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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    
Fax    
Email    
 
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  
 
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  
 
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 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
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
 
 
ExclusionCriteria 
Details  ..Nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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 
 
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 
 
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" 
Phase of Trial   N/A 
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 
Estimated Duration of Trial   Years="3"
Months="0"
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  


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

● Neonatal Emergencies

● 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

 
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