跳至主要内容
临床试验/CTRI/2025/04/084170
CTRI/2025/04/084170进行中(未招募)不适用

Protocol for a Cluster Randomized Controlled Trial Evaluating the Effectiveness of the Hello Bundle Intervention in Reducing Burnout among ICU Healthcare Professionals.

Elie Azoulay1 个研究点 分布在 1 个国家目标入组 7,300 人开始时间: 2025年4月14日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
7,300
试验地点
1
主要终点
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(greater than or equal to 27)and/or high depersonalization(greater than or equal to 10)scores will be considered to have symptoms of burnout.

研究概览

简要总结

Professional burnout among intensive care healthcare professionals is a major concern with implications both at the individual level and at the level of the quality of care delivered to patients. This protocol describes a cluster randomized controlled trial designed to evaluate the effectiveness of an intervention consisting of encouraging healthcare professionals in intensive care to say “hello” to each other. The intervention includes several components aimed at fostering a positive and supportive work environment, including the distribution of Hello campaign posters, email reminders, morning meetings, message boxes and leadership initiatives by the example set by department heads and nursing executives. Finally, a board on which caregivers can exchange messages of sympathy will be available. The trial will involve 146 participating centers affiliated with ESICM, randomly allocated between intervention and control groups. French centers will be part of the study. Each center must include on average 50 (between 25 and 100) health professionals (doctors, nurses, caregivers, physiotherapists, psychologists, dietitians, etc.). The professional burnout score (MBI) will be collected one month before and one month after the intervention. Data on caregiver satisfaction, professionals’ intention to leave intensive care and perceptions of the ethical climate will also be collected. No patient or family data will be collected. The statistical analysis will compare the results between the 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 statistical power by 90%. This trial has the potential to provide valuable information on effective strategies to prevent burnout in intensive care, ultimately benefiting both healthcare professionals and patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Consenting ICUs participating in the Hello trial, each including 50 Healthcare Providers.

排除标准

  • Non consenting participant ICUs with less than 50 healthcare providers.

结局指标

主要结局

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(greater than or equal to 27)and/or high depersonalization(greater than or equal to 10)scores will be considered to have symptoms of burnout.

时间窗: Baseline 4 weeks

次要结局

  • satisfaction with work, HCPs intent to leave the ICU, & ethical climate rank.(4 weeks)

研究者

发起方
Elie Azoulay
申办方类型
Other [n/a]
责任方
Principal Investigator
主要研究者

Dr Ashish Bindra

AIIMS, NEW DELHI

研究点 (1)

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