| CTRI Number |
CTRI/2024/01/061304 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Emergency Care: A Study on Patient-Focused Services in Indias Selected Districts |
|
Scientific Title of Study
|
An implementation research study on developing a high quality patient-centric integrated model for emergency care system in selected districts of India |
| Trial Acronym |
INDIA-EMS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person Scientific Query
|
| Name |
Dr Meenakshi Sharma |
| Designation |
Scientist G |
| Affiliation |
Indian Council of Medical Research |
| Address |
1st Floor,Division of NCD
Indian Council of Medical Research
Ansari Nagar, New Delhi - 110029
New Delhi DELHI 110029 India |
| Phone |
9810376304 |
| Fax |
|
| Email |
smeenakshi@hotmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Meenakshi Sharma |
| Designation |
Scientist-G |
| Affiliation |
Indian Council of Medical Research |
| Address |
1st Floor,Division of NCD
Indian Council of Medical Research
Ansari Nagar, New Delhi - 110029
DELHI 110029 India |
| Phone |
9810376304 |
| Fax |
|
| Email |
smeenakshi@hotmail.com |
|
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Source of Monetary or Material Support
|
| Indian Council of Medical Research,V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
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Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
|
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Saigal |
All India Institute of Medical Sciences Bhopal |
Third floor,Medical ICU,
Department of Anesthesiology & Critical Care, Saket Nagar, Bhopal - 462020 Vidisha MADHYA PRADESH |
9425301181
saurabh.criticalcare@aiimsbhopal.edu.in |
| Dr Arvind Kumar Singh |
All India Institute of Medical Sciences Bhubaneswar |
Room No. 320 Level 3. Academic Block.Department Of Community Medicine and Family Medicine, Sijua. District Khordha. 751019
Khordha ORISSA |
9438884016
arvind28aug@gmail.com |
| Dr Jeyaraj Durai Pandian |
Christian Medical College |
Ground floor office
Department of Neurology
Brown Road Ludhiana Ludhiana PUNJAB |
9915784750
jeyarajpandian@hotmail.com |
| Dr Manu Ayyan |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
First Floor
EMS Office
EMSD Building
Dhanvantri Nagar
Puducherry
Pondicherry PONDICHERRY |
9846556133
manuayyan@hotmail.com |
| Dr Shreyas Patel |
Parul Institute of Medical Sciences and Research |
315
Third floor
Faculty of medicine
Parul university
PO Limba
Tal. Waghodia Vadodara Vadodara GUJARAT |
8980808273
shreyas384@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institute Ethics committee Aiims Bhubaneswar |
Approved |
| Institutional Ethics Committe for observational studies |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Human Ethics Committee |
Approved |
| Parul University Institutional Ethics Committee for human research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: I63||Cerebral infarction, (3) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (4) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (5) ICD-10 Condition: I21||Acute myocardial infarction, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients: Individuals who have experienced an emergency condition. within the study geography during the study period and have visited a health facility
2.Community or households, caregivers
3.Community representatives: Local political leaders (including Panchayats and Block Development Officers), village self-help groups
4.Potential first responders: Road safety authority (including traffic police), Ambulance drivers and paramedics community groups, Taxi and auto drivers, shopkeepers, bystanders, family members etc.
5.Health care providers and managers: The study participants include staff and administration of health facilities, including private sector
6.Policy makers: Health policy makers and health system management involved in the management and decision-making processes of the emergency care system eg. Secretary Health, Mission Director- National Health Mission, Directorate of health services, public health and medical education, nodal officer trauma and emergency care, any other key personnel as identified by the State), National Health Authority, regulators, and legal advisors
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| ExclusionCriteria |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1.To develop an implementation model for high-quality patient-centric integrated emergency care through iterative processes.
2.To evaluate the optimized model through iterative cycle’s in terms of coverage, implementation, costing, and impact on outcomes across six districts, with the aim of achieving 80% population coverage.
|
1.9 months
2.11months,12 months,23 months,24 months,29 months,20 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To conduct a situational analysis to understand the current state of emergency care systems in the study geography,with the aim of identifying potential barriers and facilitators and to identify the ability of the existing system to integrate emergency care.
|
4months,5months,6 months
|
| 2.To disseminate the research findings and best practices at the national level and assist the state in scaling up the optimized model. |
34months,35 months,36 months |
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Target Sample Size
|
Total Sample Size="30451" Sample Size from India="30451"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
01/02/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The current emergency care system in India suffers from severe fragmentation, leading to gaps in the delivery of care.NITI Aayog, recently unveiled two detailed reports assessing the nation’s secondary and tertiary healthcare, as well as district-level emergency and injury care. The evaluations revealed significant disparities in care delivery, attributed to gaps in prehospital emergency medicine (ambulance) services, healthcare infrastructure, workforce, and medical provisions. The findings indicated that emergency and injury cases comprised 36% of annual hospital admissions.. However, research on emergency care systems in India remains sparse, leaving policy-makers and planners with limited guidance for resource allocation and program development. To develop and successfully implement an integrated emergency care system, it is imperative to take into consideration the current state of emergency care, identify gaps in the system, and assess the scope for improvement.
India’s emergency care system, while evolving, still confronts several challenges. Notable progress has been made in recent years, but considerable obstacles persist. These range from limited community access and inadequate infrastructure to poor coordination between health facilities, personnel shortages,lack of public awareness, scarcity of training resources and a disjointed continuum of care. This spans from on scene care ,prehospital care , primary care facilities, all the way to tertiary care hospitals. Additionally, there’s a notable absence of robust public-private partnerships, leading to inefficiencies, delays in care, and subpar patient outcomes. Timely access is paramount for an effective emergency care system, as it can drastically reduce fatalities and long-term disabilities arising from emergency situations. However, in the current landscape, a majority of emergency services in India are restricted predominantly to the tertiary level, leaving prehospital, primary, and secondary care systems with limited capabilities and accessibility. This misalignment greatly impacts health outcomes. To address these gaps, there’s an urgent need to develop a district-based, high-quality, integrated, patient-centric emergency care system model in India. The proposed model aims to manage time-sensitive emergencies more adeptly by creating a seamless continuum of services. These services would span different healthcare facilities and would be interconnected through effective communication, transportation, and both referral and counter-referral systems. As of now, large-scale implementation research, using an integrated approach to develop a scalable patient-centric emergency care system, remains sparse in India
This will be a muti-district implementation research conducted along with the State health department with a concurrent mixed methods design. The study will be conducted to develop and implement a high-quality emergency care system with a focus on following time-sensitive emergencies: a)Trauma and Burns b) ST-Elevated Myocardial Infarction (STEMI) c) Stroke d) Acute Respiratory Illness e) Postpartum Hemorrhage and Preeclampsia â— Neonatal Emergencies â— Snake Bite and Poisoning.
The study will start with formative research which will identify gaps and help in developing the initial model (M0) of integrated emergency. The model will be optimized using qualitative research and outcome indicators through three iterative cycles of 3 months each, implementing it through a single selected hub and spoke cluster designed as a continuum of care pathway that spans from the community, through prehospital, to various levels of care. The final high-quality integrated emergency care model will be scaled up to the entire district in consultation with the State government and its impact on population coverage will be evaluated |