Prevalence of Burn-out Among Intensive Care ProfessionalsHELLONCT06453616
Evaluating the Effectiveness of the "Hello Bundle" Intervention in Reducing Burnout Among ICU Healthcare Professionals
A study testing Hello bundle in people with Prevalence of Burn-out Among Intensive Care Professionals, run by Saint-Louis Hospital, Paris, France at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevalence of Burn-out Among Intensive Care Professionals
- What is being tested?
- Hello bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,300 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Oct 2024to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthcare professionals working in intensive care.
Who cannot join
- under 18 years of age healthcare professionals
- healthcare professionals not working in intensive care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Controlled Trial Evaluating the Effectiveness of the "Hello Bundle" Intervention in Reducing Burnout Among ICU Healthcare Professionals
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.
Read the detailed description
ESICM affiliates (those registered on the ESICM mailing list) will receive a message in May 2024 with an invitation to take part in the cluster randomized trial. Two reminders will be sent until June 2024.
In each participating ICU, a dyad of investigators (physician and a nurse) will complete the ICU questionnaire (hospital size and ICU type, university affiliated, specialized ICU) and collect the willingness of each HCP to participate in the study. Participation rate will need to be >50% to be eligible for the trial. For those who are eligible, email addresses of HCPs will be required to be able to encourage them to implement the intervention. Online consent will be obtained from all participants to take part in the study and to use the data collected in the questionnaires. HCP characteristics, including age, sex, experience, and working conditions, will be collected. The dyad of investigators in each ICU will also set up a designated "Hello Board" every day with a date where staff members can write short greetings or positive messages to each other using markers or sticky notes. This can serve as a visual reminder to greet each other and foster a sense of camaraderie among team members.
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), which includes three subscales: emotional exhaustion (9 items), depersonalization (5 items), and personal accomplishment (8 items). Each item is scored from 0 (never) to 6 (every day). Respondents with high emotional exhaustion (≥27) and/or high depersonalization (≥10) scores will be considered to have symptoms of burnout.
Visual analogue scales (VAS) are used to assess the intensity of unidimensional measures. Two anchors are provided: for 0 (no symptom/lowest rating) and 10 (the most intense symptom/highest rating). VASs are convenient, easy, and rapid to administer and have been proved reliable for measuring a characteristic, subjective phenomenon, or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
It is proposed to have a cluster randomized controlled trial with 146 participating centers, randomly assigned to intervention and control groups. All centers will be affiliated with ESICM, and data will be collected from HCP without involving any patient data. The primary endpoint is the prevalence of burnout measured by the Maslach Burnout Inventory (MBI) scale, between intervention and control groups with secondary endpoints including the comparison of burn-out prevalence before and after the intervention, HCP, satisfaction with work, HCP's intent to leave the ICU, and ethical climate rank and the importance of family and patient-centered care.
Statistical Analysis Quantitative variables will be described as median (interquartile range [IQR]) and will be compared between groups using the non-parametric Wilcoxon rank-sum test. Qualitative variables will be described as frequency (percentages) and will be compared between groups using Fisher's exact test.
Primary endpoint will be prevalence of burn out as defined by a high emotional exhaustion (score, ≥27) and/or high depersonalization (score, ≥10). Secondary endpoint will include individual components of the Maslach Burn Out Inventory and VAS, as well as HCP's intent to leave the ICU and ethical climate.
Primary and secondary analyses will be performed at an individual level adjusting for clustering. No imputation will be performed for missing variables.
Subgroup analyses will be conducted to explore potential moderators of intervention effectiveness.
Statistical analyses will be performed with R statistical software, version 3.4.3 (available online at http://www.r-project.org/) and packages 'lme4',and 'lmerTest'. A p value <0.05 will be considered significant.
Sample size:
Assuming an intra-class correlation of 0.3, 146 centers and 50 respondents per center, the study would allow to demonstrate a reduction in burnout prevalence from 40% to 30% with a statistical power of 90%.
How to get 200 centers, each including 50 healthcare providers? The steering committee includes 20 persons, each inviting 4 centers = 80 ESICM executive committee and council include 30 more people, each inciting 2 ICUs: 60 Note that immediately upon acceptance, centers complete the ICU characteristics form to be published anywhere to foster the group feeling.
The "Hello Bundle" intervention will be implemented in intervention group centers over a period of 30 days. The Hello board that is updated every day and regular communication will ensure adherence to the intervention components, and centers will receive support as needed to facilitate implementation. Training sessions and educational materials will be provided to ensure staff understanding and engagement with the intervention.
To allow control centers benefit from the intervention and avoid frustration, the intervention will be made possible (but optional) in the control centers 90 days after the end of the trial, and will not be followed by other measurements.
The intervention closed in the intervention groups on November 10, 2024. The collection of the post-intervention burn-out questionnaires has started and it is set to close on 20 December 2024.
- Being tested
- Hello bundle
- Keywords
- Burn-out, Healthcare professionals, Job leave intent, Ethical climate, Intensive care medicine
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hello bundleBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (10)
The number of healthcare professionals with high emotional exhaustion.
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The number of healthcare professionals with high depersonalization.
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The median score of the "loss of accomplishment at work" domain of the Maslach Burnout inventory.
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The perception of ethical climate at work
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The perception of satisfaction at work
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The perception of professional conflicts (visual analogue scale).
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The intention to leave the ICU
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The rating of patient centered care
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The rating of family centered care
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
The proportion of burnout before and after the intervention (in the intervention cluster)
When specified, the outcome will be measured using Visual Analogue Scales that assess the intensity of unidimensional measures. Two anchors are provided and respondents provide an answer that ranges between zero (minimal symptoms/negative experience) to ten (maximum symptoms/positive experience).
Measured: 1 Month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start14 Oct 2024
- Primary completion10 Nov 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Prevalence of Burn-out Among Intensive Care ProfessionalsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Louis Hospital, Paris, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elie Azoulay, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453616
- Sponsor's protocol ID
- HELLO
- Acronym
- HELLO
- Status last verified
- Mar 2026
- First submitted
- 18 May 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32259193Shanafelt 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.
PubMed 22911330Azoulay 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.
PubMed 32770449Azoulay 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.
PubMed 22086984Aiken 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.
PubMed 12387650Dres 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.
PubMed 36976563Azoulay 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.
PubMed 34023323Azoulay 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.
PubMed 38163380Dzau 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.
PubMed 29365296West 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.
PubMed 27692469Xu 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.
PubMed 32813371Quenot 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.
PubMed 22127481Bienvenu 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.
PubMed 27530295Andersen 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.
PubMed 33947518Atay 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.
PubMed 36303467
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial Evaluating the Effectiveness of the "Hello Bundle" Intervention in Reducing Burnout Among ICU Healthcare Professionals
- ClinicalTrials.gov ID
- NCT06453616
- Acronym / sponsor ID
- HELLO / HELLO
- Keywords
- Burn-out, Healthcare professionals, Job leave intent, Ethical climate, Intensive care medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,300 participants (actual)
- Lead sponsor
- Saint-Louis Hospital, Paris, FranceUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 11 Jun 2024 (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.
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.
Detailed description
ESICM affiliates (those registered on the ESICM mailing list) will receive a message in May 2024 with an invitation to take part in the cluster randomized trial. Two reminders will be sent until June 2024.
In each participating ICU, a dyad of investigators (physician and a nurse) will complete the ICU questionnaire (hospital size and ICU type, university affiliated, specialized ICU) and collect the willingness of each HCP to participate in the study. Participation rate will need to be >50% to be eligible for the trial. For those who are eligible, email addresses of HCPs will be required to be able to encourage them to implement the intervention. Online consent will be obtained from all participants to take part in the study and to use the data collected in the questionnaires. HCP characteristics, including age, sex, experience, and working conditions, will be collected. The dyad of investigators in each ICU will also set up a designated "Hello Board" every day with a date where staff members can write short greetings or positive messages to each other using markers or sticky notes. This can serve as a visual reminder to greet each other and foster a sense of camaraderie among team members.
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), which includes three subscales: emotional exhaustion (9 items), depersonalization (5 items), and personal accomplishment (8 items). Each item is scored from 0 (never) to 6 (every day). Respondents with high emotional exhaustion (≥27) and/or high depersonalization (≥10) scores will be considered to have symptoms of burnout.
Visual analogue scales (VAS) are used to assess the intensity of unidimensional measures. Two anchors are provided: for 0 (no symptom/lowest rating) and 10 (the most intense symptom/highest rating). VASs are convenient, easy, and rapid to administer and have been proved reliable for measuring a characteristic, subjective phenomenon, or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
It is proposed to have a cluster randomized controlled trial with 146 participating centers, randomly assigned to intervention and control groups. All centers will be affiliated with ESICM, and data will be collected from HCP without involving any patient data. The primary endpoint is the prevalence of burnout measured by the Maslach Burnout Inventory (MBI) scale, between intervention and control groups with secondary endpoints including the comparison of burn-out prevalence before and after the intervention, HCP, satisfaction with work, HCP's intent to leave the ICU, and ethical climate rank and the importance of family and patient-centered care.
Statistical Analysis Quantitative variables will be described as median (interquartile range [IQR]) and will be compared between groups using the non-parametric Wilcoxon rank-sum test. Qualitative variables will be described as frequency (percentages) and will be compared between groups using Fisher's exact test.
Primary endpoint will be prevalence of burn out as defined by a high emotional exhaustion (score, ≥27) and/or high depersonalization (score, ≥10). Secondary endpoint will include individual components of the Maslach Burn Out Inventory and VAS, as well as HCP's intent to leave the ICU and ethical climate.
Primary and secondary analyses will be performed at an individual level adjusting for clustering. No imputation will be performed for missing variables.
Subgroup analyses will be conducted to explore potential moderators of intervention effectiveness.
Statistical analyses will be performed with R statistical software, version 3.4.3 (available online at http://www.r-project.org/) and packages 'lme4',and 'lmerTest'. A p value <0.05 will be considered significant.
Sample size:
Assuming an intra-class correlation of 0.3, 146 centers and 50 respondents per center, the study would allow to demonstrate a reduction in burnout prevalence from 40% to 30% with a statistical power of 90%.
How to get 200 centers, each including 50 healthcare providers? The steering committee includes 20 persons, each inviting 4 centers = 80 ESICM executive committee and council include 30 more people, each inciting 2 ICUs: 60 Note that immediately upon acceptance, centers complete the ICU characteristics form to be published anywhere to foster the group feeling.
The "Hello Bundle" intervention will be implemented in intervention group centers over a period of 30 days. The Hello board that is updated every day and regular communication will ensure adherence to the intervention components, and centers will receive support as needed to facilitate implementation. Training sessions and educational materials will be provided to ensure staff understanding and engagement with the intervention.
To allow control centers benefit from the intervention and avoid frustration, the intervention will be made possible (but optional) in the control centers 90 days after the end of the trial, and will not be followed by other measurements.
The intervention closed in the intervention groups on November 10, 2024. The collection of the post-intervention burn-out questionnaires has started and it is set to close on 20 December 2024.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| The Hello arm (Intervention arm) | Experimental | Behavioral: Hello bundleThe 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. |
| The usual arm (Controlled arm) | No intervention | –No intervention will be performed in the control groups which will behave as per their standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthcare professionals working in intensive care.
Key exclusion criteria (2 listed)
- under 18 years of age healthcare professionals
- healthcare professionals not working in intensive care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hello bundleHello 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) | Behavioural | The Hello arm (Intervention arm) |
Primary outcome
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
Time frame: 1 month
Primary endpoint will be prevalence of burn out as defined by a high emotional exhaustion (score, ≥27) and/or high depersonalization (score, ≥10).
10 secondary outcomes
The number of healthcare professionals with high emotional exhaustion.
Time frame: 1 Month after the intervention
The number of healthcare professionals with high depersonalization.
Time frame: 1 Month after the intervention
The median score of the "loss of accomplishment at work" domain of the Maslach Burnout inventory.
Time frame: 1 Month after the intervention
The perception of ethical climate at work
Time frame: 1 Month after the intervention
The perception of satisfaction at work
Time frame: 1 Month after the intervention
The perception of professional conflicts (visual analogue scale).
Time frame: 1 Month after the intervention
The intention to leave the ICU
Time frame: 1 Month after the intervention
The rating of patient centered care
Time frame: 1 Month after the intervention
The rating of family centered care
Time frame: 1 Month after the intervention
The proportion of burnout before and after the intervention (in the intervention cluster)
Time frame: 1 Month after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 32259193Shanafelt 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.
- Results publication: PubMed 22911330Shanafelt 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.
- Results publication: PubMed 32770449Azoulay 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.
- Results publication: PubMed 22086984Azoulay 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.
- Results publication: PubMed 12387650Aiken 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.
- Results publication: PubMed 36976563Dres 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.
- Results publication: PubMed 34023323Azoulay 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.
- Results publication: PubMed 38163380Azoulay 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.
- Results publication: PubMed 29365296Dzau 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.
- Results publication: PubMed 27692469West 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.
- Results publication: PubMed 32813371Xu 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.
- Results publication: PubMed 22127481Quenot 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.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hello bundle in people with Prevalence of Burn-out Among Intensive Care Professionals, run by Saint-Louis Hospital, Paris, France at 1 site in Belgium.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 16 Mar 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 month). 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 NCT06453616, which also lists 21 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 16 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.