Evaluating the Effectiveness of the "Hello Bundle" Intervention in Reducing Burnout Among ICU Healthcare Professionals
NCT ID: NCT06453616
Last Updated: 2024-12-19
Study Results
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Basic Information
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COMPLETED
NA
7300 participants
INTERVENTIONAL
2024-10-14
2024-12-18
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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The Hello arm (Intervention arm)
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.
Hello bundle
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 usual arm (Controlled arm)
No intervention will be performed in the control groups which will behave as per their standard.
No interventions assigned to this group
Interventions
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Hello bundle
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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* healthcare professionals not working in intensive care.
18 Years
ALL
No
Sponsors
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European Society of Intensive Care Medicine
OTHER
Responsible Party
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Locations
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European Society of Intensive Care medicine
Brussels, , Belgium
Countries
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References
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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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HELLO
Identifier Type: -
Identifier Source: org_study_id