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Идёт набор NCT07069010

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

Наблюдательное Burnout Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Burnout Syndrome. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Burnout Syndrome Among Healthcare Professionals in Intensive Care Units Within the EPIC (Enhancing Palliative Care in ICU) Research

Обзор

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.

Подробное описание

One hundred ICU physicians, nurses and clinical psychologists drawn from the twenty-eight 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)

Первичные конечные точки

  • Change in clinician burnout by the Maslach Burnout Inventory (MBI) [Срок оценки: 3 years]
  • Change in clinician burnout by the Oldenburg Burnout Inventory (OLBI) [Срок оценки: 3 years]
Вторичные конечные точки (4)
  • ICU stressors and moral dilemmas frequency [Срок оценки: 3 years]
  • Maslach Burnout Inventory subscale scores [Срок оценки: 3 years]
  • Oldenburg Burnout Inventory subscale scores [Срок оценки: 3 years]
  • Self-Compassion Score -Short Form [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Греция · 1 центр
  • National and Kapodistrian University of Athens — Athens

Публикации

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT07069010 · 247-24/4/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗