CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7,300 enrolled
Drug / intervention
Hello bundlebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06453616
NCT06453616N/ACompleted

Cluster Randomized Controlled Trial Evaluating the Effectiveness of the "Hello Bundle" Intervention in Reducing Burnout Among ICU Healthcare Professionals

Saint-Louis Hospital, Paris, France·interventional·Posted Jun 11, 2024·Updated Mar 16, 2026

In Brief

A clinical study evaluating Hello bundle for Prevalence of Burn-out Among Intensive Care Professionals. Completed, enrolled 7,300 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedJun 11, 2024
Enrollment StartOct 14, 2024
Primary CompletionNov 10, 2024
Study CompletionDec 18, 2024
TodayJul 2, 2026
Enrollment to primary: 26 daysPosted 2.1 years ago

Interventions

Hello bundlebehavioral

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)