Evaluating the Effectiveness of the "Hello Bundle" Intervention in Reducing Burnout Among ICU Healthcare Professionals

NCT06453616 | Completed

• 1 other identifier: HELLO
• Study Type: interventional
• Target: 7,300
• Locations: 1 country
• Sites: 1

Brief Summary

Burnout among healthcare professionals in intensive care units (ICUs) is a prevalent concern with significant implications for both staff well-being and patient care outcomes. This protocol outlines a cluster randomized controlled trial designed to evaluate the effectiveness of the "Hello Bundle" intervention in reducing burnout among ICU healthcare professionals. The intervention comprises of various components aimed at fostering a positive and supportive work environment, including the distribution of Hello Campaign Posters, Email Reminders, Morning Huddles, Hello Jars, and Lead by Example initiatives. A hello board updated daily will be made available in each ICU. The trial will involve 146 participating centers affiliated with the ESICM, randomly assigned to intervention and control groups. Each center will have to include at least 50 HCP. Data will be collected from healthcare professionals at baseline, during the intervention period, and at follow-up, focusing on the prevalence of burnout, satisfaction with care, professional's intent to leave the ICU, and perceptions of the ethical climate. Statistical analysis will compare outcomes between intervention and control groups, aiming to demonstrate a reduction in the prevalence of burnout from 40% to 30% with an intra-class coefficient of 0.3 and a statistical power of 90%. This trial holds the potential to provide valuable insights into effective strategies for addressing burnout in ICU settings, ultimately benefiting both staff and patients.

Conditions

Prevalence of Burn-out Among Intensive Care Professionals

Keywords

Burn-out; Healthcare professionals; Job leave intent; Ethical climate; Intensive care medicine

Outcome Measures

Primary Outcomes (1)

• The number of healthcare professionals with symptoms of burnout as defined by a high emotional exhaustion and/or a high depersonalization in the Maslach Burnout inventory

  Primary endpoint will be prevalence of burn out as defined by a high emotional exhaustion (score, ≥27) and/or high depersonalization (score, ≥10).

  1 month

Secondary Outcomes (10)

• The number of healthcare professionals with high emotional exhaustion.

  1 Month after the intervention

• The number of healthcare professionals with high depersonalization.

  1 Month after the intervention

• The median score of the "loss of accomplishment at work" domain of the Maslach Burnout inventory.

  1 Month after the intervention

• The perception of ethical climate at work

  1 Month after the intervention

• The perception of satisfaction at work

  1 Month after the intervention

Study Arms (2)

The Hello arm (Intervention arm)

EXPERIMENTAL

The intervention arms will receive the Hello Bundle (posters, email reminders, morning huddles, hello jar, hello board and a led example). The bundle includes six components: displaying Hello posters all over the ICU, email reminders every week to study investigators (4 times for the 4 week study period), inciting Hello during morning huddles, lead by example by ICU heads, Hello Jar to insert messages emphasizing well being at work and posters to allow HCP write hello messages.

Behavioral: Hello bundle

The usual arm (Controlled arm)

NO INTERVENTION

No intervention will be performed in the control groups which will behave as per their standard.

Interventions

Hello bundle BEHAVIORAL

Hello Bundle comprises : posters, email reminders, morning huddles, hello jar, hello board and a led example. Participants will have to fill out a questionnaire before and after the intervention. The main components of the questionnaire include respondent's characteristics, visitation policies, team-family interactions, family-centeredness (VAS), and practices at the end of life. ICU-conflicts (VAS), symptoms of burnout, and a VAS to rank the ethical climate, satisfaction with work, and intent to leave the job. Symptoms of burnout will be measured using the validated version of the 22-item Maslach Burnout Inventory (MBI, Human Services version)

The Hello arm (Intervention arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthcare professionals working in intensive care.

You may not qualify if:

• under 18 years of age healthcare professionals
• healthcare professionals not working in intensive care.

Sponsors & Collaborators

• Saint-Louis Hospital, Paris, France: lead

Study Sites (1)

European Society of Intensive Care medicine

Brussels, Belgium

Location

Related Publications (20)

• Shanafelt T, Ripp J, Trockel M. Understanding and Addressing Sources of Anxiety Among Health Care Professionals During the COVID-19 Pandemic. JAMA. 2020 Jun 2;323(21):2133-2134. doi: 10.1001/jama.2020.5893. No abstract available.

  PMID: 32259193 RESULT

• Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.

  PMID: 22911330 RESULT

• Azoulay E, De Waele J, Ferrer R, Staudinger T, Borkowska M, Povoa P, Iliopoulou K, Artigas A, Schaller SJ, Hari MS, Pellegrini M, Darmon M, Kesecioglu J, Cecconi M; ESICM. Symptoms of burnout in intensive care unit specialists facing the COVID-19 outbreak. Ann Intensive Care. 2020 Aug 8;10(1):110. doi: 10.1186/s13613-020-00722-3.

  PMID: 32770449 RESULT

• Azoulay E, Herridge M. Understanding ICU staff burnout: the show must go on. Am J Respir Crit Care Med. 2011 Nov 15;184(10):1099-100. doi: 10.1164/rccm.201109-1638ED. No abstract available.

  PMID: 22086984 RESULT

• Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002 Oct 23-30;288(16):1987-93. doi: 10.1001/jama.288.16.1987.

  PMID: 12387650 RESULT

• Dres M, Copin MC, Cariou A, Mathonnet M, Gaillard R, Shanafelt T, Riou B, Darmon M, Azoulay E. Job Strain, Burnout, and Suicidal Ideation in Tenured University Hospital Faculty Staff in France in 2021. JAMA Netw Open. 2023 Mar 1;6(3):e233652. doi: 10.1001/jamanetworkopen.2023.3652.

  PMID: 36976563 RESULT

• Azoulay E, Pochard F, Reignier J, Argaud L, Bruneel F, Courbon P, Cariou A, Klouche K, Labbe V, Barbier F, Guitton C, Demoule A, Kouatchet A, Guisset O, Jourdain M, Papazian L, Van Der Meersch G, Reuter D, Souppart V, Resche-Rigon M, Darmon M, Kentish-Barnes N; FAMIREA Study Group. Symptoms of Mental Health Disorders in Critical Care Physicians Facing the Second COVID-19 Wave: A Cross-Sectional Study. Chest. 2021 Sep;160(3):944-955. doi: 10.1016/j.chest.2021.05.023. Epub 2021 May 21.

  PMID: 34023323 RESULT

• Azoulay E, Pochard F, Argaud L, Cariou A, Clere-Jehl R, Guisset O, Labbe V, Tamion F, Bruneel F, Jourdain M, Reuter D, Klouche K, Kouatchet A, Souppart V, Lautrette A, Bohe J, Vieillard Baron A, Dellamonica J, Papazian L, Reignier J, Barbier F, Dumas G, Kentish-Barnes N. Resilience and Mental-Health Symptoms in ICU Healthcare Professionals Facing Repeated COVID-19 Waves. Am J Respir Crit Care Med. 2024 Mar 1;209(5):573-583. doi: 10.1164/rccm.202305-0806OC.

  PMID: 38163380 RESULT

• Dzau VJ, Kirch DG, Nasca TJ. To Care Is Human - Collectively Confronting the Clinician-Burnout Crisis. N Engl J Med. 2018 Jan 25;378(4):312-314. doi: 10.1056/NEJMp1715127. No abstract available.

  PMID: 29365296 RESULT

• West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.

  PMID: 27692469 RESULT

• Xu HG, Kynoch K, Tuckett A, Eley R. Effectiveness of interventions to reduce emergency department staff occupational stress and/or burnout: a systematic review. JBI Evid Synth. 2020 Jun;18(6):1156-1188. doi: 10.11124/JBISRIR-D-19-00252.

  PMID: 32813371 RESULT

• Quenot JP, Rigaud JP, Prin S, Barbar S, Pavon A, Hamet M, Jacquiot N, Blettery B, Herve C, Charles PE, Moutel G. Suffering among carers working in critical care can be reduced by an intensive communication strategy on end-of-life practices. Intensive Care Med. 2012 Jan;38(1):55-61. doi: 10.1007/s00134-011-2413-z. Epub 2011 Nov 30.

  PMID: 22127481 RESULT

• Bienvenu OJ. Is this critical care clinician burned out? Intensive Care Med. 2016 Nov;42(11):1794-1796. doi: 10.1007/s00134-016-4497-y. Epub 2016 Aug 16. No abstract available.

  PMID: 27530295 RESULT

• Andersen S, Mintz-Binder R, Sweatt L, Song H. Building nurse resilience in the workplace. Appl Nurs Res. 2021 Jun;59:151433. doi: 10.1016/j.apnr.2021.151433. Epub 2021 Apr 14.

  PMID: 33947518 RESULT

• Atay N, Sahin-Bayindir G, Buzlu S, Koc K, Kuyuldar Y. The relationship between posttraumatic growth and psychological resilience of nurses working at the pandemic clinics. Int J Nurs Knowl. 2023 Jul;34(3):226-235. doi: 10.1111/2047-3095.12397. Epub 2022 Oct 27.

  PMID: 36303467 RESULT

• Sadeghi Avval Shahr H, Yazdani S, Afshar L. Professional socialization: an analytical definition. J Med Ethics Hist Med. 2019 Dec 7;12:17. doi: 10.18502/jmehm.v12i17.2016. eCollection 2019.

  PMID: 32328230 RESULT

• McAleer P, Todorov A, Belin P. How do you say 'hello'? Personality impressions from brief novel voices. PLoS One. 2014 Mar 12;9(3):e90779. doi: 10.1371/journal.pone.0090779. eCollection 2014.

  PMID: 24622283 RESULT

• Barth A, Cecconi M, Boulanger C, Azoulay E, Barnes NK. "It changed the atmosphere, but how long will it last?": healthcare professionals' experiences of an intervention to improve positive communication in intensive care. Ann Intensive Care. 2026 Mar 19;16:100047. doi: 10.1016/j.aicoj.2026.100047. eCollection 2026.

  PMID: 41890437 DERIVED

• Azoulay E, Myatra SN, Heras La Calle G, Jaber S, Boulanger C, Demirkyran O, Theodorakopoulou M, Paiva JA, Arabi YM, Burghi G, van Heerden PV, Al Fares A, Kentish-Barnes N, Martin-Delgado MC, Mistraletti G, Francois G, Barth A, De Waele J, Shanafelt TD, Darmon M, Cecconi M; European Society of Intensive Care Medicine. Positive communication for decreasing burnout in intensive-care-unit staff: a cluster-randomized trial. Intensive Care Med. 2025 Nov;51(11):2031-2041. doi: 10.1007/s00134-025-08134-2. Epub 2025 Oct 30.

  PMID: 41165789 DERIVED

• Azoulay E, Barnes NK, Myatra SN, Delgado MM, Arabi Y, Boulanger C, Mistraletti G, Theodorakopoulou M, Van Heerden V, Paiva JA, Demirkyran O, La Calle GH, Al Fares A, Burghi G, Francois G, Barth A, De Waele J, Jaber S, Darmon M, Cecconi M. HELLO: a protocol for a cluster randomized controlled trial to enhance interpersonal relationships and team cohesion among ICU healthcare professionals. Intensive Care Med Exp. 2024 Oct 7;12(1):90. doi: 10.1186/s40635-024-00677-w.

  PMID: 39373831 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The methodologists will be blind of the study group and not aware on whether group A and B are control or intervention groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Saint-Louis Hospital

Model Details: cluster randomized controlled trial

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 11, 2024
• Study Start: October 14, 2024
• Primary Completion: November 10, 2024
• Study Completion: December 18, 2024
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)