Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453616
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-18
Brief Title:
Evaluating the Effectiveness of the Hello Bundle Intervention in Reducing Burnout Among ICU Healthcare Professionals
Sponsor:
European Society of Intensive Care Medicine
Organization:
European Society of Intensive Care Medicine
Study Overview
Official Title:
Cluster Randomized Controlled Trial Evaluating the Effectiveness of the Hello Bundle Intervention in Reducing Burnout Among ICU Healthcare Professionals
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELLO
Brief 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 professionals 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 03 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 respondents 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 andor 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 symptomlowest rating and 10 the most intense symptomhighest 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 HCPs 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 Fishers exact test
Primary endpoint will be prevalence of burn out as defined by a high emotional exhaustion score 27 andor high depersonalization score 10 Secondary endpoint will include individual components of the Maslach Burn Out Inventory and VAS as well as HCPs 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 343 available online at httpwwwr-projectorg and packages lme4and lmerTest A p value 005 will be considered significant
Sample size
Assuming an intra-class correlation of 03 146 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
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 respondents 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 andor 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 symptomlowest rating and 10 the most intense symptomhighest 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 HCPs 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 Fishers exact test
Primary endpoint will be prevalence of burn out as defined by a high emotional exhaustion score 27 andor high depersonalization score 10 Secondary endpoint will include individual components of the Maslach Burn Out Inventory and VAS as well as HCPs 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 343 available online at httpwwwr-projectorg and packages lme4and lmerTest A p value 005 will be considered significant
Sample size
Assuming an intra-class correlation of 03 146 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None