systematic Literature Review and Updated Experience from Shandong Province. Telemed J E Health. 2023 May;29(5):646-656. doi: 10.1089/tmj.2022.0302. Epub 2022 Oct 11.

  PMID: 36251955 BACKGROUND

• From the Editor-in-Chief. Postgrad Med. 1973 Jun;53(7):25. doi: 10.1080/00325481.1973.11713476. No abstract available.

  PMID: 27392663 BACKGROUND

• Levinson W, Kao A, Kuby A, Thisted RA. Not all patients want to participate in decision making. A national study of public preferences. J Gen Intern Med. 2005 Jun;20(6):531-5. doi: 10.1111/j.1525-1497.2005.04101.x.

  PMID: 15987329 BACKGROUND

• Benetti F, Baldi E, Bucherelli C, Blandina P, Passani MB. Histaminergic ligands injected into the nucleus basalis magnocellularis differentially affect fear conditioning consolidation. Int J Neuropsychopharmacol. 2013 Apr;16(3):575-82. doi: 10.1017/S1461145712000181. Epub 2012 Mar 15.

  PMID: 22418001 BACKGROUND

• 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.

  PMID: 27776092 BACKGROUND

• Schroeder DA, Stephens E, Colgan D, Hunsinger M, Rubin D, Christopher MS. A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial. Am J Lifestyle Med. 2016 Feb 4;12(1):83-91. doi: 10.1177/1559827616629121. eCollection 2018 Jan-Feb.

  PMID: 30202383 BACKGROUND

• Schoenherr LA, Cook A, Peck S, Humphreys J, Goto Y, Saks NT, Huddleston L, Elia G, Pantilat SZ. Proactive Identification of Palliative Care Needs Among Patients With COVID-19 in the ICU. J Pain Symptom Manage. 2020 Sep;60(3):e17-e21. doi: 10.1016/j.jpainsymman.2020.06.008. Epub 2020 Jun 14.

  PMID: 32544647 BACKGROUND

• Scandrett KG, Reitschuler-Cross EB, Nelson L, Sanger JA, Feigon M, Boyd E, Chang CH, Paice JA, Hauser JM, Chamkin A, Balfour P, Stolbunov A, Bennett CL, Emanuel LL. Feasibility and effectiveness of the NEST13+ as a screening tool for advanced illness care needs. J Palliat Med. 2010 Feb;13(2):161-9. doi: 10.1089/jpm.2009.0170.

  PMID: 19821699 BACKGROUND

• Aiken LH, Sloane DM, Cimiotti JP, Clarke SP, Flynn L, Seago JA, Spetz J, Smith HL. Implications of the California nurse staffing mandate for other states. Health Serv Res. 2010 Aug;45(4):904-21. doi: 10.1111/j.1475-6773.2010.01114.x. Epub 2010 Apr 9.

  PMID: 20403061 BACKGROUND

• Raab K. Mindfulness, self-compassion, and empathy among health care professionals: a review of the literature. J Health Care Chaplain. 2014;20(3):95-108. doi: 10.1080/08854726.2014.913876.

  PMID: 24926896 BACKGROUND

• Gomez-Veiga F, Alcaraz-Asensio A, Burgos-Revilla J, Cozar-Olmo J. Developments in urologic oncology "OncoForum": The best of 2017. Actas Urol Esp (Engl Ed). 2018 Oct;42(8):488-498. doi: 10.1016/j.acuro.2018.06.001. Epub 2018 Jun 21. English, Spanish.

  PMID: 29935800 BACKGROUND

• Xue H, Ren C, Yang J, Sun Z, Li S, Jin Z, Shen K, Zhou W. Histogram analysis of apparent diffusion coefficient for the assessment of local aggressiveness of cervical cancer. Arch Gynecol Obstet. 2014 Aug;290(2):341-8. doi: 10.1007/s00404-014-3221-9. Epub 2014 Apr 1.

  PMID: 24687746 BACKGROUND

• Schoener CA, Hutson HN, Peppas NA. pH-responsive hydrogels with dispersed hydrophobic nanoparticles for the oral delivery of chemotherapeutics. J Biomed Mater Res A. 2013 Aug;101(8):2229-36. doi: 10.1002/jbm.a.34532. Epub 2012 Dec 28.

  PMID: 23281185 BACKGROUND

• Michalsen A, Neitzke G, Dutzmann J, Rogge A, Seidlein AH, Jobges S, Burchardi H, Hartog C, Nauck F, Salomon F, Duttge G, Michels G, Knochel K, Meier S, Gretenkort P, Janssens U. [Overtreatment in intensive care medicine-recognition, designation, and avoidance : Position paper of the Ethics Section of the DIVI and the Ethics section of the DGIIN]. Med Klin Intensivmed Notfmed. 2021 May;116(4):281-294. doi: 10.1007/s00063-021-00794-4. Epub 2021 Mar 1. German.

  PMID: 33646332 BACKGROUND

• Mentzelopoulos SD, Chen S, Nates JL, Kruser JM, Hartog C, Michalsen A, Efstathiou N, Joynt GM, Lobo S, Avidan A, Sprung CL; End-of-life Practice Score Study Group. Derivation and performance of an end-of-life practice score aimed at interpreting worldwide treatment-limiting decisions in the critically ill. Crit Care. 2022 Apr 13;26(1):106. doi: 10.1186/s13054-022-03971-9.

  PMID: 35418103 BACKGROUND

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

  PMID: 11148311 BACKGROUND

• Maslach C, Leiter MP. Understanding the burnout experience: recent research and its implications for psychiatry. World Psychiatry. 2016 Jun;15(2):103-11. doi: 10.1002/wps.20311.

  PMID: 27265691 BACKGROUND

• Perrochon A, Kemoun G. The Walking Trail-Making Test is an early detection tool for mild cognitive impairment. Clin Interv Aging. 2014;9:111-9. doi: 10.2147/CIA.S53645. Epub 2014 Jan 7.

  PMID: 24426778 BACKGROUND

• MacBeth A, Gumley A. Exploring compassion: a meta-analysis of the association between self-compassion and psychopathology. Clin Psychol Rev. 2012 Aug;32(6):545-52. doi: 10.1016/j.cpr.2012.06.003. Epub 2012 Jun 23.

  PMID: 22796446 BACKGROUND

• Ma J, Chi S, Buettner B, Pollard K, Muir M, Kolekar C, Al-Hammadi N, Chen L, Kollef M, Dans M. Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial. Crit Care Med. 2019 Dec;47(12):1707-1715. doi: 10.1097/CCM.0000000000004016.

  PMID: 31609772 BACKGROUND

• Oner A, Lips T, Walter U, Storch A, Ince H, Caglayan E, Yucel S, Ortak J, Schmidt C. Detection of arrhythmia using an implantable cardiac monitor following a cryptogenic stroke: a single-center observational study. Eur J Med Res. 2020 Jun 29;25(1):25. doi: 10.1186/s40001-020-00424-3.

  PMID: 32600384 BACKGROUND

• Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852.

  PMID: 25574794 BACKGROUND

• Jox RJ, Krebs M, Fegg M, Reiter-Theil S, Frey L, Eisenmenger W, Borasio GD. Limiting life-sustaining treatment in German intensive care units: a multiprofessional survey. J Crit Care. 2010 Sep;25(3):413-9. doi: 10.1016/j.jcrc.2009.06.012. Epub 2009 Aug 13.

  PMID: 19682847 BACKGROUND

• Filip X, Filip C. Can the conformation of flexible hydroxyl groups be constrained by simple NMR crystallography approaches? The case of the quercetin solid forms. Solid State Nucl Magn Reson. 2015 Feb;65:21-8. doi: 10.1016/j.ssnmr.2014.10.006. Epub 2014 Nov 4.

  PMID: 25465481 BACKGROUND

• Garcia AKA, Furuya RK, Conchon MF, Rossetto EG, Dantas RAS, Fonseca LF. Menthol chewing gum on preoperative thirst management: randomized clinical trial. Rev Lat Am Enfermagem. 2019 Oct 7;27:e3180. doi: 10.1590/1518-8345.3070.3180. eCollection 2019.

  PMID: 31596415 BACKGROUND

• Woo K, Hill R, LeBlanc K, Percival SL, Schultz G, Weir D, Swanson T, Mayer DO. Effect of a surfactant-based gel on patient quality of life. J Wound Care. 2018 Oct 2;27(10):664-678. doi: 10.12968/jowc.2018.27.10.664.

  PMID: 30332359 BACKGROUND

• Saha S, Bose R, Chakraborty S, Ain R. Tipping the balance toward stemness in trophoblast: Metabolic programming by Cox6B2. FASEB J. 2022 Nov;36(11):e22600. doi: 10.1096/fj.202200703RR.

  PMID: 36250984 BACKGROUND

• Demerouti E, Bakker AB, Nachreiner F, Schaufeli WB. A model of burnout and life satisfaction amongst nurses. J Adv Nurs. 2000 Aug;32(2):454-64. doi: 10.1046/j.1365-2648.2000.01496.x.

  PMID: 10964195 BACKGROUND

• Roe KL, Barbeau KA. Uptake mechanisms for inorganic iron and ferric citrate in Trichodesmium erythraeum IMS101. Metallomics. 2014 Nov;6(11):2042-51. doi: 10.1039/c4mt00026a.

  PMID: 25222699 BACKGROUND

• Clark D, Baur N, Clelland D, Garralda E, Lopez-Fidalgo J, Connor S, Centeno C. Mapping Levels of Palliative Care Development in 198 Countries: The Situation in 2017. J Pain Symptom Manage. 2020 Apr;59(4):794-807.e4. doi: 10.1016/j.jpainsymman.2019.11.009. Epub 2019 Nov 22.

  PMID: 31760142 BACKGROUND

• Epstein RL. Antitrust aspects of the future health planning. Issues Health Care. 1981;2(1):36-41. No abstract available.

  PMID: 10253126 BACKGROUND

• Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.

  PMID: 15090940 BACKGROUND

• Serafim Junior V, Fernandes GMM, Oliveira-Cucolo JG, Pavarino EC, Goloni-Bertollo EM. Role of Tropomyosin-related kinase B receptor and brain-derived neurotrophic factor in cancer. Cytokine. 2020 Dec;136:155270. doi: 10.1016/j.cyto.2020.155270. Epub 2020 Sep 7.

  PMID: 32911446 BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Spyros D Mentzelopoulos, Professor

CONTACT

+302132043308; sdmentzelopoulos@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Intensive Care Medicine, National and Kapodistrian University of Athens Medical School

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)