Burnout SyndromeBURNOUT-EPICNCT07069010
Burnout Syndrome in the Intensive Care Unit Before and During a Palliative Care Trial
An observational study of Burnout Syndrome, run by University of Athens at 1 site in Greece.
Trial summary
One hundred ICU doctors, nurses and psychologists from 4 / 8 ICUs of the Greek group of the 28 European 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burnout Syndrome
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jul 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
National and Kapodistrian University of Athens
Athens
Spyros D Mentzelopoulos, Professor, 2132043308 ext. +30, sdmentzelopoulos@yahoo.com
Erietta - Christina Arnaoutaki, Psychologist, echarnaoutaki@gmail.com
About this study
Official title: Evaluation of Burnout Syndrome Among Healthcare Professionals in Intensive Care Units Within the EPIC (Enhancing Palliative Care in ICU) Research
One hundred ICU doctors, nurses and psychologists from 4 / 8 ICUs of the Greek group of the 28 European 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.
Read the detailed description
One hundred ICU physicians, nurses and clinical psychologists drawn from 4 / 8 ICUs of the Greek group of the 28 European adult units enrolled in the EPIC stepped-wedge trial (ClinicalTrials.gov NCT06605079) will each complete an identical four-part survey twice-once during their unit's usual-care phase and again after crossover into the EPIC tele-palliative-care intervention. Administered in two stages (Parts A and B via secure email link; Parts C and D during a facilitated online session), the entire battery requires about forty minutes per administration and produces detailed profiles of clinician demographics, workplace stressors, core burnout dimensions and self-compassion. Within-subject repeated-measures analyses will then quantify how the combination of blended-learning palliative-care modules and standardized teleconsultations influences individual well-being over time.
Part A consists of fifteen fixed-response items capturing demographic and professional background. Respondents select from categorical options for gender (male/female), age bracket, family status and number of children, as well as highest educational attainment (secondary, vocational, undergraduate, postgraduate, PhD) and whether they have previously received palliative-care or ethics training (yes/no). Work-related variables include role (doctor, nurse, psychologist), years of ICU experience (0-10, 10-20, 20-30, >30), average evening hours per month (<3, 3-5, >5), typical nightly sleep duration (<5 hours, 5-7 hours, >7 hours) and annual leave days (<15, 15-30, >30). Participants also indicate the type of unit in which they work (mixed/multi-purpose, surgical, cardiology or other). These objective data provide essential covariates for exploring whether baseline characteristics moderate the EPIC intervention's effects on burnout and self-compassion trajectories.
Part B probes the frequency of twenty-two common ICU stressors and ethical dilemmas using a five-point Likert frequency scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always). Questions address emotional distance from colleagues, resource constraints that force care adjustments, pressure from patient families, internal moral conflict between life-support and quality-of-life decisions, perceived control over treatment choices, work-life balance and opportunities for professional development. For example, clinicians rate how often they must limit treatments due to limited resources, experience doubts about ethical issues in prognostic decision-making or feel that their performance does not reflect their skills. By capturing both external pressures and internal moral distress, Part B establishes a baseline against which EPIC's specialist palliative consultations can be assessed for stress-reduction efficacy.
Part C combines two respected burnout instruments. The first is a nineteen-item subset of the Maslach Burnout Inventory (MBI), administered on a seven-point frequency scale (1 = Never, 2 = A few times a year, 3 = Once a month, 4 = A few times a month, 5 = Once a week, 6 = A few times a week, 7 = Every day). Items form three subscales-emotional exhaustion (for instance, "I feel emotionally drained by my work"), depersonalization ("I treat some patients as if they were objects") and personal accomplishment ("I feel I have achieved many worthwhile things in this job"). Previous ICU studies consistently report Cronbach's alpha of approximately 0.90 for the MBI total and its subscales, indicating excellent internal consistency. The second is a sixteen-item subset of the Oldenburg Burnout Inventory (OLBI), using a four-point agreement scale (1 = Strongly agree, 2 = Probably agree, 3 = Probably disagree, 4 = Strongly disagree). The OLBI yields two subscales-exhaustion ("After work I often feel worn out") and disengagement ("I feel indifferent toward my work"). Cronbach's alpha for the combined OLBI scale typically exceeds 0.80, with subscale values around 0.87 for exhaustion and 0.81 for disengagement. By utilizing both instruments, Part C captures affective depletion and cognitive withdrawal components of burnout, providing a comprehensive measurement of clinicians' occupational distress.
Part D employs the full sixteen-item Self-Compassion Scale developed by Neff, rated on a five-point frequency scale (1 = Almost never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Almost always). Items evaluate three positive dimensions-self-kindness, common humanity and mindfulness-and their negative counterparts-self-judgment, isolation and over-identification. Sample statements include "I try to be understanding toward those aspects of my personality I don't like" and "When I'm feeling down I tend to obsess on everything that's wrong." In Greek ICU populations, both the positive and negative subscales consistently achieve Cronbach's alpha near 0.86, confirming reliable assessment of clinicians' self-compassion levels. Because higher self-compassion has been shown to buffer against burnout, Part D provides critical insight into personal resilience factors that EPIC may enhance.
To maximize data integrity, Parts A and B are distributed seven days before the scheduled online session via encrypted email links, allowing clinicians to complete demographic and stressor items thoughtfully at their convenience. During a facilitator-led videoconference, respondents then complete Parts C and D in real time, with on-screen guidance to clarify any item interpretations. Electronic responses are pseudonymized and stored in a secure database meeting GDPR requirements. Ethical approval covers both survey administrations, and informed consent materials emphasize voluntary participation, the right to withdraw at any point and assurances that individual responses will remain confidential and not influence professional evaluations.
The primary analytical objective is to test within-subject changes in total and subscale scores for Part B stressors, Part C burnout dimensions and Part D self-compassion between the control and EPIC phases. Mixed-effects models-with clinician as a random intercept and fixed effects for time period, unit and relevant Part A covariates such as years of experience or prior palliative training-will assess whether the blended-learning modules and teleconsultations yield statistically significant reductions in emotional exhaustion, depersonalization and disengagement, alongside increases in self-compassion. Secondary analyses will explore moderation by baseline characteristics, clarifying which clinician subgroups derive the greatest benefit from EPIC. Effect sizes will be interpreted against established benchmarks for within-subject interventions, with special attention to medium-sized shifts in Cronbach's alpha-validated scales.
By integrating rich background profiles, a granular inventory of ICU stressors, complementary burnout measures and a validated self-compassion assessment-all framed within a robust repeated-measures design-this extended four-part survey promises nuanced insights into how telemedicine-enabled palliative-care integration can bolster resilience, reduce moral distress and foster sustainable clinician engagement in the high-pressure ICU environment.
Sample Size Determination A priori power analysis using a one-group, two-measurement repeated-measures ANOVA (within-subjects) indicated that, to detect a medium effect size (f = 0.25) on the primary outcome (within-subject change in composite burnout score) with α = 0.01, 95% power, a correlation of 0.5 between pre- and during-intervention scores, and perfect sphericity (ε = 1), 75 clinicians are required (denominator df = 74, λ = 18.75, critical F = 6.99). To allow for up to 25% attrition and support subgroup and moderator analyses, the target enrollment is set at 100 ICU clinicians.
Multivariable mixed-effects logistic regression will test the odds of a clinically meaningful burnout change-defined by 95% minimal detectable change thresholds (≥7-point reduction on the Maslach Burnout Inventory or ≥8-point reduction on the Oldenburg Burnout Inventory). The binary responder outcome (achieved vs. not achieved) will include a random intercept for ICU site to account for clustering.
Fixed-effect predictors (up to 10) will include:
- Age (years)
- Gender
- Profession (nurse, physician, other)
- Years of ICU experience
- Unit type (medical, surgical, mixed)
- Shift pattern (day, night, mixed)
- Baseline burnout score
- Baseline self-compassion score
- Prior palliative-care training (yes/no)
- EPIC trial phase (intervention vs. control)
- Conditions
- Burnout Syndrome
- Keywords
- ICU burnout, Moral distress, self compassion, Tele-palliative care, repeated measures survey
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU healthcare professionals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Secondary outcomes (4)
ICU stressors and moral dilemmas frequency
Percent change in total frequency score and in key clusters (resource constraints, family pressures, moral conflict, emotional distancing, control, work-life balance, professional development)
Measured: 3 years
Maslach Burnout Inventory subscale scores
Percent change in 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.
Measured: 3 years
Oldenburg Burnout Inventory subscale scores
Percent change in Exhaustion and Disengagement subscores between the usual care phase and the palliative care intervention phase. Exhaustion and Disengagement subscores subscores range within 0-32 and 0-32, respectively. Higher subscores of both subcomponents indicate worse burnout.
Measured: 3 years
Self-Compassion Score -Short Form
Percent change in the short form version of Neff's self-compassion score. The self compassion score ranges within 0-5, with higher values indicating higher self compassion.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Burnout SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyros D. Mentzelopoulos, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069010
- Sponsor's protocol ID
- 247-24/4/2024
- Acronym
- BURNOUT-EPIC
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data protection
Publications
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.
PubMed 29791247Weissman 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.
PubMed 21133809Martin-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.
PubMed 31784799Vallbracht 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.
PubMed 29437979Ubel 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.
PubMed 29111936Sundin EC, Horowitz MJ. Impact of Event Scale: psychometric properties. Br J Psychiatry. 2002 Mar;180:205-9. doi: 10.1192/bjp.180.3.205.
PubMed 11872511Mark 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.
PubMed 25904183Barbieri 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.
PubMed 31664426Song 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.
PubMed 36251955From the Editor-in-Chief. Postgrad Med. 1973 Jun;53(7):25. doi: 10.1080/00325481.1973.11713476. No abstract available.
PubMed 27392663Levinson 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.
PubMed 15987329Benetti 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.
PubMed 22418001Schwarzkopf 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.
PubMed 27776092Schroeder 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.
PubMed 30202383Schoenherr 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.
PubMed 32544647
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Burnout Syndrome Among Healthcare Professionals in Intensive Care Units Within the EPIC (Enhancing Palliative Care in ICU) Research
- ClinicalTrials.gov ID
- NCT07069010
- Acronym / sponsor ID
- BURNOUT-EPIC / 247-24/4/2024
- Conditions
- Burnout Syndrome
- Keywords
- ICU burnout, Moral distress, self compassion, Tele-palliative care, repeated measures survey
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One hundred ICU doctors, nurses and psychologists from 4 / 8 ICUs of the Greek group of the 28 European 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.
Detailed description
One hundred ICU physicians, nurses and clinical psychologists drawn from 4 / 8 ICUs of the Greek group of the 28 European adult units enrolled in the EPIC stepped-wedge trial (ClinicalTrials.gov NCT06605079) will each complete an identical four-part survey twice-once during their unit's usual-care phase and again after crossover into the EPIC tele-palliative-care intervention. Administered in two stages (Parts A and B via secure email link; Parts C and D during a facilitated online session), the entire battery requires about forty minutes per administration and produces detailed profiles of clinician demographics, workplace stressors, core burnout dimensions and self-compassion. Within-subject repeated-measures analyses will then quantify how the combination of blended-learning palliative-care modules and standardized teleconsultations influences individual well-being over time.
Part A consists of fifteen fixed-response items capturing demographic and professional background. Respondents select from categorical options for gender (male/female), age bracket, family status and number of children, as well as highest educational attainment (secondary, vocational, undergraduate, postgraduate, PhD) and whether they have previously received palliative-care or ethics training (yes/no). Work-related variables include role (doctor, nurse, psychologist), years of ICU experience (0-10, 10-20, 20-30, >30), average evening hours per month (<3, 3-5, >5), typical nightly sleep duration (<5 hours, 5-7 hours, >7 hours) and annual leave days (<15, 15-30, >30). Participants also indicate the type of unit in which they work (mixed/multi-purpose, surgical, cardiology or other). These objective data provide essential covariates for exploring whether baseline characteristics moderate the EPIC intervention's effects on burnout and self-compassion trajectories.
Part B probes the frequency of twenty-two common ICU stressors and ethical dilemmas using a five-point Likert frequency scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always). Questions address emotional distance from colleagues, resource constraints that force care adjustments, pressure from patient families, internal moral conflict between life-support and quality-of-life decisions, perceived control over treatment choices, work-life balance and opportunities for professional development. For example, clinicians rate how often they must limit treatments due to limited resources, experience doubts about ethical issues in prognostic decision-making or feel that their performance does not reflect their skills. By capturing both external pressures and internal moral distress, Part B establishes a baseline against which EPIC's specialist palliative consultations can be assessed for stress-reduction efficacy.
Part C combines two respected burnout instruments. The first is a nineteen-item subset of the Maslach Burnout Inventory (MBI), administered on a seven-point frequency scale (1 = Never, 2 = A few times a year, 3 = Once a month, 4 = A few times a month, 5 = Once a week, 6 = A few times a week, 7 = Every day). Items form three subscales-emotional exhaustion (for instance, "I feel emotionally drained by my work"), depersonalization ("I treat some patients as if they were objects") and personal accomplishment ("I feel I have achieved many worthwhile things in this job"). Previous ICU studies consistently report Cronbach's alpha of approximately 0.90 for the MBI total and its subscales, indicating excellent internal consistency. The second is a sixteen-item subset of the Oldenburg Burnout Inventory (OLBI), using a four-point agreement scale (1 = Strongly agree, 2 = Probably agree, 3 = Probably disagree, 4 = Strongly disagree). The OLBI yields two subscales-exhaustion ("After work I often feel worn out") and disengagement ("I feel indifferent toward my work"). Cronbach's alpha for the combined OLBI scale typically exceeds 0.80, with subscale values around 0.87 for exhaustion and 0.81 for disengagement. By utilizing both instruments, Part C captures affective depletion and cognitive withdrawal components of burnout, providing a comprehensive measurement of clinicians' occupational distress.
Part D employs the full sixteen-item Self-Compassion Scale developed by Neff, rated on a five-point frequency scale (1 = Almost never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Almost always). Items evaluate three positive dimensions-self-kindness, common humanity and mindfulness-and their negative counterparts-self-judgment, isolation and over-identification. Sample statements include "I try to be understanding toward those aspects of my personality I don't like" and "When I'm feeling down I tend to obsess on everything that's wrong." In Greek ICU populations, both the positive and negative subscales consistently achieve Cronbach's alpha near 0.86, confirming reliable assessment of clinicians' self-compassion levels. Because higher self-compassion has been shown to buffer against burnout, Part D provides critical insight into personal resilience factors that EPIC may enhance.
To maximize data integrity, Parts A and B are distributed seven days before the scheduled online session via encrypted email links, allowing clinicians to complete demographic and stressor items thoughtfully at their convenience. During a facilitator-led videoconference, respondents then complete Parts C and D in real time, with on-screen guidance to clarify any item interpretations. Electronic responses are pseudonymized and stored in a secure database meeting GDPR requirements. Ethical approval covers both survey administrations, and informed consent materials emphasize voluntary participation, the right to withdraw at any point and assurances that individual responses will remain confidential and not influence professional evaluations.
The primary analytical objective is to test within-subject changes in total and subscale scores for Part B stressors, Part C burnout dimensions and Part D self-compassion between the control and EPIC phases. Mixed-effects models-with clinician as a random intercept and fixed effects for time period, unit and relevant Part A covariates such as years of experience or prior palliative training-will assess whether the blended-learning modules and teleconsultations yield statistically significant reductions in emotional exhaustion, depersonalization and disengagement, alongside increases in self-compassion. Secondary analyses will explore moderation by baseline characteristics, clarifying which clinician subgroups derive the greatest benefit from EPIC. Effect sizes will be interpreted against established benchmarks for within-subject interventions, with special attention to medium-sized shifts in Cronbach's alpha-validated scales.
By integrating rich background profiles, a granular inventory of ICU stressors, complementary burnout measures and a validated self-compassion assessment-all framed within a robust repeated-measures design-this extended four-part survey promises nuanced insights into how telemedicine-enabled palliative-care integration can bolster resilience, reduce moral distress and foster sustainable clinician engagement in the high-pressure ICU environment.
Sample Size Determination A priori power analysis using a one-group, two-measurement repeated-measures ANOVA (within-subjects) indicated that, to detect a medium effect size (f = 0.25) on the primary outcome (within-subject change in composite burnout score) with α = 0.01, 95% power, a correlation of 0.5 between pre- and during-intervention scores, and perfect sphericity (ε = 1), 75 clinicians are required (denominator df = 74, λ = 18.75, critical F = 6.99). To allow for up to 25% attrition and support subgroup and moderator analyses, the target enrollment is set at 100 ICU clinicians.
Multivariable mixed-effects logistic regression will test the odds of a clinically meaningful burnout change-defined by 95% minimal detectable change thresholds (≥7-point reduction on the Maslach Burnout Inventory or ≥8-point reduction on the Oldenburg Burnout Inventory). The binary responder outcome (achieved vs. not achieved) will include a random intercept for ICU site to account for clustering.
Fixed-effect predictors (up to 10) will include:
- Age (years)
- Gender
- Profession (nurse, physician, other)
- Years of ICU experience
- Unit type (medical, surgical, mixed)
- Shift pattern (day, night, mixed)
- Baseline burnout score
- Baseline self-compassion score
- Prior palliative-care training (yes/no)
- EPIC trial phase (intervention vs. control)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU healthcare professionals | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in clinician burnout by the Maslach Burnout Inventory (MBI)
Time frame: 3 years
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.
Change in clinician burnout by the Oldenburg Burnout Inventory (OLBI)
Time frame: 3 years
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.
4 secondary outcomes
ICU stressors and moral dilemmas frequency
Time frame: 3 years
Maslach Burnout Inventory subscale scores
Time frame: 3 years
Oldenburg Burnout Inventory subscale scores
Time frame: 3 years
Self-Compassion Score -Short Form
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 29791247White 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.
- Background: PubMed 21133809Weissman 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.
- Background: PubMed 31784799Martin-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.
- Background: PubMed 29437979Vallbracht 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.
- Background: PubMed 29111936Ubel 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.
- Background: PubMed 11872511Sundin EC, Horowitz MJ. Impact of Event Scale: psychometric properties. Br J Psychiatry. 2002 Mar;180:205-9. doi: 10.1192/bjp.180.3.205.
- Background: PubMed 25904183Mark 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.
- Background: PubMed 31664426Barbieri 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.
- Background: PubMed 36251955Song 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.
- Background: PubMed 27392663From the Editor-in-Chief. Postgrad Med. 1973 Jun;53(7):25. doi: 10.1080/00325481.1973.11713476. No abstract available.
- Background: PubMed 15987329Levinson 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.
- Background: PubMed 22418001Benetti 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.
- Individual participant dataSharing planned: No. Personal data protection
Related trials for Burnout Syndrome
Recruiting
Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers
Psychiatric Disorder
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Recruiting
THE EFFECT OF EDUCATION IN PATIENTS WITH HYPERTENSION
Hypertension
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Enrolling by invitation
Physical and Psychosocial Outcomes of 16-Week Classroom-Based Morning Exercise Program
Healthy Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout Syndrome, run by University of Athens at 1 site in Greece.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Spyros D Mentzelopoulos, Professor (+302132043308, sdmentzelopoulos@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinician burnout by the Maslach Burnout Inventory (MBI) (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT07069010, which also lists 41 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 7 Oct 2026.