ClinicalTrials.gg
RecruitingNCT07069010BURNOUT-EPICUpdated Oct 7, 2026

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

An observational study in Burnout Syndrome, sponsored by University of Athens. Recruiting at 1 site in Greece. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by University of Athens · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Updated Oct 7, 2026Study documents postedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
100
Sex
All
01

Study 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 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)
02

Conditions studied

  • Burnout Syndrome

Keywords

  • ICU burnout
  • Moral distress
  • self compassion
  • Tele-palliative care
  • repeated measures survey
03

In context

Burnout, Psychological

467 studies on the registry are indexed under Burnout, Psychological; 121 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 117 observational studies indexed under Burnout, Psychological.

Browse Burnout, Psychological studies →

Lead sponsor

University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • ICU healthcare professionals
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

Secondary outcomes

  1. 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)

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

  3. 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.

    Time frame: 3 years

  4. 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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

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  • 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. PubMed 31609772 ↗
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Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Personal data protection

09

Updates

1 registry update since Sep 25, 2026
Documents
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Documents Study protocol ↗ posted
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07069010
Responsible party
Spyros D. Mentzelopoulos (Professor in Intensive Care Medicine, National and Kapodistrian University of Athens Medical School, University of Athens) — Principal investigator
First posted
Jul 16, 2025
Start date
Jul 15, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Spyros D Mentzelopoulos, Professor
Contact
sdmentzelopoulos@yahoo.com
+302132043308

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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