| CTRI Number |
CTRI/2024/05/067765 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [use of MEWS as assessment scale to identify the patient at risk of deterioration] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An experimental study to see the effectiveness of Modified early warning score on selected patient outcomes in emergency department of hospital |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of Modified Early Warning score in terms of selected patient outcomes among adult patients admitted in emergency department of Safdarjung Hospital, New Delhi a randomized control trial |
| 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 Arin Choudhury |
| Designation |
HOD, Department of Emergency Medicine |
| Affiliation |
VMMC And Safdarjung Hospital |
| Address |
room no- 12 , CMO office,
department of emergency medicine
Safdarjung hospital
South
DELHI
110029
India |
| Phone |
7838756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tapasi Mandal |
| Designation |
M.Sc Nursing |
| Affiliation |
Rajkumari Amrit Kaur College of Nursing |
| Address |
Room no -15, Department of Critical Care Nursing,
Ground Floor
Rajkumari Amrit Kaur College of Nursing
Lajpat Nagar-IV
New Delhi-24
South
DELHI
110024
India |
| Phone |
9531754533 |
| Fax |
|
| Email |
tapasimandal91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tapasi Mandal |
| Designation |
M.Sc Nursing |
| Affiliation |
Rajkumari Amrit Kaur College of Nursing |
| Address |
Room no-15,
Department of Critical Care Nursing,
Ground floor
Rajkumari Amrit Kaur College of Nursing
Lajpat Nagar-IV
New Delhi-24
South
DELHI
110024
India |
| Phone |
9531754533 |
| Fax |
|
| Email |
tapasimandal91@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital
NEW DELHI -110029 |
|
|
Primary Sponsor
|
| Name |
Dr Sujata Chaudhury Prof Head Department of Anaesthesia |
| Address |
New Emergency Block
VMMC and Safdarjung hospital, Ansari Nagar, Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Tapasi Mandal |
VMMC AND SAFDARJUNG HOSPITAL, NEW DELHI |
Emergency Department , New Emergency Building
VMMC and Safdarjung Hospital, New Delhi-29 , India
South
DELHI |
9531754533
tapasimandal91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi- 110029Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z038||Encounter for observation for other suspected diseases and conditions ruled out, (2) ICD-10 Condition: Z139||Encounter for screening, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
By using MEWS score scale, the patient will be assessed in experimental group |
In experimental group MEWS score will be assessed and according to the score in emergency department, alarm will be raised followed by intervention will be given
followed by patients outcomes in terms of length of stay in emergency department, patient shifted to ICU/HDU/WARD, total length of stay in hospital, total discharge rate and total mortality follow up till 15 days from the admission |
| Comparator Agent |
Control Arm |
Routine care at emergency which the control group will be getting, and followed by which the patient outcomes in terms of length of stay in emergency department, patient shifted to ICU/HDU/WARD will be seen, total length of stay in hospital, total discharge and total death till 15 days from the date of admission |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patient coming to emergency department
with medical emergency condition and willing to participate |
|
| ExclusionCriteria |
| Details |
Trauma and surgical condition
and brought death patient |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shifting to ICU/HDU with MEWS score more than 3 and patient will be followed up till 15 days from the day of admission |
Patient will be assessed based on the MEWS score
if the score is 0-1 then 12 hourly MEWS Scoring will be done, if scores between 2-3 every 4th hourly assessment
if the score is 4-5 then every hourly assessment and if the scoring is more than5 ,every 15 minute the assessment will be done and followed by which alarm raised and intervention will be given
If patient is shifted from the emergency department in any other ward or ICU/HDU the patient will be followed till 15 days from the admission. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of stay at hospital, Rate of death, discharge |
15 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patient safety in healthcare is one of the cornerstones of quality of care. Within the emergency department (ED) the inherent nature of the place, where errors and safety issues are liable to occur. The Modified Early Warning Score (MEWS) was introduced as a structured method to detect early indicators of clinical decline. The purpose of this study is to evaluate the effectiveness of modified early warning scores in various patient-related outcomes. However, the implementation of MEWS in the emergency department remains variable, and its effectiveness in this specific context requires further investigation. Therefore, this randomized control trial study seeks to contribute to the existing body of literature by evaluating the impact of MEWS implementation on patient outcomes in the emergency department. |