FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074887 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational trial 
Study Design  Other 
Public Title of Study   A clinical trial to evaluate the impact of following standardized order sets on the outcomes of patients with Acute Ischemic Stroke 
Scientific Title of Study   Impact of order sets on outcome of acute ischemic stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarang Dilip Videkar 
Designation  DM Scholar 
Affiliation  Jawaharlal Nehru medical college,Wardha,Maharashtra,Pincode 442107 
Address  Room no.304.Laxmi Hostel,Jawaharlal Nehru medical college and Acharaya Vinoba Bhave Rural hospital,Datta Meghe institute of higher education and research ,Sawangi (Meghe),Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  8446644025  
Fax    
Email  videkarsarang89@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Tushar Patil 
Designation  Professor 
Affiliation  Jawaharlal Nehru medical college,Wardha,Maharashtra,Pincode 442107 
Address  Prof.and Head of Department,Neurology,Jawaharlal Nehru medical college and Acharaya Vinoba Bhave Rural hospital,Datta Meghe institute of higher education and research ,Sawangi (Meghe),Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  9021810293  
Fax    
Email  tushar.neuro@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sarang Dilip Videkar 
Designation  DM Scholar 
Affiliation  Jawaharlal Nehru medical college,Wardha,Maharashtra,Pincode 442107 
Address  Room no.304.Laxmi Hostel,Jawaharlal Nehru medical college and Acharaya Vinoba Bhave Rural hospital,Datta Meghe institute of higher education and research ,Sawangi (Meghe),Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  8446644025  
Fax    
Email  videkarsarang89@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru medical college and Acharaya Vinoba Bhave Rural hospital,Datta Meghe institute of higher education and research,Sawangi (Meghe),Wardha,Maharashtra,India,pin code 442107 
 
Primary Sponsor  
Name  Dr Sarang Dilip Videkar 
Address  Room No.304,Laxmi hostel,Jawaharlal Nehru medical college and Acharaya Vinoba Bhave Rural hospital,Datta Meghe institute of higher education and research ,Sawangi (Meghe),Wardha,Maharashtra,India,Pin Code 442107 
Type of Sponsor  Other [SELF] 
 
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 Sarang Dilip Videkar  Acharaya Vinoba Bhave Rural hospital,,Sawangi (Meghe),Wardha  Room No.1,Department Of Neurosciences,Division-Neurology
Wardha
MAHARASHTRA 
8446644025

videkarsarang89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Jawaharlal Nehru medical college,Datta Meghe institute of higher education and research ,Sawangi (Meghe),Wardha,Pin Code 442107  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Patients aged 18 years and above.
2)Diagnosed with acute ischemic stroke confirmed by Neuro-imaging (CT or MRI).
3)Patients admitted under Neurology department of the hospital.
 
 
ExclusionCriteria 
Details  1)Patients with hemorrhagic stroke.
2)Patients with transient ischemic attack (TIA).
3)Patients or families who decline participation in the study.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the effect of standardized order sets on the functional outcomes of patients with acute ischemic stroke, measured by the modified Rankin Scale (mRS) at discharge.
 
Measured by the modified Rankin Scale(mRS)scores at discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
Impact on outcome of thrombolysis  Time from patient arrival at the emergency department to the administration of thrombolytic therapy 
The length of hospital stay for patients with acute ischemic stroke.  Total days of hospital stay 
In-hospital mortality rates among patients with acute ischemic stroke.  Total days of hospital stay. 
Overall adherence to stroke management guidelines before & after the implementation of standardized order sets.  Total days of hospital stay 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   18/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality globally, accounting for a significant portion of the overall stroke burden. In India, stroke incidence is increasing, with a substantial impact on the rural population due to limited access to specialized stroke care facilities. Timely and effective management of acute ischemic stroke is crucial in reducing the associated disability and death rates.

Standardized order sets, which are pre-defined templates that guide clinical decision-making and treatment protocols, have been shown to improve the quality of care in various medical conditions, including stroke. These order sets can streamline the management process, ensuring that critical interventions such as thrombolysis are administered promptly and that care adheres to evidence-based guidelines.

The implementation of order sets for stroke management has demonstrated positive outcomes in several studies conducted in high-resource settings. The American Stroke Association recommends the use of standardized order sets to enhance the efficiency and effectiveness of acute stroke treatment. However, there is a paucity of data on the impact of such interventions in resource-limited settings, particularly in rural India.

In rural tertiary care hospitals in India, the challenge is compounded by factors such as delayed patient presentation, inadequate infrastructure, and lack of trained personnel. These challenges often result in sub-optimal stroke care and poorer outcomes. Therefore, introducing standardized order sets in such settings could potentially bridge the gap in stroke management quality and improve patient outcomes.

This study aims to evaluate the impact of implementing standardized order sets on the outcomes of patients with acute ischemic stroke in a tertiary care rural hospital in India. By examining key metrics such as functional outcomes, time to critical interventions, length of hospital stays, and in-hospital mortality, this research seeks to provide evidence for the effectiveness of order sets in improving stroke care in a resource-limited environment.

_ 
Close