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CTRI Number  CTRI/2024/11/076361 [Registered on: 07/11/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [intervention for fostering a positive and supportive work environment]  
Study Design  Cluster Randomized Trial 
Public Title of Study   An international study to evaluate the effect of Hello Bundle- an intervention aimed to provide positive and supportive work culture in reducing the stress among doctors and nurses working in ICU  
Scientific Title of Study   A Cluster Randomized Controlled Trial Evaluating the Effectiveness of the Hello Bundle Intervention in Reducing Burnout among ICU Healthcare Professionals 
Trial Acronym  Hello Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4526 V No 1.0(TMH) Dated 3 June 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical Care and Pain, second floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel,

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical Care and Pain, second floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel,


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical Care and Pain, second floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel,


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  European Society of Intensive Care Medicine 
Address  Rue Belliard, 19 B-1040 Brussels Belgium  
Type of Sponsor  Other [Society ] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     France
India
Italy
Norway
Saudi Arabia
Spain
United Kingdom  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vignesh  Apollo Hospital  Door29, Plot-1997 J Block, 13th Main Road Annanagar, Chennai, Tamil Nadu 600040
Chennai
TAMIL NADU 
04443502252

vignesh@icuconsultants.com 
Dr Sukhyanti Kerai  Maulana Azad Medical College  Department of Anaesthesiology and Intensive Care, First floor, block A, Ward 9, Lok Nayak G.B. Pant Insititute of Postgraduate Medical Education and Reserach Hospital, Guru Nanak Eye CEntre New Delhi 110002
New Delhi
DELHI 
996852722

drsukhi25@gmail.com 
Dr Anant Vikram Pachisia  Medanta The Medicinty  Sector-38 Gurgaon, Haryana-122001
Gurgaon
HARYANA 
9813125253

Anant.Pachisia@medanta.org 
Dr Sheila Myatra  Tata Memorial Hospital  MB101 and MB201, Main Building, first and Second floor, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Apollo Hospital, Chennai  Submittted/Under Review 
Dr B L Kapur Institutional Ethics Committee  Approved 
Maulana Azad Medical College, New Delhi  Approved 
Medanta Medicity IEC  Approved 
Tata Memorial Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All doctors and nurses working in the Intensive care unit 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Intensive care units without Hello Bundle interventions. The intensive care unit will continue to function as usual and will not receive any intervention.  
Intervention  Hello Bundle  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. The "Hello Bundle" intervention will be implemented in intervention group centers over a period of 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. ESICM affiliates Intensive Care Unit
2 healthcare professionals doctors and nurses working in intensive care
 
 
ExclusionCriteria 
Details  1.consent refusal
2. under 18 years of age healthcare professionals
3. healthcare professionals not working in intensive care. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
prevalence of burn out as defined by a high emotional exhaustion (score, ≥27) and/or high depersonalization (score, ≥10).   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Individual components of the Maslach Burn Out Inventory and VAS, as well as HCP’s intent to leave the ICU and ethical climate  30 days 
satisfaction with work, HCP’s intent to leave the ICU, and ethical climate rank.
 
30 days 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  data will be collected through personalised online survey link made thorugh Redcap software by the coordinating centre

  6. For how long will this data be available start date provided 01-10-2024 and end date provided 31-03-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The "Hello Trial" is an international prospective Cluster Randomized Controlled study led by proposed by VITAL group of the European Society of Intensive Care Medicine (ESICM). The trial aims to assess the effectiveness of the "Hello Bundle" intervention in reducing burnout among healthcare professionals in ICUs. The study emphasizes the importance of effective communication, teamwork, and a supportive ethical climate in reducing burnout. The intervention has a 30-day implementation period and adherence support.

Intervention: The "Hello Bundle" intervention includes several components:

·         Hello Campaign Posters: Colorful and engaging posters displaying the word "Hello" will be placed in visible areas around the ICU workstations and break rooms

·         Email Reminders: Participants will receive a friendly email focusing importance of cultivating a supportive and positive work environment. It will encourages all ICU staff to greet each other with a simple "Hello" or a smile during their shifts

·         Morning Huddles: It will encourage everyone to take a moment during team morning huddles or shift change meetings to greet with "hello" ritual

·         Hello Jar: A jar or container will be placed near the nurses’ station, inviting staff to

·         write short, positive messages or compliments for their colleagues which will be read a loud at weekends.

·         Lead by Example Leaders/ consultants are encouraged to set a positive tone by greeting their colleagues with a warm "Hello" and a smile. Their positive attitude and friendly demeanor can serve as a model for others to follow.

·         Hello Board: Updated daily with greetings and positive messages.

Participants and Recruitment: The study will involve 146 ICUs affiliated with the European Society of Intensive Care Medicine (ESICM). Each ICU must have at least 50 HCPs participating. Recruitment will be facilitated through the ESICM mailing list, with reminders sent to encourage participation. We will enroll all Health care professionals-Doctors and Nurses- working in both first floor and second floor ICU at Tata Memorial Hospital. Also HCPs working in ACTREC will be enroll as a separate site.

Data will be collected before and after the intervention period. Additional data on intervention fidelity and adherence will also be gathered. Data will be directly collected from the Health care Professionals enrolled in the study through online survey forms. Data will be collected at baseline, during the intervention, and at follow-up, focusing on burnout prevalence, satisfaction with care, HCPs’ intent to leave the ICU, and perceptions of the ethical climate. The trial will use the Maslach Burnout Inventory (MBI) to measure burnout and visual analogue scales (VAS) for other outcomes, Results of burnout survey will not be share with the site principal investigators. Confidentiality will be ensured, and no sensitive data will be collected.

Results will be shared through scientific publications and conference presentations to encourage the adoption of effective interventions for addressing burnout in ICUs.

 
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