| 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
|
|
|
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
|
|
|
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.
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