| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- 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
- 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.
- 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. |