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

March 12, 2026 updated by: Elie Azoulay, Saint-Louis Hospital, Paris, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • European Society of Intensive Care medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • healthcare professionals working in intensive care.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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)
No Intervention: The usual arm (Controlled arm)
No intervention will be performed in the control groups which will behave as per their standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of healthcare professionals with high emotional exhaustion.
Time Frame: 1 Month after the intervention
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).
1 Month after the intervention
The number of healthcare professionals with high depersonalization.
Time Frame: 1 Month after the intervention
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).
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
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).
1 Month after the intervention
The perception of ethical climate at work
Time Frame: 1 Month after the intervention
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).
1 Month after the intervention
The perception of satisfaction at work
Time Frame: 1 Month after the intervention
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).
1 Month after the intervention
The perception of professional conflicts (visual analogue scale).
Time Frame: 1 Month after the intervention
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).
1 Month after the intervention
The intention to leave the ICU
Time Frame: 1 Month after the intervention
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).
1 Month after the intervention
The rating of patient centered care
Time Frame: 1 Month after the intervention
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).
1 Month after the intervention
The rating of family centered care
Time Frame: 1 Month after the intervention
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).
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
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).
1 Month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Louis Hospital, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

November 10, 2024

Study Completion (Actual)

December 18, 2024

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELLO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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