| CTRI Number |
CTRI/2024/01/061092 [Registered on: 03/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
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Public Title of Study
|
Effectiveness of Modified Early Warning Score (MEWS) on Patients Outcome and Barriers related to its use by Nursing Officers in Medicine Ward, AIIMS, New Delhi. |
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Scientific Title of Study
|
To assess the effectiveness of Modified Early Warning Score (MEWS) on Patients Outcome and Barriers related to its use by Nursing Officers in Medicine Ward, AIIMS, New Delhi. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKRITI CHAUDHARY |
| Designation |
M.Sc Critical Care Nursing |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing
AIIMS, New Delhi
Central DELHI 110029 India |
| Phone |
6398346911 |
| Fax |
|
| Email |
akritichaudhary0904@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Milan Tirwa |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing
AIIMS, New Delhi
Central DELHI 110029 India |
| Phone |
9999253321 |
| Fax |
|
| Email |
tirwamilan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
AKRITI CHAUDHARY |
| Designation |
M.Sc Critical Care Nursing |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing
AIIMS, New Delhi
Central DELHI 110029 India |
| Phone |
6398346911 |
| Fax |
|
| Email |
akritichaudhary0904@gmail.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
College of Nursing, AIIMS , New Delhi |
| Address |
College of Nursing
AIIMS, New Delhi
PIN Code-110029 |
| Type of Sponsor |
Research institution and hospital |
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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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AKRITI CHAUDHARY |
AIIMS, NEW DELHI |
MEDICINE WARD (C2 AND D2 Ward) South DELHI |
6398346911
akritichaudhary0904@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
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: Z00-Z99||Factors influencing health status and contact with health services, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implementation of Modified Early Warning Score (MEWS) in experimental group. |
Nursing Officers in the C2 Medicine Ward will do the implementation of Modified Early Warning Score (MEWS) based on physiological vital parameters of the patients such as Respiratory rate ,Heart rate , Systolic BP , Level of consciousness, Temperature, SpO2 , Urine output they will calculate total MEWS Score and will then triage the patient as either green if the total MEWS score is between 0-1 , yellow if the total MEWS score is between 2-4, Orange if the total MEWS score is between 5-6, red if the total MEWS score is ≥7. Based on the total MEWS score of the patient the frequency of monitoring of the vital parameters will also change.If the MEWS score is increasing then the frequency of monitoring of vital parameters will also increase and the nursing officer will inform the physician to take the necessary action according to the total MEWS score. Physician will review the patient within 30 minutes and will give the necessary intervention. The monitoring and calculation of MEWS will continue until the total MEWS score get decreased. The MEWS monitoring will start from the time of admission of the Patient in to the C2 Ward and will continue till the Discharge or Death of the patient. |
| Comparator Agent |
Standard Monitoring of Vital signs of the patient with no calculation of MEWS score. |
Nursing officer in D2 ward will do the routine Monitoring of Vital parameters of the patient such as of respiratory rate, heart rate, Systolic BP , Level of consciousness , Temperature , SpO2 , Urine output but will not implement the Modified Early Warning Score and will not calculate any score. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients age> 18 years are enrolled in the study. |
|
| ExclusionCriteria |
| Details |
patients who do not agree to give the consent.
patients who are on ventilator.
patients who died within 24 hours after recruitment to the study. |
|
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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
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the effect of Modified Early Warning Score (MEWS) on Patients Outcome in Experimental and Control group.
To identify the barriers related to implementation and use of Modified Early Warning Score (MEWS) by Nursing Officers in Medicine Ward of AIIMS, New Delhi. |
The effect of implementation of Modified Early Warning Score(MEWS) on Patients outcome will be assessed from the time of admission to the ward till the occurrence of any adverse outcome or till discharge of the patient from the ward.
Barriers faced by nursing officers will be assessed at the end of the study. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of patients outcome with selected demographic variables of the patient. |
It will be determined after data collection. |
|
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Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
09/01/2024 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Researcher is conducting a research study to assess the effectiveness of Modified Early Warning Score (MEWS) assessment on patient’s outcome and barriers that are faced by nursing officers during implementation of MEWS in Medicine Ward of AIIMS New Delhi.Early detection of clinically unstable patients is the cornerstone in improving the patient’s outcome that require a series of steps, including vital signs documentation and interpretation, subsequent meaningful communication, timely and appropriate management.(14) Implementation and use of MEWS Scale will help nurses identify the subtle signs of early deterioration of the patient and make the proper clinical decisions to prevent complications. It will also improve the patient’s outcome, adds to the knowledge of the nurses in early recognition and development of interprofessional relationship. Nurses are the frontline healthcare workers taking care of the patients using a standard nursing process. They need to be competent and efficient enough to assess the signs of early deterioration of the patient to prevent further complications. Failure of the nurses in identifying the deteriorated patient and providing the early intervention can lead to severity of illness that can result in worsening morbidity and mortality. MEWS Scale is not being implemented in the current setting and hence the Nurses are not able to recognize sign of deterioration with the help of MEWS Scale and it places the patient at risk of developing uneventful conditions that can lead to death. Therefore, the goal of this study is to make nurses more efficient and competent in implementation and use of MEWS Scale in recognizing the early signs of patient’s deterioration. It will also help in determining the effectiveness of MEWS on patient’s outcome, providing early treatment and preventing untoward events as cardiac arrest, shock, intubations, mortality. Researcher intend to increase the nurses knowledge to effectively use and implement MEWS to prevent patients from developing complications by early recognization of changing vital parameters. It will also benefit the patients by decrease adverse events and mortality. |