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CTRI Number  CTRI/2024/05/067678 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study To Assess The Quality and Safety Of Care Provided To Patients Admitted In The Paediatric Intensive Care Unit of Paediatric Oncology Services with an Aim To Develop a Paediatric Oncology Intensive Care Services Quality Assurance Programme. 
Scientific Title of Study   Road Map to Quality Assurance in The Paediatric Intensive Care Unit Services of Paediatric Oncology. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avinash Thumallapalli 
Designation  Senior Medical Officer 
Affiliation  Kidwai Memorial Institute of Oncology 
Address  Department of Paediatric Oncology, First Floor, Infosys OPD Building, Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road,Bengaluru.

Bangalore
KARNATAKA
560029
India 
Phone  9482217391  
Fax    
Email  t.avinash@ka.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Avinash Thumallapalli 
Designation  Senior Medical Officer 
Affiliation  Kidwai Memorial Institute of Oncology 
Address  Department of Paediatric Oncology, First Floor, Infosys OPD Building, Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road,Bengaluru.

Bangalore
KARNATAKA
560029
India 
Phone  9482217391  
Fax    
Email  t.avinash@ka.gov.in  
 
Details of Contact Person
Public Query
 
Name  Avinash Thumallapalli 
Designation  Senior Medical Officer 
Affiliation  Kidwai Memorial Institute of Oncology 
Address  Department of Paediatric Oncology, First Floor, Infosys OPD Building, Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road,Bengaluru.

Bangalore
KARNATAKA
560029
India 
Phone  9482217391  
Fax    
Email  t.avinash@ka.gov.in  
 
Source of Monetary or Material Support  
Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road, Bengaluru-560029. 
 
Primary Sponsor  
Name  Kidwai Memorial Institute of Oncology 
Address  Office of The Chief Adminstrative Officer, Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road, Bengaluru, 560029. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arun Kumar  Kidwai Memorial Institute of Oncology, Bengakuru.  Room No 2, Paediatric Intensive Care Unit, Department of Paediatric Oncology, Ground Floor, Kapur SBM Paediatric Block, Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road, Bengaluru, 560029.
Bangalore
KARNATAKA 
9740612324

dr.arun123@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kidwai Memorial Institute of Oncology -IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z129||Encounter for screening for malignant neoplasm, site unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL as this is an Observational study  NIL as this is an Observational study 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children Admitted In Paediatric Intensive Care Unit of Department of Paediatric Oncology, Kidwai Memorial Institute of Oncology with Diagnosed Cancer. 
 
ExclusionCriteria 
Details  Children Diagnosed To Have No Cancer. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify Concerns for poit of care quality improvement through well designed quality imrovement projects.  Baseline, 4 weeks, 8 Weeks and 12 Weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To Identify & formulate aPaediatric Intensive Care Unit, Paediatric Oncology, Kidwai Memorial Institute of Oncology Specific Safety & Quality Indicators.  Baseline, 4 Weeks, 8 Weeks, 12 Weeks 16 Weeks, 20 Weeks & 24 Weeks. 
To compile the Quality Improvement Manual for the Paediatric Intensive CareUnit, Paediatric Oncology, Kidwai Memorial Institute of Oncology, Kidwai Memorial Institute Of Oncology which IncludesStandard Operating Procedures, Guidelines, Policies, Forms & Formats.  Baseline, 4 Weeks, 8 Weeks, 12 Weeks, 16 Weeks, 20 Weeks, 24 Weeks 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   31/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Paediatric Oncology Services have grown exponentially in India in the last decade. The country has been witnessing transformative steps towards Quality in all the Domains including the Healthcare Sector. It is prudent that there is a Quality Assurance Programme developed at all Points of Care in the Public Health Facilities. The Pillar 4 Evaluation and monitoring with information systems to improve outcomes of The WHO Global Initiative for Childhood Cancers publication CureAll Framework emphasises the need for capturing Quality indicators to monitor the quality of care at the Institutional, Regional, and National levels. Objectifiable and well-measurable quality criteria are necessary for direct information about the quality of care delivered to children with cancers in healthcare settings.  Hence the time is now ripe to develop Institutional and National Quality criteria in Paediatric Oncology.  Hence, this study titled Road Map To  Quality Assurance Programme in Paediatric Intensive Care Unit, Department of Paediatric Oncology Kidwai Memorial Institute of Oncology Bengalur  is envisaged as the First Step to achieve the above-mentioned Objective. There are very few Studies conducted about assessing the Health Care Quality and Patient Safety in The Paediatric Oncology Intensive Care Units. This Study aims to Continually Measure Quality Indicators and Develop the Quality Assurance Program for the Paediatric Intensive Care Unit of the Department of Paediatric Oncology, Kidwai Memorial Institute of Oncology, Bengaluru with the Objectives of Identifying Concerns for Point-of Care Quality Improvement through well-designed Quality Improvement Projects, To Identify and formulate a Paediatric  Oncologys Intensive Care Units specific Safety and Quality Indicators  and To compile the Quality Improvement Manual for the Paediatric Oncologys Intensive Care Unit. The National Health Systems Resource Centres NHSRC National Quality Assurance Standards NQAS checklists as applicable to Intensive Care Units and the National Accreditation Board For Hospitals and Healthcare Providers NABH 5Th Edition Hospital Accreditation Checklist would be used to assess the Current Status of Health Care Quality & Patient Safety. The NABH and NQAS Quality Indicators would be used to capture Outcome Indicators and formulate Paediatric Oncology Intensive Care Unit Specific Quality Indicators. The A3 Methodology would be implemented to Perform a Quality Improvement Project. The End Objective is to Evolve a Paediatric Oncology Intensive Care Unit Quality Assurance Programme which could be a precursor for a Paediatric Oncology Health Care Quality Assurance Programme.

 
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