| 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
|
|
|
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
|
|
|
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. |